New Insulin Therapy by Multiwave Bolus

Type1diabetes Clinical Trial

— EVANEWFIT2  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03311516
• Other study ID #: 2017-A02414-49
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2019
• Est. completion date: June 2021

Study information

• Verified date: July 2020
• Source: Central Hospital, Nancy, France
• Contact: SIHAM BENZIRAR
• Phone: 0033383155028
• Email: s.benzirar[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

Other:
• New functional insulin therapy
the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to a new FIT
• functional insulin therapy
the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to FIT

Locations

Country	Name	City	State
France	Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition	Besançon
France	Service d'endocrinologie et maladies métaboliques	Dijon
France	Service d'Endocrinologie, Diabétologie et Nutrition	Nancy
France	Service Endocrinologie Diabète Nutrition	Reims
France	Structure d'Endocrinologie, Diabète et Nutrition	Strasbourg
France	Service de diabétologie, maladies métaboliques et nutrition	Toulouse

Sponsors (6)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Central Hospital, Besançon, France, Central Hospital, Dijon, France, Central Hospital, Reims, France, Central Hospital, Strasbourg, France, Central Hospital, Toulouse, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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	at 14 weeks and at 28 weeks since the patient randomization
Secondary	HbA1c	HbA1C dosage to assess glycemic control	at 14 weeks and at 28 weeks since the patient randomization
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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