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Clinical Trial Details

Trial ID: L6747
Source ID: NCT02229097
Associated Drug: Normal Bolus
Title: Efficacy of Coordinated Insulin Boluses in Type 1 Diabetic Patients
Acronym: COBOL
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 1 Diabetes
Interventions: DRUG: Normal bolus|DRUG: Coordinated bolus
Outcome Measures: Primary: postprandial glycaemia, measured by Self Monitoring of Blood Glucose, 2 hours after eating during 4 weeks | Secondary: adverse events, Throughout the study (4 weeks)|severe hypoglycaemia frequency, Throughout the study (4 weeks)|insulin doses, basal rate and boluses|mean glycaemia, data from Self Monitoring of Blood Glucose, before eating and 2 hours after eating during 4 weeks|standard deviation of glycaemia, data from Self Monitoring of Blood Glucose, before eating and 2 hours after eating during 4 weeks|frequency of glycaemia < or = 60mg/dl, data from Self Monitoring of Blood Glucose, before eating and 2 hours after eating during 4 weeks|frequency of glycaemia between 61-140mg/dl, data from Self Monitoring of Blood Glucose, before eating and 2 hours after eating during 4 weeks|frequency of glycaemia >140mg/dl, data from Self Monitoring of Blood Glucose, before eating and 2 hours after eating during 4 weeks|mean glycemia, data from Continue Glycemia Monitoring, Throughout the day during 4 weeks|standard deviation, data from Continue Glycemia Monitoring, Throughout the day during 4 weeks|time spent within glucose range < or = 60mg/dl, data from Continue Glycemia Monitoring, Throughout the day during 4 weeks|time spent within glucose range between 61-140mg/dl, data from Continue Glycemia Monitoring, Throughout the day during 4 weeks|time spent within glucose range mg/dl, data from Continue Glycemia Monitoring, Throughout the day during 4 weeks|fructosamine, day 1|fructosamine, day 1 + 2 weeks|fructosamine, day 1 + 4 weeks
Sponsor/Collaborators: Sponsor: University Hospital, Toulouse
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 17
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2014-10
Completion Date: 2016-11
Results First Posted:
Last Update Posted: 2017-02-23
Locations: University Hospital Toulouse Rangueil, Toulouse, Haute Garonne, 31059, France|Saint-André Hospital, Bordeaux, 33000, France|Lapeyronie Hospital, Montpellier, 34295, France
URL: https://clinicaltrials.gov/show/NCT02229097