Enhancing Telemedicine for T2D

NCT06740435 | Active Not Recruiting

• 2 other identifiers: STUDY24060062K23DK135794
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pilot clinical trial is to assess feasibility of an intervention to deliver comprehensive, high-quality diabetes care through telemedicine among adults with type 2 diabetes who use insulin and have multiple chronic health conditions. The main question it aims to answer is: Is an enhanced telemedicine intervention for type 2 diabetes compared to usual telemedicine care feasible? Researchers will compare the enhanced telemedicine intervention to usual telemedicine care to see if there are differences in patient satisfaction or preliminary clinical outcomes. Participants will complete 2-3 telemedicine diabetes care visits over approximately 6 months, as well as complete survey measures with each diabetes care visit. Patients in the intervention group will also receive additional support, including pre-visit preparation phone calls, diabetes self-management education and support aligned with their visits, and post-visit follow-up calls.

Conditions

Type 2 Diabetes

Keywords

Telemedicine

Outcome Measures

Primary Outcomes (2)

• Recruitment percentage

  Percent of eligible patients approached who are enrolled

  12 months

• Loss to follow up

  Percent of enrolled patients who do not complete study, defined as not completing at least 2 study visits and associated surveys

  6 months

Secondary Outcomes (16)

• Recruitment rate

  12 months

• Eligibility percentage

  12 months

• Visit attendance

  6 months

• Number of between-visit contacts

  6 months

• Blood glucose data availability

  6 months

Study Arms (2)

Enhanced Telemedicine Care

EXPERIMENTAL

Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist, with additional multidisciplinary support from the diabetes care team.

Other: Enhanced Telemedicine for Type 2 Diabetes

Usual Care

ACTIVE COMPARATOR

Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist following usual clinical care protocols.

Other: Usual Telemedicine Endocrinology Care for T2D

Interventions

Enhanced Telemedicine for Type 2 Diabetes OTHER

Telemedicine-based endocrinology specialty care for type 2 diabetes with multidisciplinary diabetes care team support including pre-visit preparation, in-visit support and self-management education, and post-visit follow-up.

Enhanced Telemedicine Care

Usual Telemedicine Endocrinology Care for T2D OTHER

Routine telemedicine-based endocrinology specialty care for type 2 diabetes, generally consisting of synchronous virtual visit with an endocrinologist and additional support including self-management education on an individualized basis.

Usual Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults 18 years or older
• Diagnosis of type 2 diabetes based on abbreviated ICD-10 code E11.X in medical record or self-report
• HbA1c greater than or equal to 8% based on most recent value at time of recruitment
• Patients must own or have access to a smart phone, tablet, or home computer with data or internet connection that allows access to video-based visits
• Patient must use insulin
• Patients must have \>2 comorbid chronic health conditions
• Be able to provide informed consent
• Reside in Pennsylvania

You may not qualify if:

• Age over 80 based on date of birth in electronic medical record
• Visit with an endocrinologist in the prior 1 years
• Dementia, ESRD, malignancy based on abbreviated ICD-10 codes below in medical record or self-report of associated condition
• Dementia: A81.0x, F01.5x, F02.8x, F03.9x, F10.27, F10.97, F13.27, F13.97, F18.97, F19.17, F19.27, F19.97, G30.x, G31.0x, G31.1, G31.83, G31.85
• Malignancy, except non-melanoma skin cancer: C00.x-C14.x, C15.x-C26.x, C3x.xx, C40.xx-C41.x, C43.x, C4A.xx, C45.x-C49.xx, C50.xxx, C51.x-C58, C60.x-C63.x, C64.x- C68.x, C69.xx-C72.x, C73-C76.x, C7A.xx, C80.xx-C96.x (except C90.x1, C91.x1, C92.x1, C93.x1, C94.x1, C95.x1)
• ESRD N18.6
• Type 1, gestational, or other diabetes based on abbreviated ICD-10 codes below in medical record or self-report of associated condition
• Type 1 diabetes: E10.X
• Gestational diabetes: O24.X, E08.X
• Other diabetes: E09.X, E13.2
• Pregnant or planning to become pregnant in next 6 months
• Currently enrolled in another diabetes management intervention study

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Margaret Zupa, MDMS

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: February 3, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available no later than 12 months and ending 36 months after the primary trial results are published.
• Access Criteria: No access will be granted until the requesting investigator vetting process is completed including an IRB-approved protocol and data use agreement with the University of Pittsburgh.The data that may be shared includes: de-identified participant data, tables, figures, appendices, analysis plan, and protocol.

Locations

US (1)