Diabetes (Insulin-requiring, Type 1 or Type 2)
Conditions
Keywords
Diabetes type 1, Diabetes type 2, Nutrition app, Medical Nutrition Therapy (MNT), MNT, CGM, Continuous Glucose Monitor, Personalized Nutrition
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.
Interventions
DEVICEUndermyfork 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.
OTHERUsual Care
Participants in the control group will receive usual diabetes MNT including reassessment, intervention, treatment recommendations.
Sponsors
Weill Medical College of Cornell University
West Chester University of Pennsylvania
Academy of Nutrition and Dietetics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Diabetes Quality of Life subscale Satisfaction at 6 Months as measured by DQoL-B subscale Satisfaction | 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 | 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. |
| 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Macronutrient Distribution at 6 Months | 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 Physical Activity at 6 Months as measured by the Godin Leisure-Time Exercise Questionnaire | 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 | Baseline-6 Months | — |
| Change from Baseline in Dietary Fiber Intake at 6 Months | 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 Food Groups at 6 Months | 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 in Daily Average Energy Intake at 6 Months | 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 Added Sugar Intake at 6 Months | 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 | Baseline-6 Months | — |
| Change from Baseline in Time Below Range as measured by continuous glucose monitoring at 6 Months | Baseline-6 Months | — |
| Change from Baseline in Time Above Range as measured by continuous glucose monitoring at 6 Months | Baseline-6 Months | — |
| Change from Baseline in Lipid Panel at 6 Months | Baseline-6 Months | Total Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides |
Countries
United States
Contacts
CONTACTPatricia Davidson, DCN
PRINCIPAL_INVESTIGATORRachel Salzman
Weill Medical College of Cornell University
PRINCIPAL_INVESTIGATORPatricia Davidson
Westchester University-PA
Outcome results
None listed