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

Type 1 Diabetes Mellitus Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758082
• Other study ID #: 2008-A00389-46
• Status: Completed
• Phase: Phase 3
• First received: September 19, 2008
• Last updated: March 10, 2010
• Start date: July 2008
• Est. completion date: March 2010

Study information

• Verified date: March 2010
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Device:
• paper support
Patients will have face to face visits at 3 months and no PDA-phone. Patients will record glycemia on paper support.
• PDA-phone + telemonitoring
Patients will received PDA-phone + a telephone follow up + standard visit at 3 months

Locations

Country	Name	City	State
France	University Hospital Grenoble	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	AGIR à Dom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of HbA1c means		M0 (start) and M3 (3 months)	No
Secondary	Difference between theoretical insulin dose and actual dose, one week before the 3-month reevaluation session		M0 (start) and M3 (3 months)	No
Secondary	DHP scale of quality of life and satisfaction dimension of the DQOL questionnaire		M0 (start) and M3 (3 months)	No
Secondary	Time spent by physicians and nurses in the different groups		M0 (start) and M3 (3 months)	No
Secondary	Weight changes during the 3-month period		M0 (start) and M3 (3 months)	No
Secondary	Number of hypoglycemias (moderate and severe) during the 3-month period		M0 (start) and M3 (3 months)	No