N/A
Completed N=419
MedStar Health Type 2 Diabetes Pathway to Control
Source: ClinicalTrials.gov NCT02925312 ↗Enrolled (actual)
419
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Percentage Change in Hemoglobin A1C From Baseline to 3 Months — 3.08; 1.64 percentage — p=0.05
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change in Hemoglobin A1C From Baseline to 3 Months |
3.08; 1.64 | 0.05 |
| 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. |
0.568; 0.646 | — |
| SECONDARY Adherence to Prescribed Diabetes Medications |
— | — |
| SECONDARY Frequency of Eye Exams |
— | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of type 2 diabetes for >=1 year
- Active practice patient
- A1C > 9.0% at their last visit to Medical Home, ED or hospital admission plus one more high risk factor (ED visit or hospitalization in past 12 mos)
- Primary Care Provider willing to have patient enter the program
- Patient is able and willing to participate in the program and exhibits readiness to change DM self-management
- Proficient in English
Exclusion Criteria
- Known history of DKA
- No MedStar PCP visit within past 12 months
- Endocrine or Diabetes Education consult referral order in the past 6 months which resulted in Endo visit(s) or DSME visit(s) documented in chart or self-reported by patient during initial screen
- Active additional medical issues which in the opinion of the care team would preclude concentrating on BG control and/or would predispose to ED visits and/or hospital admits independent of glycemic control, e.g.: severe CHF, severe COPD; severe mental illness.
- Resident of skilled nursing facility, nursing home or receiving home health care services.
- Active cancer in the preceding 3 years excluding nonmalignant basal cell cancer
- Supraphysiologic doses of glucocorticoids (hydrocortisone > 30mg/day; prednisone > 5-6mg daily; dexamethasone > 2mg daily).
- Pregnant or anticipates attempting conception in the following year
- Patient and/or custodial caregiver unwilling and/or unable to participate in program-related activities
Data sourced from ClinicalTrials.gov (NCT02925312). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.