ClinicalTrials.gg
Status unknownNCT01520428Updated Sep 27, 2012

Interventions to Prevent Adolescents With Type 1 Diabetes From Long-term Complications

An interventional study of Motivational Interviewing, CBT and E-mail support in Diabetes Mellitus, Type 1, sponsored by Medical University of Vienna. Status unknown at 1 site in Austria. Open to participants aged 13 Years to 20 Years. Per ClinicalTrials.gov, last updated 2012-09-27.

Sponsored by Medical University of Vienna · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Sep 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
13 Years to 20 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effectiveness of diabetes management training combined with the method of Motivational Interviewing with elements of Cognitive Behaviour Therapy and E-mail support in the treatment of type 1 diabetes in adolescents (age range 13-20 years) compared to a control group. The investigators assess motivational changes and effects on metabolic control.

Read the detailed description

Diabetes mellitus type1 requires lifelong insulin substitution, aiming at near normal glycaemia. Insufficient metabolic control (HbA1c > 8 %) leads to micro and macro- vascular complications. Especially in adolescence a lack of compliance leads to deteriorated metabolic control. Motivational factors play a pivotal role in this age-group, however they have neither been studied so far nor considered in interventions with diabetes patients.

Therefore, the aim of this study is to evaluate in a multi-centred randomized controlled trial the effectiveness of diabetes management training with the method of Motivational Interviewing with elements of Cognitive Behaviour Therapy and E-mail support.

Sixty adolescents within the age group of 13-20 years and HbA1c levels > 8 % will - after a refresher course in diabetes education - be involved to 2-weekly individual interventions sessions including motivational interviewing and CBT-modules with a psychologist and weekly e-mail support for a period of six month in order to improve HbA1c levels, self- efficacy in diabetes management and general quality of life.

As control group sixty adolescents within the age group of 13-20 years and HbA1c levels > 8 will - after a refresher course in diabetes education - get treatment as usual, including routine medical support visits, unspecific psychological consultations and unspecific e-mail support to match with the intervention group for time bonus.

We assess motivational changes and effects on metabolic control (HbA1c) and define the predictors of positive effects on glycaemic control.

02

Conditions studied

  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's planned enrollment of 120 is above the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,105 studies on the registry; 182 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
13 Years to 20 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Diabetes mellitus, type1
  • HbA1c>8
  • 1 year of diagnosis
  • Access to Internet available

Exclusion criteria

Exclusion Criteria:

  • N/A
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Active comparator
    Motivational Interviewing, CBT and E-mail support

    Behavioral: Motivational Interviewing, CBT and E-mail support

  • Active comparator
    E-Mail-support

    Behavioral: Motivational Interviewing, CBT and E-mail support

Interventions

  • BehavioralMotivational Interviewing, CBT and E-mail support

    Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support

    Also known as: Motivational Interviewing, Cognitive Behaviour Therapy, Diabetes mellitus type 1, children, adolescents

06

What researchers measure

Primary outcomes

  1. HbA1C

    Metabolic control

    Time frame: after 8 months

Secondary outcomes

  1. Predictors of positive effects on glycaemic control

    Time frame: after 6 months and after 12 months

  2. Motivational changes

    Time frame: after 6 months and 12 months

  3. HbA1c

    Metabolic control

    Time frame: after 12 months

07

Study locations

1 site
  • Medical University of Vienna
    Vienna, 1090, Austria
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2010, a primary completion of Jan 2013 and a completion of Jan 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 19, 2012
First posted
Jan 30, 2012
Start
Jun 2010
Primary completionEst.
Jan 2013
CompletionEst.
Jan 2014
Last update
Sep 27, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 27, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01520428
Collaborators
National Bank of Austria
Responsible party
Rami-Merhar, Birgit, Univ. Prof. Dr. Med. MBA (Univ.Prof.Dr.Med.MBA, Medical University of Vienna) — Principal investigator
First posted
Jan 30, 2012
Start date
Jun 2010
Primary completion
Jan 2013 (estimated)
Completion
Jan 2014 (estimated)
Last update
Sep 27, 2012

Study contacts

Birgit Rami-Merhar, MD, Uni Prof
principal investigator · Medical University of Vienna, Dep. of Pediatrics and Adolescent Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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