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

NCT00758082 | Completed Phase 3

• 1 other identifier: 2008-A00389-46
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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)

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes; PDA phone (Personal Digital Assistant); HbA1c

Outcome Measures

Primary Outcomes (1)

• Comparison of HbA1c means

  M0 (start) and M3 (3 months)

Secondary Outcomes (5)

• 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)

• Time spent by physicians and nurses in the different groups

  M0 (start) and M3 (3 months)

• Weight changes during the 3-month period

  M0 (start) and M3 (3 months)

• Number of hypoglycemias (moderate and severe) during the 3-month period

  M0 (start) and M3 (3 months)

Study Arms (2)

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

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

PDA-phone + telemonitoring DEVICE

Patients will received PDA-phone + a telephone follow up + standard visit at 3 months

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 diabetes mellitus for ≥ 6 months or more
• Age \> 18 year old
• The patient has attended a functional insulin therapy class or workshop
• 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

You may not qualify if:

• 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
• Patient who needs a more frequent diabetic follow-up than in the protocol (especially severe or evolving complication due to diabetes)
• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• AGIR à Dom: collaborator

Study Sites (1)

University Hospital Grenoble

Grenoble, 38043, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Pierre Y Benhamou, PhD

  University Hospital, Grenoble

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 19, 2008
• First Posted: September 23, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 11, 2010

Record last verified: 2010-03

Locations

FR (1)