Text Message for Adolescents With Poorly Controlled Type 1 Diabetes (Diabeto-SMS)

July 19, 2016 updated by: Assistance Publique - Hôpitaux de Paris

Impact of Mobile Phone Short Text Messages on the Glycaemic Control of Adolescents With Poorly Controlled Type 1 Diabetes.

The purpose of this study is to assess HbA1c reduction after supportive care by SMS among adolescents with poorly controlled type 1 diabetes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In 2010, the number of children with type 1 diabetes in France is estimated at 12,000 with 60% of them aged 12 to 17 years. Compliance is a major issue during adolescence. Mobile text message is one of the strategies to enhance adherence. The main aim of this study is to assess HbA1c reduction after a 6 month SMS support among adolescents with poorly controlled type 1 diabetes. Adherence and quality of life will also be assessed at the end of the trial. This study is a prospective randomized monocentric trial. Sixty adolescents with type 1 diabetes and HbA1c equal or higher than 8.5 % will be randomized according to the method of Zelen in two groups : standard treatment versus standard treatment plus support by SMS. The patients will receive one SMS before each injection of insulin.

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • AP-HP Necker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • aged between 12 and 21 years old
  • with type 1 diabetes for more than 6 months
  • HbA1c at enrollment > 8.5%
  • non-opposition of one of the parents
  • previous medical exam (art. L.1121-11 du CSP)
  • Possible follow-up for 6 months
  • social welfare coverage
  • Adolescents with a mobile phone, able to receive short text message

Exclusion Criteria:

  • aged less than 12 or higher than 21 years old
  • with HbA1c at enrollment < 8.5%
  • pregnancy
  • psychiatric disease
  • do not understand french

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Text message arm
Behavioral: Text message arm
Text message sent before each injection of insulin
Other Names:
  • Mobile phone short text message
No Intervention: No text message arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HbA1c level
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c level
Time Frame: 3 months
3 months
Compliance
Time Frame: 3 months
blood glucose level
3 months
Compliance
Time Frame: 6 months
blood glucose level
6 months
Quality of life
Time Frame: 3 months
PedsQL version 4.0
3 months
Quality of life
Time Frame: 6 months
PedsQL version 4.0
6 months
Satisfaction survey
Time Frame: 6 months
7 items for patients randomized in the "Text message arm"
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Study Director: Jean-Marc Tréluyer, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

August 7, 2014

First Submitted That Met QC Criteria

August 28, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Estimate)

July 20, 2016

Last Update Submitted That Met QC Criteria

July 19, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-A00915-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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