Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Continuous Glucose Monitoring With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes

Conditions
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Pre-diabetes

Intervention / Treatment
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* Other: Normal Diet
* Other: Low carb diet
* Device: CGM with no real time feedback
* Device: CGM with real time feedback)
* Behavioral: Education material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A1C Glucose Measurement between 5.7 to 6.4 (for most recent A1C test, not older than 1 year) No diabetes medication including Metformin BMI (body mass index) >30 Must speak, read, and write in English No current pregnancy or breastfeeding Must not classify as either Vegan or Vegetarian Must be a patient at the Livonia Health Center Exclusion Criteria: previous bariatric surgery

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Normal Diet + CGM then low carb + CGM<br>Phase I (part 1) - regular diet: Patients will wear a CGM sensor (with no real time feedback) for 11 days; document what they eat on a food log; and rate their postprandial fatigue and cravings. Phase II (part 2) - low carb diet: Patients will wear a CGM sensor (with real time feedback) for 11 days; document what they eat on a food log; and rate their postprandial fatigue and cravings; document their blood sugar before and two hours after eating (as well as before breakfast and before going to bed). | Other: Normal Diet<br>* Phase I (regular diet): all participants will eat their normal diet and will log their food.<br>Other: Low carb diet<br>* Phase II (low carb diet): participants will be asked to eat a low carb diet and log their food<br>Device: CGM with no real time feedback<br>* Phase I will collect CGM without real time feedback<br>Device: CGM with real time feedback)<br>* 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.<br>Behavioral: Education material<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 60 days (30 days after visit 3 completion) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility, Measured by Recruitment | Successful recruitment completed within 3 months | 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 | completed within 60 days of enrollment | 
| Weight Change | Change between visit 1 and the final visit. | 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. | 33 days after day 1 | 
| Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call | During the health check phone call survey, participants were asked to report whether they experienced any side effects. | 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. | 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. | 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. | 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. | 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. | 60 days (30 days after visit 3 completion) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre-diabetes, low carbohydrate diet