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Transdisciplinary Versus Usual Care for Type1 Diabetes in Adolescence

NCT03557151 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2022-08-05

Study results available
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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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

OTHER

Usual Care

Usual Care participants will receive the same excellent multidisciplinary Care they would receive at the same center were they not enrolled in the trial. In clinic visits scheduled at approximately 3-month intervals, they will see subspecialty board certified or eligible pediatric endocrinologists, supplemented as needed with involvement of certified diabetes educators, dietitians, social workers or psychologists. HbA1c target is \< 7.5% with no severe hypoglycemia and acceptable quality of life. About half are expected to be on insulin pumps and carbohydrate counting, while the great majority of others are following basal-bolus multiple daily injection regimens, also based on carbohydrate counting. A rising proportion of patients use continuous glucose monitors and this trend is likely to accelerate during the study.

BEHAVIORAL

Transdisciplinary Care-In Person & Telehealth

TC participants will receive all elements of the Usual Care intervention but they will do so in the context of face to face or telehealth delivery of TC follow-up visits with simultaneous involvement of an advanced practice nurse, dietitian and psychologist at each visit.

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    collaborator NIH

  • Nemours Children's Clinic

    lead OTHER

Principal Investigators

  • Melissa Alderfer, PhD · Nemours Children's Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
11 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-13
Primary Completion
2021-03-31
Completion
2022-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03557151 on ClinicalTrials.gov