This trial is active, not recruiting.

Condition diabetes
Treatment diabetes pathway
Sponsor Medstar Health Research Institute
Collaborator MedStar Health
Start date November 2014
End date June 2016
Trial size 450 participants
Trial identifier NCT02925312, 2014-191


The MedStar Diabetes Institute (MDI), in partnership with key MedStar Health system diabetes stakeholders, seeks to implement an evidence-based innovative integrated care pathway for MedStar patients with uncontrolled diabetes which will demonstrate improvement in diabetes care outcomes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Patients receive the full diabetes pathway intervention
diabetes pathway
Medication algorithm, survival skills education, enhanced patient-provider communication
(No Intervention)
patients receive standard of care

Primary Outcomes

Reduction in A1C by > 1% over 3 months
time frame: 3 months
Increased adherence to diabetes medications as measured using MMS by 25% from baseline to 3 months for intervention subjects
time frame: 3 months
Increase the proportion of patients receiving an eye exam by 20% in the 6 months following the start of the intervention as compared to baseline and to concurrent chart controls.
time frame: 6 months

Secondary Outcomes

trend in the composite endpoint of diabetes-related ED visits and hospitalizations compared to both 6 month pre-intervention and among concurrent chart controls.
time frame: 6 months
- Reduction in self-reported absenteeism (or days missed from usual daily activities) during the intervention period when compared to 6 months prior to enrollment
time frame: 6 months

Eligibility Criteria

Male or female participants from 21 years up to 75 years old.

Inclusion Criteria: - Diagnosis of type 2 diabetes for >=1 year - Active practice patient - A1C > 9.0% at their last visit to MedStar Medical Home, ED or hospital admission plus one more high risk factor - Primary Care Provider willing to have patient enter the program - Patient is able and willing to participate in the program - 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

Additional Information

Official title MedStar Pathway to Diabetes Control Demonstration Project
Principal investigator Michelle F Magee, MD
Description - The program is designed to bring diabetes specialty services to Primary Care practices to support PCPs and their patients in improving diabetes-related outcomes. - High-risk patients from MedStar Primary Care practices who have uncontrolled type 2 diabetes and meet the target population inclusion and exclusion criteria will be invited to participate in an intensive and concise medication management and education intervention of ~4-8 weeks duration. - The intervention will consist of three key components: (1) intensive, algorithm-based medication management (Appendix A), based on continuous review and management of blood sugars; (2) survival skills diabetes self-management education; (3) enhanced patient-provider communication, all provided by Endocrinologist supervised allied health professionals (in this instance CDEs). - Survival skills DSME will focus on nutrition and meal plan basics, blood glucose targets, taking medications as prescribed, hyper- and hypoglycemia recognition and treatment, and when to seek medical help. - The intervention will start with one to two face-to-face meetings with the CDE, to be followed by virtual meetings though a variety of media based on patient preference and health literacy. - Various technology tools will be used to facilitate patient engagement and attainment of glycemic targets, including smart meters, virtual meeting platforms, web-based education content and surveys via tablets, etc. - Concurrent matched charts of patients receiving standard care at the three MedStar locations will serve as a basis of comparison in assessing the impact of MDI on clinical and education outcomes and process of care. - Based on patient progress towards improved glycemic control, the patient will 'graduate' from the program and the CDE will refer the patient back to their PCP in 8-12 weeks with a full report of medication changes, blood glucose readings and further diabetes management recommendations eg referrals; further DSME, etc.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Medstar Health Research Institute.