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A Diabetes Institute (MDI), in partnership with key stakeholders-including Primary Care Providers- in a northeastern US regional, mixed-payer healthcare system), seeks to implement an evidence-based, technology-enabled, innovative, and integrated diabetes care management pathway (Boot Camp) for adult patients with uncontrolled type 2 diabetes (A1C>/=9%) which will demonstrate improvement in diabetes clinical and health resources utilization outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Patients receive the full diabetes pathway intervention consisting of: individualized diabetes self-management education and support; T2DM meds management by clinician-supervised diabetes educators using an evidence-based algorithm and FDA approved anti-hyperglycemic agents; near, real-time blood glucose monitoring, delivered via a combination of two in-person and weekly remote (telephone/text) visits. |
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| Matched controls | No Intervention | Patients receive standard of care from their primary care provider. Usual care visits are typically conducted quarterly per national guidelines for management of T2DM in adults, or more frequently as needed. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diabetes Pathway | Other | Medication algorithm, survival skills education, enhanced patient-provider communication facilitated by near, real-time blood glucose monitoring |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage Change in Hemoglobin A1C From Baseline to 3 Months | Comparison of the percentage change in A1C from baseline to 3 months between the intervention and the control group | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Risk of Experiencing a Composite Endpoint of All Cause ED Visits and Hospitalizations at 6 Months Post Intervention vs 6 Months Pre-intervention for Cases and Controls. | Health care utilization measure. We compared the risk of experiencing an emergency room and/or hospital visit at 6 months from baseline for both groups. this was done by calculating he Incidence Risk Ratio of ED visits/hospitalizations for intervention and control patients to assess whether the pathway impacted the risk for ED visits/hospitalizations at 6 months from baseline and comparing them. We looked at these measures for the 6-month period that preceded the baseline visit and the 6-month period that followed the baseline visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle F Magee, MD | Medstar Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31798894 | Background | Magee MF, Baker KM, Fernandez SJ, Huang CC, Mete M, Montero AR, Nassar CM, Sack PA, Smith K, Youssef GA, Evans SR. Redesigning ambulatory care management for uncontrolled type 2 diabetes: a prospective cohort study of the impact of a Boot Camp model on outcomes. BMJ Open Diabetes Res Care. 2019 Nov 13;7(1):e000731. doi: 10.1136/bmjdrc-2019-000731. eCollection 2019. | |
| 34758807 |
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Upon request to the PI including provision of details of how the IPD will be utilized by the requestor, the study team will decide whether to release the IPD. The study protocol, SAP, ICF and clinical study report will be available.
Upon final completion of reporting of main study results the study protocol, SAF, ICF and CSR will be available for 5 years.
Deidentified data for scientific use that may contribute to the body of evidence to inform diabetes care management.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication |
| FG001 | Matched Controls | patients receive standard of care |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication |
| BG001 | Matched Controls |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage Change in Hemoglobin A1C From Baseline to 3 Months | Comparison of the percentage change in A1C from baseline to 3 months between the intervention and the control group | Boot camp completers during the study period were compared to concurrent, propensity-matched chart controls. | Posted | Mean | Standard Deviation | percentage | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Patients receive the full diabetes pathway intervention Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Michelle Magee | Medstar Health Research Institute | 2028772383 | michelle.f.magee@medstar.net |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 6 months |
| Adherence to Prescribed Diabetes Medications | Change in Adherence to Diabetes Medications as Measured Using MMS From Baseline to 3 Months for Intervention Subjects | 90 days |
| Frequency of Eye Exams | Change in the Proportion of Patients Receiving an Eye Exam in the 6 Months Following the Start of the Intervention as Compared to Baseline and to Concurrent Chart Controls | 90 days |
| Montero AR, Toro-Tobon D, Gann K, Nassar CM, Youssef GA, Magee MF. Implications of remote monitoring Technology in Optimizing Traditional Self-Monitoring of blood glucose in adults with T2DM in primary care. BMC Endocr Disord. 2021 Nov 10;21(1):222. doi: 10.1186/s12902-021-00884-6. |
patients receive standard of care
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | Risk of Experiencing a Composite Endpoint of All Cause ED Visits and Hospitalizations at 6 Months Post Intervention vs 6 Months Pre-intervention for Cases and Controls. | Health care utilization measure. We compared the risk of experiencing an emergency room and/or hospital visit at 6 months from baseline for both groups. this was done by calculating he Incidence Risk Ratio of ED visits/hospitalizations for intervention and control patients to assess whether the pathway impacted the risk for ED visits/hospitalizations at 6 months from baseline and comparing them. We looked at these measures for the 6-month period that preceded the baseline visit and the 6-month period that followed the baseline visit. | Poisson Regression Models of all utilizations (ED + hospitalization) at 6-month visits by Study Groups: Incidence rate ratios (IRRs) reported. In the six months after enrollment, controls are expected to have 0.646 admissions on average, and cases are expected to have 56.8% of the number of admissions that the controls had, or a reduction of 43.2% | Posted | Number | 95% Confidence Interval | ratio of risk incidences | 6 months |
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| Secondary | Adherence to Prescribed Diabetes Medications | Change in Adherence to Diabetes Medications as Measured Using MMS From Baseline to 3 Months for Intervention Subjects | This outcome measure was eliminated during the course of the study and data was not collected | Posted | 90 days |
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| Secondary | Frequency of Eye Exams | Change in the Proportion of Patients Receiving an Eye Exam in the 6 Months Following the Start of the Intervention as Compared to Baseline and to Concurrent Chart Controls | Technology to perform eye exams in primary care offices was not deployed as had been anticipated, therefore data was not collected for this outcome | Posted | 90 days |
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|
| 0 |
| 121 |
| 0 |
| 121 |
| EG001 | Matched Controls | patients receive standard of care | 0 | 294 | 0 | 294 |
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| D004700 | Endocrine System Diseases |