NCT03561714

Brief Summary

A pragmatic, quasi-experimental (non-randomized) design was used to evaluate clinical and cost outcomes among patients with type 1 or 2 diabetes (T1D or T2D) at two primary care clinics (n=1 intervention, n=1 usual care) between March 2012 and September 2014. At the intervention clinic, the 12-month Cardio-metabolic Care-Team Intervention (CMC-TI) was delivered to all qualifying patients; surveys were administered to evaluate relevant patient-reported outcomes over 12 months, and a process evaluation gauged CMC-TI feasibility and satisfaction.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
475

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Typical duration for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2014

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
Last Updated

December 9, 2022

Status Verified

December 1, 2022

Enrollment Period

2.6 years

First QC Date

June 2, 2018

Last Update Submit

December 7, 2022

Conditions

Cardio-metabolic Care-Team Intervention (CMC-TI)

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Change in HbA1c between Intervention and Comparator sites

    12 months

Secondary Outcomes (3)

  • Hospital/ER costs

    12 months

  • LDL

    12 months

  • Blood pressure

    12 months

Study Arms (2)

CMC-TI

Cardiometabolic Care Team Intervention

Behavioral: Cardometabolic Team Intervention

Non-Intervention Comparator site

Non intervention comparator site with usual care

Interventions

Cardometabolic Team InterventionBEHAVIORAL

The CMC-TI team included a registered nurse/certified diabetes educator (RN/CDE) Care Manager, medical assistant (MA) Health Coach, and RN Depression Care Manager. Decision support tools guided therapy for glucose, BP, low-density lipoprotein cholesterol (LDL-c), and depression. At the intervention clinic, the 12-month CMC-TI was delivered to all qualifying patients; surveys were administered to evaluate relevant patient-reported outcomes over 12 months.

CMC-TI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

\- All patients with type 1 and type 2 diabetes within two primary care clinics at Scripps Coastal Medical Group.

You may qualify if:

  • All patients with type 1 and type 2 diabetes

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Corporate Vice President

Study Record Dates

First Submitted

June 2, 2018

First Posted

June 19, 2018

Study Start

March 1, 2012

Primary Completion

September 30, 2014

Study Completion

December 30, 2014

Last Updated

December 9, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share