Continuous Glucose Monitoring in Diabetes and Prediabetes

A Pilot Study on the Use of Real-Time Continuous Glucose Monitoring (RT-CGM) as an Educational Tool for Patients With Prediabetes and Diabetes

Evaluate the use of brief serial real time continuous monitoring (RT-CGM) as a behavior modification tool in obese patients with prediabetes and diabetes. After receiving RT-CGM, nutrition and exercise education, participants will be able to monitor their blood sugar in real time for 2 sessions . Education on how to interpret CGM in the setting of food choices and exercise coupled with nutrition and exercise information should lead to improved weight and other nutritional and exercise changes.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus, Type 2; PreDiabetes
• Intervention / Treatment: Device: DEXCOM G6 RT-CGM

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • GWU Medical Faculty Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18-55
2. Prediabetes (A1c 6.0-6.4) or Diabetes (A1c 7.0-10)
3. BMI ≥ 30 kg/m2
4. Willing to wear pedometer during study period
5. Able to walk 2 city blocks at baseline without assistance (self-reported)
6. Reading level at least 6th grade in English
7. Expected to remain in local community for at least 4 months

8. Either is not treated with or has been on a stable treatment regimen of any of the following medications for a minimum of 3 months prior to Visit 1 (Screening/Enrollment):

   1. Sulfonylureas
   2. Biguanidine
   3. Thyroid replacement therapy
   4. Glp-1 agonists
   5. Sodium-glucose co-transporters
   6. Basal insulin
   7. Thiazolidinediones
   8. Hormone replacement therapy (female subjects) estrogen/progesterone products
   9. Oral contraceptives/birth control (female subjects)
   10. Antidepressant agents (SSRIs, Paxil, Prozac, Celexa, Zoloft, etc.)
9. Is able to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements.

Exclusion Criteria:

1. Women who are pregnant, lactating, planning to become pregnant
2. Subjects who are taking amphetamines, anabolic, or weight-reducing agents
3. Contraindications to moderate exercise
4. Pre-prandial insulin
5. On any antipsychotic medication or history of schizophrenia or bipolar disorder
6. Daily use of any form of steroid medication (oral, inhaled, injected) within the last 3 months
7. Active wounds or recent surgery within 3 months
8. Inflammatory disease, or chronic and current use of anti-inflammatory drugs or narcotics
9. Active cardiovascular diseases within 12 months of Visit 1, such as myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study
10. Presence or history of severe congestive heart failure (New York Heart Association Class IV [CCNYHA 1994])
11. Has evidence of current abuse of drugs or alcohol or a history of abuse that, in the investigator's opinion, would cause the individual to be noncompliant
12. Enrolled in another weight loss program
13. Already receiving continuous glucose monitoring (CGM)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: DEXCOM G6 RT-CGM; These participants will wear blinded continuous glucose monitoring for 10 days at baseline and 14 weeks. They will also complete real-time continuous glucose monitoring (RT-CGM) for 10 days at 2 weeks and 6 weeks. They will receive Nutrition and exercise counseling at week 2 and 6. They will also receive additional training on continuous glucose monitoring.	Device: DEXCOM G6 RT-CGM; CGM is a way to measure glucose levels in real-time. A tiny electrode called a glucose sensor is inserted under the skin to measure glucose levels in tissue fluid. A small plastic piece of tube remains inserted in the skin. It is connected to a transmitter that sits on top of the skin. It is approved for use on the abdomen for 10 days. It either records the sugars downloaded in the clinic (blinded part of the study) or it sends the information via wireless radio frequency to a monitoring/ display device or to a cellular phone so participants can see data. DEXCOM G6 is FDA approved for use in patients with diabetes and will be used in accordance with instructions as approved for diabetes.
No Intervention: Blinded CGM; These participants will have blinded continuous glucose monitoring(CGM) at the baseline and last 14 weeks. They will not wear continuous glucose monitoring at the interim appointments. They will receive 2 session of nutrition and exercise counseling at week 2 and 6.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in BMI From Baseline to 14 Weeks	weight and height will be combined to report % change BMI in kg/m^2 at 14 weeks	14 weeks
Percent Body Fat Change at 14 Weeks	Percent by Tanita scale	14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes	Experiences of CGM @Joslin 2009 scale of (5) strongly agree or (1) strongly disagree about statements/questions that measured the amount of satisfaction that was derived from continuous glucose monitoring. The larger the score the more satisfied participants were with CGM. 100 being the max score and 20 being the min score	14 weeks
Mean Glucose Change at 14 Weeks	average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks	14 weeks
Food Frequency Change in Score at 14 Weeks	Starting The Conversation (STC) is an eight-item simplified food frequency instrument/questionnaire a max score of 16 indicates poor food choices and a minimum score of 0 indicates good food choices. Results reported is change from baseline score with a negative score being a marker of improvement in food choices and a positive score being worsening of food choices	14 weeks
Change in Minutes Walked Per Week at 14 Weeks	The International Physical Activity Questionnaire(short) is as validated questionnaire which asks the time in minutes or hours in last week you do vigorous exercise, moderate intensity exercise, walking and sitting	14 weeks
MAGE Mean Amplitude of Glycemic Excursion	this is calculation of variance of glucose for CGM	14 weeks

Collaborators and Investigators

• Sponsor: Nicole Ehrhardt, MD
• Collaborators: DexCom, Inc.
• Investigators: Principal Investigator: Nicole Ehrhardt, MD, George Washington University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): July 3, 2020
• Study Completion (Actual): July 3, 2020

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 13, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): March 1, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: 180609

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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.: Yes