Clinical trial NCT01512654: Personalized Glucose Predictive and Therapy Advisory System - DIAdvisor 2
Official title: Assessment of an Enhanced Version of a Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor-2) for Diabetic Patients Treated by Basal-Bolus Insulin Regimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Keywords: diabetes
diadvisor
type 1 diabetes
type 2 diabetes
glucose prediction
cgm prediction
algorithm
therapy advices
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-01-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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 patients treated by basal-bolus insulin regimens using pumps or multiple daily injections. We want to compare the time spent in safe range while using the predictor and advisor outputs and when the patient is not using them. This is a randomized controlled crossover trial. Patient will come for two admissions of 3 days, one with the DIAdvisor system fully activated, and one with the prediction and advice features disabled.

Eligibility criteria: Inclusion Criteria:

1. Patient must be aged between 18 (inclusive) and 70 years old
2. Patients diagnosed with type 1 or type 2 diabetes according to WHO criteria for at least one year prior to study entry
3. 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.
4. Patient should have stable diabetes with a HbA1c between ≥ 7.5 % and \< 10.5 % with no keto-acidosis for the previous 6 months.
5. Patient must have a Body Mass Index (BMI) lower than 35 Kg/m²
6. Patient must be willing to undergo all study procedures
7. Patient must be affiliated or beneficiary of a social medical insurance
8. Patient has signed informed consent form prior to study entry

Exclusion Criteria:

1. Patient is pregnant, or breast feeding during the period of the study
2. Patient has impaired renal function with a creatinine blood concentration over 150 μmol/L
3. Patient has a liver disease (ALAT, ASAT \> 2 x upper limit of normal range)
4. Patient is treated by sulfamides, GLP-1 analogues, DPP-IV inhibitors or glitazones
5. Alcohol or drug addiction, as identified by investigator during screening visit
6. Allergy to sensors or one of their components
7. Manifest psychological disorders
8. Patient health status is not compatible with physical exercise
9. Patient is actively enrolled in another clinical trial or was part of study within 30 days
10. Persons deprived of freedom, adults protected by law or vulnerable persons

Primary outcomes:
measure: Percentage of total time spent by patients in safe range (70-180mg/dL)
timeFrame: during 3 days with DIAdvisor 2
Secondary outcomes:
measure: Percentage of total time spent in hypoglycemia (< 70 mg/dL)
timeFrame: during 3 days with DIAdvisor 2
measure: Percentage of total of time spent in hyperglycemia (>180 mg/dL)
timeFrame: during 3 days with DIAdvisor 2
measure: Mean of YSI blood glucose during total period, night time and meal periods
timeFrame: during the two 3 days-hospitalizations
measure: Percentage paired glucose values
timeFrame: during 3 days with DIAdvisor 2
measure: Coherence between system advices and physician recommendations > 0.80
timeFrame: during 3 days with DIAdvisor 2
measure: Score of patient survey regarding the acceptability of DIAdvisor-2 system
timeFrame: during 3 days with DIAdvisor 2
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
city: Montpellier
country: France
facility: Montpellier University Hospital
city: Padova
country: Italy
facility: Universita Degli Studi di Padova
Study officials:
References: