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Completed No phase listed Observational

Telehealth and Meal Replacement Pilot Program for Patients With Diabetes

ClinicalTrials.gov ID: NCT04885621

Public ClinicalTrials.gov record NCT04885621. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 4:34 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Telehealth and Meal Replacement Pilot Program for Improved Care of Underserved Patients With Diabetes

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This pilot study will involve intensive training in self-management of diabetes mellitus. The intensive diabetes self-management program will involve an initial diabetes assessment with the nurse/diabetes educator, an initial evaluation by the Endocrinologist, Dr. Santen, at one of the Tri-Area CHC clinics; weekly or bi-weekly phone calls to review glucose and insulin data and 3-month, 4.5 month and 6-month follow-ups on telemedicine with Dr. Santen. A cloud based glucose monitoring system will utilize the Verizon based Telcare glucose meter with glucose test strips and the Glucommander-outpatientR algorithm to make insulin dosage recommendations. The goal will be to test blood glucose 4-7 times/day. The serial glucose levels are accessible on the meter itself but also can be accessed online by the entire diabetes team. Weekly to four weekly phone calls with the UVA endocrinologist ( and nurse/diabetes educator from Tri-Area as necessary) will be completed to discuss glucose patterns and make insulin adjustments. In addition, the patient will attend four diabetes tele-education programs to learn more about improved self-management of their diabetes. To facilitate nutritional education, a modified , patient specific, Nutrisystem R diet will be supplied , designed to be the exclusive source of nutrition. This diet will involve 1200 calories for women and 1800 calories for men. Both frozen and non-frozen food will be delivered to the patient. Nutrisystems will supply these " meal replacements" at a reduced cost based on this pilot program.

Study identification

NCT ID
NCT04885621
Recruitment status
Completed
Study type
Observational
Phase
Not listed
Lead sponsor
University of Virginia
Other
Enrollment
11 participants

Conditions and interventions

Interventions

Dietary Supplement

Eligibility (public fields only)

Age range
18 Years to 75 Years
Sex
All
Healthy volunteers
Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 30, 2021
Primary completion
Sep 14, 2023
Completion
Sep 14, 2023
Last update posted
Dec 20, 2023

2021 – 2023

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
University of Virginia Charlottesville Virginia 22908

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04885621, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 20, 2023 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04885621 live on ClinicalTrials.gov.

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