Personalized Glucose Predictive and Therapy Advisory System - DIAdvisor 2

NCT ID: NCT01512654

Last Updated: 2021-10-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2012-06-30

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.

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

algorithm DIAdvisor activated

Glucose predictions and therapy advices will be displayed to the patient. Patients will be asked to follow the advices suggested by DIAdvisor system according to their own judgement. Patient will decide his need of insulin according to the results given by the HemoCue glucometer, CGM trends, glucose predictions as well as therapy advices. In case of any doubt with the predictions displayed or the advices suggested, the patients will be invited to ask study personal and/or the study physician for help.

Group Type: OTHER

Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)

Intervention Type: DEVICE

Glucose predictions and therapy advices will be displayed to the patient. Patients will be asked to follow the advices suggested by DIAdvisor system according to their own judgement. Patient will decide his need of insulin according to the results given by the HemoCue glucometer, CGM trends, glucose predictions as well as therapy advices. In case of any doubt with the predictions displayed or the advices suggested, the patients will be invited to ask study personal and/or the study physician for help.

algorithm of DIAdvisor disactivated

Glucosepredictions and therapy advices will not be displayed. Patient will decide his need of insulin according to the results given by the HemoCue glucometer and CGM trends. He/She will inject insulin at mealtimes or program a bolus on his/her pump by him/herself and will adapt his/her basal insulin doses or pump delivery rates as usual. As needed or on request and more particularly if hypo or hyperglycaemia occurs, the subject will be advised and helped by nurses and physicians.

Group Type: OTHER

Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)

Intervention Type: DEVICE

Glucose predictions and therapy advices will not be displayed. Patient will decide his need of insulin according to the results given by the HemoCue glucometer and CGM trends. He/She will inject insulin at mealtimes or program a bolus on his/her pump by him/herself and will adapt his/her basal insulin doses or pump delivery rates as usual. As needed or on request and more particularly if hypo or hyperglycaemia occurs, the subject will be advised and helped by nurses and physicians.

Interventions

Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)

Glucose predictions and therapy advices will not be displayed. Patient will decide his need of insulin according to the results given by the HemoCue glucometer and CGM trends. He/She will inject insulin at mealtimes or program a bolus on his/her pump by him/herself and will adapt his/her basal insulin doses or pump delivery rates as usual. As needed or on request and more particularly if hypo or hyperglycaemia occurs, the subject will be advised and helped by nurses and physicians.

Intervention Type: DEVICE

Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)

Glucose predictions and therapy advices will be displayed to the patient. Patients will be asked to follow the advices suggested by DIAdvisor system according to their own judgement. Patient will decide his need of insulin according to the results given by the HemoCue glucometer, CGM trends, glucose predictions as well as therapy advices. In case of any doubt with the predictions displayed or the advices suggested, the patients will be invited to ask study personal and/or the study physician for help.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute for Clinical and Experimental Medicine

Prague, , Czechia

Montpellier University Hospital

Montpellier, , France

Universita Degli Studi di Padova

Padua, , Italy

Countries

Czechia; France; Italy

Other Identifiers

ID-RCB : 2011-A00513-38

Identifier Type: OTHER

Identifier Source: secondary_id

8266 3

Identifier Type: -

Identifier Source: org_study_id