Enhancing Telemedicine for T2D

University of Pittsburgh

Status: Enrolling

Conditions: Type 2 Diabetes

Treatments: Other: Usual Telemedicine Endocrinology Care for T2D; Other: Enhanced Telemedicine for Type 2 Diabetes

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06740435

K23DK135794 (U.S. NIH Grant/Contract)

STUDY24060062

Details and patient eligibility

About

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.

Full description

This pilot study will compare an intervention to deliver high-quality diabetes care through telemedicine for adults with type 2 diabetes who have additional chronic health conditions and use insulin with usual telemedicine care. The investigators will assess feasibility, patient satisfaction, and preliminary clinical outcomes.

Fifty adults will be recruited from primary care practices. Once patients are confirmed eligible, they will be consented and enrolled. Patients will be randomized to the intervention arm or usual telemedicine care, stratified by age (above or below 65 years) and rurality, as these factors are associated with technological literacy and broadband access, which may impact telemedicine use and outcomes. Both groups will complete baseline survey measures and baseline clinical data will be collected via chart review. As this is a pragmatic pilot trial, intervention components will be delivered by usual clinical providers and staff for the intervention group. The telemedicine care intervention will include 2-3 synchronous visits with endocrinology providers over 6 months plus additional visits with multidisciplinary providers on an individualized basis. Telemedicine care will proceed as usual for the control group.

The investigators will focus pilot trial outcomes on standard metrics to assess feasibility for a future large trial. The investigators will also measure preliminary clinical outcomes.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Enhanced Telemedicine Care

Experimental group

Description:

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

Treatment:

Other: Enhanced Telemedicine for Type 2 Diabetes

Usual Care

Active Comparator group

Description:

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

Treatment:

Other: Usual Telemedicine Endocrinology Care for T2D