Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients
TELEDIAB-1
1 other identifier
interventional
180
1 country
18
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2007
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 26, 2008
CompletedFirst Posted
Study publicly available on registry
March 5, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2009
CompletedFebruary 9, 2012
August 1, 2009
1.5 years
February 26, 2008
February 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of HbA1c mean between the 3 groups
at 6 months
Secondary Outcomes (12)
Absolute HbA1c differences (M0-M6)
inclusion and M6
HbA1c changes at M0, M3 and M6
inclusion, M3 and M6
Percentage of patients reaching HbA1c <7.5% at 6 months
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
14 days prior to inclusion and prior to M6
Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period
study period
- +7 more secondary outcomes
Study Arms (3)
1
PLACEBO COMPARATORstandard visit at 3 and 6 months
2
ACTIVE COMPARATORPDA-FIT system + standard visit at 3 and 6 months
3
ACTIVE COMPARATORPDA-FIT system + 12 telephone visits + standard visit at 6 months
Interventions
Patients will have face to face visits at 3 and 6 months and no PDA-FIT system. Patients will record glycemia on paper support.
patients will have face to face visits at 3 and 6 months + PDA-FIT system
patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit at 6 months
Eligibility Criteria
You may qualify if:
- type 1 diabetes mellitus for ≥ 12 months or more (including C-peptide negative secondary diabetes)
- age \> 18 y.o.
You may not qualify if:
- patient with unstable associated evolutive pathology
- patient who need a more frequent diabetic follow up (than in the protocol)
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Centre Hospitalier de Belfort Montbéliard
Belfort, Belfort, 90016, France
CHU Jean Minjoz
Besançon, Besancon, 25030, France
CH SUD Francilien
Corbeil-Essonnes, Corbeil Essonnes, 91100, France
University Hospital Grenoble
Grenoble, Grenoble, 38043, France
CHRU Lille
Lille, Lille, 59037, France
Hopital Edouard Herriot
Lyon, Lyon, 69003, France
CHU Marseille Hôpitaux Sud
Marseille, Marseille, 13274, France
Chu Montpellier
Montpellier, Montpellier, 34295, France
CHU Hôpital Jeanne d'Arc
Nancy, Nancy, 54201, France
CHU Nantes
Nantes, Nantes, 44093, France
Hopital Hotel Dieu
Paris, Paris, 75004, France
Hopital COCHIN
Paris, Paris, 75014, France
HOPITAL Saint Louis
Paris, Paris, 75475, France
Hopital Haut Leveque
Pessac, Pessac, 33604, France
CHU Rennes
Rennes, Rennes, 35056, France
Hopital Bellevue
Saint-Etienne, Saint Etienne, 42055, France
Centre Hospitalier Strasbourg
Strasbourg, Strasbourg, 67000, France
CHU Toulouse
Toulouse, Toulouse, 31403, France
Related Publications (1)
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.
PMID: 21266648DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Pierre Yves BENHAMOU, MD PHD
University Hospital, Grenoble
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2008
First Posted
March 5, 2008
Study Start
September 1, 2007
Primary Completion
March 1, 2009
Study Completion
August 1, 2009
Last Updated
February 9, 2012
Record last verified: 2009-08