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 :
- 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
|
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
|
|
|
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 |