NCT02156037

Brief Summary

To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's use of a "diabetes dashboard" with a usual diabetes team care condition (UDC) that does not have access to the diabetes dashboard.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
399

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Jul 2009

Longer than P75 for not_applicable diabetes

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

July 1, 2009

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2014

Completed
Last Updated

June 5, 2014

Status Verified

June 1, 2014

Enrollment Period

4 years

First QC Date

June 3, 2014

Last Update Submit

June 4, 2014

Conditions

Keywords

Hispanicclinical decision supportdiabetesHba1cpsychosocial

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Change in HbA1c over 6 months

    6 months

Secondary Outcomes (2)

  • Diabetes distress

    6 months

  • Depression

    6 months

Study Arms (2)

dashboard team care intervention

EXPERIMENTAL

Dashboard team

Behavioral: Diabetes Dashboard Intervention

usual diabetes team control

ACTIVE COMPARATOR

usual clinical diabetes team with no access to the diabetes dashboard

Behavioral: Usual Diabetes Care

Interventions

The Diabetes Dashboard Intervention Condition involved a program of five, in-person, one-on-one diabetes education and behavior change visits with a diabetes nurse or diabetes dietician, scheduled at baseline, two weeks, one month, three months, and six months post-enrollment.

dashboard team care intervention

The UDC condition was delivered by four bicultural, bilingual diabetes nurses and diabetes dietitians who comprised the clinical site's long-standing, in-house diabetes program.

usual diabetes team control

Eligibility Criteria

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

You may qualify if:

  • age 18 years or older,
  • self-identified Hispanic ethnicity,
  • diagnosis of T2D,
  • HbA1c \>7.5%, and
  • provider approval given for patient participation

You may not qualify if:

  • inability to consent,
  • pregnant or planning to become pregnant in the next year,
  • taking glucocorticoid therapy, or
  • having serious psychiatric or medical complications (e.g., late stage diabetes complications, seizures, dementia, psychiatric hospitalization) that would prevent participation in study activities.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baystate Medical Center

Springfield, Massachusetts, 01199, United States

Location

Related Publications (1)

  • Welch G, Zagarins SE, Santiago-Kelly P, Rodriguez Z, Bursell SE, Rosal MC, Gabbay RA. An internet-based diabetes management platform improves team care and outcomes in an urban Latino population. Diabetes Care. 2015 Apr;38(4):561-7. doi: 10.2337/dc14-1412. Epub 2015 Jan 29.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Garry Welch, PhD

    Baystate Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 5, 2014

Study Start

July 1, 2009

Primary Completion

July 1, 2013

Study Completion

July 1, 2013

Last Updated

June 5, 2014

Record last verified: 2014-06

Locations