Continuous Glucose Monitoring With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Michigan
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Participant Satisfaction With Continuous Glucose Monitoring
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Normal Diet + CGM then low carb + CGM
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).
Intervention: Normal Diet (Other)
Normal Diet + CGM then low carb + CGM
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).
Intervention: Low carb diet (Other)
Normal Diet + CGM then low carb + CGM
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).
Intervention: CGM with no real time feedback (Device)
Normal Diet + CGM then low carb + CGM
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).
Intervention: CGM with real time feedback) (Device)
Normal Diet + CGM then low carb + CGM
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).
Intervention: Education material (Behavioral)
Outcomes
Primary Outcomes
Participant Satisfaction With Continuous Glucose Monitoring
Time Frame: 60 days (30 days after visit 3 completion)
Common qualitative themes related to participant satisfaction with CGM from post intervention interview were coded.
Participant Satisfaction With Continuous Glucose Monitoring (CGM)
Time Frame: 33 days after day 1 (visit 3 completion)
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.
Secondary Outcomes
- Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call(Approximately 5 days each new sensor is placed (days 5 and 16))
- Change in Knowledge of Low Carbohydrate Eating(baseline, day 22)
- Feasibility, Measured by Recruitment(3 months)
- Weight Change(day 11 (visit 2), day 22 (visit 3))
- Change in Cravings From Day 11 to Day 22(11 days)
- Intention to Continue Low Carbohydrate Eating(day 22)
- Change in Percentage of Time Glucose is Above 140(33 days after day 1)
- Feasibility of Pre-diabetic Patients to Wear CGM Sensors(completed within 60 days of enrollment)
- Utility of CGM Feedback for Changing Diet(60 days (30 days after visit 3 completion))
- Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log(days 11 through 22)
Investigators
Caroline Richardson
Dr Max and Buena Lichter Research Professor of Family Medicine, Assistant Chair, Department of Family Medicine and Professor of Family Medicine, Medical School
University of Michigan