Personalized Glucose Predictive and Therapy Advisory System - DIAdvisor 2

NCT01512654 | Completed DMC

• 2 other identifiers: 8266 3ID-RCB : 2011-A00513-38
• Study Type: interventional
• Target: 60
• Locations: 3 countries
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  during 3 days with DIAdvisor 2

Secondary Outcomes (6)

• Percentage of total time spent in hypoglycemia (< 70 mg/dL)

  during 3 days with DIAdvisor 2

• Percentage of total of time spent in hyperglycemia (>180 mg/dL)

  during 3 days with DIAdvisor 2

• Mean of YSI blood glucose during total period, night time and meal periods

  during the two 3 days-hospitalizations

• Percentage paired glucose values

  during 3 days with DIAdvisor 2

• Coherence between system advices and physician recommendations > 0.80

  during 3 days with DIAdvisor 2

Study Arms (2)

algorithm DIAdvisor activated

OTHER

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)

algorithm of DIAdvisor disactivated

OTHER

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)

Interventions

Personalized Glucose Predictive and Therapy Advisory System (DIAdvisor) 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.

algorithm of DIAdvisor disactivated

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (3)

Institute for Clinical and Experimental Medicine

Prague, 14021, Czechia

Location

Montpellier University Hospital

Montpellier, 34000, France

Location

Universita Degli Studi di Padova

Padua, 35128, Italy

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2011
• First Posted: January 19, 2012
• Study Start: September 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: June 1, 2012
• Last Updated: October 20, 2021

Record last verified: 2014-12

Locations

FR (1); IT (1); CZ (1)