NCT02925312

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
419

participants targeted

Target at P75+ for not_applicable type-2-diabetes-mellitus

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable type-2-diabetes-mellitus

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

July 17, 2020

Completed
Last Updated

September 23, 2020

Status Verified

September 1, 2020

Enrollment Period

1.7 years

First QC Date

October 4, 2016

Results QC Date

February 16, 2018

Last Update Submit

September 22, 2020

Conditions

Type 2 Diabetes MellitusHyperglycemia

Keywords

Diabetes Care ManagementChronic Care ModelResources UtilizationHemoglobin A1CHospitalizationsEmergency Room VisitsCost analysisReturn on Investment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • 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.

    6 months

  • Adherence to Prescribed Diabetes Medications

    90 days

  • Frequency of Eye Exams

    90 days

Study Arms (2)

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.

Other: Diabetes Pathway

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.

Interventions

Diabetes PathwayOTHER

Medication algorithm, survival skills education, enhanced patient-provider communication facilitated by near, real-time blood glucose monitoring

Also known as: Diabetes Boot Camp
Intervention

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Related Publications (2)

  • 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.

    PMID: 31798894BACKGROUND

  • 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.

    PMID: 34758807DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Hyperglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
Dr Michelle Magee
Organization
Medstar Health Research Institute
michelle.f.magee@medstar.net
2028772383

Study Officials

  • Michelle F Magee, MD

    Medstar Health Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, MedStar Diabetes Institute

Study Record Dates

First Submitted

October 4, 2016

First Posted

October 5, 2016

Study Start

November 1, 2014

Primary Completion

June 30, 2016

Study Completion

December 31, 2016

Last Updated

September 23, 2020

Results First Posted

July 17, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Upon final completion of reporting of main study results the study protocol, SAF, ICF and CSR will be available for 5 years.
Access Criteria
Deidentified data for scientific use that may contribute to the body of evidence to inform diabetes care management.

Locations

US(1)