Telehealth and Meal Replacement Pilot Program for Patients With Diabetes

NCT04885621 | Completed

• 1 other identifier: IRB 21916
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

nutrisystems; diabetes mellitus; underserved patients; glucomander-outpatient; telcare

Outcome Measures

Primary Outcomes (1)

• hemoglobin A1C levels

  measurement of average glucose levels over time

  six months

Secondary Outcomes (2)

• lipid levels

  6 months

• Weight/BMI

  6 months

Study Arms (1)

underserved patients with diabetes mellitus

patients with type 2 diabetes mellitus living in underserved, financially challenged areas of Southwest Virginia who are poorly controlled

Dietary Supplement: nutrisystem-D

Interventions

nutrisystem-D DIETARY_SUPPLEMENT

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

Also known as: Glytec glucomander-outpatient

underserved patients with diabetes mellitus

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

poorly controlled diabetes mellitus

You may qualify if:

• Hemoglobin A1C \> 8.0 on two occasions renal function at least 50% of normal persistent, poorly controlled diabetes -

You may not qualify if:

• alcohol/substance abuse, active cancer therapy, HIV/AIDS, organ transplant, cirrhosis of liver, hearing or speech impediment, dementia or psychosis, cannot speak English or interact appropriately with interpreter

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emeritus Professor of Medicine

Study Record Dates

• First Submitted: May 8, 2021
• First Posted: May 13, 2021
• Study Start: May 1, 2021
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)