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Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients (TELEDIAB-1)
This study is ongoing, but not recruiting participants.
Study NCT00629304   Information provided by Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
First Received: February 26, 2008   Last Updated: January 27, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

February 26, 2008
January 27, 2009
September 2007
Comparison of HbA1c mean between the 3 groups [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00629304 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
 
Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients
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

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
Phase III
Interventional
Prevention, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Type 1 Diabetes
  • Device: placebo
  • Device: VISITS + PDA-FIT system
  • Device: PDA-FIT System + telephone follow-up
  • Placebo Comparator: standard visit at 3 and 6 months
  • Active Comparator: PDA-FIT system + standard visit at 3 and 6 months
  • Active Comparator: PDA-FIT system + 12 telephone visits + standard visit at 6 months
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
180
September 2009
March 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
 
France
 
 
NCT00629304
Dr Guillaume Charpentier / principal investigator, Centre de Recherche sur l'Intensification du Traitement du Diabète (CERIDT)
 
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
University Hospital, Grenoble
Study Chair: Pierre Yves BENHAMOU, MD PHD University Hospital, Grenoble
Centre d’Etudes et de Recherche pour l’Intensification du Traitement du Diabète
January 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.