Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients - Full Text View

Sponsor:	Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
Collaborator:	University Hospital, Grenoble
Information provided by:	Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
ClinicalTrials.gov Identifier:	NCT00629304

Purpose

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

Condition	Intervention	Phase
Type 1 Diabetes	Device: placebo Device: VISITS + PDA-FIT system Device: PDA-FIT System + telephone follow-up	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Type 1

U.S. FDA Resources

Further study details as provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:

Primary Outcome Measures:

Comparison of HbA1c mean between the 3 groups [ Time Frame: at 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Absolute HbA1c differences (M0-M6) [ Time Frame: inclusion and M6 ] [ Designated as safety issue: No ]
HbA1c changes at M0, M3 and M6 [ Time Frame: inclusion, M3 and M6 ] [ Designated as safety issue: No ]
Percentage of patients reaching HbA1c <7.5% at 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period [ Time Frame: study period ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
8-point blood glucose profiles at inclusion and 6 months [ Time Frame: inclusion and M6 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory [ Time Frame: study period ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	September 2007
Study Completion Date:	August 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator standard visit at 3 and 6 months	Device: placebo Patients will have face to face visits at 3 and 6 months and no PDA-FIT system. Patients will record glycemia on paper support.
2: Active Comparator PDA-FIT system + standard visit at 3 and 6 months	Device: VISITS + PDA-FIT system patients will have face to face visits at 3 and 6 months + PDA-FIT system
3: Active Comparator PDA-FIT system + 12 telephone visits + standard visit at 6 months	Device: PDA-FIT System + telephone follow-up patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit 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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00629304

Locations

France
Centre Hospitalier de Belfort Montbéliard
Belfort, France, 90016
CHU Jean Minjoz
Besancon, France, 25030
CH SUD Francilien
Corbeil Essonnes, France, 91100
University Hospital Grenoble
Grenoble, France, 38043
CHRU Lille
Lille, France, 59037
Hopital Edouard Herriot
Lyon, France, 69003
CHU Marseille Hôpitaux Sud
Marseille, France, 13274
Chu Montpellier
Montpellier, France, 34295
CHU Hôpital Jeanne d'Arc
Nancy, France, 54201
CHU Toulouse
Toulouse, France, 31403
Hopital COCHIN
PARIS, France, 75014
Hopital Hotel Dieu
PARIS, France, 75004
HOPITAL Saint Louis
Paris, France, 75475
Hopital Haut Leveque
PESSAC, France, 33604
CHU Rennes
Rennes, France, 35056
Hopital Bellevue
Saint Etienne, France, 42055
Centre Hospitalier Strasbourg
Strasbourg, France, 67000
CHU Nantes
Nantes, France, 44093

Sponsors and Collaborators

Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète

University Hospital, Grenoble

Investigators

Study Chair:

Pierre Yves BENHAMOU, MD PHD

University Hospital, Grenoble

More Information

No publications provided

Responsible Party:	Centre de Recherche sur l'Intensification du Traitement du Diabète (CERIDT) ( Dr Guillaume Charpentier / principal investigator )
Study ID Numbers:	DCIC 07 08
Study First Received:	February 26, 2008
Last Updated:	August 27, 2009
ClinicalTrials.gov Identifier:	NCT00629304 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète:

type 1 diabetes
PDA phone (Personal Digital Assistant)
HbA1c

Additional relevant MeSH terms:

Autoimmune Diseases
Metabolic Diseases
Immune System Diseases
Diabetes Mellitus, Type 1

Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on February 08, 2010