Type 1 DiabetesNCT03130101
Insulin Management for Exercise in Patients With Type 1 Diabetes
A study testing Change in their basal insulin rate in people with Type 1 Diabetes and Hypoglycemia, 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 basal insulin management strategies for prolonged aerobic exercise: A) pump suspension for the duration of the activity, starting at the onset of exercise; B) A 50%… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia, Physical Activity
- What is being tested?
- Change in their basal insulin rate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- 3 Apr 2017to 1 Feb 2018
- 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, receiving daily insulin
- Last A1C ≤ 9.9%
- Age: 18-65 years
- Duration of T1D: ≥ 2 years
- Using CSII via OmniPod® for at least 1 month (~50:50 bolus basal insulin ratio and on at least .25 units of insulin per kilogram body mass per day)
- Body mass index (BMI) < 30 kg/m2
- In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations
- Willing to adhere to the protocol requirements for the duration of the study
Who cannot join
- Physician diagnosis of active diabetic retinopathy (proliferative or hemorrhage in past 6 months) that could potentially be worsened by exercise
- Physician diagnosis of peripheral neuropathy with insensate feet
- Physician diagnosis of autonomic neuropathy
- Medications: Beta blockers, agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives, Pramlinitide, any other hypoglycemic agent
- Participation in other studies involving administration of an investigational drug or device at the time of screening for the current study or planning to participate in another such study during participation in the current study
- Severe hypoglycemic event defined as the individual requiring third party assistance or hospitalization in the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: OmniPod®-Type 1 Diabetes Insulin Management for Exercise Study
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 basal insulin management strategies for prolonged aerobic exercise: A) pump suspension for the duration of the activity, starting at the onset of exercise; B) A 50% basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity; and C) An 80% basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity.
Read the detailed description
This project focuses on the effectiveness of various basal insulin reductions on the time spent in target range during and after aerobic exercise in adults with type 1 diabetes (T1D) on OmniPod® insulin pump therapy. The OmniPod® is a Health Canada approved tubing-free insulin pump device that uses an insulin delivery 'pod' and a Personal Diabetes Manager (PDM). The PDM is a wireless handheld device that programs the pod, captures diabetes management events (food, exercise, etc.), and acts as a glucose meter.
The primary objective of the protocol is to determine if a moderate basal insulin reduction (-50% of basal), performed 90-minutes before a 75-minute aerobic exercise session (with three 5-minute breaks), improves the time in target range compared to either a more aggressive basal rate reduction (-80%) or complete pump suspension at the onset of exercise in patients with T1D on continuous subcutaneous insulin infusion (CSII) therapy. The time in target will be determined for both the exercise period and during a three-hour window after a standardized meal ingestion performed 30-minutes after the end of exercise.
In all three sessions, aerobic exercise (brisk walking/light jogging) will be performed in the post-absorptive state, ~ four hours after the last meal with their usual bolus insulin given. The exercise will consist of four 15-minute bouts of jogging at 50-60% of the participant's pre-determined aerobic capacity, separated by three 5-minute breaks (to simulate what is typically done in most team and individual workouts and sports). The subjects exercise intensity will be monitored continuously using heart rate and activity monitors.
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 three days and participants will be expected to complete all sessions within ~ 12 weeks from the time of the baseline/screening visit. Participants will be advised to avoid any vigorous exercise within 24 hours before or after the laboratory-based exercise tests. Subjects will be asked about activity during each clinic visit and phone call to monitor adherence to these recommendations.
Following each exercise session, the participant will rest for 30-minutes and then consume a standardized meal (50 g of carbohydrate, ~17g protein and ~8g of fat, Lean Cuisine). The amount of bolus insulin given at the post-exercise meal will be based on the carbohydrate content of the meal and the patient's own individualized insulin to carbohydrate ratio, and insulin sensitivity index and glycemic targets on their OmniPod® PDM, corrected to 75% of total dose to account for the increase in insulin sensitivity post-exercise. Insulin "corrections" will be given based on the patient's own OmniPod® settings (i.e. usual care). Insulin will be administered 10-minutes before the start of consuming the meal. If hypoglycemia occurs prior to the meal (blood glucose ≤ 3.9 mmol/L), subjects will be treated with 16 grams of fast-acting carbohydrates (Dex4, AMG Medical) prior to meal consumption.
The participant will be monitored for at least three hours after the standardized meal prior to discharge. Continuous glucose monitoring (CGM) low- and high-glucose 'alerts' will be activated. They will also be instructed to perform a standardized basal insulin reduction overnight to help reduce the risk of post-exercise nocturnal hypoglycemia (-20% from bedtime for 6 hours).
CGM sensors will be removed the next day at home and patients will be instructed to perform data upload using the appropriate websites (i.e. Dexcom Share/Clarity). The participant will bring the device to the next visit or an investigator will arrange for pickup.
- Conditions
- Type 1 Diabetes, Hypoglycemia, Physical Activity
- Being tested
- Change in their basal insulin rate
- Keywords
- Type 1 Diabetes, Exercise, Basal insulin, CSII, OmniPod, CGM
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change in their basal insulin rateOther
Individual with type 1 diabetes on insulin pump therapy typically lower their basal insulin delivery for exercise. This study will compare 3 common strategies of basal insulin reductions for 75 minutes of aerobic exercise.
| Study group | Role | What they receive |
|---|---|---|
| 80% basal insulin reduction | Other | Not described Receives: Other: Change in their basal insulin rate |
| 50% basal insulin reduction | Other | Not described Receives: Other: Change in their basal insulin rate |
| 100% basal insulin reduction | Other | Not described Receives: Other: Change in their basal insulin rate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in interstitial glucose target range (CGM analysis)
The primary outcome for this study will be the time spent in target range during the 75-minute exercise session and during the three hours post-meal recovery period using CGM analysis. For this, interstitial glucose levels will be classified as below target, in target, or above target range.
Measured: Approximately 4-5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start3 Apr 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
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 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 (e.g. 80% reduction, 50% reduction, and 100% reduction).
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- York University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Riddell, York University
- Investigators
- Michael C Riddell, PhD, Principal investigator, York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130101
- Sponsor's protocol ID
- e2017 - 073
- Status last verified
- Jan 2019
- First submitted
- 4 Apr 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zaharieva DP, McGaugh S, Pooni R, Vienneau T, Ly T, Riddell MC. Improved Open-Loop Glucose Control With Basal Insulin Reduction 90 Minutes Before Aerobic Exercise in Patients With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion. Diabetes Care. 2019 May;42(5):824-831. doi: 10.2337/dc18-2204. Epub 2019 Feb 22.
PubMed 30796112
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OmniPod®-Type 1 Diabetes Insulin Management for Exercise Study
- ClinicalTrials.gov ID
- NCT03130101
- Acronym / sponsor ID
- e2017 - 073
- Conditions
- Type 1 Diabetes, Hypoglycemia, Physical Activity
- Keywords
- Type 1 Diabetes, Exercise, Basal insulin, CSII, OmniPod, CGM
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- York UniversityUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 26 Apr 2017 (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 basal insulin management strategies for prolonged aerobic exercise: A) pump suspension for the duration of the activity, starting at the onset of exercise; B) A 50% basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity; and C) An 80% basal rate reduction, performed 90-minutes in advance of exercise for the duration of the activity.
Detailed description
This project focuses on the effectiveness of various basal insulin reductions on the time spent in target range during and after aerobic exercise in adults with type 1 diabetes (T1D) on OmniPod® insulin pump therapy. The OmniPod® is a Health Canada approved tubing-free insulin pump device that uses an insulin delivery 'pod' and a Personal Diabetes Manager (PDM). The PDM is a wireless handheld device that programs the pod, captures diabetes management events (food, exercise, etc.), and acts as a glucose meter.
The primary objective of the protocol is to determine if a moderate basal insulin reduction (-50% of basal), performed 90-minutes before a 75-minute aerobic exercise session (with three 5-minute breaks), improves the time in target range compared to either a more aggressive basal rate reduction (-80%) or complete pump suspension at the onset of exercise in patients with T1D on continuous subcutaneous insulin infusion (CSII) therapy. The time in target will be determined for both the exercise period and during a three-hour window after a standardized meal ingestion performed 30-minutes after the end of exercise.
In all three sessions, aerobic exercise (brisk walking/light jogging) will be performed in the post-absorptive state, ~ four hours after the last meal with their usual bolus insulin given. The exercise will consist of four 15-minute bouts of jogging at 50-60% of the participant's pre-determined aerobic capacity, separated by three 5-minute breaks (to simulate what is typically done in most team and individual workouts and sports). The subjects exercise intensity will be monitored continuously using heart rate and activity monitors.
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 three days and participants will be expected to complete all sessions within ~ 12 weeks from the time of the baseline/screening visit. Participants will be advised to avoid any vigorous exercise within 24 hours before or after the laboratory-based exercise tests. Subjects will be asked about activity during each clinic visit and phone call to monitor adherence to these recommendations.
Following each exercise session, the participant will rest for 30-minutes and then consume a standardized meal (50 g of carbohydrate, ~17g protein and ~8g of fat, Lean Cuisine). The amount of bolus insulin given at the post-exercise meal will be based on the carbohydrate content of the meal and the patient's own individualized insulin to carbohydrate ratio, and insulin sensitivity index and glycemic targets on their OmniPod® PDM, corrected to 75% of total dose to account for the increase in insulin sensitivity post-exercise. Insulin "corrections" will be given based on the patient's own OmniPod® settings (i.e. usual care). Insulin will be administered 10-minutes before the start of consuming the meal. If hypoglycemia occurs prior to the meal (blood glucose ≤ 3.9 mmol/L), subjects will be treated with 16 grams of fast-acting carbohydrates (Dex4, AMG Medical) prior to meal consumption.
The participant will be monitored for at least three hours after the standardized meal prior to discharge. Continuous glucose monitoring (CGM) low- and high-glucose 'alerts' will be activated. They will also be instructed to perform a standardized basal insulin reduction overnight to help reduce the risk of post-exercise nocturnal hypoglycemia (-20% from bedtime for 6 hours).
CGM sensors will be removed the next day at home and patients will be instructed to perform data upload using the appropriate websites (i.e. Dexcom Share/Clarity). The participant will bring the device to the next visit or an investigator will arrange for pickup.
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 (e.g. 80% reduction, 50% reduction, and 100% reduction).
| Arm | Type | Receives |
|---|---|---|
| 80% basal insulin reduction | Other | Other: Change in their basal insulin rate |
| 50% basal insulin reduction | Other | Other: Change in their basal insulin rate |
| 100% basal insulin reduction | Other | Other: Change in their basal insulin rate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical diagnosis of presumed autoimmune type 1 diabetes, receiving daily insulin
- Last A1C ≤ 9.9%
- Age: 18-65 years
- Duration of T1D: ≥ 2 years
- Using CSII via OmniPod® for at least 1 month (~50:50 bolus basal insulin ratio and on at least .25 units of insulin per kilogram body mass per day)
Key exclusion criteria (6 listed)
- Physician diagnosis of active diabetic retinopathy (proliferative or hemorrhage in past 6 months) that could potentially be worsened by exercise
- Physician diagnosis of peripheral neuropathy with insensate feet
- Physician diagnosis of autonomic neuropathy
- Medications: Beta blockers, agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives, Pramlinitide, any other hypoglycemic agent
- Participation in other studies involving administration of an investigational drug or device at the time of screening for the current study or planning to participate in another such study during participation in the current study
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 |
|---|---|---|
| Change in their basal insulin rateIndividual with type 1 diabetes on insulin pump therapy typically lower their basal insulin delivery for exercise. This study will compare 3 common strategies of basal insulin reductions for 75 minutes of aerobic exercise. | Other | 100% basal insulin reduction, 50% basal insulin reduction, 80% basal insulin reduction |
Primary outcome
Time in interstitial glucose target range (CGM analysis)
Time frame: Approximately 4-5 hours
The primary outcome for this study will be the time spent in target range during the 75-minute exercise session and during the three hours post-meal recovery period using CGM analysis. For this, interstitial glucose levels will be classified as below target, in target, or above target range.
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 15 Jan 2019.
- Derived from this study: PubMed 30796112Zaharieva DP, McGaugh S, Pooni R, Vienneau T, Ly T, Riddell MC. Improved Open-Loop Glucose Control With Basal Insulin Reduction 90 Minutes Before Aerobic Exercise in Patients With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion. Diabetes Care. 2019 May;42(5):824-831. doi: 10.2337/dc18-2204. Epub 2019 Feb 22.
- 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 C 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 Change in their basal insulin rate in people with Type 1 Diabetes and Hypoglycemia, 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 8 inclusion and 6 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 15 Jan 2019. 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 interstitial glucose target range (CGM analysis) (time frame: Approximately 4-5 hours). 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 NCT03130101, 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 15 Jan 2019.