N/A
N=133
Shared Medical Decision Making in Pediatric Diabetes
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02496156 ↗Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Feb 2024
Primary outcome: Primary: Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile — 32.5; 34.2; 40.1; 35.7 score on a scale — p=<0.39
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Usual Clinical Practice (Behavioral); Shared Medical Decision Making (Behavioral)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Continuous Glucose Monitor Use Profile or Insulin Pump Use Profile |
32.5; 34.2; 40.1; 35.7; 33.8; 33.7 | <0.39 |
| SECONDARY Glycated Hemoglobin (Hemoglobin A1C) |
8.61; 8.53; 8.54; 8.24; 8.80; 8.55 | >0.05 |
| SECONDARY Decision Regret Scale |
9.14; 9.85; 8.69; 8.53 | >0.05 |
| SECONDARY Knowledge of Insulin Pump or Continuous Glucose Monitor |
2.86; 2.76; 3.14; 3.40 | >0.05 |
| SECONDARY Diabetes Self Management Profile Self Report Form |
55.03; 56.19; 55.91; 56.25; 56.08; 54.14 | — |
| SECONDARY SURE Test |
3.43; 3.74; 3.70; 3.73 | >0.05 |
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. 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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- Open case with child protection agency
- Unable to read and speak English
Data sourced from ClinicalTrials.gov (NCT02496156). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.