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

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ClinicalTrials.gov Identifier: NCT03695913
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Caroline Richardson, 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.


Condition or disease Intervention/treatment Phase
Pre-diabetes Other: Normal Diet Other: Low carb diet Device: CGM with no real time feedback Device: CGM with real time feedback) Behavioral: Education material Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Continuous Glucose Monitoring With a Low Carbohydrate Diet to Reduce Weight in Patients With Pre-Diabetes
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : October 15, 2019
Estimated Study Completion Date : October 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes

Arm Intervention/treatment
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).

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.





Primary Outcome Measures :
  1. 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).

  2. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Weight change [ Time Frame: day 11 (visit 2), day 22 (visit 3) ]
    Pounds

  4. Change in Percentage of time glucose is above 140 [ Time Frame: 33 days after day 1 ]
    Shown in reports provided by CGM sensor data

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Intention to continue Low Carbohydrate eating [ Time Frame: day 22 ]
    Question on the completion survey

  10. Utility of CGM feedback for changing diet [ Time Frame: 60 days (30 days after visit 3 completion) ]
    Qualitative Interview



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695913


Contacts
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Contact: Spring Stonebraker 734 998-7120 sprstone@med.umich.edu
Contact: Caroline Richardson, MD 734-998-7120 caroli@med.umich.edu

Locations
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United States, Michigan
The University of Michigan Recruiting
Livonia, Michigan, United States, 48152
Contact: Spring Stonebraker    734-998-7120    sprstone@med.umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
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Principal Investigator: Caroline Richardson, MD University of Michigan

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Responsible Party: Caroline Richardson, Dr Max and Buena Lichter Research Professor of Family Medicine, Assistant Chair, Department of Family Medicine and Professor of Family Medicine, Medical School, University of Michigan
ClinicalTrials.gov Identifier: NCT03695913     History of Changes
Other Study ID Numbers: HUM00145667
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan to share IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Caroline Richardson, University of Michigan:
Pre-diabetes, low carbohydrate diet

Additional relevant MeSH terms:
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Diabetes Mellitus
Prediabetic State
Glucose Intolerance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia