Text Message for Adolescents With Poorly Controlled Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Behavioral: Text message arm

• Registration Number: NCT02230137
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-08-07
• Study First Submitted QC: 2014-08-28
• Study First Posted: 2014-09-03
• Study Start: 2015-02
• Status Verified: 2016-07
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Last Update Submitted: 2016-07-19
• Last Update Posted: 2016-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Text message arm	Text message arm	-

Primary Outcome Measures

Name	Time	Method
HbA1c level	6 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

AP-HP Necker; 🇫🇷 Paris, France