Multicenter Assessment of the PDA-FIT System in Type 1 Diabetic Patients
NCT ID: NCT00629304
Last Updated: 2012-02-09
Study Results
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Basic Information
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COMPLETED
PHASE3
180 participants
INTERVENTIONAL
2007-09-30
2009-08-31
Brief Summary
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Main judgment criteria: comparison of HbA1c means between the 3 groups at 6 months
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
standard visit at 3 and 6 months
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.
2
PDA-FIT system + standard visit at 3 and 6 months
VISITS + PDA-FIT system
patients will have face to face visits at 3 and 6 months + PDA-FIT system
3
PDA-FIT system + 12 telephone visits + standard visit at 6 months
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
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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)
18 Years
ALL
No
Sponsors
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University Hospital, Grenoble
OTHER
Centre d'Etudes et de Recherche pour l'Intensification du Traitement du Diabète
OTHER
Responsible Party
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Principal Investigators
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Pierre Yves BENHAMOU, MD PHD
Role: STUDY_CHAIR
University Hospital, Grenoble
Locations
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Centre Hospitalier de Belfort Montbéliard
Belfort, Belfort, France
CHU Jean Minjoz
Besançon, Besancon, France
CH SUD Francilien
Corbeil-Essonnes, Corbeil Essonnes, France
University Hospital Grenoble
Grenoble, Grenoble, France
CHRU Lille
Lille, Lille, France
Hopital Edouard Herriot
Lyon, Lyon, France
CHU Marseille Hôpitaux Sud
Marseille, Marseille, France
Chu Montpellier
Montpellier, Montpellier, France
CHU Hôpital Jeanne d'Arc
Nancy, Nancy, France
CHU Nantes
Nantes, Nantes, France
Hopital Hotel Dieu
Paris, Paris, France
Hopital COCHIN
Paris, Paris, France
HOPITAL Saint Louis
Paris, Paris, France
Hopital Haut Leveque
Pessac, Pessac, France
CHU Rennes
Rennes, Rennes, France
Hopital Bellevue
Saint-Etienne, Saint Etienne, France
Centre Hospitalier Strasbourg
Strasbourg, Strasbourg, France
CHU Toulouse
Toulouse, Toulouse, France
Countries
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References
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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.
Other Identifiers
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DCIC 07 08
Identifier Type: -
Identifier Source: org_study_id
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