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 (TELFIT)
Primary Purpose
Type 1 Diabetes Mellitus
Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
paper support
PDA-phone + telemonitoring
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring type 1 diabetes, PDA phone (Personal Digital Assistant), HbA1c
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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)
Sites / Locations
- University Hospital Grenoble
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1
2
Arm Description
Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support
PDA-phone + phone consultations + standard visit at 3 months
Outcomes
Primary Outcome Measures
Comparison of HbA1c means
Secondary Outcome Measures
Difference between theoretical insulin dose and actual dose, one week before the 3-month reevaluation session
DHP scale of quality of life and satisfaction dimension of the DQOL questionnaire
Time spent by physicians and nurses in the different groups
Weight changes during the 3-month period
Number of hypoglycemias (moderate and severe) during the 3-month period
Full Information
NCT ID
NCT00758082
First Posted
September 19, 2008
Last Updated
March 10, 2010
Sponsor
University Hospital, Grenoble
Collaborators
AGIR à Dom
1. Study Identification
Unique Protocol Identification Number
NCT00758082
Brief Title
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
Acronym
TELFIT
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Grenoble
Collaborators
AGIR à Dom
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 is to evaluate whether a PDA with telemonitoring by phone reinforces the effects of the functional insulin therapy training course as compared with conventional care.
Main judgment criteria: comparison of HbA1c means between M0 (start) and M3(3 months)
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 physician. The other group will only have the usual paper support. This study compares the evolution of HbA1c in the 2 groups over a period of 3 months. It also assesses time spent by nurses and physicians, changes in quality of life, hypoglycaemia frequency and weight changes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
type 1 diabetes, PDA phone (Personal Digital Assistant), HbA1c
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
62 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support
Arm Title
2
Arm Type
Experimental
Arm Description
PDA-phone + phone consultations + standard visit at 3 months
Intervention Type
Device
Intervention Name(s)
paper support
Intervention Description
Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support.
Intervention Type
Device
Intervention Name(s)
PDA-phone + telemonitoring
Intervention Description
Patients will received PDA-phone + a telephone follow up + standard visit at 3 months
Primary Outcome Measure Information:
Title
Comparison of HbA1c means
Time Frame
M0 (start) and M3 (3 months)
Secondary Outcome Measure Information:
Title
Difference between theoretical insulin dose and actual dose, one week before the 3-month reevaluation session
Time Frame
M0 (start) and M3 (3 months)
Title
DHP scale of quality of life and satisfaction dimension of the DQOL questionnaire
Time Frame
M0 (start) and M3 (3 months)
Title
Time spent by physicians and nurses in the different groups
Time Frame
M0 (start) and M3 (3 months)
Title
Weight changes during the 3-month period
Time Frame
M0 (start) and M3 (3 months)
Title
Number of hypoglycemias (moderate and severe) during the 3-month period
Time Frame
M0 (start) and M3 (3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Y Benhamou, PhD
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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