Back to resultsNew Insulin Therapy by Multiwave Bolus (EVANEWFIT2)
Primary Purpose
Type1diabetes
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
New functional insulin therapy
functional insulin therapy
Sponsored by
About this trial
This is an interventional treatment trial for Type1diabetes focused on measuring insulin therapy
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
Sites / Locations
- Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition
- Service d'endocrinologie et maladies métaboliquesRecruiting
- Service d'Endocrinologie, Diabétologie et NutritionRecruiting
- Service Endocrinologie Diabète Nutrition
- Structure d'Endocrinologie, Diabète et Nutrition
- Service de diabétologie, maladies métaboliques et nutrition
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Group A
Group B
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
HbA1c
HbA1C dosage to assess glycemic control
Sensor wearing time
Sensor wearing time over the 3-month period and the 13-day CGM recording period
Number of sensor scans
Number of sensor scans performed by the patient with corresponding time periods
Number of boluses performed
Number of boluses performed over the 13-day period of the CGM
Satisfaction of the patient with regard to his treatment
Patient satisfaction assessed by the DTSQs (status) and DTSQc (change)
Usability of the insulin pump
Evaluate the use of pump functions by patient ex. Bolus calculator, Temporary base rate
Full Information
NCT ID
NCT03311516
First Posted
October 12, 2017
Last Updated
July 21, 2020
Sponsor
Central Hospital, Nancy, France
Collaborators
Central Hospital, Reims, France, Central Hospital, Toulouse, France, Central Hospital, Strasbourg, France, Central Hospital, Besançon, France, Central Hospital, Dijon, France
1. Study Identification
Unique Protocol Identification Number
NCT03311516
Brief Title
New Insulin Therapy by Multiwave Bolus
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 10, 2019 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Hospital, Nancy, France
Collaborators
Central Hospital, Reims, France, Central Hospital, Toulouse, France, Central Hospital, Strasbourg, France, Central Hospital, Besançon, France, Central Hospital, Dijon, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
Keywords
insulin therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group A
Arm Type
Experimental
Arm Description
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
Arm Title
Group B
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
New functional insulin therapy
Other Intervention Name(s)
FIT based on a Carbohydrate / Lipid / Protein count
Intervention Description
the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to a new FIT
Intervention Type
Other
Intervention Name(s)
functional insulin therapy
Other Intervention Name(s)
FIT based on a carbohydrate count only
Intervention Description
the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to FIT
Primary Outcome Measure Information:
Title
The ratio of normoglycemia values to total glucose values
Description
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
Secondary Outcome Measure Information:
Title
Continuous Glucose Measurement (CGM)
Description
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
Title
HbA1c
Description
HbA1C dosage to assess glycemic control
Time Frame
at 14 weeks and at 28 weeks since the patient randomization
Title
Sensor wearing time
Description
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
Title
Number of sensor scans
Description
Number of sensor scans performed by the patient with corresponding time periods
Time Frame
14 weeks and 28 weeks since the patient randomization
Title
Number of boluses performed
Description
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
Title
Satisfaction of the patient with regard to his treatment
Description
Patient satisfaction assessed by the DTSQs (status) and DTSQc (change)
Time Frame
at inclusion, at 12 weeks and 26 weeks since randomisation
Title
Usability of the insulin pump
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SIHAM BENZIRAR
Phone
0033383155028
Email
s.benzirar@chru-nancy.fr
First Name & Middle Initial & Last Name or Official Title & Degree
JULIE LECOMTE-LEHMANN
Phone
0033383155278
Email
ju.lecomte@chru-nancy.fr
Facility Information:
Facility Name
Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition
City
Besançon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie BOROT
Phone
0033381668229
Email
sophie.borot@univ-fcomte.fr
First Name & Middle Initial & Last Name & Degree
Sophie BOROT
Facility Name
Service d'endocrinologie et maladies métaboliques
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine RUDONI
Phone
0033380293453
Email
sabine.rudoni@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Sabine RUDONI
Facility Name
Service d'Endocrinologie, Diabétologie et Nutrition
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Siham BENZIRAR
Phone
0033383155028
Email
s.benzirar@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Bruno GUERCI
Facility Name
Service Endocrinologie Diabète Nutrition
City
Reims
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandrine PLISSON-RONEZ
Phone
0033326787159
Email
splisson-ronez@chu-reims.fr
First Name & Middle Initial & Last Name & Degree
Céline LUKAS-CROISIER
Facility Name
Structure d'Endocrinologie, Diabète et Nutrition
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphanie Kocakaya
Phone
0033388116603
Email
Stephanie.KOCAKAYA@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Nathalie JEANDIDIER
First Name & Middle Initial & Last Name & Degree
Laurent MEYER
Facility Name
Service de diabétologie, maladies métaboliques et nutrition
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent CAZALS
Phone
0033561323361
Email
cazals.l@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Hélène HANAIRE
12. IPD Sharing Statement
Learn more about this trial
New Insulin Therapy by Multiwave Bolus
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