Enhancing Telemedicine for T2D

Pilot Study Enhancing Telemedicine Care Delivery for Adults With Complex Type 2 Diabetes

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Enhanced Telemedicine for Type 2 Diabetes; Other: Usual Telemedicine Endocrinology Care for T2D

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Telemedicine Care; 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; 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.
Active Comparator: Usual Care; Specialty care for type 2 diabetes delivered via telemedicine by an endocrinologist following usual clinical care protocols.	Other: Usual Telemedicine Endocrinology Care for T2D; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate	Number of patients recruited per month	12 months
Eligibility percentage	Percent of patients approached who are eligible	12 months
Visit attendance	Percent of scheduled visits completed per patient	6 months
Number of between-visit contacts	Number of successful and attempted patient contacts by clinicians between visits per patient	6 months
Blood glucose data availability	Number of telemedicine visits with blood glucose data available at visit per patient	6 months
Diabetes Treatment Satisfaction Questionnaire-static version	Total score of 8-item measure of global satisfaction with diabetes treatment regimen. The static version will be used at baseline. Items 1, 4, 5, 6, 7 & 8 are summed to produce a Treatment Satisfaction score (range:0 to 36). The higher the score, the greater the satisfaction with treatment. 'Perceived frequency of hyperglycaemia' (item 2) & 'Perceived frequency of hypoglycaemia' (item 3): Both rated: 6 ('most of the time') to 0 ('none of the time'). Here, lower scores indicate blood glucose levels closer to the ideal. Higher scores indicate problems.	Baseline
Diabetes Treatment Satisfaction Questionnaire-change version	Total score of 8-item measure of global satisfaction with diabetes treatment regimen. The change version will be used at 6 months.Items 1, 4, 5, 6, 7 and 8 are summed to produce a Treatment Satisfaction (change) score (range: +18 to -18). The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represents no change. Two remaining items ('Perceived change in frequency of hyperglycaemia' (item 2) and 'Perceived change in frequency of hypoglycaemia' (item 3)) are treated individually: Both rated: +3 ('much more of the time now') to -3 ('much less of the time now'). Here, negative scores indicate fewer problems with blood glucose levels. Positive scores indicate more problems than before.	6 months
T2D Diabetes Distress Core Scale	Change in total score of 8-item measure of diabetes-related distress over prior month from baseline to 6 months. The Diabetes Distress Core scale is scored by averaging the value for each item, ranked from 1 to 5 scale (score range 1-5), with higher scores indicating more distress.	Baseline and 6 months
HbA1c change	Change in glycemic control from baseline to 6 months	Baseline and 6 months
Prescription of guideline-based GLP-1 receptor agonist	Number of patients with indications for GLP-1 receptor agonist therapy who are prescribed the indicated medication	Baseline and 6 months
Prescription of guideline-based SGLT2 inhibitor	Number of patients with indications for SGLT2 inhibitor therapy who are prescribed the indicated medication	Baseline and 6 months
Retinal examination	Number of patients with documentation of retinal examination performed in last year in medical record	6 months
Urine protein testing	Number of patients with documentation of urine protein testing performed in last year in medical record	6 months
Immunization-pneumococcal	Number of patients with documentation of pneumococcal vaccination in medical record	6 months
Immunization-influenza	Number of patients with documentation of influenza vaccination in medical record	6 months
Patient satisfaction with telemedicine diabetes care	Percent of patients reporting satisfied or very satisfied on a 5-point Likert scale ranging from 1 "strongly disagree" to 5 "strongly agree" with the statement "Overall, I am satisfied with the quality of service being provided via telemedicine" with higher scores indicating greater satisfaction	6 months

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Margaret Zupa, MDMS, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 13, 2024
• First Submitted That Met QC Criteria: December 13, 2024
• First Posted (Actual): December 18, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Telemedicine
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: STUDY24060062; K23DK135794 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A deidentified dataset including limited demographic, encounter, laboratory result, clinical observations, medication orders, care utilization, and survey (intervention satisfaction, treatment satisfaction, diabetes distress) data will be created. To protect research participant identities, datasets will not include any potentially identifying participant information.
• IPD Sharing Time Frame: The data will become available no later than 12 months and ending 36 months after the primary trial results are published.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No