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

NCT07773779 | Recruiting FDA Device

• 2 other identifiers: 24-1202835271484
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Diabetes type 1; Diabetes type 2; Nutrition app; Medical Nutrition Therapy (MNT); MNT; CGM; Continuous Glucose Monitor; Personalized Nutrition

Outcome Measures

Primary Outcomes (6)

• Change from Baseline in A1C at 6 Months

  Baseline-6 Months

• Change from Baseline in Time in Range as measured by continuous glucose monitoring at 6 Months

  Baseline-6 Months

• Change from Baseline in Diabetes Quality of Life at 6 Months as measured by the Diabetes Quality of Life Brief Clinical Inventory (DQOL-B)

  The Diabetes Quality of Life Brief Clinical Inventory (DQOL-B) measures diabetes quality of life. Total scores range from 13-65, with lower scores indicating better quality of life (less impact/worry, higher satisfaction), whereas higher scores reflect higher distress/dissatisfaction.

  Baseline-6 Months

• Change from Baseline in Diabetes Quality of Life subscale Impact at 6 Months as measured by DQoL-B subscale Impact

  The Diabetes Quality of Life Brief Clinical Inventory (DQoL-B) subscale Impact measures diabetes quality of life. Total scores range from 4-20, with lower scores indicating less impact, whereas higher scores reflect more impact.

  Baseline-6 Months

• Change from Baseline in Diabetes Quality of Life subscale Satisfaction at 6 Months as measured by DQoL-B subscale Satisfaction

  The Diabetes Quality of Life Brief Clinical Inventory (DQoL-B) subscale Satisfaction measures diabetes quality of life. Total scores range from 6-30, with lower scores indicating less satisfaction, whereas higher scores reflect more satisfaction.

  Baseline-6 Months

• Change from Baseline in Diabetes Quality of Life subscale Satisfaction at 6 Months as measured by DQoL-B subscale Worry

  The Diabetes Quality of Life Brief Clinical Inventory (DQoL-B) subscale Worry measures diabetes quality of life. Total scores range from 3-15, with lower scores indicating less worry, whereas higher scores reflect more worry.

  Baseline-6 Months

Secondary Outcomes (11)

• Change from Baseline in Physical Activity at 6 Months as measured by the Godin Leisure-Time Exercise Questionnaire

  Baseline-6 Months

• Change from Baseline in Body Weight at 6 Months

  Baseline-6 Months

• Change from Baseline in Dietary Fiber Intake at 6 Months

  Baseline-6 Months

• Change from Baseline in Daily Average Energy Intake at 6 Months

  Baseline-6 Months

• Change from Baseline in Macronutrient Distribution at 6 Months

  Baseline-6 Months

Study Arms (2)

MNT Usual Care (Control)

OTHER

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

Other: Usual Care

App-Enhanced MNT

EXPERIMENTAL

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.

Device: Undermyfork Care App

Interventions

Undermyfork Care App DEVICE

\- 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.

App-Enhanced MNT

Usual Care OTHER

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

MNT Usual Care (Control)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female 18-75 years of age.
• Documentation of a T1D or T2D diagnosis.
• A1C of 6.5 or greater.
• Access to a compatible smartphone.
• Using a Dexcom continuous glucose monitoring device (due to compatibility with Undermyfork app) for at least 1 month with an active time of at least 70% within the last 14 days.

You may not qualify if:

• Heart failure.
• Advanced kidney disease.
• Severe cognitive or psychological disabilities.
• Depression.
• Pregnant or breastfeeding.

Sponsors & Collaborators

• West Chester University of Pennsylvania: collaborator
• Academy of Nutrition and Dietetics: collaborator
• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Officials

• Rachel Salzman

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Patricia Davidson

  Westchester University-PA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia Davidson, DCN

CONTACT

610-436-1066; pdavidson@wcupa.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled participants will be randomized in a 1:1 ratio using random permuted blocks stratified by diabetes type (1 vs 2), by age, BMI, A1C, and gender to ensure similar distribution of participants in each group.

Study Record Dates

• First Submitted: August 14, 2026
• First Posted: August 19, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: August 19, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)