- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01512654
Personalized Glucose Predictive and Therapy Advisory System - DIAdvisor 2
October 18, 2021 updated by: University Hospital, Montpellier
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
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.
Study Overview
Status
Completed
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.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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.
|
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.
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.
|
Other: 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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of total time spent by patients in safe range (70-180mg/dL)
Time Frame: during 3 days with DIAdvisor 2
|
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.
|
during 3 days with DIAdvisor 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of total time spent in hypoglycemia (< 70 mg/dL)
Time Frame: during 3 days with DIAdvisor 2
|
during 3 days with DIAdvisor 2
|
|
Percentage of total of time spent in hyperglycemia (>180 mg/dL)
Time Frame: during 3 days with DIAdvisor 2
|
during 3 days with DIAdvisor 2
|
|
Mean of YSI blood glucose during total period, night time and meal periods
Time Frame: during the two 3 days-hospitalizations
|
during the two 3 days-hospitalizations
|
|
Percentage paired glucose values
Time Frame: during 3 days with DIAdvisor 2
|
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
|
during 3 days with DIAdvisor 2
|
Coherence between system advices and physician recommendations > 0.80
Time Frame: during 3 days with DIAdvisor 2
|
during 3 days with DIAdvisor 2
|
|
Score of patient survey regarding the acceptability of DIAdvisor-2 system
Time Frame: during 3 days with DIAdvisor 2
|
during 3 days with DIAdvisor 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
September 29, 2011
First Submitted That Met QC Criteria
January 14, 2012
First Posted (Estimate)
January 19, 2012
Study Record Updates
Last Update Posted (Actual)
October 20, 2021
Last Update Submitted That Met QC Criteria
October 18, 2021
Last Verified
December 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8266 3
- ID-RCB : 2011-A00513-38 (Other Identifier: Afssaps)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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