Type 1 Diabetes
Conditions
Keywords
adolescents, type 1 diabetes, poorly controlled, SMS, Improve glycaemic control, HbA1c reduction, poorly controlled type 1 diabetic adolescents
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.
Interventions
BEHAVIORALText message arm
Text message sent before each injection of insulin
Sponsors
Assistance Publique - Hôpitaux de Paris
URC-CIC Paris Descartes Necker Cochin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA1c level | 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c level | 3 months | — |
| Compliance | 3 months | blood glucose level |
| Quality of life | 3 months | PedsQL version 4.0 |
| Satisfaction survey | 6 months | 7 items for patients randomized in the "Text message arm" |
Countries
France
Contacts
STUDY_DIRECTORJean-Marc Tréluyer, MD, PhD
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed