Clinical trial NCT03311516: New Insulin Therapy by Multiwave Bolus
Official title: Evaluation of Insulin Therapy by Multiwave Bolus Based on the Lipid and Protein Content in Addition to the Carbohydrates Content Compared to Insulin Therapy Based Only on the Carbohydrates Content in type1 Diabetes Treated by Insulin Pump
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type1diabetes
Keywords: insulin therapy
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
Collaborators: name: Central Hospital, Reims, France
name: Central Hospital, Toulouse, France
name: Central Hospital, Strasbourg, France
name: Central Hospital, Besançon, France
name: Central Hospital, Dijon, France
First posted: 2017-10-17
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetic patient for more than one year, practicing functional insulin for at least 3 months but not more than 5 years
* Patient treated with external insulin pump (Medtronic or Omnipod pump)
* Patient performing intermittent blood glucose monitoring by the continuous interstitial glucose measurement system (Freestyle Libre) and who regularly wears this device with an achievement of at least 4 scans per day to obtain at least 90% of the possible values
* Patient with HbA1c ≤10.0% less than 3 months
* Patient with a willingness and ability to comply with study requirements and schedule of visits
* Patient who received complete information and signed informed consent

Exclusion Criteria:

* Patient with contraindication for rapid or ultra-rapid insulin analogues
* Patient for whom a change of insulin in the next 3 to 6 months is planned
* Women of childbearing age who do not have effective contraception
* Women who are pregnant or breast feeding or plan on becoming pregnant during the study
* Patient taking medication that interferes with interpretation of study results such as chronic corticosteroid therapy
* Patient with a chimio - or radiotherapy is in progress or is planned
* Patient abusing substances
* Patient who participated in another clinical study in the four weeks prior to inclusion
* Patient with or suspected of having any physical, psychological or cognitive disorders interfering with adherence to insulin therapy by pump, or compliance with dietary advice, or completion of the patient's diary
* Patient unable to comply with clinical guidelines, and unable to comply with 3-month follow-up
* Patient unable to understand information, to sign informed consent or to manage glycemic sensor

Primary outcomes:
measure: The ratio of normoglycemia values to total glucose values
timeFrame: at 14 weeks since the patient randomization
Secondary outcomes:
measure: Continuous Glucose Measurement (CGM)
timeFrame: at 14 weeks and at 28 weeks since the patient randomization
measure: HbA1c
timeFrame: at 14 weeks and at 28 weeks since the patient randomization
measure: Sensor wearing time
timeFrame: 12 weeks, 14 weeks, 26 weeks and 28 weeks since the patient randomization
measure: Number of sensor scans
timeFrame: 14 weeks and 28 weeks since the patient randomization
measure: Number of boluses performed
timeFrame: at 14 weeks and at 28 weeks since the patient randomization
measure: Satisfaction of the patient with regard to his treatment
timeFrame: at inclusion, at 12 weeks and 26 weeks since randomisation
measure: Usability of the insulin pump
timeFrame: 14 weeks and 28 weeks since the patient randomization
Other outcomes:
Locations:
city: Besançon
country: France
facility: Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition
city: Dijon
country: France
facility: Service d'endocrinologie et maladies métaboliques
city: Nancy
country: France
facility: Service d'Endocrinologie, Diabétologie et Nutrition
city: Reims
country: France
facility: Service Endocrinologie Diabète Nutrition
city: Strasbourg
country: France
facility: Structure d'Endocrinologie, Diabète et Nutrition
city: Toulouse
country: France
facility: Service de diabétologie, maladies métaboliques et nutrition
Study officials:
References: