APP-MNT: App-Enhanced Medical Nutrition Therapy on Glycemic Outcomes and Quality of Life

Summary

The purpose of the study is to see if using a diabetes app along with nutrition counseling from a registered dietitian nutritionist can help improve blood sugars and cholesterol levels, quality of life, physical activity, and food and beverage choices.

Conditions

• Diabetes (Insulin-requiring, Type 1 or Type 2)

Interventions

DEVICE

Undermyfork Care App

\- Intervention Group Participants assigned to the intervention group will be encouraged to use the app as frequently as they prefer (with minimum of 2 x week) for 6 months. Information that will be tracked includes food intake by photos and/or text, physical activity, glucose levels, and insulin dosing if applicable. Additional patient-generated health data to include in the app will be based on the participant's diabetes treatment plan and determined in collaboration with the RDN. The RDN will review each participants data from the Undermyfork Care as needed between visits (e.g. patient initiated question) and will message or call the participant to encourage engagement if data input is lacking. At each follow up visit, the RDN will review the participants data through Undermyfork Care to help make informed treatment recommendations and troubleshooting the use of the app if needed.

OTHER

Usual Care

Participants in the control group will receive usual diabetes MNT including reassessment, intervention, treatment recommendations.

Sponsors & Collaborators

• West Chester University of Pennsylvania

  collaborator OTHER

• Academy of Nutrition and Dietetics

  collaborator OTHER

• Weill Medical College of Cornell University

  lead OTHER

Principal Investigators

• Rachel Salzman · Weill Medical College of Cornell University

• Patricia Davidson · Westchester University-PA

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-29

Primary Completion

2027-07-31

Completion

2027-07-31

FDA Device

Yes

Countries

• United States

Study Locations