Continuous Glucose Monitoring in Diabetes and Prediabetes

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03805412
• Other study ID #: 180609
• Status: Completed
• Phase: N/A
• Start date: January 10, 2019
• Est. completion date: July 3, 2020

Study information

• Verified date: February 2023
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: July 3, 2020
• Est. primary completion date: July 3, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose Intolerance
• Obesity
• PreDiabetes
• Prediabetic State

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	GWU Medical Faculty Associates	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Nicole Ehrhardt, MD	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percent Body Fat Change at 14 Weeks	Percent by Tanita scale	14 weeks
Secondary	Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes	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	14 weeks
Secondary	Mean Glucose Change at 14 Weeks	average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks	14 weeks
Secondary	Food Frequency Change in Score at 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	14 weeks
Secondary	Change in Minutes Walked Per Week at 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	14 weeks
Secondary	MAGE Mean Amplitude of Glycemic Excursion	this is calculation of variance of glucose for CGM	14 weeks