New Insulin Therapy by Multiwave Bolus

NCT03311516 | Unknown

• 1 other identifier: 2017-A02414-49
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

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.

Conditions

Type1diabetes

Keywords

insulin therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Continuous Glucose Measurement (CGM)

  at 14 weeks and at 28 weeks since the patient randomization

• HbA1c

  at 14 weeks and at 28 weeks since the patient randomization

• Sensor wearing time

  12 weeks, 14 weeks, 26 weeks and 28 weeks since the patient randomization

• Number of sensor scans

  14 weeks and 28 weeks since the patient randomization

• Number of boluses performed

  at 14 weeks and at 28 weeks since the patient randomization

Study Arms (2)

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

Other: New functional insulin therapy

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.

Other: functional insulin therapy

Interventions

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

Also known as: FIT based on a Carbohydrate / Lipid / Protein count

Group A

functional insulin therapy OTHER

the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to FIT

Also known as: FIT based on a carbohydrate count only

Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead
• Central Hospital, Reims, France: collaborator
• Central Hospital, Toulouse, France: collaborator
• Central Hospital, Strasbourg, France: collaborator
• Central Hospital, Besançon, France: collaborator
• Central Hospital, Dijon, France: collaborator

Study Sites (6)

Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition

Besançon, France

NOT YET RECRUITING

Service d'endocrinologie et maladies métaboliques

Dijon, France

RECRUITING

Service d'Endocrinologie, Diabétologie et Nutrition

Nancy, France

RECRUITING

Service Endocrinologie Diabète Nutrition

Reims, France

NOT YET RECRUITING

Structure d'Endocrinologie, Diabète et Nutrition

Strasbourg, France

NOT YET RECRUITING

Service de diabétologie, maladies métaboliques et nutrition

Toulouse, France

NOT YET RECRUITING

MeSH Terms

Interventions

Lipids

Central Study Contacts

SIHAM BENZIRAR

CONTACT

0033383155028; s.benzirar@chru-nancy.fr

JULIE LECOMTE-LEHMANN

CONTACT

0033383155278; ju.lecomte@chru-nancy.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: October 17, 2017
• Study Start: October 10, 2019
• Primary Completion: December 1, 2020
• Study Completion: June 1, 2021
• Last Updated: July 23, 2020

Record last verified: 2020-07

Locations

FR (6)