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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
52
\- 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.
Participants in the control group will receive usual diabetes MNT including reassessment, intervention, treatment recommendations.
Weill Cornell Medicine
New York, New York, United States
RECRUITINGChange 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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Baseline-6 Months
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
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
Total Cholesterol, LDL Cholesterol, HDL Cholesterol, and Triglycerides
Time frame: Baseline-6 Months