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Type 1 DiabetesPhase 2NCT02855307

Closed-loop Control of Glucose Levels (Artificial Pancreas) During Postprandial Exercise in Adults With Type 1 Diabetes

A Phase 2 study testing 60-minute exercise, Insulin pump and Dexcom G4 Platinum glucose sensor in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.

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

Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
60-minute exercise, Insulin pump and Dexcom G4 Platinum glucose sensor
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteCanada
Study dates
Sep 2016to Dec 2018
Phase
Phase 2
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females ≥ 18 years of old.
  • Clinical diagnosis of type 1 diabetes for at least one year.
  • The subject will have been on insulin pump therapy for at least 3 months.
  • Last (less than 3 months) HbA1c ≤ 12%.

Who cannot join

  • Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
  • Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • Use of medication with an effect on heart rate (e.g. beta-blockers).
  • Abnormal blood panel and/or anemia.
  • Ongoing or planned pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
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  • Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
  • Failure to comply with team's recommendations (e.g. not willing to eat snack, not willing to change pump parameters, etc).
  • Problems with venous access.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Institut de recherches cliniques de Montréal

    Montreal, Quebec, H2W 1R7

Other trials in Canada

About this study

Official title: A Single-blind, Randomized, Cross-over Study to Assess the Efficacy of Single-hormone Closed-loop Strategy at Preventing Hypoglycemia During Unannounced and Announced Exercise in Adults With Type 1 Diabetes

Regular physical activity is associated with many health benefits for individuals with type 1 diabetes including improved cardiovascular fitness and vascular health, decreased insulin requirements, improved body composition and quality of life. However, exercise-induced hypoglycemia is very frequent and thus is the main limiting factor for physical activity practice in this population.

The artificial pancreas is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. The artificial pancreas has the potential to reduce the risk of exercise-induced hypoglycemia but the importance of announcing exercise to the artificial pancreas is yet to be explored.

The objective of this study is to investigate 1) if announcing postprandial exercise to the artificial pancreas is beneficial in reducing the risk of hypoglycemia and 2) if an insulin bolus reduction is necessary when announcing the exercise to the artificial pancreas.

Conditions
Type 1 Diabetes
Being tested
60-minute exercise, Insulin pump, Dexcom G4 Platinum glucose sensor, Insulin, Single-hormone closed-loop strategy
Keywords
Closed-loop system, Artificial pancreas, Exercise, Hypoglycemia, Insulin, Type 1 diabetes
Medical subject headings
Diabetes Mellitus, Type 1, Motor Activity, Hypoglycemia, Insulin Resistance

What participants receive

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

  • 60-minute exerciseOther

    Patients will be admitted at the research clinical facility at 6:30. The artificial pancreas intervention will start at 7:00. A standardized breakfast will be served at 8:00. At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max. At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served. Patients will be discharged after lunch consumption.

  • Insulin pumpDevice

    Patient's insulin pump will be used to infuse insulin.

  • Dexcom G4 Platinum glucose sensorDevice

    The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.

  • InsulinDrug

    Patient's usual fast-acting insulin analog will be used.

  • Single-hormone closed-loop strategyOther

    Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump. The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes. The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.

Study groups in NCT02855307
Study groupRoleWhat they receive
Unannounced exerciseActive comparatorThe target blood glucose of the algorithm will be as usual. A pre-meal full insulin bolus will be given.
Receives: Other: 60-minute exercise; Device: Insulin pump; Device: Dexcom G4 Platinum glucose sensor; Drug: Insulin; Other: Single-hormone closed-loop strategy
Announced exercise with pre-meal full bolusActive comparatorThe target blood glucose of the algorithm will be increased and a pre-meal full bolus will be given
Receives: Other: 60-minute exercise; Device: Insulin pump; Device: Dexcom G4 Platinum glucose sensor; Drug: Insulin; Other: Single-hormone closed-loop strategy
Announced exercise with reduced insulin bolusActive comparatorThe target blood glucose of the algorithm will be increased and the pre-meal insulin bolus will be reduced by 33%.
Receives: Other: 60-minute exercise; Device: Insulin pump; Device: Dexcom G4 Platinum glucose sensor; Drug: Insulin; Other: Single-hormone closed-loop strategy

What is being measured

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

  1. Percentage of time of plasma glucose levels spent below 3.9 mmol/L

    Measured: From 9:30 to 11:30 (120 minutes)

Secondary outcomes (14)

  1. Relative decrease in glucose levels during exercise compared to pre-breakfast levels

    Difference between pre-breakfast levels and the lowest glucose level from the start of the exercise until 20 minutes after exercise

    Measured: From 8:00 to 10:50 (170 minutes)

  2. Number of patients experiencing exercise-induced hypoglycemia requiring treatment

    Measured: From 9:30 to 10:30 (60 minutes)

  3. Decremental area under the curve from the start of the exercise

    Measured: From 9:30 to 11:00 (90 minutes)

  4. Percentage of time of plasma glucose levels spent below 3.9 mmol/L

    Measured: From 9:30 to 10:30 (60 minutes)

  5. Percentage of time of plasma glucose levels spent below 3.3 mmol/L

    Measured: From 9:30 to 10:30 (60 minutes)

  6. Percentage of time of plasma glucose levels spent below 2.8 mmol/L

    Measured: From 9:30 to 10:30 (60 minutes)

  7. Percentage of time of plasma glucose levels spent between 3.9 and 7.8 mmol/L

    Measured: From 9:30 to 10:30 (60 minutes)

  8. Percentage of time of plasma glucose levels spent above 10 mmol/L

    Measured: From 9:30 to 10:30 (60 minutes)

  9. Percentage of time of plasma glucose levels spent above 13.9 mmol/L

    Measured: From 9:30 to 10:30 (60 minutes)

  10. Percentage of time of plasma glucose levels spent above 16.7 mmol/L

    Measured: From 9:30 to 10:30 (60 minutes)

  11. Mean plasma glucose levels

    Measured: From 8:00 to 11:30 (210 minutes)

  12. Standard deviation of glucose levels

    Measured: From 8:00 to 11:30 (210 minutes)

  13. Coefficient of variation of glucose levels

    Measured: From 8:00 to 11:30 (210 minutes)

  14. Mean time (minutes) to the first hypoglycemic event

    Measured: From 9:30 to 10:30 (60 minutes)

Timeline

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

  1. First posted4 Aug 2016 (estimated)
  2. Study startSep 2016
  3. Primary completionDec 2018
  4. Study completionDec 2018

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02855307
Sponsor's protocol ID
CLASS-16
Status last verified
Feb 2019
First submitted
1 Aug 2016
Last updated
11 Feb 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Tagougui S, Taleb N, Legault L, Suppere C, Messier V, Boukabous I, Shohoudi A, Ladouceur M, Rabasa-Lhoret R. A single-blind, randomised, crossover study to reduce hypoglycaemia risk during postprandial exercise with closed-loop insulin delivery in adults with type 1 diabetes: announced (with or without bolus reduction) vs unannounced exercise strategies. Diabetologia. 2020 Nov;63(11):2282-2291. doi: 10.1007/s00125-020-05244-y. Epub 2020 Aug 1.

    PubMed 32740723

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 60-minute exercise, Insulin pump and Dexcom G4 Platinum glucose sensor in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal 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 4 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 Feb 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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 of plasma glucose levels spent below 3.9 mmol/L (time frame: From 9:30 to 11:30 (120 minutes)). 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 NCT02855307, 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 11 Feb 2019; AzTrials last refreshed its copy on 6 Nov 2026.

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