NCT02230137

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 7, 2014

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1.4 years

First QC Date

August 7, 2014

Last Update Submit

March 23, 2026

Conditions

Type 1 Diabetes

Keywords

adolescentstype 1 diabetespoorly controlledSMSImprove glycaemic controlHbA1c reductionpoorly controlled type 1 diabetic adolescents

Outcome Measures

Primary Outcomes (1)

  • HbA1c level

    6 months

Secondary Outcomes (6)

  • HbA1c level

    3 months

  • Compliance

    3 months

  • Compliance

    6 months

  • Quality of life

    3 months

  • Quality of life

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Text message arm

EXPERIMENTAL
Behavioral: Text message arm

No text message arm

NO INTERVENTION

Interventions

Text message armBEHAVIORAL

Text message sent before each injection of insulin

Also known as: Mobile phone short text message
Text message arm

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • aged less than 12 or higher than 21 years old
  • with HbA1c at enrollment \< 8.5%
  • pregnancy
  • psychiatric disease
  • do not understand french

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AP-HP Necker

Paris, 75015, France

Location

Related Publications (4)

  • 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.

    PMID: 22646659BACKGROUND

  • 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.

    PMID: 17395516BACKGROUND

  • 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.

    PMID: 16670859BACKGROUND

  • 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.

    PMID: 33720997RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jean-Marc Tréluyer, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2014

First Posted

September 3, 2014

Study Start

February 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)