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

Pre-diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03695913
• Other study ID #: HUM00145667
• Status: Completed
• Phase: N/A
• Start date: October 16, 2018
• Est. completion date: September 26, 2019

Study information

• Verified date: February 2020
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: September 26, 2019
• Est. primary completion date: March 7, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Glucose Intolerance
• Pre-diabetes
• Prediabetic State

Intervention

Other:
• Normal Diet
Phase I (regular diet): all participants will eat their normal diet and will log their food.
• Low carb diet
Phase II (low carb diet): participants will be asked to eat a low carb diet and log their food

Device:
• CGM with no real time feedback
Phase I will collect CGM without real time feedback
• CGM with real time feedback)
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.

Behavioral:
• Education material
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.

Locations

Country	Name	City	State
United States	The University of Michigan	Livonia	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	Feasibility, Measured by Recruitment	Successful recruitment completed within 3 months	3 months
Secondary	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
Secondary	Weight Change	Change between visit 1 and the final visit.	day 11 (visit 2), day 22 (visit 3)
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)