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NCT Number: NCT00629304

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

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier de Belfort Montbéliard, Belfort, France

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

PLACEBO

Device

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

VISITS + PDA-FIT system

Device

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

PDA-FIT System + telephone follow-up

Device

patients will received PDA-FIT system + a telephone follow up (12 phone calls) and a face to face visit at 6 months

Other names: face to face visit at 6 months, telephone visits each 2 weeks, PDA-FIT system

Primary outcomes

  1. Comparison of HbA1c mean between the 3 groups

    Time frame: at 6 months

Secondary outcomes

  1. Absolute HbA1c differences (M0-M6)

    Time frame: inclusion and M6

  2. HbA1c changes at M0, M3 and M6

    Time frame: inclusion, M3 and M6

  3. Percentage of patients reaching HbA1c <7.5% at 6 months

    Time frame: 6 months

  4. 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

  5. Frequency of severe hypoglycaemic episodes and ketoacidosis episodes during the study period

    Time frame: study period

  6. 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

  7. 8-point blood glucose profiles at inclusion and 6 months

    Time frame: inclusion and M6

  8. 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

  9. Improvement in diabetes care, as assessed by the change in blood glucose testing frequency, reflected by the glucose meter memory

    Time frame: study period

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • University Hospital, Grenoble

Registry information

Official study 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

Acronym: TELEDIAB-1

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 5, 2008
Registry last updated
Feb 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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