Diabetes Mellitus, Type 1NCT04089462

Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study

A study testing "Five sessions per period" - "Two sessions per period" and "Two sessions per period" - "Five sessions per period" in people with Diabetes Mellitus, Type 1 and Insulin Hypoglycemia, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Diabetes Mellitus, Type 1, Insulin Hypoglycemia
What is being tested?: "Five sessions per period" - "Two sessions per period" and "Two sessions per period" - "Five sessions per period"
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteDenmark
Study dates: 30 Sep 2019to 1 Jan 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Type 1 Diabetes ≥ 2 year
Insulin pump ≥ 1 year.
Use of carbohydrate counting and the insulin pump bolus calculator for all meals

Who cannot join

Use of anti-diabetic medicine (other than insulin), per oral or injected corticosteroids or other drugs affecting glucose metabolism during the intervention period or within 30 days prior to study start
Known or suspected alcohol or drug abuse
Other concomitant medical or psychological condition that according to the investigator's assessment makes the participant unsuitable for study participation
Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
Inability to understand the participants' information and to give informed consent
Chronic use or unable to stop acetaminophen (paracetamol) use

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Allergy to the patch of CGM
Hypoglycemia unawareness, quantified by Pedersen-Bjergaard
Severe hypoglycemia within the last year
Vigorous-intensity exercise for more than 60 minutes on 3 days or more per week

Trial locations and contacts

1 site in 1 country.

Denmark1 site

Steno Diabetes Center Copenhagen
Gentofte Municipality, 2820

Other trials in Denmark

About this study

Official title: Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes - A Randomized Crossover Study

According to the Standards of Medical Care in Diabetes by the American Diabetes Association, people with diabetes should aim for 30 minutes of moderate-to-vigorous intensity aerobic exercise at least 5 days a week or a total of 150 minutes per week and doing some type of strength training at least 2 times per week in addition to aerobic activity. However, the effects of different forms and intervals of exercise on glycemic control are not well established. Exercise increases the risk of hypoglycemia both during and several hours after exercise.

There are several strategies to avoid hypoglycemia during exercise. The most common strategy is to reduce insulin and to take carbohydrates before the exercise starts. Short-acting insulin analogs have a duration of approximately four hours, thus reductions need to be planned and done well in advance before the exercise starts. Since different types of exercise (aerobic, strength training or high intensity training) affect blood glucose in different ways and most exercise sessions include a combination of the types, these strategies are often associated with difficulties in obtaining stable blood glucose. The American Diabetes Association guidelines do not explicitly recommend a daily workout routine but outline recommendations for weekly amounts of exercise as there is currently insufficient evidence on the ideal timing, frequency and duration of exercise for preventing hypoglycemia.

Hypothesis: in people with type 1 diabetes, time in hypoglycemia can be reduced if exercise is performed daily over five consecutive days compared to the same total amount of exercise performed at 2 days with at least 2 days interval.

Aim: to evaluate the impact of the same total amount of exercise split into either five consecutive sessions or two sessions with at least 2 days in between on percentage of time spent in hypoglycemia and other glycemic parameters in people with type 1 diabetes.

Read the detailed description

The participants will go through two interventions: Exercise one session per day for five consecutive days and Exercise one session per day for two days within five days. The exercise session will start with anaerobic (push-ups, back-curls, sit-ups, triceps-dips and jumps) exercise followed by aerobic exercise (moderate intensity of running, walking or cycling). Between the two intervention periods, there will be a wash-out period.

Intervention: 'Exercise one session per day for five consecutive days'. Duration per session: Anaerobic: 4 min, Aerobic: 30 min. Sessions per intervention period: Five. Total duration per intervention period: Anaerobic: 20 min. Aerobic: 150 min. Total: 170 min

Intervention:Exercise one session per day for two days within five days. Duration per session: Anaerobe: 10 min, Aerobe: 75 min. Sessions per intervention period: 2. Total duration per intervention period: Anaerob: 20 min Aerobe: 150 min Total: 170 min

Conditions: Diabetes Mellitus, Type 1, Insulin Hypoglycemia
Being tested: "Five sessions per period" - "Two sessions per period", "Two sessions per period" - "Five sessions per period"
Keywords: Exercise, Insulin pump, Diabetes Mellitus, Type 1, Guidelines
Medical subject headings: Diabetes Mellitus, Type 1, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

"Five sessions per period" - "Two sessions per period"Behavioural
Period 1: 5 exercise sessions on 5 consecutive days (4 min anaerobic exercise and 30 min aerobic exercise per session)
Period 2: 2 exercise sessions within a 5-day period (10 min anaerobic exercise and 75 min aerobic exercise per session)
"Two sessions per period" - "Five sessions per period"Behavioural
Period 1: 2 exercise sessions within a 5-day period (10 min anaerobic exercise and 75 min aerobic exercise per session)
Period 2: 5 exercise sessions on 5 consecutive days (4 min anaerobic exercise and 30 min aerobic exercise per session)

Study groups in NCT04089462
Study group	Role	What they receive
1. "Five sessions per period" - "Two sessions per period"	Other	Not described Receives: Behavioral: "Five sessions per period" - "Two sessions per period"
2. "Two sessions per period" - "Five sessions per period"	Other	Not described Receives: Behavioral: "Two sessions per period" - "Five sessions per period"

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l)
Intention-to-treat analysis (ITT).
Measured: The primary intervention period from 06:00h study day 1 - 06:00h study day 6 (ITT)

Secondary outcomes (105)

Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l)
Per protocol analysis (PP)
Measured: Primary intervention period from 06:00h study day 1 - 06:00h study day 6 PP
Percentage of time spent in the alert and clinical hypoglycemic range
Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
Measured: Study day 1: The day when the first exercise session is performed and registered.
Percentage of time spent in the alert and clinical hypoglycemic range
Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is also compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Percentage of time spent in the alert and clinical hypoglycemic range
Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is also compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Percentage of time spent in the alert and clinical hypoglycemic range
Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is also compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
Measured: Day time: 06:00-22:00h from during study day 1 to study day 6.
Percentage of time spent in the alert and clinical hypoglycemic range
Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
Measured: Night time: 22:00-06:00h from during study day 1 to study day 6.
Percentage of time spent in the alert and clinical hypoglycemic range
Level 1 (alert): CGM or SMBG value of 3.0-3.9 mmol/l with or without symptoms. Level 2 (clinical): CGM or SMBG value of < 3.0 mmol/l with or without symptoms. Outcome is compared between the two intervention periods in a per protocol analysis (PP) and intention-to-treat analysis (ITT)
Measured: The time the participant has recorded start and end of exercise session during study day 1 to study day 6
Number of alert and clinical hypoglycemia events
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Number of alert and clinical hypoglycemia events
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Number of alert and clinical hypoglycemia events
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1 - study day 6
Number of alert and clinical hypoglycemia events
Per protocol analysis and intention-to-treat analysis
Measured: Night time: 22:00-06:00h during study day 1 - study day 6
Number of alert and clinical hypoglycemia events
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 study day 6
Number of severe hypoglycemia events during
Per protocol analysis and intention-to-treat analysis
Measured: Study day 1: The day when the first exercise session is performed and registered
Number of severe hypoglycemia events
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Number of severe hypoglycemia events
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Number of severe hypoglycemia events
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1 - study day 6
Number of severe hypoglycemia events
Per protocol analysis and intention-to-treat analysis
Measured: Night time: 22:00-06:00h during study day 1 - study day 6
Number of severe hypoglycemia events
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 - study day 6
Percentage of time in range (3.9-10 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Study day 1: The day when the first exercise session is performed and registered
Percentage of time in range (3.9-10 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Percentage of time in range (3.9-10 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Percentage of time in range (3.9-10 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1-study day 6
Percentage of time in range (3.9-10 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Night time: 22:00-06:00h during study day 1 -study day 6
Percentage of time in range (3.9-10 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Percentage of time in good range (3.9-7.8 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Study day 1: The day when the first exercise session is performed and registered.
Percentage of time in good range (3.9-7.8 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Percentage of time in good range (3.9-7.8 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Percentage of time in good range (3.9-7.8 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h and Night time: 22:00-06:00h during study day 1-study day 6
Percentage of time in good range (3.9-7.8 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1-study day 6
Percentage of time in hyperglycemia (>10 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Study day 1: The day when the first exercise session is performed and registered.
Percentage of time in hyperglycemia (>10 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Percentage of time in hyperglycemia (>10 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1-study day 6
Percentage of time in hyperglycemia (>10 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Night time: 22:00-06:00h during study day 1 -study day 6
Percentage of time in hyperglycemia (>10 mmol/l)
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1-study day 6
Percentage of time in hyperglycemia (>10 mmol/l) during all the predefined time blocks. Per protocol analysis and intention-to-treat analysis
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Study day 1: The day when the first exercise session is performed and registered.
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1-study day 6
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Night time: 22:00-06:00h during study day 1 -study day 6
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Mean CGM glucose level du during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Study day 1: The day when the first exercise session is performed and registered.
Mean CGM glucose level du during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Mean CGM glucose level du during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Mean CGM glucose level du during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1-study day 6
Mean CGM glucose level du during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Night time: 22:00-06:00h during study day 1 -study day 6
Mean CGM glucose level du during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
CGM estimated eA1c during the primary intervention period
Per protocol analysis and intention-to-treat analysis
Measured: The Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Study day 1: The day when the first exercise session is performed and registered.
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1-study day 6
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Night time: 22:00-06:00h during study day 1 -study day 6
Total carbohydrate intake registered from the insulin pumps during all the predefined time blocks in the intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Carbohydrate interventions for prevention and treatment of hypoglycemia registered by the participants in the booklet for the primary and total intervention period
Per protocol analysis and intention-to-treat analysis c) Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Carbohydrate interventions for prevention and treatment of hypoglycemia registered by the participants in the booklet for the primary and total intervention period
Per protocol analysis and intention-to-treat analysis c) Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Change in total daily insulin dose (basal and bolus insulin) of 7 days prior to screening day and during the primary and total intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Change in total daily insulin dose (basal and bolus insulin) of 7 days prior to screening day and during the primary and total intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Actigraph wrist wear time during all predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Actigraph wrist wear time during all predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Actigraph wrist wear time during all predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1-study day 6
Actigraph wrist wear time during all predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Night time: 22:00-06:00h during study day 1 -study day 6
Actigraph wrist wear time during all predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1-study day 6
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Night time: 22:00-06:00h during study day 1 -study day 6
Physical activity energy expenditure (accelerometer and heart rate based) measured as kcal during all predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Metabolic expenditure rate for the primary intervention periods
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Metabolic expenditure rate for the primary intervention periods
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Number of exercise (light to vigorous) and sedentary bouts in the primary intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Number of exercise (light to vigorous) and sedentary bouts in the primary intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Time in sedentary during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Time in sedentary during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Time in sedentary during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1-study day 6
Time in sedentary during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Night time: 22:00-06:00h during study day 1 -study day 6
Time in sedentary during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Time in light physical activity during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Time in light physical activity during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Time in light physical activity during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1-study day 6
Time in light physical activity during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Time in moderate physical activity during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Time in moderate physical activity during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Time in moderate physical activity during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1-study day 6
Time in moderate physical activity during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Time in vigorous physical activity during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Time in vigorous physical activity during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Time in vigorous physical activity during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1-study day 6
Time in vigorous physical activity during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Number of steps during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Number of steps during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Number of steps during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Day time: 06:00-22:00h during study day 1-study day 6
Number of steps during predefined time blocks
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Heart rate during exercise sessions
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
R-R intervals during exercise sessions (f)
Per protocol analysis and intention-to-treat analysis
Measured: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Sleep latency (min) during the primary and total intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Sleep latency (min) during the primary and total intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Total sleep time (min) during the primary and total intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Total sleep time (min) during the primary and total intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Sleep efficiency (%) during the primary and total intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Sleep efficiency (%) during the primary and total intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Number of awakening during sleep in the primary and total intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Number of awakening during sleep in the primary and total intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Time of awakening during sleep in the primary and total intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Time of awakening during sleep in the primary and total intervention period
Per protocol analysis and intention-to-treat analysis
Measured: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days)
Question about patient preference regarding the two study arms
Per protocol analysis and intention-to-treat analysis
Measured: At the end of study. Study day 6 the last interventions period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Sep 20191 Jan 2021

First posted13 Sep 2019
Study start30 Sep 2019
Primary completion15 Oct 2020
Study completion1 Jan 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: An open-labelled randomized controlled crossover study will be performed. The participants will go through the following elements: 1. Screening day 2. Run-in period 3. Intervention period 4. Wash-out period 5. Intervention period
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04089462
Sponsor's protocol ID: H-19035830
Status last verified: Jun 2020
First submitted: 5 Sep 2019
Last updated: 28 Sep 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Data are processed and merged into at least one scientific article published in international peer-reviewed scientific journal. Positive, negative and inconclusive results will be published as soon as scientifically justifiable.

Publications

Steineck IIK, Ranjan AG, Schmidt S, Norgaard K. Time spent in hypoglycemia is comparable when the same amount of exercise is performed 5 or 2 days weekly: a randomized crossover study in people with type 1 diabetes. BMJ Open Diabetes Res Care. 2021 Jan;9(1):e001919. doi: 10.1136/bmjdrc-2020-001919.
PubMed 33509935

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes - A Randomized Crossover Study
ClinicalTrials.gov ID: NCT04089462
Acronym / sponsor ID: H-19035830
Conditions: Diabetes Mellitus, Type 1, Insulin Hypoglycemia
Keywords: Exercise, Insulin pump, Diabetes Mellitus, Type 1, Guidelines
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Steno Diabetes Center CopenhagenUniversity, hospital or other
Study start: 30 Sep 2019 (actual)
Primary completion: 15 Oct 2020 (actual)
Study completion: 1 Jan 2021 (actual)
First posted: 13 Sep 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2
Model description: An open-labelled randomized controlled crossover study will be performed. The participants will go through the following elements: 1. Screening day 2. Run-in period 3. Intervention period 4. Wash-out period 5. Intervention period

Arm	Type	Receives
1. "Five sessions per period" - "Two sessions per period"	Other	Behavioral: "Five sessions per period" - "Two sessions per period"
2. "Two sessions per period" - "Five sessions per period"	Other	Behavioral: "Two sessions per period" - "Five sessions per period"

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Type 1 Diabetes ≥ 2 year
Insulin pump ≥ 1 year.
Use of carbohydrate counting and the insulin pump bolus calculator for all meals

Key exclusion criteria (10 listed)

Use of anti-diabetic medicine (other than insulin), per oral or injected corticosteroids or other drugs affecting glucose metabolism during the intervention period or within 30 days prior to study start
Known or suspected alcohol or drug abuse
Other concomitant medical or psychological condition that according to the investigator's assessment makes the participant unsuitable for study participation
Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
Inability to understand the participants' information and to give informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
"Five sessions per period" - "Two sessions per period"Period 1: 5 exercise sessions on 5 consecutive days (4 min anaerobic exercise and 30 min aerobic exercise per session) Period 2: 2 exercise sessions within a 5-day period (10 min anaerobic exercise and 75 min aerobic exercise per session)	Behavioural	1. "Five sessions per period" - "Two sessions per period"
"Two sessions per period" - "Five sessions per period"Period 1: 2 exercise sessions within a 5-day period (10 min anaerobic exercise and 75 min aerobic exercise per session) Period 2: 5 exercise sessions on 5 consecutive days (4 min anaerobic exercise and 30 min aerobic exercise per session)	Behavioural	2. "Two sessions per period" - "Five sessions per period"

Primary outcome

Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l)
Time frame: The primary intervention period from 06:00h study day 1 - 06:00h study day 6 (ITT)
Intention-to-treat analysis (ITT).

105 secondary outcomes

Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l)
Time frame: Primary intervention period from 06:00h study day 1 - 06:00h study day 6 PP
Percentage of time spent in the alert and clinical hypoglycemic range
Time frame: Study day 1: The day when the first exercise session is performed and registered.
Percentage of time spent in the alert and clinical hypoglycemic range
Time frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Percentage of time spent in the alert and clinical hypoglycemic range
Time frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Percentage of time spent in the alert and clinical hypoglycemic range
Time frame: Day time: 06:00-22:00h from during study day 1 to study day 6.
Percentage of time spent in the alert and clinical hypoglycemic range
Time frame: Night time: 22:00-06:00h from during study day 1 to study day 6.
Percentage of time spent in the alert and clinical hypoglycemic range
Time frame: The time the participant has recorded start and end of exercise session during study day 1 to study day 6
Number of alert and clinical hypoglycemia events
Time frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Number of alert and clinical hypoglycemia events
Time frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Number of alert and clinical hypoglycemia events
Time frame: Day time: 06:00-22:00h during study day 1 - study day 6
Number of alert and clinical hypoglycemia events
Time frame: Night time: 22:00-06:00h during study day 1 - study day 6
Number of alert and clinical hypoglycemia events
Time frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 study day 6
Number of severe hypoglycemia events during
Time frame: Study day 1: The day when the first exercise session is performed and registered
Number of severe hypoglycemia events
Time frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Number of severe hypoglycemia events
Time frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Number of severe hypoglycemia events
Time frame: Day time: 06:00-22:00h during study day 1 - study day 6
Number of severe hypoglycemia events
Time frame: Night time: 22:00-06:00h during study day 1 - study day 6
Number of severe hypoglycemia events
Time frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 - study day 6
Percentage of time in range (3.9-10 mmol/l)
Time frame: Study day 1: The day when the first exercise session is performed and registered
Percentage of time in range (3.9-10 mmol/l)
Time frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Percentage of time in range (3.9-10 mmol/l)
Time frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Percentage of time in range (3.9-10 mmol/l)
Time frame: Day time: 06:00-22:00h during study day 1-study day 6
Percentage of time in range (3.9-10 mmol/l)
Time frame: Night time: 22:00-06:00h during study day 1 -study day 6
Percentage of time in range (3.9-10 mmol/l)
Time frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6
Percentage of time in good range (3.9-7.8 mmol/l)
Time frame: Study day 1: The day when the first exercise session is performed and registered.
Percentage of time in good range (3.9-7.8 mmol/l)
Time frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Percentage of time in good range (3.9-7.8 mmol/l)
Time frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Percentage of time in good range (3.9-7.8 mmol/l)
Time frame: Day time: 06:00-22:00h and Night time: 22:00-06:00h during study day 1-study day 6
Percentage of time in good range (3.9-7.8 mmol/l)
Time frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1-study day 6
Percentage of time in hyperglycemia (>10 mmol/l)
Time frame: Study day 1: The day when the first exercise session is performed and registered.
Percentage of time in hyperglycemia (>10 mmol/l)
Time frame: Secondary intervention period: 08:00h day 1 - 08:00h day 8 (= 7 x 24-hour days).
Percentage of time in hyperglycemia (>10 mmol/l)
Time frame: Day time: 06:00-22:00h during study day 1-study day 6
Percentage of time in hyperglycemia (>10 mmol/l)
Time frame: Night time: 22:00-06:00h during study day 1 -study day 6
Percentage of time in hyperglycemia (>10 mmol/l)
Time frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1-study day 6
Percentage of time in hyperglycemia (>10 mmol/l) during all the predefined time blocks. Per protocol analysis and intention-to-treat analysis
Time frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period
Time frame: Study day 1: The day when the first exercise session is performed and registered.
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period
Time frame: Primary intervention period: 06:00h study day 1 - 06:00h study day 6 (= 5 x 24-hour days)
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period
Time frame: Day time: 06:00-22:00h during study day 1-study day 6
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period
Time frame: Night time: 22:00-06:00h during study day 1 -study day 6
Glycemic variability measured as standard deviation (SD), coefficient of variation (CV) and low and high blood glucose index (LBGI/HBGI) during all the predefined time blocks in the intervention period
Time frame: Exercise time: The time the participant has recorded start and end of exercise session during study day 1 -study day 6

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
Derived from this study: PubMed 33509935Steineck IIK, Ranjan AG, Schmidt S, Norgaard K. Time spent in hypoglycemia is comparable when the same amount of exercise is performed 5 or 2 days weekly: a randomized crossover study in people with type 1 diabetes. BMJ Open Diabetes Res Care. 2021 Jan;9(1):e001919. doi: 10.1136/bmjdrc-2020-001919.
Individual participant dataSharing planned: Yes. Data are processed and merged into at least one scientific article published in international peer-reviewed scientific journal. Positive, negative and inconclusive results will be published as soon as scientifically justifiable.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Isabelle IK Steineck, MD principal investigator

Steno Diabetes Center Copenhagen

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time spent in the hypoglycemic range (CGM <3.9 mmol/l) (time frame: The primary intervention period from 06:00h study day 1 - 06:00h study day 6 (ITT)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04089462, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.