Impaired Glucose Tolerance, Pre-diabetes
Conditions
Brief summary
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
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.
Interventions
BEHAVIORALRT-CGM
Dexcom Seven+
Sponsors
DexCom, Inc.
Walter Reed National Military Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in blood glucose | baseline, 18 months | Changes in A1c and fasting blood glucose over time and between the intervention and control groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Glucose dynamics | baseline, 18 months | Comparison of intervention and control group on standard measures of glucose dynamics. |
| Differences in blood pressure. | baseline, 18 months | Objective comparison between the control and experimental group in changes in blood pressure. |
| Impact of lifestyle changes | baseline, 18 months | Evaluating the impact of lifestyle changes on levels of glycemic control in the control and experimental groups. |
| Differences in weight | baseline, 18 months | Objective comparison between the control group and the experimental group on changes in weight. |
| Changes in medication use | baseline, 18 months | An objective comparison between the control and experimental group on changes in medication use. |
| Differences in lipids. | baseline, 18 months | Objective comparison between the control group and the experimental group on changes in lipids. |
Countries
United States
Outcome results
None listed