New Insulin Therapy by Multiwave Bolus (EVANEWFIT2)

July 21, 2020 updated by: Central Hospital, Nancy, France

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

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 Overview

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Besançon, France
        • Not yet recruiting
        • Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition
        • Contact:
        • Principal Investigator:
          • Sophie Borot
      • Dijon, France
        • Recruiting
        • Service d'endocrinologie et maladies métaboliques
        • Contact:
        • Principal Investigator:
          • Sabine RUDONI
      • Nancy, France
        • Recruiting
        • Service d'Endocrinologie, Diabétologie et Nutrition
        • Contact:
        • Principal Investigator:
          • Bruno GUERCI
      • Reims, France
        • Not yet recruiting
        • Service Endocrinologie Diabète Nutrition
        • Contact:
        • Principal Investigator:
          • Céline LUKAS-CROISIER
      • Strasbourg, France
        • Not yet recruiting
        • Structure d'Endocrinologie, Diabète et Nutrition
        • Contact:
        • Principal Investigator:
          • Nathalie Jeandidier
        • Sub-Investigator:
          • Laurent MEYER
      • Toulouse, France
        • Not yet recruiting
        • Service de diabétologie, maladies métaboliques et nutrition
        • Contact:
        • Principal Investigator:
          • Hélène Hanaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
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
the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to a new FIT
Other Names:
  • FIT based on a Carbohydrate / Lipid / Protein count
Other: Group B
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.
the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to FIT
Other Names:
  • FIT based on a carbohydrate count only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The ratio of normoglycemia values to total glucose values
Time Frame: at 14 weeks since the patient randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Continuous Glucose Measurement (CGM)
Time Frame: at 14 weeks and at 28 weeks since the patient randomization
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
HbA1c
Time Frame: at 14 weeks and at 28 weeks since the patient randomization
HbA1C dosage to assess glycemic control
at 14 weeks and at 28 weeks since the patient randomization
Sensor wearing time
Time Frame: 12 weeks, 14 weeks, 26 weeks and 28 weeks since the patient randomization
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
Time Frame: 14 weeks and 28 weeks since the patient randomization
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
Time Frame: at 14 weeks and at 28 weeks since the patient randomization
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
Time Frame: at inclusion, at 12 weeks and 26 weeks since randomisation
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
Time Frame: 14 weeks and 28 weeks since the patient randomization
Evaluate the use of pump functions by patient ex. Bolus calculator, Temporary base rate
14 weeks and 28 weeks since the patient randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2019

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

October 12, 2017

First Submitted That Met QC Criteria

October 12, 2017

First Posted (Actual)

October 17, 2017

Study Record Updates

Last Update Posted (Actual)

July 23, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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