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Completed

NCT Number: NCT03695913

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

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.

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Key information

Conditions

Pre-diabetes Glucose Intolerance Glucose Metabolism Disorders Hyperglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Livonia, Michigan, 48152, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normal Diet

Other

Phase I (regular diet):

all participants will eat their normal diet and will log their food.

Low Carb Diet

Other

Phase II (low carb diet):

participants will be asked to eat a low carb diet and log their food

CGM with no real time feedback

Device

Phase I will collect CGM without real time feedback

CGM with real time feedback)

Device

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.

Education material

Behavioral

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 outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Feasibility, Measured by Recruitment

    Time frame: 3 months

    Successful recruitment completed within 3 months

  2. Feasibility of Pre-diabetic Patients to Wear CGM Sensors

    Time frame: 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

  3. Weight Change

    Time frame: day 11 (visit 2), day 22 (visit 3)

    Change between visit 1 and the final visit.

  4. Change in Percentage of Time Glucose is Above 140

    Time frame: 33 days after day 1

    Comparison between the first sensor wear period and the second sensor wear period.

  5. Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM at Health Check Phone Call

    Time frame: 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.

  6. Number of Participants Who Reported Side Effects of Low Carbohydrate Eating and CGM in Patient Log

    Time frame: days 11 through 22

    In the patient side effect log, participants recorded whether they experienced any side effects.

  7. Change in Knowledge of Low Carbohydrate Eating

    Time frame: 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.

  8. Change in Cravings From Day 11 to Day 22

    Time frame: 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.

  9. Intention to Continue Low Carbohydrate Eating

    Time frame: 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.

  10. Utility of CGM Feedback for Changing Diet

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 4, 2018
Registry last updated
Mar 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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