Text Message for Adolescents With Poorly Controlled Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— Diabeto-SMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230137
• Other study ID #: 2014-A00915-42
• Status: Completed
• Phase: N/A
• First received: August 7, 2014
• Last updated: July 19, 2016
• Start date: February 2015
• Est. completion date: July 2016

Study information

• Verified date: July 2016
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 20 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Behavioral:
• Text message arm
Text message sent before each injection of insulin

Locations

Country	Name	City	State
France	AP-HP Necker	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (3)

Benhamou PY, Melki V, Boizel R, Perreal F, Quesada JL, Bessieres-Lacombe S, Bosson JL, Halimi S, Hanaire H. One-year efficacy and safety of Web-based follow-up using cellular phone in type 1 diabetic patients under insulin pump therapy: the PumpNet study. Diabetes Metab. 2007 Jun;33(3):220-6. Epub 2007 Mar 28. — View Citation

Louch G, Dalkin S, Bodansky J, Conner M. An exploratory randomised controlled trial using short messaging service to facilitate insulin administration in young adults with type 1 diabetes. Psychol Health Med. 2013;18(2):166-74. doi: 10.1080/13548506.2012.689841. Epub 2012 May 30. — View Citation

Rami B, Popow C, Horn W, Waldhoer T, Schober E. Telemedical support to improve glycemic control in adolescents with type 1 diabetes mellitus. Eur J Pediatr. 2006 Oct;165(10):701-5. Epub 2006 May 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c level		6 months	No
Secondary	HbA1c level		3 months	No
Secondary	Compliance	blood glucose level	3 months	No
Secondary	Compliance	blood glucose level	6 months	No
Secondary	Quality of life	PedsQL version 4.0	3 months	No
Secondary	Quality of life	PedsQL version 4.0	6 months	No
Secondary	Satisfaction survey	7 items for patients randomized in the "Text message arm"	6 months	No