Continuous Glucose Monitoring in Diabetes and Prediabetes

NCT ID: NCT03805412

Last Updated: 2023-03-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2020-07-03

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.

Conditions

Diabetes Mellitus, Type 2; PreDiabetes; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

DEXCOM G6 RT-CGM

Intervention Type: DEVICE

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Nicole Ehrhardt, MD

OTHER

Sponsor Role: lead

Responsible Party

Nicole Ehrhardt, MD

Endocrinologist, Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Nicole Ehrhardt, MD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

GWU Medical Faculty Associates

Washington D.C., District of Columbia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

180609

Identifier Type: -

Identifier Source: org_study_id