Text Message for Adolescents With Poorly Controlled Type 1 Diabetes

NCT ID: NCT02230137

Last Updated: 2016-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2016-07-31

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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Text message arm

Group Type EXPERIMENTAL

Text message arm

Intervention Type BEHAVIORAL

Text message sent before each injection of insulin

No text message arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Text message arm

Text message sent before each injection of insulin

Intervention Type BEHAVIORAL

Other Intervention Names

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Mobile phone short text message

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
Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Marc Tréluyer, MD, PhD

Role: STUDY_DIRECTOR

Assistance Publique - Hôpitaux de Paris

Locations

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AP-HP Necker

Paris, , France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 22646659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17395516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16670859 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33720997 (View on PubMed)

Other Identifiers

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2014-A00915-42

Identifier Type: -

Identifier Source: org_study_id

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