Type 1 Diabetes
Conditions
Keywords
Glycemic control algorithm, closed loop, artificial pancreas
Brief summary
To assess whether the DIABELOOP algorithm provides better glycemic control than the usual algorithm of T1D patients on pump therapy: * at meals, with CHO roughly assessed by the patient. * during and after physical activity sessions qualified as moderate by the patient. Primary endpoint : time within the glycemic reference range. The study will be conduct with 15 patients at the following investigation centers : Corbeil Hospital, CHU of Grenoble, and CHU of Montpellier.
Detailed description
The 15 patients will have 2 visits during 24 hours (day and night), once with their usual algorithm and once with the Diabeloop system.
Interventions
the insulin dose is calculated by the Diabeloop algorithm and then administered to the patient
Sponsors
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient type 1 diabetic for at least one year * Patient treated by external insulin pump for at least 6 months * Patients with HbA1c \<9% * Patient affiliated with Social Security. * Patient able to perform two tests of physical activity of 30 minutes (one event in each treatment period); * aged at least 18 years Patient; * Patient who signed consent
Exclusion criteria
* All serious disease that could interfere with the study * BMI \> 30 kg/m2 * insulin requirement \> 2 U/kg/day * Patient benefiting from a measure of legal protection; * Pregnant or likely to be women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time spent in blood glucose range [70-180 mg/dl] | up to 24 hours after each treatment period | comparing the time spent in \[70-180 mg/dl\] with usual algorithm vs Diabeloop algorithm. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time spent Blood Glucose range [80-140 mg/dl] | 24 hours after each treatment period | Comparing the time spent in range \[80-140 mg/dl\] with usual algorithm vs Diabeloop algorithm |
| time spent below 70 mg/dl and above 180 mg/dl | up to 24 hours after each treatment period | — |
Countries
France
Outcome results
None listed