Clinical trial NCT03805412: Continuous Glucose Monitoring in Diabetes and Prediabetes
Official title: A Pilot Study on the Use of Real-Time Continuous Glucose Monitoring (RT-CGM) as an Educational Tool for Patients With Prediabetes and Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
PreDiabetes
Obesity
Lead sponsor: George Washington University
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2019-01-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Percent Change in BMI From Baseline to 14 Weeks
timeFrame: 14 weeks
measure: Percent Body Fat Change at 14 Weeks
timeFrame: 14 weeks
Secondary outcomes:
measure: Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes
timeFrame: 14 weeks
measure: Mean Glucose Change at 14 Weeks
timeFrame: 14 weeks
measure: Food Frequency Change in Score at 14 Weeks
timeFrame: 14 weeks
measure: Change in Minutes Walked Per Week at 14 Weeks
timeFrame: 14 weeks
measure: MAGE Mean Amplitude of Glycemic Excursion
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Washington
country: United States
facility: GWU Medical Faculty Associates
state: District of Columbia
Study officials:
affiliation: George Washington University
name: Nicole Ehrhardt, MD
role: PRINCIPAL_INVESTIGATOR
References: