Status:
COMPLETED
Reinforcement of the Impact of a Functional Insulin Therapy Training Course by Telemonotoring With a PDA-phone in Type 1 Diabetic Patients. The TELFIT Study Patients
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
AGIR à Dom
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
TELFIT is a monocenter, controlled, randomised trial. It focuses on type 1 diabetes patients that have attended a functional insulin therapy training course. The Primary objective of the TELFIT study ...
Detailed Description
All patients will attend a functional insulin therapy training course and be randomized into 2 groups. One group will receive a PDA-phone and one month of phone consultations with a nurse and a physic...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus for ≥ 6 months or more
- Age \> 18 year old
- The patient has attended a functional insulin therapy class or workshop
- Insulin basal-bolus therapy for at least 6 months. At inclusion, patients should be treated either with a long-acting insulin and insulin rapid analog before each meal, or with rapid insulin analog delivered with a pump
- Ability to understand how the PDA-phone works and ability to use it
- Social Security membership or benefit from Social Security
- Patients equipped with a memory blood glucose monitor
- Informed consent, with a signed and approved form
Exclusion
- Underage patient, major patient under guardianship or protected by the Law
- Patient with any unstable associated evolutive pathology that could cause a diabetes imbalance within the coming year
- Change in diabetes treatment within the 3 months before inclusion or planned during the study
- Patient who needs a more frequent diabetic follow-up than in the protocol (especially severe or evolving complication due to diabetes)
- Patient attending another education program within the 3 months before inclusion or planning to attend one during the study
- Patient with toxicomania, alcoholism or psychological troubles that could impact the study
- Type-2-diabetic patient
- Patient who doesn't need strict metabolic objectives
- Pregnant or possibly pregnant woman
- Person with no freedom (prisoner)
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00758082
Start Date
July 1 2008
End Date
March 1 2010
Last Update
March 11 2010
Active Locations (1)
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1
University Hospital Grenoble
Grenoble, France, 38043