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NCT04885621 · ClinicalTrials.gov registry record

Telehealth and Meal Replacement Pilot Program for Patients With Diabetes

A clinical trial, sponsored by University of Virginia.

Completed
Registry status
11
Enrollment target

NCT04885621 is a clinical trial that has completed, run by University of Virginia. The registered enrollment target is 11 participants.

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The verdict

NCT04885621 has completed, sponsored by University of Virginia.

COMPLETED
Registry status
11 participants
Enrollment target

Study Summary

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.

Interventions

  • DIETARY_SUPPLEMENT nutrisystem-D

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2021-05-01
Est. Completion 2023-09-15

Sponsor

University of Virginia

449 total trials

What the Registry Record Tells You About NCT04885621

The ClinicalTrials.gov registry entry for NCT04885621 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which nutrisystem-D is the first listed.

NCT04885621 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04885621 about?

NCT04885621 is a clinical study titled "Telehealth and Meal Replacement Pilot Program for Patients With Diabetes". 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 ...

What is the current status of trial NCT04885621?

This trial is currently completed. The enrollment target is 11 participants. The study started on 2021-05-01. Estimated completion is 2023-09-15.

What interventions are being tested in trial NCT04885621?

The interventions under investigation include: nutrisystem-D (DIETARY_SUPPLEMENT).

Who is sponsoring clinical trial NCT04885621?

This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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