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Type 1 DiabetesDIABETO-SMSNCT02230137

Text Message for Adolescents With Poorly Controlled Type 1 Diabetes

A study testing Text message arm in people with Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 12 to 20 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Text message arm
Could I receive a placebo?
No, everyone receives an active treatment
How many people
92 participants
Where
1 siteFrance
Study dates
Feb 2015to Jul 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 20 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

France1 site

  • AP-HP Necker

    Paris, 75015

Other trials in France

About this study

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

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

Read the 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.

Conditions
Type 1 Diabetes
Being tested
Text message arm
Keywords
adolescents, type 1 diabetes, poorly controlled, SMS, Improve glycaemic control, HbA1c reduction, poorly controlled type 1 diabetic adolescents
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Text message armBehavioural

    Also called Mobile phone short text message

    Text message sent before each injection of insulin

Study groups in NCT02230137
Study groupRoleWhat they receive
Text message armExperimentalNot described
Receives: Behavioral: Text message arm
No text message armNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HbA1c level

    Measured: 6 months

Secondary outcomes (6)

  1. HbA1c level

    Measured: 3 months

  2. Compliance

    blood glucose level

    Measured: 3 months

  3. Compliance

    blood glucose level

    Measured: 6 months

  4. Quality of life

    PedsQL version 4.0

    Measured: 3 months

  5. Quality of life

    PedsQL version 4.0

    Measured: 6 months

  6. Satisfaction survey

    7 items for patients randomized in the "Text message arm"

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2014 (estimated)
  2. Study startFeb 2015
  3. Primary completionJul 2016
  4. Study completionJul 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
92 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02230137
Sponsor's protocol ID
K151005
Other IDs
2014-A00915-42
Acronym
DIABETO-SMS
Status last verified
Mar 2026
First submitted
7 Aug 2014
Last updated
27 Mar 2026
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22646659

  • 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.

    PubMed 17395516

  • 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.

    PubMed 16670859

  • 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.

    PubMed 33720997

Questions about this trial

What is this clinical trial studying?

A study testing Text message arm in people with Type 1 Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HbA1c level (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02230137, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.

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