Back to resultsContinuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
Primary Purpose
Pre-diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Normal Diet
Low carb diet
CGM with no real time feedback
CGM with real time feedback)
Education material
Sponsored by
About this trial
This is an interventional treatment trial for Pre-diabetes focused on measuring Pre-diabetes, low carbohydrate diet
Eligibility Criteria
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
Sites / Locations
- The University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Normal Diet + CGM then low carb + CGM
Arm Description
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).
Outcomes
Primary Outcome Measures
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.
Participant Satisfaction With Continuous Glucose Monitoring
Common qualitative themes related to participant satisfaction with CGM from post intervention interview were coded.
Secondary Outcome Measures
Feasibility, Measured by Recruitment
Successful recruitment completed within 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
Weight Change
Change between visit 1 and the final visit.
Change in Percentage of Time Glucose is Above 140
Comparison between the first sensor wear period and the second sensor wear period.
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.
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03695913
Brief Title
Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
Official Title
Continuous Glucose Monitoring With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
October 16, 2018 (Actual)
Primary Completion Date
March 7, 2019 (Actual)
Study Completion Date
September 26, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-diabetes
Keywords
Pre-diabetes, low carbohydrate diet
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal Diet + CGM then low carb + CGM
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Normal Diet
Intervention Description
Phase I (regular diet):
all participants will eat their normal diet and will log their food.
Intervention Type
Other
Intervention Name(s)
Low carb diet
Intervention Description
Phase II (low carb diet):
participants will be asked to eat a low carb diet and log their food
Intervention Type
Device
Intervention Name(s)
CGM with no real time feedback
Intervention Description
Phase I will collect CGM without real time feedback
Intervention Type
Device
Intervention Name(s)
CGM with real time feedback)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Education material
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participant Satisfaction With Continuous Glucose Monitoring (CGM)
Description
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.
Time Frame
33 days after day 1 (visit 3 completion)
Title
Participant Satisfaction With Continuous Glucose Monitoring
Description
Common qualitative themes related to participant satisfaction with CGM from post intervention interview were coded.
Time Frame
60 days (30 days after visit 3 completion)
Secondary Outcome Measure Information:
Title
Feasibility, Measured by Recruitment
Description
Successful recruitment completed within 3 months
Time Frame
3 months
Title
Feasibility of Pre-diabetic Patients to Wear CGM Sensors
Description
Feasibility is measured by the number of participants who wore a sensor for at least 20 out of 22 days
Time Frame
completed within 60 days of enrollment
Title
Weight Change
Description
Change between visit 1 and the final visit.
Time Frame
day 11 (visit 2), day 22 (visit 3)
Title
Change in Percentage of Time Glucose is Above 140
Description
Comparison between the first sensor wear period and the second sensor wear period.
Time Frame
33 days after day 1
Title
Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call
Description
During the health check phone call survey, participants were asked to report whether they experienced any side effects.
Time Frame
Approximately 5 days each new sensor is placed (days 5 and 16)
Title
Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log
Description
In the patient side effect log, participants recorded whether they experienced any side effects.
Time Frame
days 11 through 22
Title
Change in Knowledge of Low Carbohydrate Eating
Description
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.
Time Frame
baseline, day 22
Title
Change in Cravings From Day 11 to Day 22
Description
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.
Time Frame
11 days
Title
Intention to Continue Low Carbohydrate Eating
Description
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.
Time Frame
day 22
Title
Utility of CGM Feedback for Changing Diet
Description
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.
Time Frame
60 days (30 days after visit 3 completion)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caroline Richardson, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share IPD
Learn more about this trial
Continuous Glucose Monitoring (CGM) With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
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