Recruiting

NCT Number: NCT07773779

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

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.

Recruiting

Interested in participating?

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Key information

Conditions

Diabetes (Insulin-requiring, Type 1 or Type 2) Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10021, United States

Location status: Recruiting

Location contact

Rachel Stahl Salzman Stahl Salzman, MS, RD, CDN, CDCES, MS

CONTACT

[email protected]

6469622065

Rachel Stahl Salzman, MS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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

Treatment and study plan

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.

Usual Care

Other

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

Primary outcomes

Change from Baseline in A1C at 6 Months

Time frame: Baseline-6 Months
Change from Baseline in Time in Range as measured by continuous glucose monitoring at 6 Months

Time frame: 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)

Time frame: Baseline-6 Months

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

Time frame: Baseline-6 Months

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

Time frame: Baseline-6 Months

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

Time frame: Baseline-6 Months

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.

Secondary outcomes

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

Time frame: Baseline-6 Months

This is brief self-administered validated questionnaire measuring the number of times one engages in strenuous, moderate, and mild exercise in periods of 15-minute increment within a week. A Godin score of >24 units= active, 14-23 units= moderately active, and <14 units= sedentary
Change from Baseline in Body Weight at 6 Months

Time frame: Baseline-6 Months
Change from Baseline in Dietary Fiber Intake at 6 Months

Time frame: Baseline-6 Months

The records will be analyzed by using ESHA version 11.6 (https://esha.com), which is a diet analysis software, with more dietary fiber intake indicating more closely aligning with diabetes nutrition recommendation.
Change from Baseline in Daily Average Energy Intake at 6 Months

Time frame: Baseline-6 Months

The records will be analyzed by using ESHA version 11.6 (https://esha.com), which is a diet analysis software, for Daily Average Energy Intake for change from baseline to 6 months.
Change from Baseline in Macronutrient Distribution at 6 Months

Time frame: Baseline-6 Months

The records will be analyzed by using ESHA version 11.6 (https://esha.com), which is a diet analysis software, for macronutrient distribution for change from baseline to 6 months. The Carbohydrate % of Total Calories, Fat % of Total Calories, and Protein % of Total Calories will be reported.
Change from Baseline in Food Groups at 6 Months

Time frame: Baseline-6 Months

The records will be analyzed by using ESHA version 11.6 (https://esha.com), which is a diet analysis software, with food groups aligning with the USDA My Plate and categorizing common foods by servings of fruits, vegetables, grains, protein, and dairy and non-dairy alternatives (milk).
Change from Baseline Added Sugar Intake at 6 Months

Time frame: Baseline-6 Months

The records will be analyzed by using ESHA version 11.6 (https://esha.com), which is a diet analysis software, with change in added sugar intake measured in grams from baseline to 6 months.
Change from Baseline in Glycemic Variability as measured by continuous glucose monitoring at 6 Months

Time frame: Baseline-6 Months
Change from Baseline in Time Below Range as measured by continuous glucose monitoring at 6 Months

Time frame: Baseline-6 Months
Change from Baseline in Time Above Range as measured by continuous glucose monitoring at 6 Months

Time frame: Baseline-6 Months
Change from Baseline in Lipid Panel at 6 Months

Time frame: Baseline-6 Months

Total Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides

Study contacts

Contact information is provided by the study sponsor or research team.

Patricia Davidson, DCN

CONTACT

[email protected]

610-436-1066

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

Academy of Nutrition and Dietetics
West Chester University of Pennsylvania

Registry information

Acronym: App-MNT

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Aug 19, 2026
Registry last updated: Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Key information

Conditions

Age range

Sex eligibility

Study type

Phase

Primary location

Weill Cornell Medicine

Location contact

Who can participate

Treatment and study plan

Undermyfork Care App

Usual Care

Primary outcomes

Change from Baseline in A1C at 6 Months

Change from Baseline in Time in Range as measured by continuous glucose monitoring at 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)

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

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

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

Secondary outcomes

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

Change from Baseline in Body Weight at 6 Months

Change from Baseline in Dietary Fiber Intake at 6 Months

Change from Baseline in Daily Average Energy Intake at 6 Months

Change from Baseline in Macronutrient Distribution at 6 Months

Change from Baseline in Food Groups at 6 Months

Change from Baseline Added Sugar Intake at 6 Months

Change from Baseline in Glycemic Variability as measured by continuous glucose monitoring at 6 Months

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

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

Change from Baseline in Lipid Panel at 6 Months

Study contacts

Sponsors and collaborators

Lead sponsor

Collaborators

Registry information

Important dates

Related clinical trials

Integrating New Skills Into Diabetes Education With CGM

Pilot Study of Intrapartum Insulin Pump

MiniMed Fit Payload Wear Pediatric Study

Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy.