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

NCT03695913 | Completed Results FDA Device

• 1 other identifier: HUM00145667
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Pre-diabetes

Keywords

Pre-diabetes, low carbohydrate diet

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (10)

• Feasibility, Measured by Recruitment

  3 months

• Feasibility of Pre-diabetic Patients to Wear CGM Sensors

  completed within 60 days of enrollment

• Weight Change

  day 11 (visit 2), day 22 (visit 3)

• Change in Percentage of Time Glucose is Above 140

  33 days after day 1

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

  Approximately 5 days each new sensor is placed (days 5 and 16)

Study Arms (1)

Normal Diet + CGM then low carb + CGM

EXPERIMENTAL

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; Other: Low carb diet; Device: CGM with no real time feedback; Device: CGM with real time feedback); Behavioral: Education material

Interventions

Normal Diet OTHER

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

Normal Diet + CGM then low carb + CGM

Low carb diet OTHER

Phase II (low carb diet): participants will be asked to eat a low carb diet and log their food

Normal Diet + CGM then low carb + CGM

CGM with no real time feedback DEVICE

Phase I will collect CGM without real time feedback

Normal Diet + CGM then low carb + CGM

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.

Normal Diet + CGM then low carb + CGM

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.

Normal Diet + CGM then low carb + CGM

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• previous bariatric surgery

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

The University of Michigan

Livonia, Michigan, 48152, United States

Location

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Limitations and Caveats

This was a small pilot study to test feasibility of CGM. No statistical analysis was conducted because of the small sample size.

Results Point of Contact

• Title: Spring Stonebraker
• Organization: University of Michigan

sprstone@med.umich.edu

734-649-0219

Study Officials

• Caroline Richardson, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Max and Buena Lichter Research Professor of Family Medicine, Assistant Chair, Department of Family Medicine and Professor of Family Medicine, Medical School

Study Record Dates

• First Submitted: October 2, 2018
• First Posted: October 4, 2018
• Study Start: October 16, 2018
• Primary Completion: March 7, 2019
• Study Completion: September 26, 2019
• Last Updated: March 16, 2020
• Results First Posted: March 16, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)