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Clinical Trial Details

Trial ID: L3698
Source ID: NCT01754181
Associated Drug: Insulin
Title: Initial Testing of the Diabeloop Algorithm in T1D Patients on Pump Therapy Over the Prandial Period and Physical Activity.
Acronym: DiabeloopWP6-0
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Insulin
Outcome Measures: Primary: Time spent in glucose reference intervals, After the end of the tests | Secondary: Measuring glucose sensor 2h, 3h and 4h post-prandial and AUC, in every situation tested to evaluate the efficacy and safety (time spent in hypoglycemia), To evaluate the efficacy and safety of prandial algorithm, informed carbohydrate intake by the patient either quantitatively or semi-quantitative, or not informed way., After the end of the tests | Other: Comparison of glucose sensor 2h, 3h and 4h post-prandial and AUC in conditions identical meals for each trigger level (50 or 75%). Measuring AUC during and 2 hours after physical activity, then to lunch time, during dinner and throughout the night., 1. Comparison of glucose sensor 2h, 3h and 4h post-prandial and AUC, in conditions identical meals for each trigger level (50 or 75%). 2. Comparison of blood glucose 2h, 3h and 4h post-prandial and AUC, in conditions identical meals for each trigger level, in three configurations: quantitative, semi-quantitative and bolus omitted. 3. Measuring AUC, during and 2 hours after physical activity, then to lunch time, during dinner and throughout the night; 4. Measure the time spent in hypoglycemia (\<0.70 g / l) 5. Measuring the number of carbohydrate ingested, After the end of the tests
Sponsor/Collaborators: Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 18
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2013-03
Completion Date: 2013-07
Results First Posted:
Last Update Posted: 2014-10-27
Locations: Centre Hospitalier Sud Francilien, Evry, 91058, France|University Hospital of Grenoble, Grenoble, 38043, France|University Hospital of Toulouse, Toulouse, 31403, France
URL: https://clinicaltrials.gov/show/NCT01754181