Continuous Glucose Monitoring in Diabetes and Prediabetes

Nicole Ehrhardt, MD

Status: Completed

Conditions: Obesity; Diabetes Mellitus, Type 2; PreDiabetes

Treatments: Device: DEXCOM G6 RT-CGM

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03805412

180609

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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23 participants in 2 patient groups

DEXCOM G6 RT-CGM

Active Comparator group

Description:

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.

Treatment:

Device: DEXCOM G6 RT-CGM

Blinded CGM

No Intervention group

Description:

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.