Back to resultsPersonalized Glucose Predictive and Therapy Advisory System - DIAdvisor 2
Primary Purpose
Diabetes Mellitus, Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)
Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)
Sponsored by
About this trial
This is an interventional other trial for Diabetes Mellitus focused on measuring diabetes, diadvisor, type 1 diabetes, type 2 diabetes, glucose prediction, cgm prediction, algorithm, therapy advices
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Institute for Clinical and Experimental Medicine
- Montpellier University Hospital
- Universita Degli Studi di Padova
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
algorithm DIAdvisor activated
algorithm of DIAdvisor disactivated
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Percentage of total time spent by patients in safe range (70-180mg/dL)
The primary endpoint is the percentage of total time spent by patients in safe range (70-180mg/dL). A clinically significant benefit will be reached if an increase of at least 10% of total time in range is obtained while using DIAdvisor-2.
Secondary Outcome Measures
Percentage of total time spent in hypoglycemia (< 70 mg/dL)
Percentage of total of time spent in hyperglycemia (>180 mg/dL)
Mean of YSI blood glucose during total period, night time and meal periods
Percentage paired glucose values
Percentage paired glucose values: Predicted glucose t+20min vs. real glucose t to t+20min in A&B zones of EGA > 80% AND < 5% in E zone of EGA
Coherence between system advices and physician recommendations > 0.80
Score of patient survey regarding the acceptability of DIAdvisor-2 system
Full Information
NCT ID
NCT01512654
First Posted
September 29, 2011
Last Updated
October 18, 2021
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT01512654
Brief Title
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
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
algorithm DIAdvisor activated
Arm Type
Other
Arm Description
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.
Arm Title
algorithm of DIAdvisor disactivated
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)
Intervention Description
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
Intervention Name(s)
Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of total time spent by patients in safe range (70-180mg/dL)
Description
The primary endpoint is the percentage of total time spent by patients in safe range (70-180mg/dL). A clinically significant benefit will be reached if an increase of at least 10% of total time in range is obtained while using DIAdvisor-2.
Time Frame
during 3 days with DIAdvisor 2
Secondary Outcome Measure Information:
Title
Percentage of total time spent in hypoglycemia (< 70 mg/dL)
Time Frame
during 3 days with DIAdvisor 2
Title
Percentage of total of time spent in hyperglycemia (>180 mg/dL)
Time Frame
during 3 days with DIAdvisor 2
Title
Mean of YSI blood glucose during total period, night time and meal periods
Time Frame
during the two 3 days-hospitalizations
Title
Percentage paired glucose values
Description
Percentage paired glucose values: Predicted glucose t+20min vs. real glucose t to t+20min in A&B zones of EGA > 80% AND < 5% in E zone of EGA
Time Frame
during 3 days with DIAdvisor 2
Title
Coherence between system advices and physician recommendations > 0.80
Time Frame
during 3 days with DIAdvisor 2
Title
Score of patient survey regarding the acceptability of DIAdvisor-2 system
Time Frame
during 3 days with DIAdvisor 2
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Facility Information:
Facility Name
Institute for Clinical and Experimental Medicine
City
Prague
ZIP/Postal Code
14021
Country
Czechia
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Universita Degli Studi di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
12. IPD Sharing Statement
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Personalized Glucose Predictive and Therapy Advisory System - DIAdvisor 2
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