search
Back to results

Continuous Glucose Monitoring in Diabetes and Prediabetes

Primary Purpose

Diabetes Mellitus, Type 2, PreDiabetes, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DEXCOM G6 RT-CGM
Sponsored by
Nicole Ehrhardt, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • GWU Medical Faculty Associates

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

DEXCOM G6 RT-CGM

Blinded CGM

Arm 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.

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.

Outcomes

Primary Outcome Measures

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
Percent Body Fat Change at 14 Weeks
Percent by Tanita scale

Secondary Outcome Measures

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
Mean Glucose Change at 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
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
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
MAGE Mean Amplitude of Glycemic Excursion
this is calculation of variance of glucose for CGM

Full Information

First Posted
December 19, 2018
Last Updated
February 1, 2023
Sponsor
Nicole Ehrhardt, MD
Collaborators
DexCom, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT03805412
Brief Title
Continuous Glucose Monitoring in Diabetes and Prediabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
July 3, 2020 (Actual)
Study Completion Date
July 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nicole Ehrhardt, MD
Collaborators
DexCom, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, PreDiabetes, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
23 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEXCOM G6 RT-CGM
Arm Type
Active Comparator
Arm 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.
Arm Title
Blinded CGM
Arm Type
No Intervention
Arm 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.
Intervention Type
Device
Intervention Name(s)
DEXCOM G6 RT-CGM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent Change in BMI From Baseline to 14 Weeks
Description
weight and height will be combined to report % change BMI in kg/m^2 at 14 weeks
Time Frame
14 weeks
Title
Percent Body Fat Change at 14 Weeks
Description
Percent by Tanita scale
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Questionnaire: Experiences With Glucose Monitoring (CGM) Diabetes
Description
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
Time Frame
14 weeks
Title
Mean Glucose Change at 14 Weeks
Description
average glucose during 10 days of wearing continuous glucose monitoring (CGM) at baseline and 14 weeks
Time Frame
14 weeks
Title
Food Frequency Change in Score at 14 Weeks
Description
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
Time Frame
14 weeks
Title
Change in Minutes Walked Per Week at 14 Weeks
Description
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
Time Frame
14 weeks
Title
MAGE Mean Amplitude of Glycemic Excursion
Description
this is calculation of variance of glucose for CGM
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Hormone replacement therapy (female subjects) estrogen/progesterone products Oral contraceptives/birth control (female subjects) Antidepressant agents (SSRIs, Paxil, Prozac, Celexa, Zoloft, etc.) 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: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Ehrhardt, MD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
GWU Medical Faculty Associates
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Continuous Glucose Monitoring in Diabetes and Prediabetes

We'll reach out to this number within 24 hrs