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 children with type 1 diabetes in a diabetes camp. The investigators hypothesized that dual-hormone closed-loop strategy reduces the time spent in hypoglycemia in children with type 1 diabetes (T1D) compared to single-hormone closed-loop strategy, which in turn is more effective than the conventional pump therapy to reduce time spent in hypoglycemia
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. The investigators aim to conduct a randomized three-way cross-over trial comparing single hormone closed-loop strategy, dual-hormone closed-loop strategy and the conventional pump therapy. The investigators aim to compare the three interventions for 3 consecutive nights in children with type 1 diabetes in a diabetes camp.
Interventions
Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
DEVICEDual-hormone closed-loop strategy
Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) and Glucagon (Eli Lilly and Company) will be used.
DEVICEInsulin pump therapy
Subjects will use conventional pump therapy to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
Sponsors
Montreal Children's Hospital of the MUHC
Institut de Recherches Cliniques de Montreal
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
* Males or females between the 8 and 17 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. * HbA1c ≤ 11.0%.
Exclusion criteria
* Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. * Severe hypoglycemic episode within two weeks of inclusion in the study. A severe hypoglycemic episode is defined as loss of conscience, seizure or a hospital emergency visit. * Current use of oral glucocorticoid medication (except low stable dose according to investigator judgement). Stable doses of inhaled steroids are acceptable. * Known or suspected allergy to the trial products. * Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. * Failure to comply with team's recommendations (e.g. not willing to use trial pump, etc).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of time of glucose levels spent below 4.0 mmol/L. | Up to 8 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time of glucose levels spent below 3.5 mmol/L | Up to 8 hours | — |
| Percentage of time of glucose levels spent below 3.3 mmol/L | Up to 8 hours | — |
| Percentage of time of glucose levels spent above 8 mmol/L | Up to 8 hours | — |
| Percentage of time of glucose levels spent above 10 mmol/L. | Up to 8 hours | — |
| Area under the curve of glucose levels below 4.0 mmol/L | Up to 8 hours | — |
| Area under the curve of glucose levels below 3.5 mmol/L | Up to 8 hours | — |
| Area under the curve of glucose levels below 3.3 mmol/L | Up to 8 hours | — |
| Percentage of time of glucose levels spent between 4.0 and 8.0 mmol/L | Up to 8 hours | — |
| Area under the curve of glucose levels above 10.0 mmol/L. | Up to 8 hours | — |
| Mean glucose levels. | Up to 8 hours | — |
| Standard deviation of glucose levels | Up to 8 hours | Measure of glucose variability. |
| Total insulin delivery | Up to 8 hours | — |
| Hypoglycemic risk assessed by the total number of hypoglycemic event (> 15 minutes) below 3.1 mmol/L | Up to 8 hours | — |
| Hypoglycemic risk assessed by the number of patients experiencing at least one hypoglycemic event (> 15 minutes) below 3.1 mmol/L | Up to 8 hours | — |
| Area under the curve of glucose levels above 8.0 mmol/L | Up to 8 hours | — |
Countries
Canada
Outcome results
None listed