Continuous Glucose Monitoring in Diabetes and Prediabetes

NCT03805412 | Completed Results FDA Device

• 1 other identifier: 180609
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes

  14 weeks

• Mean Glucose Change at 14 Weeks

  14 weeks

• Food Frequency Change in Score at 14 Weeks

  14 weeks

• Change in Minutes Walked Per Week at 14 Weeks

  14 weeks

• MAGE Mean Amplitude of Glycemic Excursion

  14 weeks

Study Arms (2)

DEXCOM G6 RT-CGM

ACTIVE COMPARATOR

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

Blinded CGM

NO INTERVENTION

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.

Interventions

DEXCOM G6 RT-CGM 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.

DEXCOM G6 RT-CGM

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-55
• Prediabetes (A1c 6.0-6.4) or Diabetes (A1c 7.0-10)
• BMI ≥ 30 kg/m2
• Willing to wear pedometer during study period
• Able to walk 2 city blocks at baseline without assistance (self-reported)
• Reading level at least 6th grade in English
• Expected to remain in local community for at least 4 months
• 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):
• Sulfonylureas
• Biguanidine
• Thyroid replacement therapy
• Glp-1 agonists
• Sodium-glucose co-transporters
• Basal insulin
• Thiazolidinediones

You may not qualify if:

• Women who are pregnant, lactating, planning to become pregnant
• Subjects who are taking amphetamines, anabolic, or weight-reducing agents
• Contraindications to moderate exercise
• Pre-prandial insulin
• On any antipsychotic medication or history of schizophrenia or bipolar disorder
• Daily use of any form of steroid medication (oral, inhaled, injected) within the last 3 months
• Active wounds or recent surgery within 3 months
• Inflammatory disease, or chronic and current use of anti-inflammatory drugs or narcotics
• 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
• Presence or history of severe congestive heart failure (New York Heart Association Class IV \[CCNYHA 1994\])
• 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
• Enrolled in another weight loss program
• Already receiving continuous glucose monitoring (CGM)

Sponsors & Collaborators

• Nicole Ehrhardt, MD: lead
• DexCom, Inc.: collaborator

Study Sites (1)

GWU Medical Faculty Associates

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Prediabetic State; Obesity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Nicole Ehrhardt
• Organization: University of Washington Diabetes Institute

nehrhard@uw.edu

202-741-3422

Study Officials

• Nicole Ehrhardt, MD

  George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Endocrinologist, Principal Investigator

Study Record Dates

• First Submitted: December 19, 2018
• First Posted: January 15, 2019
• Study Start: January 10, 2019
• Primary Completion: July 3, 2020
• Study Completion: July 3, 2020
• Last Updated: March 1, 2023
• Results First Posted: March 1, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)