Enhancing Telemedicine for T2D

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes

• Registration Number: NCT06740435
• Lead Sponsor: University of Pittsburgh

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.

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 Timeline

• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-13
• Study First Posted: 2024-12-18
• Study Start: 2025-02-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-15
• Primary Completion: 2026-04-30
• Study Completion: 2026-07-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment percentage	12 months	Percent of eligible patients approached who are enrolled
Loss to follow up	6 months	Percent of enrolled patients who do not complete study, defined as not completing at least 2 study visits and associated surveys

Secondary Outcome Measures

Name	Time	Method
Immunization-influenza	6 months	Number of patients with documentation of influenza vaccination in medical record
Immunization-pneumococcal	6 months	Number of patients with documentation of pneumococcal vaccination in medical record
Recruitment rate	12 months	Number of patients recruited per month
Eligibility percentage	12 months	Percent of patients approached who are eligible
Visit attendance	6 months	Percent of scheduled visits completed per patient
Number of between-visit contacts	6 months	Number of successful and attempted patient contacts by clinicians between visits per patient
Blood glucose data availability	6 months	Number of telemedicine visits with blood glucose data available at visit per patient
Patient satisfaction with telemedicine diabetes care	6 months	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
Diabetes Treatment Satisfaction Questionnaire-static version	Baseline	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.
Diabetes Treatment Satisfaction Questionnaire-change version	6 months	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.
T2D Diabetes Distress Core Scale	Baseline and 6 months	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.
HbA1c change	Baseline and 6 months	Change in glycemic control from baseline to 6 months
Prescription of guideline-based GLP-1 receptor agonist	Baseline and 6 months	Number of patients with indications for GLP-1 receptor agonist therapy who are prescribed the indicated medication
Prescription of guideline-based SGLT2 inhibitor	Baseline and 6 months	Number of patients with indications for SGLT2 inhibitor therapy who are prescribed the indicated medication
Retinal examination	6 months	Number of patients with documentation of retinal examination performed in last year in medical record
Urine protein testing	6 months	Number of patients with documentation of urine protein testing performed in last year in medical record

Trial Locations

Locations (1)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States