Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients (TELEDIAB-1)
Primary Purpose
Type 1 Diabetes
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
placebo
VISITS + PDA-FIT system
PDA-FIT System + telephone follow-up
Sponsored by
About this trial
This is an interventional prevention trial for Type 1 Diabetes focused on measuring type 1 diabetes, PDA phone (Personal Digital Assistant), HbA1c
Eligibility Criteria
Inclusion Criteria:
- type 1 diabetes mellitus for ≥ 12 months or more (including C-peptide negative secondary diabetes)
- age > 18 y.o.
- intensive insulin basal-bolus therapy for ≥ 6 months. At inclusion, patients should be treated, either with a combination of a basal, long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
- chronically uncontrolled diabetes with HbA1c ≥ 8 % during the past 12 months and at inclusion
Exclusion Criteria:
- patient with unstable associated evolutive pathology
- patient who need a more frequent diabetic follow up (than in the protocol)
- patient with a education teaching within the 3 months before inclusion
- patient with a hemoglobinopathy
- patient with toxicomania, alcoholism or psychological troubles
- type 2 diabetes patients
- patient who don't need strict metabolic objectives
- pregnant or parturient women
- person with no freedom (prisoner)
Sites / Locations
- Centre Hospitalier de Belfort Montbéliard
- CHU Jean Minjoz
- CH SUD Francilien
- University Hospital Grenoble
- CHRU Lille
- Hopital Edouard Herriot
- CHU Marseille Hôpitaux Sud
- Chu Montpellier
- CHU Hôpital Jeanne d'Arc
- CHU Nantes
- Hopital Hotel Dieu
- Hopital COCHIN
- HOPITAL Saint Louis
- Hopital Haut Leveque
- CHU Rennes
- Hopital Bellevue
- Centre Hospitalier Strasbourg
- CHU Toulouse
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
standard visit at 3 and 6 months
PDA-FIT system + standard visit at 3 and 6 months
PDA-FIT system + 12 telephone visits + standard visit at 6 months
Outcomes
Primary Outcome Measures
Comparison of HbA1c mean between the 3 groups
Secondary Outcome Measures
Absolute HbA1c differences (M0-M6)
HbA1c changes at M0, M3 and M6
Percentage of patients reaching HbA1c <7.5% at 6 months
Mean of blood glucose values as provided by glucose meters during the 14 days prior to inclusion and prior to the 6 months-visit
Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period
Frequency of symptomatic benign hypoglycaemic episodes during the week prior to inclusion and prior to the 6 months-visit
8-point blood glucose profiles at inclusion and 6 months
Quality of life at inclusion and 6 months, using the DHP scale and the Satisfaction item of the DQOL questionnaire
Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory
Time spent by physicians with patients during visits (either face to face visits or phone call visits) and time spent by patients during transport, waiting time and lost working time
Satisfaction of patients and physicians with the system and willingness to carry on the use of the system in routine care
Effective number of patients carrying on the use of the system in routine care, at their own expense and in agreement with their physician
Full Information
NCT ID
NCT00629304
First Posted
February 26, 2008
Last Updated
February 8, 2012
Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Collaborators
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT00629304
Brief Title
Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients
Acronym
TELEDIAB-1
Official Title
Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients With Chronic Failure of Intensive Insulin Therapy and Conventional Care. The TELEDIAB-1 STUDY
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
Collaborators
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
TELEDIAB-1 is a national, multicenter, controlled, randomised trial. The Primary objective of the TELEDIAB-1 study is to demonstrate that the PDA-FIT system (PDA-Phone and/or telemonitoring) is able to improve metabolic control of chronically uncontrolled type 1 diabetic patients, despite intensive insulin therapy (multiple daily injections with basal-bolus insulin or insulin pump), as compared with conventional care.
Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months
Detailed Description
Secondary Objectives :
To assess the improvement of blood glucose control and quality of life in patients using the PDA-FIT system
To assess the improvement in diabetes care provided by the use of the PDA-FIT system
Satisfaction of patients and physicians towards the PDA-FIT system
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
type 1 diabetes, PDA phone (Personal Digital Assistant), HbA1c
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Placebo Comparator
Arm Description
standard visit at 3 and 6 months
Arm Title
2
Arm Type
Active Comparator
Arm Description
PDA-FIT system + standard visit at 3 and 6 months
Arm Title
3
Arm Type
Active Comparator
Arm Description
PDA-FIT system + 12 telephone visits + standard visit at 6 months
Intervention Type
Device
Intervention Name(s)
placebo
Other Intervention Name(s)
paper support for glycemia, face to face visits at 3 and 6 months, without PDA-FIT system
Intervention Description
Patients will have face to face visits at 3 and 6 months and no PDA-FIT system. Patients will record glycemia on paper support.
Intervention Type
Device
Intervention Name(s)
VISITS + PDA-FIT system
Other Intervention Name(s)
face to face visits at 3 and 6 months, PDA-FIT system
Intervention Description
patients will have face to face visits at 3 and 6 months + PDA-FIT system
Intervention Type
Device
Intervention Name(s)
PDA-FIT System + telephone follow-up
Other Intervention Name(s)
face to face visit at 6 months, telephone visits each 2 weeks, PDA-FIT system
Intervention Description
patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit at 6 months
Primary Outcome Measure Information:
Title
Comparison of HbA1c mean between the 3 groups
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
Absolute HbA1c differences (M0-M6)
Time Frame
inclusion and M6
Title
HbA1c changes at M0, M3 and M6
Time Frame
inclusion, M3 and M6
Title
Percentage of patients reaching HbA1c <7.5% at 6 months
Time Frame
6 months
Title
Mean of blood glucose values as provided by glucose meters during the 14 days prior to inclusion and prior to the 6 months-visit
Time Frame
14 days prior to inclusion and prior to M6
Title
Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period
Time Frame
study period
Title
Frequency of symptomatic benign hypoglycaemic episodes during the week prior to inclusion and prior to the 6 months-visit
Time Frame
week before inclusion and prior to M6
Title
8-point blood glucose profiles at inclusion and 6 months
Time Frame
inclusion and M6
Title
Quality of life at inclusion and 6 months, using the DHP scale and the Satisfaction item of the DQOL questionnaire
Time Frame
inclusion and M6
Title
Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory
Time Frame
study period
Title
Time spent by physicians with patients during visits (either face to face visits or phone call visits) and time spent by patients during transport, waiting time and lost working time
Time Frame
study period
Title
Satisfaction of patients and physicians with the system and willingness to carry on the use of the system in routine care
Time Frame
6 months
Title
Effective number of patients carrying on the use of the system in routine care, at their own expense and in agreement with their physician
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
type 1 diabetes mellitus for ≥ 12 months or more (including C-peptide negative secondary diabetes)
age > 18 y.o.
intensive insulin basal-bolus therapy for ≥ 6 months. At inclusion, patients should be treated, either with a combination of a basal, long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
chronically uncontrolled diabetes with HbA1c ≥ 8 % during the past 12 months and at inclusion
Exclusion Criteria:
patient with unstable associated evolutive pathology
patient who need a more frequent diabetic follow up (than in the protocol)
patient with a education teaching within the 3 months before inclusion
patient with a hemoglobinopathy
patient with toxicomania, alcoholism or psychological troubles
type 2 diabetes patients
patient who don't need strict metabolic objectives
pregnant or parturient women
person with no freedom (prisoner)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Yves BENHAMOU, MD PHD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier de Belfort Montbéliard
City
Belfort
ZIP/Postal Code
90016
Country
France
Facility Name
CHU Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
CH SUD Francilien
City
Corbeil Essonnes
ZIP/Postal Code
91100
Country
France
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Facility Name
CHU Marseille Hôpitaux Sud
City
Marseille
ZIP/Postal Code
13274
Country
France
Facility Name
Chu Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Hôpital Jeanne d'Arc
City
Nancy
ZIP/Postal Code
54201
Country
France
Facility Name
CHU Nantes
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Hotel Dieu
City
Paris
ZIP/Postal Code
75004
Country
France
Facility Name
Hopital COCHIN
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
HOPITAL Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35056
Country
France
Facility Name
Hopital Bellevue
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Centre Hospitalier Strasbourg
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31403
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
21266648
Citation
Charpentier G, Benhamou PY, Dardari D, Clergeot A, Franc S, Schaepelynck-Belicar P, Catargi B, Melki V, Chaillous L, Farret A, Bosson JL, Penfornis A; TeleDiab Study Group. The Diabeo software enabling individualized insulin dose adjustments combined with telemedicine support improves HbA1c in poorly controlled type 1 diabetic patients: a 6-month, randomized, open-label, parallel-group, multicenter trial (TeleDiab 1 Study). Diabetes Care. 2011 Mar;34(3):533-9. doi: 10.2337/dc10-1259. Epub 2011 Jan 25.
Results Reference
derived
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Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients
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