The aim of the study is to evaluate the effect of insulin therapy when the bolus dose of insulin is calculated on the basis of protein and fat content in food intake, in addition to that of carbohydrates in T1D patients treated by insulin pump. The study is planned to recruit 150 patients with type1 diabetes already practicing functional insulin therapy based on carbohydrate counting in meals. We will therefore study the effect on continuous glucose measured by subcutaneous sensor, of meal bolus adjustments by comparing two groups of T1D patients: * Groupe A takes into account the lipid and protein content in addition to the carbohydrate content * Group B takes into account the carbohydrate content only At randomization, all patients receive dietary and adjustment of bolus doses instructions according to the randomization group. They have to apply these instructions for 3 months. At the end of 3 months, the study groups will be under glucose monitoring during two weeks in the Outpatient Clinic but returns to the investigational site in hospital to download data from the continuous measurement of glucose. In addition, we propose a period of extension similar to that of the main period, namely 3 months of application of dietetic and adaptation of bolus doses instructions and 2 weeks of continuous measurement of glucose. During each 2 weeks period will be assessed specific glucose parameters in the post-prandial period over 4hours (glycemic sensor values in the glucose range between 70-140 mg / dl, glycemic sensor values in the glucose range between 140 -180 mg /dl and \> 180 mg /dl) after taking each meal during the 13 days of Glucose Continuous Measurement (GCM), average daily glucose per meal, average blood glucose over the 13-day period after each meal.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
150
the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to a new FIT
the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to FIT
Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition
Besançon, France
NOT_YET_RECRUITINGService d'endocrinologie et maladies métaboliques
Dijon, France
RECRUITINGService d'Endocrinologie, Diabétologie et Nutrition
Nancy, France
RECRUITINGService Endocrinologie Diabète Nutrition
Reims, France
NOT_YET_RECRUITINGStructure d'Endocrinologie, Diabète et Nutrition
Strasbourg, France
NOT_YET_RECRUITINGService de diabétologie, maladies métaboliques et nutrition
Toulouse, France
NOT_YET_RECRUITINGThe ratio of normoglycemia values to total glucose values
The ratio (expressed as a%) of the number of normoglycemia values over the total number of values collected over the 13-day period of the glucose monitoring
Time frame: at 14 weeks since the patient randomization
Continuous Glucose Measurement (CGM)
Specific glycemic parameters in the post-prandial period over 4h (glycemic sensor values in the blood glucose range between 70-140 mg / dl, glycemic sensor values in the blood glucose area between 140 - 180 mg / dL and\> 180 Mg / dl) after taking each meal during the 13 days of CGM, average daily glucose per meal, average blood glucose over the 13-day period after each meal
Time frame: at 14 weeks and at 28 weeks since the patient randomization
HbA1c
HbA1C dosage to assess glycemic control
Time frame: at 14 weeks and at 28 weeks since the patient randomization
Sensor wearing time
Sensor wearing time over the 3-month period and the 13-day CGM recording period
Time frame: 12 weeks, 14 weeks, 26 weeks and 28 weeks since the patient randomization
Number of sensor scans
Number of sensor scans performed by the patient with corresponding time periods
Time frame: 14 weeks and 28 weeks since the patient randomization
Number of boluses performed
Number of boluses performed over the 13-day period of the CGM
Time frame: at 14 weeks and at 28 weeks since the patient randomization
Satisfaction of the patient with regard to his treatment
Patient satisfaction assessed by the DTSQs (status) and DTSQc (change)
Time frame: at inclusion, at 12 weeks and 26 weeks since randomisation
Usability of the insulin pump
Evaluate the use of pump functions by patient ex. Bolus calculator, Temporary base rate
Time frame: 14 weeks and 28 weeks since the patient randomization
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