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| Name | Class |
|---|---|
| Central Hospital, Reims, France | UNKNOWN |
| Central Hospital, Toulouse, France | UNKNOWN |
| Central Hospital, Strasbourg, France | UNKNOWN |
| Central Hospital, Besançon, France |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Group A = intervention group (new functional insulin therapy) who adjusts the insulin bolus according to a dose titration algorithm taking into account the lipid and protein content in addition to that of carbohydrates. The functional insulin therapy is based on a Carbohydrate / Lipid / Protein count |
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| Group B | Other | Group B=control group (functional insulin tehrapy) who adjusts the insulin bolus taking into account only the carbohydrate content. The functional insulin therapy is based on a Carbohydrate count only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| New functional insulin therapy | Other | the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to a new FIT |
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| Measure | Description | Time Frame |
|---|---|---|
| The 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 | at 14 weeks since the patient randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| SIHAM BENZIRAR | Contact | 0033383155028 | s.benzirar@chru-nancy.fr | |
| JULIE LECOMTE-LEHMANN | Contact | 0033383155278 | ju.lecomte@chru-nancy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition | Not yet recruiting | Besançon | France |
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| ID | Term |
|---|---|
| D008055 | Lipids |
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| UNKNOWN |
| Central Hospital, Dijon, France | UNKNOWN |
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| functional insulin therapy | Other | the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to FIT |
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| at 14 weeks and at 28 weeks since the patient randomization |
| HbA1c | HbA1C dosage to assess glycemic control | 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 | 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 | 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 | 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) | 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 | 14 weeks and 28 weeks since the patient randomization |
| Service d'endocrinologie et maladies métaboliques | Recruiting | Dijon | France |
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| Service d'Endocrinologie, Diabétologie et Nutrition | Recruiting | Nancy | France |
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| Service Endocrinologie Diabète Nutrition | Not yet recruiting | Reims | France |
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| Structure d'Endocrinologie, Diabète et Nutrition | Not yet recruiting | Strasbourg | France |
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| Service de diabétologie, maladies métaboliques et nutrition | Not yet recruiting | Toulouse | France |
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