Type 1 Diabetes MellitusNCT02496156
Shared Medical Decision Making in Pediatric Diabetes
A study testing Usual Clinical Practice and Shared Medical Decision Making in people with Type 1 Diabetes Mellitus, run by Nemours Children's Clinic at 1 site in United States.
Trial summary
This work is testing a shared medical decision making intervention for adolescents with type 1 diabetes and their parents who are candidates for adding either an insulin pump or continuous glucose monitor to their treatment plan. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Usual Clinical Practice and Shared Medical Decision Making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2015to 7 Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Type 1 diabetes for 1 year or more
- At least 2 diabetes clinic visits at the enrolling site in the prior year
- Considered by treating endocrinologist to be a candidate for insulin pump or continuous glucose monitor
- Intent to continue care at Nemours for 1 year
- Internet access at home, school, work or relative's home
Who cannot join
- Open case with child protection agency
- Unable to read and speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Nemours Children's Clinic
Jacksonville, Florida, 32207
About this study
This work is testing a shared medical decision making intervention for adolescents with type 1 diabetes and their parents who are candidates for adding either an insulin pump or continuous glucose monitor to their treatment plan. The first half of the work consisted of the stakeholder driven design, construction and refinement of web-delivered multimedia decision aids for each of these decisions. The randomized controlled trial of that intervention began enroling participants in February 2015. A sample of 166 eligible adolescents who receive care at an operating entity of the Nemours Children's Health System will be enrolled and randomized to either Usual Clinical Practice alone or augmented by the Shared Medical Decision Making intervention. Primary outcomes include measures of engagement with the pertinent technology if it is chosen and measures of decision quality; Secondary outcomes include indices of metabolic control, quality of life and parent-adolescent relationships around diabetes management.
Read the detailed description
Abstract (modified after achievement of Aims 1 and 2):
Treatment adherence in type 1 diabetes (T1D) tends to decline among adolescents, increasing risks of acute and chronic complications, excess health care use, poorer quality of life, and T1D-related family conflict. Poor adherence is associated with psychiatric and family dysfunction and often persists into early adulthood. Therapeutic advances such as continuous subcutaneous insulin infusion (CSII or "insulin pump") and continuous glucose monitoring (CGM) could improve metabolic control and quality of life.
But, teens often do not benefit fully from such advances. Many studies of adults show that patient-centered communication styles predict more favorable clinical outcomes. Shared medical decision making (SMDM) interventions have improved outcomes among adults with diabetes and other conditions. Research in pediatrics has also shown that patient-centered and family-centered communication styles predict favorable outcomes, but most of this research is in primary care and has not studied youth with chronic conditions. Since there have been no controlled trials of SMDM with chronically ill youths, we propose a randomized controlled trial of an SMDM intervention compared with Usual Clinical Practice (UCP). Qualitative interviews of youths and parents who have previously faced these decisions and reliance on expert consultants, pediatric endocrinologists and diabetes educators have preceded this trial and provided valued input for refining the planned intervention and adapting the structured SMDM format for pediatrics. Now, we will recruit and randomize 166 11-<17 year old youth with T1D who are candidates for CSII or CGM (and a parent/caregiver) at all Nemours sites. The SMDM intervention will be delivered via a web-based platform, facilitated by Diabetes Educators (DEs) at each site in a standardized, yet individually tailored format. SMDM will employ multimedia "decision aids" prepared with the award-winning Nemours Center for Children's Health Media and the "e-city interactive" web design firm in Philadelphia in accord with pertinent international standards. SMDM will also include individualized assistance from the DE in assuring that each youth's and parent's preferences, values and cultural beliefs are carefully addressed and communicated to the attending endocrinologist. After a baseline evaluation and randomization to SMDM or UCP, effects on the primary outcome (treatment adherence; device utilization) and secondary outcomes (glycemic control, treatment alliance, decision conflict and regret, treatment satisfaction, diabetes-related distress and self-efficacy) will be measured over 1 year. Mixed effects modeling will be the primary analytic technique for evaluating effects on primary/secondary outcomes, examining selected variables as moderators and mediators of treatment effects, and assessing whether such effects are comparable for the two medical decisions of interest. The results will verify whether SMDM in this context enhances treatment adherence, device use and parent/patient-reported outcomes in youth with T1D.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Usual Clinical Practice, Shared Medical Decision Making
- Keywords
- type 1 diabetes mellitus, adolescence, adherence, insulin pump, continuous subcutaneous insulin infusion, continuous glucose monitor, shared medical decision making
- 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.
Usual Clinical PracticeBehavioural
Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.
Shared Medical Decision MakingBehavioural
Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.
| Study group | Role | What they receive |
|---|---|---|
| Usual Clinical Practice (UCP) | Active comparator | UCP participants will receive the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who are not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient. Receives: Behavioral: Usual Clinical Practice |
| Shared Medical Decision Making (SMDM) | Experimental | Participants randomized to SMDM receive all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents will receive password-protected, secure access to the decision for their use until a decision is reached. The platform will then generate a summary report that the adolescent and parent will discuss with a diabetes nurse and then a visit with the treating endocrinologist will be scheduled to conclude the SMDM intervention for that adolescent and parent. Receives: Behavioral: Shared Medical Decision Making |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile
Adolescent and Parent report regarding degree to which use of the device of interest has become an integral part of the adolescent's daily diabetes self management. Scores may range from 10 to 50, with higher scores reflecting more frequent and meticulous use of the diabetes device of interest.
Measured: Measure was collected at each study visit after the participant actually obtained a CGM or Insulin Pump
Secondary outcomes (5)
Glycated Hemoglobin (Hemoglobin A1C)
Glycated hemoglobin (Hemoglobin A1C) expressed as the percentage of hemoglobin molecules that are bound to glucose. Normal range is approximately 4.5% to 6.5%, Higher values indicate a higher blood glucose concentration over the preceding 2-3 months.
Measured: Every 3 months for for 1 year
Decision Regret Scale
Questionnaire measuring decision making regret. Reflecting on a specific decision (accept or decline opportunity to use CGM or insulin pump), higher score reflect a greater degree of regret regarding the decision that was made. Scores may range from 5 to 20.
Measured: Obtained at Visits 3 and 5 only
Knowledge of Insulin Pump or Continuous Glucose Monitor
Brief test of parent and adolescent knowledge about the pertinent device and its use. Higher scores reflect more precise knowledge about the diabetes device of interest. Scores may range from 1 to 5.
Measured: Baseline and 3 months later
Diabetes Self Management Profile Self Report Form
Composite measure of diabetes treatment adherence consisting of combined scores based on reports of parents and adolescents. Higher scores reflect more meticulous adherence to recommended diabetes self management behaviors. Scores may range from 0 to 86.
Measured: Visits 1, 3 and 5
SURE Test
4-item questionnaire that measures patients' confidence in a health care decision that has been made. Scores may range from 0-4 with higher scores reflecting greater confidence in the decision made regarding insulin pump or CGM.
Measured: Measured at Follow-up Visits 3 and 5 only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2015 (estimated)
- Study startFeb 2015
- Primary completion7 Feb 2017
- Study completion7 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- 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
- Parallel groups
- Model description
- 2 group (Usual Clinical Practice or Shared Medical Decision Making X 5 time points (0, 3, 6, 9 and 12 months) repeated measures randomized treatments design.
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nemours Children's Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- Tim Wysocki, PhD, Principal investigator, Nemours Biomedical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02496156
- Sponsor's protocol ID
- PCORI 805
- Status last verified
- May 2023
- First submitted
- 23 Apr 2015
- Last updated
- 1 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Wysocki T, Hirschfeld F, Miller L, Izenberg N, Dowshen SA, Taylor A, Milkes A, Shinseki MT, Bejarano C, Kozikowski C, Kowal K, Starr-Ashton P, Ross JL, Kummer M, Carakushansky M, Lyness D, Brinkman W, Pierce J, Fiks A, Christofferson J, Rafalko J, Lawson ML. Consideration of Insulin Pumps or Continuous Glucose Monitors by Adolescents With Type 1 Diabetes and Their Parents: Stakeholder Engagement in the Design of Web-Based Decision Aids. Diabetes Educ. 2016 Aug;42(4):395-407. doi: 10.1177/0145721716647492. Epub 2016 May 4.
PubMed 27150606
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Medical Decision Making in Pediatric Diabetes
- ClinicalTrials.gov ID
- NCT02496156
- Acronym / sponsor ID
- PCORI 805
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes mellitus, adolescence, adherence, insulin pump, continuous subcutaneous insulin infusion, continuous glucose monitor, shared medical decision making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Nemours Children's ClinicUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Feb 2015
- Primary completion
- 7 Feb 2017 (actual)
- Study completion
- 7 Feb 2017 (actual)
- First posted
- 14 Jul 2015 (estimated)
- Results
- Posted 1 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This work is testing a shared medical decision making intervention for adolescents with type 1 diabetes and their parents who are candidates for adding either an insulin pump or continuous glucose monitor to their treatment plan. The first half of the work consisted of the stakeholder driven design, construction and refinement of web-delivered multimedia decision aids for each of these decisions. The randomized controlled trial of that intervention began enroling participants in February 2015. A sample of 166 eligible adolescents who receive care at an operating entity of the Nemours Children's Health System will be enrolled and randomized to either Usual Clinical Practice alone or augmented by the Shared Medical Decision Making intervention. Primary outcomes include measures of engagement with the pertinent technology if it is chosen and measures of decision quality; Secondary outcomes include indices of metabolic control, quality of life and parent-adolescent relationships around diabetes management.
Detailed description
Abstract (modified after achievement of Aims 1 and 2):
Treatment adherence in type 1 diabetes (T1D) tends to decline among adolescents, increasing risks of acute and chronic complications, excess health care use, poorer quality of life, and T1D-related family conflict. Poor adherence is associated with psychiatric and family dysfunction and often persists into early adulthood. Therapeutic advances such as continuous subcutaneous insulin infusion (CSII or "insulin pump") and continuous glucose monitoring (CGM) could improve metabolic control and quality of life.
But, teens often do not benefit fully from such advances. Many studies of adults show that patient-centered communication styles predict more favorable clinical outcomes. Shared medical decision making (SMDM) interventions have improved outcomes among adults with diabetes and other conditions. Research in pediatrics has also shown that patient-centered and family-centered communication styles predict favorable outcomes, but most of this research is in primary care and has not studied youth with chronic conditions. Since there have been no controlled trials of SMDM with chronically ill youths, we propose a randomized controlled trial of an SMDM intervention compared with Usual Clinical Practice (UCP). Qualitative interviews of youths and parents who have previously faced these decisions and reliance on expert consultants, pediatric endocrinologists and diabetes educators have preceded this trial and provided valued input for refining the planned intervention and adapting the structured SMDM format for pediatrics. Now, we will recruit and randomize 166 11-<17 year old youth with T1D who are candidates for CSII or CGM (and a parent/caregiver) at all Nemours sites. The SMDM intervention will be delivered via a web-based platform, facilitated by Diabetes Educators (DEs) at each site in a standardized, yet individually tailored format. SMDM will employ multimedia "decision aids" prepared with the award-winning Nemours Center for Children's Health Media and the "e-city interactive" web design firm in Philadelphia in accord with pertinent international standards. SMDM will also include individualized assistance from the DE in assuring that each youth's and parent's preferences, values and cultural beliefs are carefully addressed and communicated to the attending endocrinologist. After a baseline evaluation and randomization to SMDM or UCP, effects on the primary outcome (treatment adherence; device utilization) and secondary outcomes (glycemic control, treatment alliance, decision conflict and regret, treatment satisfaction, diabetes-related distress and self-efficacy) will be measured over 1 year. Mixed effects modeling will be the primary analytic technique for evaluating effects on primary/secondary outcomes, examining selected variables as moderators and mediators of treatment effects, and assessing whether such effects are comparable for the two medical decisions of interest. The results will verify whether SMDM in this context enhances treatment adherence, device use and parent/patient-reported outcomes in youth with T1D.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 2 group (Usual Clinical Practice or Shared Medical Decision Making X 5 time points (0, 3, 6, 9 and 12 months) repeated measures randomized treatments design.
| Arm | Type | Receives |
|---|---|---|
| Usual Clinical Practice (UCP) | Active comparator | Behavioral: Usual Clinical PracticeUCP participants will receive the same clinical and educational management for candidates for insulin pump or continuous glucose monitoring that is received by similar patients who are not enrolled in this study. The respective endocrinology practices at the enrolling sites all strive to meet or exceed the current American Diabetes Association Standards for Clinical Practice in the management of type 1 diabetes in this population. Thorough patient education is the cornerstone of that care, especially regarding the incorporation of insulin pumps and continuous glucose monitors into the treatment regimen for a given patient. |
| Shared Medical Decision Making (SMDM) | Experimental | Behavioral: Shared Medical Decision MakingParticipants randomized to SMDM receive all components of UCP supplemented with access to the decision aid website pertinent to the medical decision of interest (pump or CGM). Adolescents and parents will receive password-protected, secure access to the decision for their use until a decision is reached. The platform will then generate a summary report that the adolescent and parent will discuss with a diabetes nurse and then a visit with the treating endocrinologist will be scheduled to conclude the SMDM intervention for that adolescent and parent. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Type 1 diabetes for 1 year or more
- At least 2 diabetes clinic visits at the enrolling site in the prior year
- Considered by treating endocrinologist to be a candidate for insulin pump or continuous glucose monitor
- Intent to continue care at Nemours for 1 year
- Internet access at home, school, work or relative's home
Key exclusion criteria (2 listed)
- Open case with child protection agency
- Unable to read and speak English
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 |
|---|---|---|
| Usual Clinical PracticeDiabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site. | Behavioural | Usual Clinical Practice (UCP) |
| Shared Medical Decision MakingAccess to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen. | Behavioural | Shared Medical Decision Making (SMDM) |
Primary outcome
Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile
Time frame: Measure was collected at each study visit after the participant actually obtained a CGM or Insulin Pump
Adolescent and Parent report regarding degree to which use of the device of interest has become an integral part of the adolescent's daily diabetes self management. Scores may range from 10 to 50, with higher scores reflecting more frequent and meticulous use of the diabetes device of interest.
5 secondary outcomes
Glycated Hemoglobin (Hemoglobin A1C)
Time frame: Every 3 months for for 1 year
Decision Regret Scale
Time frame: Obtained at Visits 3 and 5 only
Knowledge of Insulin Pump or Continuous Glucose Monitor
Time frame: Baseline and 3 months later
Diabetes Self Management Profile Self Report Form
Time frame: Visits 1, 3 and 5
SURE Test
Time frame: Measured at Follow-up Visits 3 and 5 only
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27150606Wysocki T, Hirschfeld F, Miller L, Izenberg N, Dowshen SA, Taylor A, Milkes A, Shinseki MT, Bejarano C, Kozikowski C, Kowal K, Starr-Ashton P, Ross JL, Kummer M, Carakushansky M, Lyness D, Brinkman W, Pierce J, Fiks A, Christofferson J, Rafalko J, Lawson ML. Consideration of Insulin Pumps or Continuous Glucose Monitors by Adolescents With Type 1 Diabetes and Their Parents: Stakeholder Engagement in the Design of Web-Based Decision Aids. Diabetes Educ. 2016 Aug;42(4):395-407. doi: 10.1177/0145721716647492. Epub 2016 May 4.
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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.
Tim Wysocki, PhD principal investigator
Nemours Biomedical Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual Clinical Practice and Shared Medical Decision Making in people with Type 1 Diabetes Mellitus, run by Nemours Children's Clinic 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 5 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 1 Feb 2024. 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?
Yes. Results are posted in the registry (first posted 1 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile (time frame: Measure was collected at each study visit after the participant actually obtained a CGM or Insulin Pump). 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 NCT02496156, which also lists 1 linked publication.
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 1 Feb 2024.