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

Type 1 Diabetes Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00629304
• Other study ID #: DCIC 07 08
• Status: Completed
• Phase: Phase 3
• First received: February 26, 2008
• Last updated: February 8, 2012
• Start date: September 2007
• Est. completion date: August 2009

Study information

• Verified date: August 2009
• Source: Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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

Description:

Secondary Objectives :

1. To assess the improvement of blood glucose control and quality of life in patients using the PDA-FIT system

2. To assess the improvement in diabetes care provided by the use of the PDA-FIT system

3. Satisfaction of patients and physicians towards the PDA-FIT system

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: August 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.
• VISITS + PDA-FIT system
patients will have face to face visits at 3 and 6 months + PDA-FIT system
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier de Belfort Montbéliard	Belfort
France	CHU Jean Minjoz	Besancon
France	CH SUD Francilien	Corbeil Essonnes
France	University Hospital Grenoble	Grenoble
France	CHRU Lille	Lille
France	Hopital Edouard Herriot	Lyon
France	CHU Marseille Hôpitaux Sud	Marseille
France	Chu Montpellier	Montpellier
France	CHU Hôpital Jeanne d'Arc	Nancy
France	CHU Nantes	Nantes
France	Hopital COCHIN	Paris
France	Hopital Hotel Dieu	Paris
France	HOPITAL Saint Louis	Paris
France	Hopital Haut Leveque	Pessac
France	CHU Rennes	Rennes
France	Hopital Bellevue	Saint Etienne
France	Centre Hospitalier Strasbourg	Strasbourg
France	CHU Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète	University Hospital, Grenoble

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of HbA1c mean between the 3 groups		at 6 months	No
Secondary	Absolute HbA1c differences (M0-M6)		inclusion and M6	No
Secondary	HbA1c changes at M0, M3 and M6		inclusion, M3 and M6	No
Secondary	Percentage of patients reaching HbA1c <7.5% at 6 months		6 months	No
Secondary	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	No
Secondary	Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period		study period	Yes
Secondary	Frequency of symptomatic benign hypoglycaemic episodes during the week prior to inclusion and prior to the 6 months-visit		week before inclusion and prior to M6	Yes
Secondary	8-point blood glucose profiles at inclusion and 6 months		inclusion and M6	No
Secondary	Quality of life at inclusion and 6 months, using the DHP scale and the Satisfaction item of the DQOL questionnaire		inclusion and M6	No
Secondary	Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory		study period	Yes
Secondary	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		study period	No
Secondary	Satisfaction of patients and physicians with the system and willingness to carry on the use of the system in routine care		6 months	No
Secondary	Effective number of patients carrying on the use of the system in routine care, at their own expense and in agreement with their physician		6 months	No