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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Behavioral: Text message arm

Study type: Interventional

Funder types: Other

Identifiers

NCT02230137

2014-A00915-42

Details and patient eligibility

About

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

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 12 to 20 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

Text message arm

Experimental group

Treatment:

Behavioral: Text message arm

No text message arm

No Intervention group