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Text Message for Adolescents With Poorly Controlled Type 1 Diabetes (Diabeto-SMS)

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Text message arm
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring adolescents, type 1 diabetes, poorly controlled, SMS, Improve glycaemic control, HbA1c reduction, poorly controlled type 1 diabetic adolescents

Eligibility Criteria

12 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AP-HP Necker

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Text message arm

No text message arm

Arm Description

Outcomes

Primary Outcome Measures

HbA1c level

Secondary Outcome Measures

HbA1c level
Compliance
blood glucose level
Compliance
blood glucose level
Quality of life
PedsQL version 4.0
Quality of life
PedsQL version 4.0
Satisfaction survey
7 items for patients randomized in the "Text message arm"

Full Information

First Posted
August 7, 2014
Last Updated
July 19, 2016
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT02230137
Brief Title
Text Message for Adolescents With Poorly Controlled Type 1 Diabetes
Acronym
Diabeto-SMS
Official Title
Impact of Mobile Phone Short Text Messages on the Glycaemic Control of Adolescents With Poorly Controlled Type 1 Diabetes.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
adolescents, type 1 diabetes, poorly controlled, SMS, Improve glycaemic control, HbA1c reduction, poorly controlled type 1 diabetic adolescents

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
92 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Text message arm
Arm Type
Experimental
Arm Title
No text message arm
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Text message arm
Other Intervention Name(s)
Mobile phone short text message
Intervention Description
Text message sent before each injection of insulin
Primary Outcome Measure Information:
Title
HbA1c level
Time Frame
6 months
Secondary Outcome Measure Information:
Title
HbA1c level
Time Frame
3 months
Title
Compliance
Description
blood glucose level
Time Frame
3 months
Title
Compliance
Description
blood glucose level
Time Frame
6 months
Title
Quality of life
Description
PedsQL version 4.0
Time Frame
3 months
Title
Quality of life
Description
PedsQL version 4.0
Time Frame
6 months
Title
Satisfaction survey
Description
7 items for patients randomized in the "Text message arm"
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Marc Tréluyer, MD, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
AP-HP Necker
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22646659
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.
Results Reference
background
PubMed Identifier
17395516
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.
Results Reference
background
PubMed Identifier
16670859
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.
Results Reference
background
PubMed Identifier
33720997
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.
Results Reference
derived

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Text Message for Adolescents With Poorly Controlled Type 1 Diabetes

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