Status:
UNKNOWN
New Insulin Therapy by Multiwave Bolus
Lead Sponsor:
Central Hospital, Nancy, France
Collaborating Sponsors:
Central Hospital, Reims, France
Central Hospital, Toulouse, France
Conditions:
Type1diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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 carbohydra...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03311516
Start Date
October 10 2019
End Date
June 1 2021
Last Update
July 23 2020
Active Locations (6)
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1
Service d'Endocrinologie-Métabolisme et Diabétologie-Nutrition
Besançon, France
2
Service d'endocrinologie et maladies métaboliques
Dijon, France
3
Service d'Endocrinologie, Diabétologie et Nutrition
Nancy, France
4
Service Endocrinologie Diabète Nutrition
Reims, France