Continuous Glucose Monitoring in Diabetes and Prediabetes



Status:Recruiting
Conditions:Obesity Weight Loss, Endocrine, Diabetes, Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 55
Updated:1/19/2019
Start Date:January 10, 2019
End Date:February 2020
Contact:Nicole Ehrhardt, MD
Email:diabetesresearch@mfa.gwu.edu
Phone:202-741-2443

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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.


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)
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Washington, District of Columbia 20037
Phone: 202-741-2443
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