Prediabetes
Conditions
Keywords
Continuous Glucose Monitoring, A1C (or HbA1c), diabetes
Brief summary
Continuous glucose monitor (CGM) technology has become increasingly prevalent in the population and has the ability to transform care of patients living with prediabetes. While the technology was initially utilized primarily by patients living with type 1 diabetes using insulin pump therapy, it has become more widely used as part of care in patients living with type 1 or 2 diabetes on any kind of insulin therapy.
Detailed description
Additional investigation is strongly needed to further evaluate the health impacts of CGM technology in persons living with prediabetes. This study is looking to study the impact that CGM technology could have on glycemic control in patients with prediabetes, as well as secondary outcomes, such as blood pressure, weight, and patient insight into their condition and the effect on lifestyle interventions on glycemic control. The primary objective of this study is to determine the effect of CGM technology on glycemic control in patients with prediabetes, measured by the endpoints of A1c and CGM data. Specifically, CGM data will include Time-In-Range (TIR), Time-AboveRange (TAR), Time-Below-Range (TBR), Glycemic management indicator (GMI), and variability measures. Secondary endpoints include blood pressure, weight, and standardized survey data assessing behavioral modifications as a result of CGM technology.
Interventions
DEVICEStelo CGM
The Stelo Glucose Biosensor is built on the most accurate continuous glucose monitoring technology from Dexcom and is simple and painless to apply. By sending glucose levels directly to your smartphone,\* it gives you just the right amount of information to work with.
Sponsors
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
50 subjects will receive the Stelo CGM and utilize device for a duration of 3 months while enrolled in the study. Control group: 50 subjects will be treated as standard of care with no CGM interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects affiliated with one of the two institutional ambulatory clinics participating in this study who are meeting criteria for prediabetes listed on American Diabetes Association website, which includes A1c = or \> than 5.7% and \< or = 6.4%, who also have reliable access to a smartphone device compatible with the CGM application * Greater than or equal to 18 years old
Exclusion criteria
* Subjects who have been diagnosed with type 1 or type 2 diabetes mellitus, as defined as A1c \> or = 6.5% * Subjects who do not have reliable access to a smartphone device compatible with the CGM application * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| A1c value | Baseline | An A1C test measures your average blood sugar levels over the past 2 to 3 months. It is reported as a percentage. A result below 5.7% is considered normal, 5.7% to 6.4% indicates prediabetes, and 6.5% or higher indicates diabetes - the lower the value is more normal |
| CGM value | Baseline | Continuous Glucose Monitor (CGM) data tracks your interstitial glucose levels every few minutes, 24/7. It reveals exactly how meals, exercise, medications, and sleep impact your blood sugar in real-time, helping you and your healthcare provider identify specific patterns and trends Time in Range (TIR): The percentage of time spent in your target range (typically 70-180 mg/dL). Goal: Above 70%.Time Above Range (TAR): Time spent with high blood sugar (Levels 1 and 2). Goal: Keep as low as possible. Time Below Range (TBR): Time spent with low blood sugar (hypoglycemia). Goal: Less than 4% of the time, to eliminate dangerous lows. |
| Weight monitoring | Baseline | Weight measurement will be collected |
| Blood Pressure Monitoring | Baseline | Systolic (Top Number)Diastolic (Bottom Number) Normal - Less than 120and Less than 80 Elevated - 120 - 129 and Less than 80 Hypertension Stage 1 - 130 - 139 or 80 - 89 Hypertension Stage 2 -140 or higher or 90 or higher Hypertensive Crisis - Higher than 180 and/or Higher than 120 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Continuous Glucose Monitoring As a Behavior Modification Tool Survey | Month 3 | The results will be discussed by describing the percent of patients that said "Yes," "No," or "I don't know" to the questions - percentage data |
Countries
United States
Contacts
CONTACTMeghan Willoughby, MD
CONTACTCatherine Price, MD
PRINCIPAL_INVESTIGATORCatherine Price, MD
Wake Forest University Health Sciences
Outcome results
None listed