Completed

NCT Number: NCT03561714

Cardiometabolic Care-team Integration Improves Outcomes in Diabetes

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.

Completed

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

All patients with type 1 and type 2 diabetes

Exclusion criteria

None

Treatment and study plan

Cardometabolic Team Intervention

Behavioral

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.

Primary outcomes

HbA1c

Time frame: 12 months

Change in HbA1c between Intervention and Comparator sites

Secondary outcomes

Hospital/ER costs

Time frame: 12 months
LDL

Time frame: 12 months

Change in LDL between Intervention and Comparator sites
Blood pressure

Time frame: 12 months

Change in blood pressure between Intervention and Comparator sites

Sponsors and collaborators

Lead sponsor

Scripps Whittier Diabetes Institute

Other

Registry information

Official study title

Cardiometabolic Care-team Integration in Primary Care Improves Outcomes in Diabetes: a Pragmatic, Case-controlled Study

Important dates

Study start: 2012
Primary completion: 2014
Study completion: 2014
First posted: Jun 19, 2018
Registry last updated: Dec 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.