Type 1 Diabetes
Conditions
Keywords
Type 1 diabetes, Hypoglycemia, Insulin, Glucagon, Closed-loop system, Artificial pancreas
Brief 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. 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.
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).
Interventions
OTHERCarbohydrate-rich meal
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.
OTHERExercise
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.
Sponsors
Montreal Children's Hospital of the MUHC
Mount Sinai Hospital, New York
McGill University
Institut de Recherches Cliniques de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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). * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time in target range | 8 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time in target range for the pooled data | 8 hours | 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. |
| Percentage of time spent below 4.0 mmol/L | 8 hours | Percentage of time for which glucose levels are below 4.0 mmol/L. |
| Percentage of time spent below 3.3 mmol/L | 8 hours | Percentage of time for which glucose levels are spent below 3.3 mmol/L. |
| Area under the curve for glucose levels below 4.0 mmol/L | 8 hours | — |
| Area under the curve for glucose levels below 3.3 mmol/L | 8 hours | — |
| Percentage of time spent above 8.0 mmol/L | 8 hours | Percentage of time for which glucose levels are above 8.0 mmol/L |
| Percentage of time spent above 10.0 mmol/L | 8 hours | Percentage of time for which glucose levels are above 10.0 mmol/L. |
| Percentage of time in target range for each night separately | 8 hours | 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. |
| Area under the curve for glucose levels spent above 10.0 mmol/L | 8 hours | — |
| Mean glucose levels | 8 hours | — |
| Standard deviation of glucose levels | 8 hours | Standard deviation of glucose levels as a measure of glucose variability. |
| Total insulin delivery | 8 hours | — |
| Number of subjects experiencing at least one hypoglycemic event requiring treatment | 8 hours | — |
| Number of hypoglycemic events requiring treatment | 8 hours | — |
| Area under the curve for glucose levels spent above 8.0 mmol/L | 8 hours | — |
Countries
Canada
Outcome results
None listed