Telehealth and Meal Replacement Pilot Program for Patients With Diabetes

NCT04885621 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 11

Last updated 2023-12-21

No results posted yet for this 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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DIETARY_SUPPLEMENT

nutrisystem-D

Nutrisystem meal replacements and Glytec glucomander-outpatient algorithm for insulin management decisions

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2023-09-15
Completion
2023-09-15

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04885621 on ClinicalTrials.gov