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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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 group | Role | What they receive |
|---|---|---|
| Team Clinic Intervention | Experimental | Middle School and High School Team Clinic Intervention Receives: Behavioral: Team Clinic |
| Standard Clinical Care - Control | No intervention | Standard Clinical Care - Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic control
Hemoglobin A1c
Measured: 30 months
Satisfaction Questionnaire
Clinic satisfaction (patient and parent)
Measured: 30 months
Diabetes distress Questionnaire
Diabetes distress (patient and parent)
Measured: 30 months
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.
- First posted11 Sep 2015 (estimated)
- Study startOct 2012
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Sponsor
- Investigators
- Jennifer Raymond, MD, MCR, Principal investigator, University of Colorado, Denver
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Medical Appointments to Improve Outcomes in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02547311
- Acronym / sponsor ID
- 12-1281
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- Oct 2012 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 11 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Team Clinic Intervention | Experimental | Behavioral: Team ClinicMiddle School and High School Team Clinic Intervention |
| Standard Clinical Care - Control | No intervention | –Standard Clinical Care - Control |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- T1D >1 year duration, 6th-10th grade
Key exclusion criteria (2 listed)
- non-English speaking
- severe behavioral, developmental, or psychological diagnosis making group participation difficult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Team Clinic | Behavioural | Team Clinic Intervention |
Primary outcome
Glycemic control
Time frame: 30 months
Hemoglobin A1c
Satisfaction Questionnaire
Time frame: 30 months
Clinic satisfaction (patient and parent)
Diabetes distress Questionnaire
Time frame: 30 months
Diabetes distress (patient and parent)
Cost effectiveness
Time frame: 30 months
Clinical cost effectiveness of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Raymond, MD, MCR principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
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.