Improving diabetes care through telemedicine

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

This study is testing whether extra support through telemedicine can help adults with type 2 diabetes and other health issues manage their condition better than regular telemedicine care.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: University of Pittsburgh (other)
• Locations: 1 site (Pittsburgh, Pennsylvania)
• Trial ID: NCT06740435 on ClinicalTrials.gov

What this trial studies

This pilot clinical trial aims to evaluate the feasibility of an enhanced telemedicine intervention for adults with type 2 diabetes who use insulin and have multiple chronic health conditions. Participants will be randomized to receive either enhanced telemedicine care, which includes additional support and education, or usual telemedicine care. Over approximately six months, patients will complete 2-3 telemedicine visits and surveys to assess patient satisfaction and preliminary clinical outcomes. The study will focus on standard metrics to determine the feasibility of a larger trial in the future.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with type 2 diabetes, using insulin, and having multiple chronic health conditions.

Not a fit: Patients over 80 years old or those with certain severe health conditions like dementia or malignancy may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could lead to improved diabetes management and patient satisfaction for individuals with complex health needs.

How similar studies have performed: While similar telemedicine approaches have shown promise, this specific intervention is novel and aims to assess feasibility for future larger trials.

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

Where this trial is running

Pittsburgh, Pennsylvania

• University of Pittsburgh — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Margaret Zupa, MDMS — University of Pittsburgh
• Study coordinator: Margaret Zupa, MD MS

Conditions: Type 2 Diabetes, Telemedicine