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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexcom G6 (Intervention Group) | Experimental | • Intervention group: CGM using a Dexcom G6 to measure glycosylated hemoglobin levels every five minutes. Patients will be asked to download the Dexcom G6 and Clarity applications (to have access to their real-time data) and be given a link to complete an exit survey in REDCap near the end of their study participation. Data will be sent via Bluetooth and then exported by the Intermountain research team into a Tableau (or similar) dashboard for data analysis/comparison |
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| Contour NextOne (Standard of Care) Glucometer | Placebo Comparator | • Control group: A standard finger-prick protocol that will require patients to continue with their daily fingerprick regimen established by their physician. This group will be given a Contour Next One meter to ensure that each patient is receiving the same level of accuracy by the same device. A review by Ekhlaspour et al of 17 glucose meters demonstrated wide variability, with only two devices achieving the 2013 ISO standard (with the most accurate being the Contour Next). Patients in the control group will be asked to download the Contour Next application which will send data via Bluetooth similar to above. Data will be aggregated, and protected health information removed prior to analysis (by Intermountain Healthcare and Savvysherpa). At the end of the study, patients will be asked to complete a short survey in REDCap about their willingness to participate in future studies. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexcom G6 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c Variation | Coefficient of variation in HbA1c levels before, during and end of study completion. | 6 months |
| HbA1c Range | Variation of range in HbA1c levels before, during and end of study completion. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Current Diabetes Standards | Current HEDIS performance on diabetes and behavioral health measures. | 6 months |
| Behavioral Changes | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holladay Internal Medicine | Holladay | Utah | 84121 | United States | ||
| Intermountain Cottonwood Family Practice |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29940936 | Result | Lee PA, Greenfield G, Pappas Y. The impact of telehealth remote patient monitoring on glycemic control in type 2 diabetes: a systematic review and meta-analysis of systematic reviews of randomised controlled trials. BMC Health Serv Res. 2018 Jun 26;18(1):495. doi: 10.1186/s12913-018-3274-8. | |
| 23074529 | Result | Medical Advisory Secretariat. Home telemonitoring for type 2 diabetes: an evidence-based analysis. Ont Health Technol Assess Ser. 2009;9(24):1-38. Epub 2009 Oct 1. |
| Label | URL |
|---|---|
| What is Diabetes | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Feb 12, 2019 | May 21, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 8, 2018 | May 21, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Parallel Randomized Control Trial
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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.
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| Contour NextOne | Device | 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. |
|
| 6 months |
| Hypoglycemic Events | Frequency of hypoglycemic events during the study. | 6 months |
| Healthcare Utilization | Healthcare utilization per count of inpatient/outpatient visits. | 6 months |
| Glycemic Variability | Glycemic variability per mean amplitude of glycemic excursion (MAGE) | 6 months |
| Emergency Room Visits | Emergency department visits per 1000 rate, overall and for patients with diabetes, and hospitalization per 1000 rate related to. | 6 months |
| Healthcare Cost | Cost per patient of healthcare for Emergency Room visits, blood draws, inpatient/outpatient services, medications etc. | 6 months |
| Murray |
| Utah |
| 84107 |
| United States |
| Intermountain Senior Clinic | Murray | Utah | 84107 | United States |
| Avenues Internal Medicine | Salt Lake City | Utah | 84103 | United States |
| 27697848 | Result | Ekhlaspour L, Mondesir D, Lautsch N, Balliro C, Hillard M, Magyar K, Radocchia LG, Esmaeili A, Sinha M, Russell SJ. Comparative Accuracy of 17 Point-of-Care Glucose Meters. J Diabetes Sci Technol. 2017 May;11(3):558-566. doi: 10.1177/1932296816672237. Epub 2016 Oct 3. |
| 28197954 | Result | Verkuilen J. Explanatory Item Response Models: A Generalized Linear and Nonlinear Approach by P. de Boeck and M. Wilson and Generalized Latent Variable Modeling: Multilevel, Longitudinal and Structural Equation Models by A. Skrondal and S. Rabe-Hesketh. Psychometrika. 2006 Jun;71(2):415-418. doi: 10.1007/s11336-005-1333-7. No abstract available. |
| 19966070 | Result | Fong Y, Rue H, Wakefield J. Bayesian inference for generalized linear mixed models. Biostatistics. 2010 Jul;11(3):397-412. doi: 10.1093/biostatistics/kxp053. Epub 2009 Dec 4. |
| 23242683 | Result | Musio M, Sauleau EA, Augustin NH. Resources allocation in healthcare for cancer: a case study using generalised additive mixed models. Geospat Health. 2012 Nov;7(1):83-9. doi: 10.4081/gh.2012.107. |
| Preventing prediabetes | View source |
| Diabetes and glucose information | View source |
| D004700 | Endocrine System Diseases |