Status:
COMPLETED
Personalized Glucose Predictive and Therapy Advisory System - DIAdvisor 2
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The primary purpose of this study is to see whether a tool that predict blood glucose and suggest therapy advices can help type 1 diabetic patients.
Detailed Description
During this study, we would like to assess the efficacy in keeping blood glucose in a safe range (70-180 mg/dL) of the second generation of a Glucose Predictive and Therapy Advisory system in diabetic...
Eligibility Criteria
Inclusion
- Patient must be aged between 18 (inclusive) and 70 years old
- Patients diagnosed with type 1 or type 2 diabetes according to WHO criteria for at least one year prior to study entry
- Patient treated by a basal-bolus insulin therapy using an external pump or multiple-daily injections. The insulin regimen has to be stable for the previous six months. NPH insulin use will not be acceptable.
- Patient should have stable diabetes with a HbA1c between ≥ 7.5 % and \< 10.5 % with no keto-acidosis for the previous 6 months.
- Patient must have a Body Mass Index (BMI) lower than 35 Kg/m²
- Patient must be willing to undergo all study procedures
- Patient must be affiliated or beneficiary of a social medical insurance
- Patient has signed informed consent form prior to study entry
Exclusion
- Patient is pregnant, or breast feeding during the period of the study
- Patient has impaired renal function with a creatinine blood concentration over 150 μmol/L
- Patient has a liver disease (ALAT, ASAT \> 2 x upper limit of normal range)
- Patient is treated by sulfamides, GLP-1 analogues, DPP-IV inhibitors or glitazones
- Alcohol or drug addiction, as identified by investigator during screening visit
- Allergy to sensors or one of their components
- Manifest psychological disorders
- Patient health status is not compatible with physical exercise
- Patient is actively enrolled in another clinical trial or was part of study within 30 days
- Persons deprived of freedom, adults protected by law or vulnerable persons
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01512654
Start Date
September 1 2008
End Date
June 1 2012
Last Update
October 20 2021
Active Locations (3)
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1
Institute for Clinical and Experimental Medicine
Prague, Czechia, 14021
2
Montpellier University Hospital
Montpellier, France, 34000
3
Universita Degli Studi di Padova
Padua, Italy, 35128