Recruiting
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.
ClinicalTrials.gov IDNCT07773779
PhaseNA
Enrollment52
SponsorWeill Medical College of Cornell University
Age18 Years – 75 Years
SexALL
Conditions studied
Diabetes (Insulin-requiring, Type 1 or Type 2)
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.
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.
Primary outcomes
- 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) (Baseline-6 Months)
- Change from Baseline in Diabetes Quality of Life subscale Impact at 6 Months as measured by DQoL-B subscale Impact (Baseline-6 Months)
- Change from Baseline in Diabetes Quality of Life subscale Satisfaction at 6 Months as measured by DQoL-B subscale Satisfaction (Baseline-6 Months)
- Change from Baseline in Diabetes Quality of Life subscale Satisfaction at 6 Months as measured by DQoL-B subscale Worry (Baseline-6 Months)
Eligibility information
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.
Study locations
- Weill Cornell Medicine, New York, New York 10021 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-11-09.