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

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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: placebo; Device: VISITS + PDA-FIT system; Device: PDA-FIT System + telephone follow-up

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 180
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; 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.; Other Names: paper support for glycemia; face to face visits at 3 and 6 months; without PDA-FIT system
Active Comparator: 2; 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; Other Names: face to face visits at 3 and 6 months; PDA-FIT system
Active Comparator: 3; 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; Other Names: PDA-FIT system; face to face visit at 6 months; telephone visits each 2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparison of HbA1c mean between the 3 groups	at 6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
8-point blood glucose profiles at inclusion and 6 months	inclusion and M6
Quality of life at inclusion and 6 months, using the DHP scale and the Satisfaction item of the DQOL questionnaire	inclusion and M6
Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory	study period
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
Satisfaction of patients and physicians with the system and willingness to carry on the use of the system in routine care	6 months
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

Collaborators and Investigators

• Sponsor: Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
• Collaborators: University Hospital, Grenoble
• Investigators: Study Chair: Pierre Yves BENHAMOU, MD PHD, University Hospital, Grenoble

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: February 26, 2008
• First Submitted That Met QC Criteria: March 4, 2008
• First Posted (Estimate): March 5, 2008

Study Record Updates

• Last Update Posted (Estimate): February 9, 2012
• Last Update Submitted That Met QC Criteria: February 8, 2012
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: HbA1c; type 1 diabetes; PDA phone (Personal Digital Assistant)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Serine Proteinase Inhibitors; Anticoagulants; Antithrombins; Antithrombin III
• Other Study ID Numbers: DCIC 07 08