The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes

Study Overview
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Brief Summary
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This study will investigate whether real-time continuous glucose monitoring can be used as a tool for behavior change in people with pre-diabetes.

Detailed Description
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The protocol is a prospective, non-blinded, randomized controlled study in persons with newly diagnosed pre-diabetes comparing the effects of real-time continuous glucose monitoring (RT-CGM) combined with diet and lifestyle education to those who have diet and lifestyle education alone. During a wash-in phase both groups will wear a masked CGM for 1 week at baseline and again after 12 weeks. Those randomized to the RT-CGM will wear it for 4 cycles of 2 week on/1 week off over the next 12 weeks. Both groups will follow-up with their primary care providers as clinically indicated over the next year with quarterly measurements of blood pressure, weight, and BMI. At the end of this period, they will wear a masked CGM for 1 week.

Official Title
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The Effect of Real Time Continuous Glucose Monitoring in Subjects With Pre-diabetes

Conditions
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Pre-diabetes, Impaired Glucose Tolerance

Intervention / Treatment
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* Behavioral: RT-CGM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older Newly diagnosed with pre-diabetes (within the previous 6 months) with a FPG of > or = 110-125mg/dl or an A1c > or = 6% - 6.4% Able to independently measure and read finger stick blood glucose levels Willing to wear the CGM device for up to 12 weeks during the study period Willing to test blood sugar by fingerstick twice per day while wearing the CGM DEERS eligible Exclusion Criteria: Using medication for pre-diabetes Women who are pregnant, lactating, planning to become pregnant, or without a safe contraceptive method; all female subjects will undergo pregnancy testing via a serum HcG with their initial blood testing. Subjects who are taking glucocorticoids, amphetamines, anabolic, or weight-reducing agents during the course of the study. Active Duty service members likely to be deployed during the 18-month study period.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RT-CGM<br>Patients using the RT-CGM for the intervention portion of the study. | Behavioral: RT-CGM<br>* Dexcom Seven+<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in blood glucose | Changes in A1c and fasting blood glucose over time and between the intervention and control groups. | baseline, 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of lifestyle changes | Evaluating the impact of lifestyle changes on levels of glycemic control in the control and experimental groups. | baseline, 18 months | 
| Changes in Glucose dynamics | Comparison of intervention and control group on standard measures of glucose dynamics. | baseline, 18 months | 
| Differences in blood pressure. | Objective comparison between the control and experimental group in changes in blood pressure. | baseline, 18 months | 
| Differences in lipids. | Objective comparison between the control group and the experimental group on changes in lipids. | baseline, 18 months | 
| Differences in weight | Objective comparison between the control group and the experimental group on changes in weight. | baseline, 18 months | 
| Changes in medication use | An objective comparison between the control and experimental group on changes in medication use. | baseline, 18 months |