Text Message for Adolescents With Poorly Controlled Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Behavioral: Text message arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Text message arm<br> | Behavioral: Text message arm<br>* Text message sent before each injection of insulin<br>* Other names: Mobile phone short text message;|
| No Intervention: No text message arm<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c level |  | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adolescents, type 1 diabetes, poorly controlled, SMS, HbA1c reduction, poorly controlled type 1 diabetic adolescents, Improve glycaemic control