Diabetes Mellitus, Type 2
Conditions
Keywords
Continuous Glucose Monitor (CGM), Dexcom G6
Brief summary
To assess the impact of continuous glucose monitoring versus standard of care (e.g. a finger-prick protocol using a glucometer) on clinical outcomes, healthcare utilization, and cost in patients with type I or II diabetes treated within the Reimagine Primary Care clinics.
Detailed description
This is a parallel randomized controlled trial. Eligible patients who consent will be randomized to one of two groups: (1) the intervention group who will be given a Dexcom G6 for CGM, or (2) the control group who will follow their current standard finger-prick protocol via a provided Contour Next ONE glucometer. The CGM group must download the Dexcom G6 and Clarity mobile apps for data capture, whereas the standard of care group will use the Contour Next mobile app for their respective readings. The Dexcom G6 captures real-time, dynamic glucose data every five minutes. Devices used in this study are FDA approved and commercially available.
Interventions
DEVICEDexcom G6
Continuous Glucose Monitor that, after applied, sends continuous glucose readings to to the patient's smartphone every 5 minutes. This allows the patients to receive more readings over a 24 hour period versus standard of care glucometer finger sticks.
DEVICEContour NextOne
A Standard of Care Glucometer with Bluetooth capability. The patient inserts a test strip into the device, takes a finger stick and collects a small blood sample on the tip of the strip to initiate the device to detect a glucose reading.
Sponsors
Intermountain Health Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients were either randomized to the Dexcom G6 Device or the Contour NextOne a Standard of Care glucometer. Both subjects knew what they received after they were randomized.
Intervention model description
Parallel Randomized Control Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 or type 2 diabetes mellitus with a HbA1c ≥6.5% * Patients that are currently managing their glucose levels for diabetes with a glucose meter (or will be prescribed one by their healthcare provider) * Patients that are treated within the four Reimagine Primary Care clinics (Cottonwood Family Medicine, Cottonwood Senior, Avenues Internal Medicine, and Holladay Internal Medicine). • Patients 18-80 years of age
Exclusion criteria
* Patients that are not managing their glucose levels for diabetes (and not advised to use a glucose monitor by their physician) * Patients that are not treated within the four Reimagine Primary Care clinics * Patients less than 18 years of age, and 81 years of age and older * Patients with a diagnosis of dementia * If the patient is currently using a Continuous Glucose Monitor * Patients with previous hospitalization for hypoglycemia within the last 18 months * No access to a mobile phone to download the Dexcom or Contour Next applications * Patients who are pregnant or planning to become pregnant over the course of their six-month participation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c Variation | 6 months | Coefficient of variation in HbA1c levels before, during and end of study completion. |
| HbA1c Range | 6 months | Variation of range in HbA1c levels before, during and end of study completion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemic Events | 6 months | Frequency of hypoglycemic events during the study. |
| Healthcare Utilization | 6 months | Healthcare utilization per count of inpatient/outpatient visits. |
| Current Diabetes Standards | 6 months | Current HEDIS performance on diabetes and behavioral health measures. |
| Emergency Room Visits | 6 months | Emergency department visits per 1000 rate, overall and for patients with diabetes, and hospitalization per 1000 rate related to. |
| Healthcare Cost | 6 months | Cost per patient of healthcare for Emergency Room visits, blood draws, inpatient/outpatient services, medications etc. |
| Glycemic Variability | 6 months | Glycemic variability per mean amplitude of glycemic excursion (MAGE) |
| Behavioral Changes | 6 months | Subjects will complete a self reported survey related to behavioral changes at end of study to assess self empowered behavioral changes after using the devices (e.g. feeling more empowered to self-manage care, engaged with changing healthcare behaviors, and patient perceptions of the technology). |
Countries
United States
Outcome results
None listed