Reinforcement of the Impact of a Functional Insulin Thera... | NCT00758082

Status Module

Record Verification Date

Mar 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Mar 2010Actual

Completion Date

Mar 2010Actual

First Submitted Date

Sep 19, 2008

First Submission Date that Met QC Criteria

Sep 22, 2008

First Posted Date

Sep 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2010

Last Update Posted Date

Mar 11, 2010Estimated

Name	Class
AGIR à Dom	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

62Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support	Device: paper support
2	Experimental	PDA-phone + phone consultations + standard visit at 3 months	Device: PDA-phone + telemonitoring

Interventions

Name	Type	Description	Arm Group Labels	Other Names
paper support	Device	Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support.	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of HbA1c means		M0 (start) and M3 (3 months)

Secondary Outcomes

Measure	Description	Time Frame
Difference between theoretical insulin dose and actual dose, one week before the 3-month reevaluation session		M0 (start) and M3 (3 months)
DHP scale of quality of life and satisfaction dimension of the DQOL questionnaire		M0 (start) and M3 (3 months)

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases