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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: Completed study, sponsored by University of Virginia.
NCT04885621 is a clinical trial that has completed, run by University of Virginia. The registered enrollment target is 11 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
measurement of average glucose levels over time
Interventions
- DIETARY_SUPPLEMENT nutrisystem-D
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2021-05-01 |
| Est. Completion | 2023-09-15 |
What the finished NCT04885621 record still lists
NCT04885621 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 11 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which nutrisystem-D is the first listed.
NCT04885621 does not publish any study locations in the registry export this page uses.
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.
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