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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Caroline Richardson，University of Michigan

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 15, 2018

Estimated Primary Completion Date

October 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Participation Satisfaction with Continuous Glucose Monitoring[ Time Frame: 33 days after day 1 (visit 3 completion) ]

This will be measured by the post intervention survey for How likely are you to recommend that a friend or family member with pre-diabetes wear a continuous glucose monitor (CGM).

Participation Satisfaction with Continuous Glucose Monitoring[ Time Frame: 60 days (30 days after visit 3 completion) ]

Qualitative themes related to participant satisfaction with CGM coded form post intervention interview.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Feasibility and acceptability of pre-diabetic patients to wear CGM sensors and record diet, exercise and side effects on a low carbohydrate diet[ Time Frame: start of recruitment up to 3 months ]
Successful recruitment completed within 3 months
Feasibility and acceptability of pre-diabetic patients to wear CGM sensors and record diet, exercise and side effects on a low carbohydrate diet[ Time Frame: completed within 60 days of enrollment ]
Successful sensor wears time 20/22 days, Data retrieved from sensor successfully
Weight change[ Time Frame: day 11 (visit 2), day 22 (visit 3) ]
Pounds
Change in Percentage of time glucose is above 140[ Time Frame: 33 days after day 1 ]
Shown in reports provided by CGM sensor data
Side effects of low carbohydrate eating and Continuous Glucose Monitoring[ Time Frame: Approximately 5 days each new sensor is placed (days 5 and 16) ]
Health check Phone call survey. Frequency table of specific side effects reported.
Side effects of low carbohydrate eating and Continuous Glucose Monitoring[ Time Frame: days 11 through 22 ]
Patient side effect log. Frequency table of specific side effects reported.
Knowledge of Low Carbohydrate Eating[ Time Frame: baseline, day 22 ]
Low Carbohydrate Knowledge Scale, correct responses will be added for a total score at each time frame and calculated to see if there is a change.
Change in cravings and fatigue[ Time Frame: up to 22 days ]
Food logs. Craving rating (1 to 5, averaged over 10 day sensor wear time), between sensor wear time 2 and sensor wear time 1.
Intention to continue Low Carbohydrate eating[ Time Frame: day 22 ]
Question on the completion survey
Utility of CGM feedback for changing diet[ Time Frame: 60 days (30 days after visit 3 completion) ]
Qualitative Interview

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Other: Normal Diet
Phase I (regular diet): all participants will eat their normal diet and will log their food.
Other: 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
Device: 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.

Study Arms

Experimental: 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).

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 15, 2019

Estimated Primary Completion Date

October 15, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - A1C 5.7 to 6.4 (Most Resent A1C, not older than 1 year) - No diabetes medication including Metformin - BMI (body mass index) >30 - Must speak, read, adn 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

Sex/Gender

Sexes Eligible for Study:

All

Ages

21 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Caroline Richardson，University of Michigan

Study Sponsor ^ICMJE

University of Michigan

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Caroline Richardson, MD University of Michigan

PRS Account

University of Michigan

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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