Diabetes (Insulin-requiring, Type 1 or Type 2)App-MNTNCT07773779
APP-MNT: App-Enhanced Medical Nutrition Therapy on Glycemic Outcomes and Quality of Life
A study testing Undermyfork Care App in people with Diabetes (Insulin-requiring, Type 1 or Type 2), run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes (Insulin-requiring, Type 1 or Type 2)
- What is being tested?
- Undermyfork Care App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2026to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Heart failure.
- Advanced kidney disease.
- Severe cognitive or psychological disabilities.
- Depression.
- Pregnant or breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10021
Rachel Stahl Salzman Stahl Salzman, MS, RD, CDN, CDCES, MS, 6469622065, esr9014@med.cornell.edu
Rachel Stahl Salzman, MS
About this study
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.
- Being tested
- Undermyfork Care App, Usual Care
- Keywords
- Diabetes type 1, Diabetes type 2, Nutrition app, Medical Nutrition Therapy (MNT), MNT, CGM, Continuous Glucose Monitor, Personalized Nutrition
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Undermyfork Care AppDevice
- 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 CareOther
Participants in the control group will receive usual diabetes MNT including reassessment, intervention, treatment recommendations.
| Study group | Role | What they receive |
|---|---|---|
| MNT Usual Care (Control) | Other | Participants in the control group will receive usual diabetes MNT including reassessment, intervention, treatment recommendations. Receives: 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. Receives: Device: Undermyfork Care App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in A1C at 6 Months
Measured: Baseline-6 Months
Change from Baseline in Time in Range as measured by continuous glucose monitoring at 6 Months
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline-6 Months
Secondary outcomes (11)
Change from Baseline in Physical Activity at 6 Months as measured by the Godin Leisure-Time Exercise Questionnaire
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
Measured: Baseline-6 Months
Change from Baseline in Body Weight at 6 Months
Measured: Baseline-6 Months
Change from Baseline in Dietary Fiber Intake at 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.
Measured: Baseline-6 Months
Change from Baseline in Daily Average Energy Intake at 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.
Measured: Baseline-6 Months
Change from Baseline in Macronutrient Distribution at 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.
Measured: Baseline-6 Months
Change from Baseline in Food Groups at 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).
Measured: Baseline-6 Months
Change from Baseline Added Sugar Intake at 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.
Measured: Baseline-6 Months
Change from Baseline in Glycemic Variability as measured by continuous glucose monitoring at 6 Months
Measured: Baseline-6 Months
Change from Baseline in Time Below Range as measured by continuous glucose monitoring at 6 Months
Measured: Baseline-6 Months
Change from Baseline in Time Above Range as measured by continuous glucose monitoring at 6 Months
Measured: Baseline-6 Months
Change from Baseline in Lipid Panel at 6 Months
Total Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides
Measured: Baseline-6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2026
- Study start29 Jul 2026
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes (Insulin-requiring, Type 1 or Type 2)Studies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- West Chester University of Pennsylvania, Academy of Nutrition and Dietetics
- Responsible party
- Sponsor
- Investigators
- Rachel Salzman, Principal investigator, Weill Medical College of Cornell UniversityPatricia Davidson, Principal investigator, Westchester University-PA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07773779
- Sponsor's protocol ID
- 24-12028352
- Other IDs
- 71484
- Acronym
- App-MNT
- Status last verified
- Aug 2026
- First submitted
- 14 Aug 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APP-MNT: App-Enhanced Medical Nutrition Therapy on Glycemic Outcomes and Quality of Life
- ClinicalTrials.gov ID
- NCT07773779
- Acronym / sponsor ID
- App-MNT / 24-12028352
- Keywords
- Diabetes type 1, Diabetes type 2, Nutrition app, Medical Nutrition Therapy (MNT), MNT, CGM, Continuous Glucose Monitor, Personalized Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- West Chester University of Pennsylvania, Academy of Nutrition and Dietetics
- Study start
- 29 Jul 2026 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| MNT Usual Care (Control) | Other | Other: Usual CareParticipants in the control group will receive usual diabetes MNT including reassessment, intervention, treatment recommendations. |
| App-Enhanced MNT | Experimental | Device: Undermyfork Care AppParticipants 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- Heart failure.
- Advanced kidney disease.
- Severe cognitive or psychological disabilities.
- Depression.
- Pregnant or breastfeeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | App-Enhanced MNT |
| Usual CareParticipants in the control group will receive usual diabetes MNT including reassessment, intervention, treatment recommendations. | Other | MNT Usual Care (Control) |
Primary outcome
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.
11 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
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
Change from Baseline in Daily Average Energy Intake at 6 Months
Time frame: Baseline-6 Months
Change from Baseline in Macronutrient Distribution at 6 Months
Time frame: Baseline-6 Months
Change from Baseline in Food Groups at 6 Months
Time frame: Baseline-6 Months
Change from Baseline Added Sugar Intake at 6 Months
Time frame: Baseline-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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Salzman principal investigator
Weill Medical College of Cornell University
Patricia Davidson principal investigator
Westchester University-PA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Undermyfork Care App in people with Diabetes (Insulin-requiring, Type 1 or Type 2), run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia Davidson, DCN (610-436-1066, pdavidson@wcupa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in A1C at 6 Months (time frame: Baseline-6 Months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.