Clinical trial NCT02230137: Text Message for Adolescents With Poorly Controlled Type 1 Diabetes
Official title: Impact of Mobile Phone Short Text Messages on the Glycaemic Control of Adolescents With Poorly Controlled Type 1 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: adolescents
type 1 diabetes
poorly controlled
SMS
Improve glycaemic control
HbA1c reduction
poorly controlled type 1 diabetic adolescents
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-09-03
Enrollment: 92
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: HbA1c level
timeFrame: 6 months
Secondary outcomes:
measure: HbA1c level
timeFrame: 3 months
measure: Compliance
timeFrame: 3 months
measure: Compliance
timeFrame: 6 months
measure: Quality of life
timeFrame: 3 months
measure: Quality of life
timeFrame: 6 months
measure: Satisfaction survey
timeFrame: 6 months
Other outcomes:
Locations:
city: Paris
country: France
facility: AP-HP Necker
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-Marc Tréluyer, MD, PhD
role: STUDY_DIRECTOR
References:
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.
citation: 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. doi: 10.1016/j.diabet.2007.01.002. Epub 2007 Mar 28.
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. doi: 10.1007/s00431-006-0156-6. Epub 2006 May 3.
citation: Ibrahim N, Treluyer JM, Briand N, Godot C, Polak M, Beltrand J. Text message reminders for adolescents with poorly controlled type 1 diabetes: A randomized controlled trial. PLoS One. 2021 Mar 15;16(3):e0248549. doi: 10.1371/journal.pone.0248549. eCollection 2021.