Evaluation of Functional Insulin Therapy in Type 1 Diabetic Patients — IFOPI  

Type 1 Diabetes Clinical Trial

Official title: Evaluation of Functional Insulin Therapy on Blood Glucose Control in Type 1 Diabetic Patients Treated by Insulin Pumps

Status Completed

Clinical Trial Summary

Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. The hypothesis is that FIT should lead to better glycemic control (HbA1c), less hypoglycemia and better quality of life. 60 patient will be enrolled and followed during one year.

Clinical Trial Description

Functional Insulin Therapy (FIT) is an heath care method proposed to type 1 diabetic patients which focuses on patient autonomy, carbs counting and insulin dose adaptation. In this study we plan to enroll 60 patients who will be educated toFIT and followed during one year. Patient will follow normal path of eductation which is composed of a 3 days inpatient admission, a medical visit one month after the education, and a 4hours reminder session six months after the education. We will compare HbA1c, hypoglycemia, weight, before the education, and after. Patient will also wear a continuous glucose sensor during one week before, at month 6 and month 12 to allow comparison of glucose variablity. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

• NCT number: NCT01512680
• Study type: Interventional
• Source: University Hospital, Montpellier
• Status: Completed
• Phase: Phase 2
• Start date: November 2011
• Completion date: November 2015