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

Sponsors and Collaborators:	Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète 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

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin

U.S. FDA Resources

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

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
Estimated Study Completion Date:	September 2009
Estimated 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

Contacts

Contact: Guillaume Charpentier, MD	0033164968860	ceritd@ch-sud-francilien.fr
Contact: Haddouche Myriam, CRA	0033476765040	MHaddouche@chu-grenoble.fr

Locations

France
Centre Hospitalier de Belfort Montbéliard	Recruiting
Belfort, France, 90016
Principal Investigator: Patrice Winiszewski, MD
CHU Jean Minjoz	Recruiting
Besancon, France, 25030
Principal Investigator: Alfred Penfornis, MD
Sub-Investigator: Sophie Borot, MD
Sub-Investigator: Anne Begey, MD
CH SUD Francilien	Recruiting
Corbeil Essonnes, France, 91100
Contact: Guillaume Charpentier, MD 00 33 1 60 90 30 86 kerbonac@free.fr
Principal Investigator: Guillaume Charpentier, MD
Sub-Investigator: Dured Dardari, MD
Sub-Investigator: Sylvia Franc, MD
Sub-Investigator: Beatrix Boucherie, MD
University Hospital Grenoble	Recruiting
Grenoble, France, 38043
Contact: Pierre Yves Benhamou, MD PhD 0033476765040 PYBenhamou@chu-grenoble.fr
Principal Investigator: Pierre Yves Benhamou, MD PhD
CHRU Lille	Recruiting
Lille, France, 59037
Principal Investigator: Anne WAMBERGUE, MD
Sub-Investigator: Catherine FERMON-MARCOLIN, MD
Hopital Edouard Herriot	Recruiting
Lyon, France, 69003
Principal Investigator: Charles Thivolet, MD
Sub-Investigator: Sophie REFFET, MD
CHU Marseille Hôpitaux Sud	Recruiting
Marseille, France, 13274
Principal Investigator: Olivia RONSIN, MD
Sub-Investigator: Pauline SCHAEPELYNCK-BELICAR, MD
Chu Montpellier	Recruiting
Montpellier, France, 34295
Principal Investigator: Eric Renard, MD
Sub-Investigator: Anne Farret, MD
CHU Hôpital Jeanne d'Arc	Not yet recruiting
Nancy, France, 54201
Principal Investigator: Bruno Guerci, MD
CHU Toulouse	Recruiting
Toulouse, France, 31403
Principal Investigator: Hélène HANAIRE, MD
Sub-Investigator: Vincent MELKI, MD
Sub-Investigator: Monelle BERTRAND, MD
Hopital COCHIN	Recruiting
PARIS, France, 75014
Principal Investigator: Helen MOSNIER PUDAR, MD
Hopital Hotel Dieu	Recruiting
PARIS, France, 75004
Principal Investigator: Catherine VIGERAL, MD
Sub-Investigator: Agnes SOLA-CAZAGNES, MD
HOPITAL Saint Louis	Not yet recruiting
Paris, France, 75475
Principal Investigator: Jean Francois GAUTIER, MD
Sub-Investigator: Clara BOUCHE, MD
Hopital Haut Leveque	Recruiting
PESSAC, France, 33604
Principal Investigator: Bogdan CATARGI, MD
CHU Rennes	Not yet recruiting
Rennes, France, 35056
Principal Investigator: Anne Marie LEGUERRIER, MD
Sub-Investigator: Perrine PICHON, MD
Hopital Bellevue	Recruiting
Saint Etienne, France, 42055
Principal Investigator: Luc Millot, MD
Centre Hospitalier Strasbourg	Recruiting
Strasbourg, France, 67000
Principal Investigator: Laurence Kessler, MD
Sub-Investigator: Francois MOREAU, MD
CHU Nantes	Recruiting
Nantes, France, 44093
Principal Investigator: Lucy CHAILLOUS, MD

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

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:	March 4, 2008
ClinicalTrials.gov Identifier:	NCT00629304
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

Study placed in the following topic categories:

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

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 16, 2009