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

Not Applicable

Completed

• Conditions: Pre-diabetes
• Interventions: Other: Normal Diet; Other: Low carb diet; Device: CGM with no real time feedback; Device: CGM with real time feedback); Behavioral: Education material

• Registration Number: NCT03695913
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-02
• Study First Submitted QC: 2018-10-02
• Study First Posted: 2018-10-04
• Study Start: 2018-10-16
• Primary Completion: 2019-03-07
• Study Completion: 2019-09-26
• Status Verified: 2020-02
• Results First Submitted: 2020-02-10
• Results First Submitted QC: 2020-03-12
• Last Update Submitted: 2020-03-12
• Results First Posted: 2020-03-16
• Last Update Posted: 2020-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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Exclusion Criteria

• previous bariatric surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Normal Diet + CGM then low carb + CGM	CGM with real time feedback)	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).
Normal Diet + CGM then low carb + CGM	Education material	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).
Normal Diet + CGM then low carb + CGM	Low carb diet	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).
Normal Diet + CGM then low carb + CGM	Normal Diet	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).
Normal Diet + CGM then low carb + CGM	CGM with no real time feedback	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).

Primary Outcome Measures

Name	Time	Method
Participant Satisfaction With Continuous Glucose Monitoring	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)	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 Outcome Measures

Name	Time	Method
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)	During the health check phone call survey, participants were asked to report whether they experienced any side effects.
Change in Knowledge of Low Carbohydrate Eating	baseline, day 22	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.
Feasibility, Measured by Recruitment	3 months	Successful recruitment completed within 3 months
Weight Change	day 11 (visit 2), day 22 (visit 3)	Change between visit 1 and the final visit.
Change in Cravings From Day 11 to Day 22	11 days	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.
Intention to Continue Low Carbohydrate Eating	day 22	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.
Change in Percentage of Time Glucose is Above 140	33 days after day 1	Comparison between the first sensor wear period and the second sensor wear period.
Feasibility of Pre-diabetic Patients to Wear CGM Sensors	completed within 60 days of enrollment	Feasibility is measured by the number of participants who wore a sensor for at least 20 out of 22 days
Utility of CGM Feedback for Changing Diet	60 days (30 days after visit 3 completion)	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.
Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log	days 11 through 22	In the patient side effect log, participants recorded whether they experienced any side effects.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Livonia, Michigan, United States