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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention 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.
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Other
MNT Usual Care (Control) 		Participants in the control group will receive usual diabetes MNT including reassessment, intervention, treatment recommendations.
  • Other: Usual Care
    Participants in the control group will receive usual diabetes MNT including reassessment, intervention, treatment recommendations.
Experimental
App-Enhanced MNT 		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
    - 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.

Recruiting Locations

Weill Cornell Medicine
New York, New York 10021
Contact:
Rachel Stahl Salzman Stahl Salzman, MS, RD, CDN, CDCES, MS
6469622065
esr9014@med.cornell.edu

More Details

Status
Recruiting
Sponsor
Weill Medical College of Cornell University

Study Contact

Patricia Davidson, DCN
610-436-1066
pdavidson@wcupa.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.