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Type 1 DiabetesNCT02547311

Shared Medical Appointments to Improve Outcomes in Adolescents With Type 1 Diabetes

A study testing Team Clinic in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.

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

Adolescents and emerging adults with type 1 diabetes (T1D) experience significant struggles with their diabetes management resulting in worsening diabetes health and increased complications. Read more about this study

Who is it for?
Ages 11 to 17 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Team Clinic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
318 participants
Where
1 siteUnited States
Study dates
Oct 2012to Jul 2015
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 11 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • T1D >1 year duration, 6th-10th grade

Who cannot join

  • non-English speaking
  • severe behavioral, developmental, or psychological diagnosis making group participation difficult

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Colorado Denver School of Medicine Barbara Davis Center

    Aurora, Colorado, 80045

Other trials in United States

About this study

Adolescents and emerging adults with type 1 diabetes (T1D) experience significant struggles with their diabetes management resulting in worsening diabetes health and increased complications. This population's declining well-being occurs during a time when they should be at their healthiest and enjoying multiple exciting life transitions. Their worsening diabetes management is complicated by the fact they are also learning how to become more independent from their family in preparation for eventually leaving home. Furthermore, the number of people under 20 years of age diagnosed with T1D has increased dramatically over the past 10 years giving rise to increased concern about providing care to this population.

The Team Clinic Intervention is an innovative clinical care approach to address the medical and developmental needs of adolescents with T1D and their families. A group medical appointment format will be used for routine diabetes clinic visits in middle school and high school adolescents with T1D. Parents of these patients will be participating in their own group during these clinic visits. The Team Clinic model incorporates developmentally tailored peer support and novel learning tools, (e.g. games, physical activity, and/or interaction through Internet resources, e.g. blogs, forums) into the shared medical appointment design.

Read more

The goal of Team Clinic Intervention is to improve medical and psychological outcomes in adolescents with T1D and their parents. The study will investigate, in a randomized controlled trial, the efficacy of a novel clinical care model that addresses the unique developmental strengths and weaknesses of the T1D adolescent population. The Team Clinic format streamlines clinical care delivery to this often-challenging patient population without placing additional burden on youth, families, or clinics because the intervention will be completed during routine diabetes care visits. Moreover, the Team Clinic approach maximizes the benefits of peer support by delivering care in a group format to address the sense of isolation that teens and families coping with chronic illness often feel.

If successful, the Team Clinic Intervention will not only positively impact adolescents with T1D and their families, but it could be used as a model of care for other adolescents with chronic medical conditions struggling to remain involved and invested in their medical care. Team Clinics may be one approach to successfully engaging adolescents in their diabetes care prior to their transition away from home, which will help them remain invested and active in their medical care through adolescence and young adulthood.

Conditions
Type 1 Diabetes
Being tested
Team Clinic
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.

  • Team ClinicBehavioural

Study groups in NCT02547311
Study groupRoleWhat they receive
Team Clinic InterventionExperimentalMiddle School and High School Team Clinic Intervention
Receives: Behavioral: Team Clinic
Standard Clinical Care - ControlNo interventionStandard Clinical Care - Control

What is being measured

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

  1. Glycemic control

    Hemoglobin A1c

    Measured: 30 months

  2. Satisfaction Questionnaire

    Clinic satisfaction (patient and parent)

    Measured: 30 months

  3. Diabetes distress Questionnaire

    Diabetes distress (patient and parent)

    Measured: 30 months

  4. Cost effectiveness

    Clinical cost effectiveness of intervention

    Measured: 30 months

Timeline

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

  1. First posted11 Sep 2015 (estimated)
  2. Study startOct 2012
  3. Primary completionJul 2015
  4. Study completionJul 2015

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
Health services research
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
318 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02547311
Sponsor's protocol ID
12-1281
Other IDs
#2015PG-T1D080
Status last verified
Jan 2022
First submitted
9 Sep 2015
Last updated
18 Jan 2022
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Team Clinic in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.

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 1 inclusion and 2 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 18 Jan 2022. 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 United States. 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?

Glycemic control (time frame: 30 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 18 Jan 2022; AzTrials last refreshed its copy on 7 Nov 2026.

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