Type 1 DiabetesNCT04383015
Carbohydrate and Insulin Requirements During Prolonged Fasted Exercise
A study testing Exercise strategies in people with Type 1 Diabetes, run by York University at 1 site in Canada.
Trial summary
The purpose of this study is to compare the time spent in glucose target range (4.0-10.0 mmol/L) during exercise and in recovery using three different management strategies for prolonged aerobic exercise: A) carbohydrate dose of 0.3g/kg/hr; B) A 50 percent basal rate reduction, performed 90-minutes in advance of… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Exercise strategies
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 31 Oct 2018to 17 Oct 2019
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of presumed autoimmune type 1 diabetes
- Last HbA1c ≤ 9.9 percent
- Age: 17+ years
- Duration of T1D: ≥ 1.5 years
- Using insulin pump therapy: ≥3 months (at least 0.25 units of insulin per kilogram of body mass)
- In good general health with no conditions that could impact the outcome of the trial
- Willing to adhere to the protocol requirements for the duration of the study
Who cannot join
- Physician diagnosis of active diabetic retinopathy that could be worsened by exercise
- Physician diagnosis of peripheral neuropathy or autonomic neuropathy
- Medications:
- Beta-blockers
- Agents that affect hepatic glucose production (xanthine derivatives)
- Pramlintide
Show all 9Show fewer
- Any other hypoglycemic agent
- Participation in other studies involving the administration of an investigational drug or device during the duration of the current study
- Severe hypoglycemia in the last 3 months, defined as the individual requiring third party assistance or hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carbohydrate Requirements for Prolonged, Fasted Exercise With and Without Basal Rate Reductions in Individuals With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion
The purpose of this study is to compare the time spent in glucose target range (4.0-10.0 mmol/L) during exercise and in recovery using three different management strategies for prolonged aerobic exercise: A) carbohydrate dose of 0.3g/kg/hr; B) A 50 percent basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity; and C) A 50 percent basal rate reduction, performed at exercise onset, with carbohydrate dose of 0.3g/kg/hr
Read the detailed description
This project focuses on the effectiveness of various exercise strategies on the time spent in target range during and after aerobic exercise in adults with type 1 diabetes (T1D) on continuous subcutaneous insulin infusion (CSII).
The primary objective of the protocol is to determine if a moderate basal insulin reduction (-50 percent of basal), performed 90-minutes before a 120-minute aerobic exercise session (with 5-minute breaks every 30 minutes of exercise, and a ten minute break mid-exercise), improves the time in target range compared to either a carbohydrate consumption only strategy or insulin reduction (-50 percent) and carbohydrate consumption strategy both performed at the onset of exercise in patients with T1D on CSII therapy. The time in target will be determined for both the exercise period and during a 24-hour window after the end of exercise.
In all three sessions, aerobic exercise (brisk walking) will be performed in the fasted state (minimum 8 hours after the last meal) in the early-morning. The exercise will consist of four 30-minute bouts of walking at 40-50 percent of the participant's pre-determined aerobic capacity, separated by 5-10 minute breaks. The participants exercise intensity will be monitored continuously using heart rate and activity monitors. Blood glucose and blood ketone levels will be monitored throughout exercise.
Each participant will be assigned to a sequence of the three experimental visits through a randomization process. Each exercise session will be separated by at least two days and participants will be expected to complete all sessions within ~ 12 weeks from the time of the baseline/screening visit. Participants will be instructed to apply a new continuous glucose monitor (CGM) sensor between 1-5 days prior, not to perform moderate-to-vigorous exercise 24 hours prior and refrain from caffeine and alcohol 12 hours prior to each study visit. Participants are also instructed not to eat after 2330h the night before arriving to the laboratory and not to give bolus insulin or perform temporary basal rate changes after 0200h on the morning of the exercise visit. Participants are instructed to try to arrive at the laboratory with their blood glucose between 72-270 mg/dL, with no active bolus insulin according to personal CSII device, in the fasted state. If a bolus of insulin was given prior to the exercise session, the session was rescheduled. Females of reproductive capacity performed all three visits in the early follicular phase (days 1-6 of cycle). Participants arrived at the laboratory between 0600h and 1000h. Exercise start time was between 0700h and 1045h, based on participants' choice, and the timing of exercise was kept consistent within participants.
Following each exercise session, the participant will rest for 20-minutes and then leave the laboratory. The participants glucose will be monitored for 24-hours after the standardized exercise. They will also be instructed to perform a standardized basal insulin reduction overnight to help reduce the risk of post-exercise nocturnal hypoglycemia (-20 percent from bedtime for 6 hours).
- Conditions
- Type 1 Diabetes
- Being tested
- Exercise strategies
- Keywords
- Physical Activity, Exercise, Carbohydrates, Hypoglycemia, Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise strategiesOther
Strategies for exercise in type 1 diabetes to maintain glucose control
| Study group | Role | What they receive |
|---|---|---|
| Carbohydrate (CHO)-only | Other | Carbohydrate dose of 0.3g/kg/hr given every 30 minutes of exercise if blood glucose is in range with usual basal insulin infusion Receives: Other: Exercise strategies |
| 50 Percent Basal Rate Reduction (BRR) | Other | A 50 percent basal rate reduction set 90-minutes pre-exercise and throughout exercise Receives: Other: Exercise strategies |
| Combo | Other | The combination of a 50 percent basal rate reduction and carbohydrate dose of 0.3g/kg/hr (given every 30 minutes) both at exercise onset Receives: Other: Exercise strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in glucose target range during exercise intervention
The primary outcome measurement is to determine which strategy had the best time in blood glucose target range (4.0-10.0 mmol/L) during the prolonged exercise
Measured: 140 minutes
Secondary outcomes (1)
Recovery Interstitial Glucose
Using CGM to measure recovery glucose levels post-exercise to analyze time in target range, time in hypoglycemia (< 4.0 mmol/L) and time in hyperglycemia (> 10.0 mmol/L).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start31 Oct 2018
- Primary completion16 Oct 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Patients with type 1 diabetes on insulin pump therapy will remain on their usual insulin regimen. However, we are testing percent basal rate reductions during exercise (50 percent reduction) with or without carbohydrate feeding.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Collaborators
- Insulet Corporation
- Responsible party
- Principal investigator, Michael Riddell, York University
- Investigators
- Michael Riddell, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04383015
- Sponsor's protocol ID
- e2018-306
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 11 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbohydrate Requirements for Prolonged, Fasted Exercise With and Without Basal Rate Reductions in Individuals With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion
- ClinicalTrials.gov ID
- NCT04383015
- Acronym / sponsor ID
- e2018-306
- Conditions
- Type 1 Diabetes
- Keywords
- Physical Activity, Exercise, Carbohydrates, Hypoglycemia, Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Collaborators
- Insulet Corporation
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 11 May 2020 (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.
The purpose of this study is to compare the time spent in glucose target range (4.0-10.0 mmol/L) during exercise and in recovery using three different management strategies for prolonged aerobic exercise: A) carbohydrate dose of 0.3g/kg/hr; B) A 50 percent basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity; and C) A 50 percent basal rate reduction, performed at exercise onset, with carbohydrate dose of 0.3g/kg/hr
Detailed description
This project focuses on the effectiveness of various exercise strategies on the time spent in target range during and after aerobic exercise in adults with type 1 diabetes (T1D) on continuous subcutaneous insulin infusion (CSII).
The primary objective of the protocol is to determine if a moderate basal insulin reduction (-50 percent of basal), performed 90-minutes before a 120-minute aerobic exercise session (with 5-minute breaks every 30 minutes of exercise, and a ten minute break mid-exercise), improves the time in target range compared to either a carbohydrate consumption only strategy or insulin reduction (-50 percent) and carbohydrate consumption strategy both performed at the onset of exercise in patients with T1D on CSII therapy. The time in target will be determined for both the exercise period and during a 24-hour window after the end of exercise.
In all three sessions, aerobic exercise (brisk walking) will be performed in the fasted state (minimum 8 hours after the last meal) in the early-morning. The exercise will consist of four 30-minute bouts of walking at 40-50 percent of the participant's pre-determined aerobic capacity, separated by 5-10 minute breaks. The participants exercise intensity will be monitored continuously using heart rate and activity monitors. Blood glucose and blood ketone levels will be monitored throughout exercise.
Each participant will be assigned to a sequence of the three experimental visits through a randomization process. Each exercise session will be separated by at least two days and participants will be expected to complete all sessions within ~ 12 weeks from the time of the baseline/screening visit. Participants will be instructed to apply a new continuous glucose monitor (CGM) sensor between 1-5 days prior, not to perform moderate-to-vigorous exercise 24 hours prior and refrain from caffeine and alcohol 12 hours prior to each study visit. Participants are also instructed not to eat after 2330h the night before arriving to the laboratory and not to give bolus insulin or perform temporary basal rate changes after 0200h on the morning of the exercise visit. Participants are instructed to try to arrive at the laboratory with their blood glucose between 72-270 mg/dL, with no active bolus insulin according to personal CSII device, in the fasted state. If a bolus of insulin was given prior to the exercise session, the session was rescheduled. Females of reproductive capacity performed all three visits in the early follicular phase (days 1-6 of cycle). Participants arrived at the laboratory between 0600h and 1000h. Exercise start time was between 0700h and 1045h, based on participants' choice, and the timing of exercise was kept consistent within participants.
Following each exercise session, the participant will rest for 20-minutes and then leave the laboratory. The participants glucose will be monitored for 24-hours after the standardized exercise. They will also be instructed to perform a standardized basal insulin reduction overnight to help reduce the risk of post-exercise nocturnal hypoglycemia (-20 percent from bedtime for 6 hours).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Patients with type 1 diabetes on insulin pump therapy will remain on their usual insulin regimen. However, we are testing percent basal rate reductions during exercise (50 percent reduction) with or without carbohydrate feeding.
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate (CHO)-only | Other | Other: Exercise strategiesCarbohydrate dose of 0.3g/kg/hr given every 30 minutes of exercise if blood glucose is in range with usual basal insulin infusion |
| 50 Percent Basal Rate Reduction (BRR) | Other | Other: Exercise strategiesA 50 percent basal rate reduction set 90-minutes pre-exercise and throughout exercise |
| Combo | Other | Other: Exercise strategiesThe combination of a 50 percent basal rate reduction and carbohydrate dose of 0.3g/kg/hr (given every 30 minutes) both at exercise onset |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical diagnosis of presumed autoimmune type 1 diabetes
- Last HbA1c ≤ 9.9 percent
- Age: 17+ years
- Duration of T1D: ≥ 1.5 years
- Using insulin pump therapy: ≥3 months (at least 0.25 units of insulin per kilogram of body mass)
Key exclusion criteria (9 listed)
- Physician diagnosis of active diabetic retinopathy that could be worsened by exercise
- Physician diagnosis of peripheral neuropathy or autonomic neuropathy
- Medications:
- Participation in other studies involving the administration of an investigational drug or device during the duration of the current study
- Severe hypoglycemia in the last 3 months, defined as the individual requiring third party assistance or hospitalization
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 |
|---|---|---|
| Exercise strategiesStrategies for exercise in type 1 diabetes to maintain glucose control | Other | 50 Percent Basal Rate Reduction (BRR), Carbohydrate (CHO)-only, Combo |
Primary outcome
Time in glucose target range during exercise intervention
Time frame: 140 minutes
The primary outcome measurement is to determine which strategy had the best time in blood glucose target range (4.0-10.0 mmol/L) during the prolonged exercise
1 secondary outcome
Recovery Interstitial Glucose
Time frame: 24 hours
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 11 May 2020.
- Individual participant dataSharing planned: No
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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.
Michael Riddell, PhD principal investigator
York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise strategies in people with Type 1 Diabetes, run by York University at 1 site in Canada.
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 7 inclusion and 9 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 11 May 2020. 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 Canada. 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?
Time in glucose target range during exercise intervention (time frame: 140 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 11 May 2020.