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Completed

NCT Number: NCT02230137

Text Message for 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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AP-HP Necker

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Text message arm

Behavioral

Text message sent before each injection of insulin

Other names: Mobile phone short text message

Primary outcomes

  1. HbA1c level

    Time frame: 6 months

Secondary outcomes

  1. HbA1c level

    Time frame: 3 months

  2. Compliance

    Time frame: 3 months

    blood glucose level

  3. Compliance

    Time frame: 6 months

    blood glucose level

  4. Quality of life

    Time frame: 3 months

    PedsQL version 4.0

  5. Quality of life

    Time frame: 6 months

    PedsQL version 4.0

  6. Satisfaction survey

    Time frame: 6 months

    7 items for patients randomized in the "Text message arm"

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

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

Acronym: DIABETO-SMS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Sep 3, 2014
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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