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Type 1 DiabetesMODE2022NCT05619198

The Effects of Different Exercise Modalities in Adolescents With Type 1 Diabetes Using AID Systems

A study testing High Intensity Interval Exercise and Moderate Intensity Continous Exercise in people with Type 1 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Objective: The overall objective of this study is to assess the efficacy of the current recommended guidelines for physical activity (PA) in response to acute moderate intensity continous exercise (MICE) and high intensity interval exercise (HIIE) among adolescents with type 1 diabetes (T1D) using automated insulin… Read more about this study

Who is it for?
Ages 13 to 17 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
High Intensity Interval Exercise and Moderate Intensity Continous Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteDenmark
Study dates
19 Dec 2022to Nov 2024
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 13 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 13-17 years old
  • Type 1 diabetes > 1 year
  • Use of Tandem t:slim X2 Control-IQ or Medtronic MiniMed 780G with connected continous glucose monitor > 3 months
  • HbA1c below 75 mmol/L

Who cannot join

  • Use of anti-diabetic medicine other than insulin
  • Breastfeeding, pregnancy or planning to become pregnant
  • Lack of compliance with key study procedures at the discretion of the investigator

Trial locations and contacts

1 site in 1 country.

Emilie Lindkvist, MD contact

+45 20187762

emilie.lindkvist@regionh.dk

Kirsten Nørgaard contact

kirsten.noergaard@regionh.dk

Denmark1 site, 1 recruiting
  • Steno Diabetes Center Copenhagen

    Herlev, 2730

    Emilie B Lindkvist, +4520187762, emilie.lindkvist@regionh.dk

    Jannet Svensson, jannet.svensson.01@regionh.dk

    Recruiting

Other trials in Denmark

About this study

Objective:

The overall objective of this study is to assess the efficacy of the current recommended guidelines for physical activity (PA) in response to acute moderate intensity continous exercise (MICE) and high intensity interval exercise (HIIE) among adolescents with type 1 diabetes (T1D) using automated insulin delivery (AID) systems (MiniMed 780G and Tandem Control-IQ).

Read more

Methods:

This study will be a two-period, cross-over, clinical trial with between and within cohort comparisons of two different exercise modalities among a total of 24 age-, sex-, and insulin-dose-matched adolescents with T1D (12 using MiniMed 780G and 12 using Tandem Control-IQ).

Endpoint:

The primary endpoint is sensor-derived time in range (3.9 mmol/L-10.0 mmol/L) around exercise

Read the detailed description

Participants included in the study will perform a cardiopulmonary exercise testing (CPET) before the exercise study visits, to prescribe subsequent exercise intensity thresholds. Participants will have a canula placed in a antecubital vein for plasma sampling during the test.

Participants will undertake two exercise visits each including a bout of exercise on a stationary bicycle of either one of two exercise modalities; i.) high-intensity interval exercise with sprints at ~85% of VO2max (HIIE); ii.) moderate intensity continuous exercise at ~60% of VO2max (MICE).

Participants will arrive at the research facility, Steno Diabetes Center Copenhagen, in the afternoon. As per the current recommended guidelines, the MICE-session will be announced to the AID systems 60 minutes in advance, whereas the HIIE-session will not be announced. Participants will have a canula placed in a antecubital vein for plasma sampling.

Participants will rest for 60 minutes, exercise for 45 minutes and rest again for 75 minutes before leaving the research facility. During exercise participants will be fitted with a spirometry face mask to compute ventilatory thresholds and indirect calorimetry (Vyaire Vyntus® CPX, Intramedic A/S) and a telemetry chest strap (Polar H10) for integrated HR heart rate (HR) measurements with the spirometry device.

In the MICE session: After 15 minutes post-exercise rest the temporary target/exercise mode is turned off.

Around each study visit (24 hours prior until 24 hours after), sensor glucose as well as sleep and physical activity will be recorded. Sensor glucose will be measured by participants' own devices. Sleep and physical activity level will be assessed with a wrist-worn accelerometer, ActiGraph wGT3X-BT (ActiGraph, Pensacola, FL).

Study days will be separated by at least three days.

Conditions
Type 1 Diabetes
Being tested
High Intensity Interval Exercise, Moderate Intensity Continous Exercise
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

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

  • High Intensity Interval ExerciseBehavioural

    High Intensity Interval Exercise:

    • 5 minutes resting phase @ 0 watts.
    • 5-minute warm up phase @ 20 watts.
    • 40 minutes of interval work consisting of eight bouts of 1-minute cycling at a power output corresponding to ~85% of VO2max interspersed with 4-minute recovery periods at 20 watts.
    • 5 minutes resting phase @ 0 watts.
  • Moderate Intensity Continous ExerciseBehavioural

    Moderate Intensity Continous Exercise:

    • 5 minutes resting phase @ 0 watts.
    • 5-minute warm up phase @ 20 watts.
    • 40 minutes of MICE 65% VO2max.
    • 5 minutes resting phase @ 0 watts.
Study groups in NCT05619198
Study groupRoleWhat they receive
High Intensity Interval ExerciseActive comparatorPlasma and sensor glucose is monitored before, during and after a bout of high intensity interval exercise
Receives: Behavioral: High Intensity Interval Exercise
Moderate Intensity Continous ExerciseActive comparatorPlasma and sensor glucose is monitored before, during and after a bout of moderate intensity continous exercise
Receives: Behavioral: Moderate Intensity Continous Exercise

What is being measured

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

  1. Percentage of time spent in sensor-derived time in range (3.9-10.0 mmol/L) during and after a bout of exercise

    Percentage

    Measured: T = 0 to T = +120 (120 minutes)

Secondary outcomes (32)
  1. Number of hypo- (<3.9 mmol/L) and hyperglycemic (>10.0 mmol/L) occurrences during exercise session as measured by sensor and plasma sampling

    Number

    Measured: T = 0 to T = +45 (45 minutes)

  2. Percentage of time spent below (<3.9 mmol/L), in (3.9-10.0 mmol/L) and above (>10.0 mmol/L) range during in-clinic phase, measured by sensor and plasma sampling

    Percentage

    Measured: T= -60 minutes to T= +120 minutes (3 hours)

  3. Percentage of time spent below (<3.9 mmol/L), in (3.9-10.0 mmol/L) and above (>10.0 mmol/L) range during home-phase, measured by glucose sensor

    Percentage

    Measured: 24 hours

  4. Glycemic variability as coefficient of variation, measured by sensor during in-clinic phase

    Percentage

    Measured: T= -60 minutes to T= +120 minutes (3 hours)

  5. Glycemic variability as coefficient of variation, measured by plasma sampling during in-clinic phase

    Percentage

    Measured: T= -60 minutes to T= +120 minutes (3 hours)

  6. Glycemic variability as standard deviation, measured by sensor during in-clinic phase

    mmol/L

    Measured: T= -60 minutes to T= +120 minutes (3 hours)

  7. Glycemic variability as standard deviation, measured by plasma sampling during in-clinic phase

    mmol/L

    Measured: T= -60 minutes to T= +120 minutes (3 hours)

  8. Glycemic variability as coefficient of variation measured by glucose sensor during home-phase

    Percentage

    Measured: 24 hours

  9. Glycemic variability as standard deviation measured by glucose sensor during home-phase

    Mmol/L

    Measured: 24 hours

  10. Number of rescue glucose interventions to treat hypoglycemia (<3.9 mmol/L) during in-clinic and home-phase

    Number

    Measured: 27 hours

  11. Area Under the Curve and absolute concentration of serum total insulin during in-clinic phase

    Units

    Measured: T= -60 minutes to T= +120 minutes (3 hours)

  12. Dynamics of plasma glucoregulatory hormone responses during in-clinic phase

    Change in concentration

    Measured: T= -60 minutes to T= +120 minutes (3 hours)

  13. Dynamics of plasma metabolites during in-clinic phase

    Change in concentration

    Measured: T= -60 minutes to T= +120 minutes (3 hours)

  14. Glucose changes during exercise (delta change expressed as absolute [mmol/L]) during in-clinic phase

    mmol/L

    Measured: T= -60 minutes to T= +120 minutes (3 hours)

  15. Glucose changes during exercise (delta change relativized as a rate of change [mmol/min]) during in-clinic phase

    mmol/min

    Measured: T= -60 minutes to T= +120 minutes (3 hours)

  16. Amount of correction boluses given by each automated insulin delivery system during activation of temporary target and exercise mode

    Number

    Measured: T= -60 minutes to T= +60 minutes (2 hours)

  17. Comparison of heart rate (HR) during high intensity interval exercise and moderate intensity continous exercise session

    Beats pr minute

    Measured: T = 0 to T = +45 (45 minutes)

  18. Comparison of respiratory exchange ratio (RER) during high intensity interval exercise and moderate intensity continous exercise session

    Ratio

    Measured: T = 0 to T = +45 (45 minutes)

  19. Comparison of oxygen consumption (VO2) during high intensity interval exercise and moderate intensity continous exercise session

    L/min

    Measured: T = 0 to T = +45 (45 minutes)

  20. Comparison of carbon dioxide output (VCO2) during high intensity interval exercise and moderate intensity continous exercise session

    L/min

    Measured: T = 0 to T = +45 (45 minutes)

  21. Comparison of carbohydrate oxidation during high intensity interval exercise and moderate intensity continous exercise session

    g/min

    Measured: T = 0 to T = +45 (45 minutes)

  22. Comparison of lipid oxidation during high intensity interval exercise and moderate intensity continous exercise session

    g/min

    Measured: T = 0 to T = +45 (45 minutes)

  23. Comparison of resting metabolic rate after exercise session

    kj/min

    Measured: T =+45 to T=+120 (75 minutes)

  24. Plasma lactate response before, during and after cardiopulmonary exercise testing

    mmol/L

    Measured: 30 minutes

  25. Plasma glucose response before, during and after cardiopulmonary exercise testing

    mmol/L

    Measured: 30 minutes

  26. Respiratory exchange ratio (RER) collected continuously during cardiopulmonary exercise testing visit

    L/min

    Measured: 30 minutes

  27. Oxygen consumption (VO2) collected continuously during cardiopulmonary exercise testing visit

    L/min

    Measured: 30 minutes

  28. Carbon dioxide output (VCO2) collected continuously during cardiopulmonary exercise testing visit

    L/min

    Measured: 30 minutes

  29. Sleep efficiency assessed by Actigraph GT3x the night before study visits compared to after study visits.

    Percentage

    Measured: Night 1-2

  30. Wake time after sleep onset assessed by Actigraph GT3x the night before study visits compared to after study visits

    Mins

    Measured: Night 1- 2

  31. Energy expenditure assessed by Actigraph GT3x.

    Kcal

    Measured: Day 1-3

  32. Physical activity level assessed by Actigraph GT3x

    sedentary, light or moderate-to-vigorous

    Measured: Day1-3

Timeline

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

  1. First posted16 Nov 2022
  2. Study start19 Dec 2022
  3. Primary completionNov 2024 (estimated)
  4. Study completionNov 2024 (estimated)

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Crossover
Model description
A two-period, cross-over, clinical trial with between and within cohort comparisons of two different exercise modalities in adolescents with type 1 diabetes
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05619198
Sponsor's protocol ID
MODE2022
Acronym
MODE2022
Status last verified
Nov 2022
First submitted
5 Oct 2022
Last updated
14 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Exercise and Moderate Intensity Continous Exercise in people with Type 1 Diabetes, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 14 Apr 2023. 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?

Results are not available in the source record.

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

Contact Emilie Lindkvist, MD (+45 20187762, emilie.lindkvist@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of time spent in sensor-derived time in range (3.9-10.0 mmol/L) during and after a bout of exercise (time frame: T = 0 to T = +120 (120 minutes)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 14 Apr 2023.

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