Clinical trial NCT06740435: Enhancing Telemedicine for T2D
Official title: Pilot Study Enhancing Telemedicine Care Delivery for Adults With Complex Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Telemedicine
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2024-12-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment percentage
timeFrame: 12 months
measure: Loss to follow up
timeFrame: 6 months
Secondary outcomes:
measure: Recruitment rate
timeFrame: 12 months
measure: Eligibility percentage
timeFrame: 12 months
measure: Visit attendance
timeFrame: 6 months
measure: Number of between-visit contacts
timeFrame: 6 months
measure: Blood glucose data availability
timeFrame: 6 months
measure: Patient satisfaction with telemedicine diabetes care
timeFrame: 6 months
measure: Diabetes Treatment Satisfaction Questionnaire-static version
timeFrame: Baseline
measure: Diabetes Treatment Satisfaction Questionnaire-change version
timeFrame: 6 months
measure: T2D Diabetes Distress Core Scale
timeFrame: Baseline and 6 months
measure: HbA1c change
timeFrame: Baseline and 6 months
measure: Prescription of guideline-based GLP-1 receptor agonist
timeFrame: Baseline and 6 months
measure: Prescription of guideline-based SGLT2 inhibitor
timeFrame: Baseline and 6 months
measure: Retinal examination
timeFrame: 6 months
measure: Urine protein testing
timeFrame: 6 months
measure: Immunization-pneumococcal
timeFrame: 6 months
measure: Immunization-influenza
timeFrame: 6 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Margaret Zupa, MDMS
role: PRINCIPAL_INVESTIGATOR
References: