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Type 1 DiabetesPhase 2NCT01905020

Closed-loop Control of Overnight Glucose Levels in Adults and Adolescents With Type 1 Diabetes

A Phase 2 study testing Carbohydrate-rich meal and Exercise in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 3 sites 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

Closed-loop strategy 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Type 1 Diabetes
What is being tested?
Carbohydrate-rich meal and Exercise
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
3 sitesCanada
Study dates
Jul 2013to Sep 2014
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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Males and females aged ≥ 12 years of old.
  • Body mass index < 35
  • Clinical diagnosis of type 1 diabetes for at least one year.
  • The subject will have been on insulin pump therapy for at least 4 months.
  • HbA1c < 12%.
  • At least two visits with an endocrinology team in the past 1 year.

Who cannot join

  • Clinically significant nephropathy, neuropathy (peripheral or autonomic e.g. significant gastroparesis) or retinopathy as judged by the investigator.
  • Recent (< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
  • A recent injury to body or limb, muscular disorder, use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
  • Ongoing pregnancy.
  • Severe hypoglycemic episode within two weeks of screening.
  • Current use of glucocorticoid medication (except low stable dose and inhaled therapy).
Show all 10Show fewer
  • Known or suspected allergy to the insulin aspart, glucagon, Medtronic sensors, or Medtronic infusion sets..
  • Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
  • Anticipating a significant change in treatment regimen between admissions (such as a major change in an exercise routine, significant change in dietary routine or in insulin therapy.
  • Failure to comply with team's recommendations.

Trial locations and contacts

3 sites in 1 country.

Canada3 sites

  • Institut de recherches cliniques de Montréal

    Montreal, Quebec

  • Montreal Children Hospital

    Montreal, Quebec

  • Mount Sinai Hospital

    Toronto, Ontario

Other trials in Canada

About this study

Official title: An Open-label, Randomized, Three-way, Multicenter Study to Compare the Efficacy of Single-hormone Closed-loop Strategy, Dual-hormone Closed-loop Strategy and Conventional Insulin Pump Therapy in Regulating Overnight Glucose Levels at Home in Adolescents and Adults With Type 1 Diabetes

Closed-loop strategy 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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

The main objective of this project is to compare the efficacy of single-hormone closed-loop strategy, dual-hormone closed-loop strategy and pump therapy to regulate overnight glucose levels in a out-patient study in adults and adolescents with type 1 diabetes.

The investigators hypothesized that dual-hormone closed-loop strategy is more effective in regulating overnight glucose levels in adults and adolescents with type 1 diabetes compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy.

Read the detailed description

Closed-loop strategy 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. A dual-hormone closed-loop system would regulate glucose levels through the infusion of two hormone: insulin and glucagon.

We aim to conduct a multicenter study to compare the efficacy of conventional pump therapy, single-hormone closed-loop strategy and dual-hormone closed-loop strategy to regulate overnight glucose levels, at home, in adolescents and adults with type 1 diabetes. Each intervention will be tested on two nights: 1) After a carbohydrate-rich dinner meal (to exaggerate hyperglycemic risk and; 2) After an evening exercise (to exaggerate hypoglycemic risk).

Conditions
Type 1 Diabetes
Being tested
Carbohydrate-rich meal, Exercise
Keywords
Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop system, Artificial pancreas
Medical subject headings
Diabetes Mellitus, Type 1, Hypoglycemia, Insulin Resistance

What participants receive

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

  • Carbohydrate-rich mealOther

    At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females). Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.

  • ExerciseOther

    Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve. The workout will be on a treadmill and/or a stationary bicycle. Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.

Study groups in NCT01905020
Study groupRoleWhat they receive
Conventional insulin pump therapryActive comparatorSubjects will use conventional pump therapy to regulate their glucose levels.
Receives: Other: Carbohydrate-rich meal; Other: Exercise
Single-hormone closed-loop systemActive comparatorVariable subcutaneous insulin infusion rate will be used to regulate glucose levels. Insulin Aspart (Novorapid) will be infused using a subcutaneous infusion pump. The glucose level as measured by the real time sensor 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 recommendations of infusion rates.
Receives: Other: Carbohydrate-rich meal; Other: Exercise
Dual-hormone closed-loop systemActive comparatorInsulin Aspart (Novorapid) and glucagon (Paladin) will be infused using two separate subcutaneous infusion pumps. The glucose levels as measured by the real time sensor will be entered manually into the computer every 10 minutes. The pumps' infusion rate will then be changed manually based on the computer generated-recommendation delivery levels.
Receives: Other: Carbohydrate-rich meal; Other: Exercise

What is being measured

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

  1. Percentage of time in target range

    Percentage of time for which glucose levels (as measured by the glucose sensor) are in target range. Target range is defined to be between 4.0 to 8.0 mmol/L

    Measured: 8 hours

Secondary outcomes (15)

  1. Percentage of time in target range for each night separately

    Percentage of time for which glucose levels are in target range for each night separately. Target range is defined to be between 4.0 and 8.0 mmol/L.

    Measured: 8 hours

  2. Percentage of time in target range for the pooled data

    Percentage of time for which glucose levels are in target range for the pooled data. Target range is defined to be between 4.0 to 8.0 mmol/L.

    Measured: 8 hours

  3. Percentage of time spent below 4.0 mmol/L

    Percentage of time for which glucose levels are below 4.0 mmol/L.

    Measured: 8 hours

  4. Percentage of time spent below 3.3 mmol/L

    Percentage of time for which glucose levels are spent below 3.3 mmol/L.

    Measured: 8 hours

  5. Area under the curve for glucose levels below 4.0 mmol/L

    Measured: 8 hours

  6. Area under the curve for glucose levels below 3.3 mmol/L

    Measured: 8 hours

  7. Percentage of time spent above 8.0 mmol/L

    Percentage of time for which glucose levels are above 8.0 mmol/L

    Measured: 8 hours

  8. Percentage of time spent above 10.0 mmol/L

    Percentage of time for which glucose levels are above 10.0 mmol/L.

    Measured: 8 hours

  9. Area under the curve for glucose levels spent above 8.0 mmol/L

    Measured: 8 hours

  10. Area under the curve for glucose levels spent above 10.0 mmol/L

    Measured: 8 hours

  11. Mean glucose levels

    Measured: 8 hours

  12. Standard deviation of glucose levels

    Standard deviation of glucose levels as a measure of glucose variability.

    Measured: 8 hours

  13. Total insulin delivery

    Measured: 8 hours

  14. Number of subjects experiencing at least one hypoglycemic event requiring treatment

    Measured: 8 hours

  15. Number of hypoglycemic events requiring treatment

    Measured: 8 hours

Timeline

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

  1. First posted22 Jul 2013 (estimated)
  2. Study startJul 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

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
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01905020
Sponsor's protocol ID
CLASS-04
Status last verified
Oct 2014
First submitted
12 Jul 2013
Last updated
21 Oct 2014
Results posted
No
Data monitoring committee
No

Publications

  • Haidar A, Rabasa-Lhoret R, Legault L, Lovblom LE, Rakheja R, Messier V, D'Aoust E, Falappa CM, Justice T, Orszag A, Tschirhart H, Dallaire M, Ladouceur M, Perkins BA. Single- and Dual-Hormone Artificial Pancreas for Overnight Glucose Control in Type 1 Diabetes. J Clin Endocrinol Metab. 2016 Jan;101(1):214-23. doi: 10.1210/jc.2015-3003. Epub 2015 Nov 2.

    PubMed 26523526

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Carbohydrate-rich meal and Exercise in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 3 sites 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 6 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 21 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 in target range (time frame: 8 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 NCT01905020, 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 21 Oct 2014.

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