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Personalized Glucose Predictive and Therapy Advisory System - DIAdvisor 2

This study is currently recruiting participants.
Verified January 2012 by University Hospital, Montpellier
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier
ClinicalTrials.gov Identifier:
NCT01512654
First received: September 29, 2011
Last updated: January 14, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus,
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
 Device: Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Montpellier:

Primary Outcome Measures:
  • Percentage of total time spent by patients in safe range (70-180mg/dL) [ Time Frame: during 3 days with DIAdvisor 2 ] [ Designated as safety issue: No ]
    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) [ Time Frame: during 3 days with DIAdvisor 2 ] [ Designated as safety issue: No ]
  • Percentage of total of time spent in hyperglycemia (>180 mg/dL) [ Time Frame: during 3 days with DIAdvisor 2 ] [ Designated as safety issue: No ]
  • Mean of YSI blood glucose during total period, night time and meal periods [ Time Frame: during the two 3 days-hospitalizations ] [ Designated as safety issue: No ]
  • Percentage paired glucose values [ Time Frame: during 3 days with DIAdvisor 2 ] [ Designated as safety issue: No ]
    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 [ Time Frame: during 3 days with DIAdvisor 2 ] [ Designated as safety issue: No ]
  • Score of patient survey regarding the acceptability of DIAdvisor-2 system [ Time Frame: during 3 days with DIAdvisor 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
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.
 Device: 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.

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01512654

Contacts
Contact: Eric RENARD, MD +33 4 67 33 83 82 e-renard@chu-montpellier.fr

Locations
Czech Republic
Institute for Clinical and Experimental Medicine Recruiting
Prague, Czech Republic, 14021
Contact: Frantisek Saudek, MD         frsa@medicon.cz    
France
Montpellier University Hospital Recruiting
Montpellier, France, 34000
Contact: Eric RENARD, MD     +33 4 67 33 83 82     e-renard@chu-montpellier.fr    
Principal Investigator: Eric RENARD, MD            
Sub-Investigator: Anne FARRET, MD            
Italy
Universita Degli Studi di Padova Recruiting
Padova, Italy, 35128
Contact: Alberto Maran, MD     +39-049-821-2178     alberto.maran@unipd.it    
Sponsors and Collaborators
University Hospital, Montpellier
  More Information

No publications provided

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT01512654     History of Changes
Other Study ID Numbers: UF 8266 3, ID-RCB : 2011-A00513-38
Study First Received: September 29, 2011
Last Updated: January 14, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Montpellier:
diabetes
diadvisor
type 1 diabetes
type 2 diabetes
 glucose prediction
cgm prediction
algorithm
therapy advices

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013