N/A
N=208
Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence
Type 1 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT03557151 ↗Enrolled (actual)
208
Serious AEs
9.6%
Results posted
Jul 2022
Primary outcome: Primary: Glycosylated Hemoglobin (HbA1c) — 8.59; 9.02; 8.71; 9.03 percentage of glycosylated hemoglobin — p=0.895
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Usual Care (Other); Transdisciplinary Care-In Person & Telehealth (Behavioral)
- Age
- Pediatric · 11+ yrs
- Sex
- All
- Sponsor
- Nemours Children's Clinic
- Primary completion
- Mar 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glycosylated Hemoglobin (HbA1c) |
8.59; 9.02; 8.71; 9.03; 8.59; 8.98 | 0.895 |
| SECONDARY Diabetes Self Management Profile-Self Report Form |
53.45; 55.99; 53.97; 55.09 | .33 |
| SECONDARY Diabetes Self Management Profile - Parent Proxy Report |
53.73; 54.44; 52.67; 55.64 | .07 |
Summary
This study will consist of a randomized controlled trial to test a novel Transdisciplinary Care (TC) model of delivery of care for type 1 diabetes in adolescence. Adolescents and their parents/caregivers (n=150) will be randomized to Usual Care or TC care in a 1:2 ratio. Approximately half of those in TC care will received TC in person and half will receive it through telehealth. TC visits will consist of conjoint management of T1D by a TC team consisting of an Advanced Practice Nurse, Dietitian and Psychologist who will see parent-adolescent dyads together within the same visit. TC team members have trained each other in their respective disciplines. Outcome measures include glycohemoglobin (HbA1c) and questionnaires assessing diabetes self management behaviors. Other ancillary/exploratory measures are also completed.
Eligibility Criteria
Adolescents:
- Age > 11 years but 1 year
- Most recent HbA1C or mean HbA1C over the prior year 7.5-10.0%, inclusive
- Has had at least one clinic visit for T1D at a Nemours Children's Clinic within the past year
- Is not currently participating in any other research in which treatment adherence or glycemic control are study outcomes
- No T1D clinic visits in the preceding 12 months in which two or more care providers saw the patient together
- Is not on daily oral glucocorticoid treatment
- Is considered developmentally normal by the treating clinician (not in a self- contained special education classroom or been retained in 2 or more grades)
- Is able to read/comprehend study questionnaires in English
- Is not currently undergoing treatment for a coincident medical condition that, in the opinion of the treating physician, represents a contraindication to study participation
- Family must be able to access the internet
Parents:
- Is either a biological parent or legally appointed caregiver of the child
- Is the primary diabetes caregiver of the child: and at least weekly involvement in T1D care
- Routinely accompanies child for diabetes care at Nemours
- Is willing to schedule T1D clinic visits at a specific available location in Orlando or Wilmington
- Capable of participating in conversations in English during medical visits
- Anticipates continued medical care for T1D at Nemours for a year following study enrollment
- Is able to read/comprehend study questionnaires and decision aids in English
- Does not have an open abuse/neglect case with any child protection agency over the prior 3 years
- There is no evidence of frequent changes in the adolescent's household or living arrangements
Data sourced from ClinicalTrials.gov (NCT03557151). 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.