NCT01965639

Brief Summary

The purpose of the Southeastern Diabetes Initiative Clinical Intervention is to augment existing standard of care in an effort to (1) improve population level diabetes management, health outcomes and quality of life for diagnosed and undiagnosed adults living with Type 2 Diabetes Mellitus, (2) reduce disparities in diabetes management, health outcomes and quality of life for adults living with Type 2 Diabetes Mellitus, and (3) reduce healthcare costs associated with Type 2 Diabetes Mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
648

participants targeted

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

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

4 active sites

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

April 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 17, 2016

Status Verified

April 1, 2015

Enrollment Period

3.2 years

First QC Date

October 16, 2013

Last Update Submit

June 16, 2016

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus Type 2Standard of careQuality of lifeDisease management

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Up to 24 months

Secondary Outcomes (8)

  • Rate of health services utilization

    up to 24 months

  • Change in Medication Adherence

    Baseline, 6, 12, 18, and 24 months

  • Change in HbA1c

    Baseline, 6, 12, 18, and 24 months

  • Change in blood lipids

    Baseline, 6, 12, 18, and 24 months

  • Change in blood glucose

    Baseline, 6, 12, 18, and 24 months

  • +3 more secondary outcomes

Study Arms (1)

High Risk group

EXPERIMENTAL

Extension of Care

Other: Extension of Care

Interventions

Extension of CareOTHER

Clinical care will be delivered by a multidisciplinary team including (but not limited to) a physician, nurse practitioner, dietitian, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker in community settings including home visits and community based clinics.

High Risk group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults \>=18yrs
  • Diagnosis of Type 2 diabetes
  • Reside in Durham County, NC, Cabarrus County, NC, Quitman County, MS or Mingo County, WV or the neighboring areas and receive the majority of their healthcare in the four listed counties.
  • Have capacity to give consent (or have a surrogate legally authorized representative or caregiver provide consent on their behalf).
  • Defined as high risk by the risk algorithm or their primary care clinician.
  • Referral from the primary care clinician or patient's medical home if one has been designated.

You may not qualify if:

  • Lack capacity to make decisions and do not have a surrogate with authority to make health care decisions.
  • Have a terminal illness with a life expectancy of 6 months or less
  • Diagnosis of Type 1 diabetes or gestational diabetes
  • Currently pregnant (confirmed via self-report and/or medical record)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Mississippi Public Health Institute

Madison, Mississippi, United States

Location

Durham County Department of Public Health

Durham, North Carolina, United States

Location

Cabarrus Health Alliance

Kannapolis, North Carolina, United States

Location

Williamson Health and Wellness Center

Williamson, West Virginia, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Robert Califf, MD

    Duke Translational Medicine Institute

    PRINCIPAL INVESTIGATOR

  • Bryan Batch, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2013

First Posted

October 18, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 17, 2016

Record last verified: 2015-04

Locations

US(4)