This study will recruit pre-diabetic patients to see if continuous glucose monitoring (CGM) with a low carbohydrate diet can reduce the percentage of time the CGM readings are above the normal range. Through this study it will demonstrate the feasibility of using CGM with a low carbohydrate diet to reduce weight and risk of developing diabetes in patients with pre-diabetes. Patients that appear to be eligible will be recruited from Michigan Medicine in the Family Medicine Clinic at the Livonia Center.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Phase I (regular diet): all participants will eat their normal diet and will log their food.
Phase II (low carb diet): participants will be asked to eat a low carb diet and log their food
Phase I will collect CGM without real time feedback
The University of Michigan
Livonia, Michigan, United States
Participant Satisfaction With Continuous Glucose Monitoring (CGM)
Satisfaction is measured using responses to the post intervention survey question, "How likely are you to recommend that a friend or family member with pre-diabetes wear a continuous glucose monitor (CGM)?". A 5 point scale was used, ranging from 1 to 5, where a score of 1 is "extremely likely" and 5 is "would not recommend". Satisfied respondents answered either 1 or 2 on the scale.
Time frame: 33 days after day 1 (visit 3 completion)
Participant Satisfaction With Continuous Glucose Monitoring
Common qualitative themes related to participant satisfaction with CGM from post intervention interview were coded.
Time frame: 60 days (30 days after visit 3 completion)
Feasibility, Measured by Recruitment
Successful recruitment completed within 3 months
Time frame: 3 months
Feasibility of Pre-diabetic Patients to Wear CGM Sensors
Feasibility is measured by the number of participants who wore a sensor for at least 20 out of 22 days
Time frame: completed within 60 days of enrollment
Weight Change
Change between visit 1 and the final visit.
Time frame: day 11 (visit 2), day 22 (visit 3)
Change in Percentage of Time Glucose is Above 140
Comparison between the first sensor wear period and the second sensor wear period.
Time frame: 33 days after day 1
Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call
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Phase II participants will be asked to scan their sensor at least every eight hours and document their blood sugar before and two hours after eating as well as before breakfast and before going to bed.
Phase I: participants will be given the book Always Hungry and be asked to read chapters 1-5 after a health check phone call approximately 5 days after the sensor is placed. Phase II: participants will be taught about carbohydrates and the benefits and side effects. Additionally, they will be given multiple resources to assist them regarding carbohydrates as well as a book entitled "The Calorie King, Calories, Fat, and Carbohydrates." Groceries will also be delivered for 2 recipes that the participants choose from to make.
During the health check phone call survey, participants were asked to report whether they experienced any side effects.
Time frame: Approximately 5 days each new sensor is placed (days 5 and 16)
Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log
In the patient side effect log, participants recorded whether they experienced any side effects.
Time frame: days 11 through 22
Change in Knowledge of Low Carbohydrate Eating
The Low Carbohydrate Knowledge Scale ranges from 15-41, where 15 is a low score and 41 is a high score. Participants were asked to report knowledge at baseline and completion. A positive score indicates an increase from baseline in knowledge, while a score of 15 indicates no change and a negative score indicates a decrease in knowledge from baseline.
Time frame: baseline, day 22
Change in Cravings From Day 11 to Day 22
Participants recorded cravings in food logs. Craving rating scale ranges from 1 to 5, where a score of 1 is low and a score of 5 is high.
Time frame: 11 days
Intention to Continue Low Carbohydrate Eating
The completion survey asked participants a question, "How confident are you that you can maintain a low carbohydrate diet for the next 12 months?" Intention to Continue Low Carbohydrate eating used a scale of 1 to 5, where a score of 1 was not confident at all and a score of 5 was very confident.
Time frame: day 22
Utility of CGM Feedback for Changing Diet
Utility of CGM feedback is expressed as the number of participants who qualitatively indicated that CGM feedback helped them to change their diet. Themes were identified and coded from qualitative interviews around this topic. Two qualitative coders identified themes that supported this construct.
Time frame: 60 days (30 days after visit 3 completion)