Continuous Glucose Monitoring in Diabetes and Prediabetes

Not Applicable

Completed

• Conditions: Obesity; Diabetes Mellitus, Type 2; PreDiabetes
• Interventions: Device: DEXCOM G6 RT-CGM

• Registration Number: NCT03805412
• Lead Sponsor: Nicole Ehrhardt, MD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-19
• Study Start: 2019-01-10
• Study First Submitted QC: 2019-01-13
• Study First Posted: 2019-01-15
• Primary Completion: 2020-07-03
• Study Completion: 2020-07-03
• Results First Submitted: 2021-09-10
• Status Verified: 2023-02
• Results First Submitted QC: 2023-02-01
• Last Update Submitted: 2023-02-01
• Results First Posted: 2023-03-01
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEXCOM G6 RT-CGM	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.

Primary Outcome Measures

Name	Time	Method
Percent Change in BMI From Baseline to 14 Weeks	14 weeks	weight and height will be combined to report % change BMI in kg/m\^2 at 14 weeks
Percent Body Fat Change at 14 Weeks	14 weeks	Percent by Tanita scale

Secondary Outcome Measures

Name	Time	Method
Change in Minutes Walked Per Week at 14 Weeks	14 weeks	The International Physical Activity Questionnaire(short) is as validated questionnaire which asks the time in minutes or hours in last week you do vigorous exercise, moderate intensity exercise, walking and sitting
Mean Glucose Change at 14 Weeks	14 weeks	average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks
Food Frequency Change in Score at 14 Weeks	14 weeks	Starting The Conversation (STC) is an eight-item simplified food frequency instrument/questionnaire a max score of 16 indicates poor food choices and a minimum score of 0 indicates good food choices. Results reported is change from baseline score with a negative score being a marker of improvement in food choices and a positive score being worsening of food choices
MAGE Mean Amplitude of Glycemic Excursion	14 weeks	this is calculation of variance of glucose for CGM
Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes	14 weeks	Experiences of CGM @Joslin 2009 scale of (5) strongly agree or (1) strongly disagree about statements/questions that measured the amount of satisfaction that was derived from continuous glucose monitoring. The larger the score the more satisfied participants were with CGM. 100 being the max score and 20 being the min score

Trial Locations

Locations (1)

GWU Medical Faculty Associates; 🇺🇸 Washington, District of Columbia, United States