NCT01611168

Brief Summary

The proposed research study aims to determine whether applying the University of Pittsburgh Medical Center Nurse-Directed Diabetes Management Protocols (NDMPs) leads to improved clinical outcome and process measures as recommended by American Diabetes Association (ADA), quality of life, treatment satisfaction and medication adherence for adults with diabetes, and favorable providers' satisfaction as compared to usual diabetes care. Furthermore, the cost-effectiveness of performing the NDMPs compared to usual diabetes care in primary care settings will also be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable type-2-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

April 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

June 2, 2023

Status Verified

May 1, 2017

Enrollment Period

3.7 years

First QC Date

May 15, 2012

Last Update Submit

May 31, 2023

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (3)

  • Glycated hemoglobin (A1C)

    Change in HbA1c blood test

    1 year

  • Blood pressure (systolic and diastolic blood pressure

    Change in systolic and diastolic blood pressure reading

    1 year

  • Lipids (LDLc, HDLc, cholesterol, and triglyceride)

    Change in LDLc, HDLc, cholesterol, and triglyceride values

    1 year

Study Arms (2)

Usual Care

NO INTERVENTION

Intervention Group, treatment algorithms

EXPERIMENTAL
Other: Treatment Algorithms

Interventions

Treatment AlgorithmsOTHER

subjects in the intervention group will receive diabetes care from a well-trained registered nurse (RN) who will follow approved treatment algorithms/protocols for glycemia, high blood pressure, lipids and microalbuminuria.

Intervention Group, treatment algorithms

Eligibility Criteria

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

You may qualify if:

  • Adults aged 18 or greater
  • The diagnosis of type 2 diabetes of the subjects should be 1 year or more prior to the inception of this study
  • Subjects will be on medication treatment for their type 2 diabetes
  • Subjects' A1C levels should be higher than 7% for study entry
  • LDLc\>100mg/d\*l or
  • Blood Pressure \>130/80\*mg/dl
  • Any combination of the #4, 5 \&6 At least one visit to the practice within the previous 12 months.

You may not qualify if:

  • Non-ambulatory
  • Gestational diabetes
  • Pregnant women (by self-report)
  • Subjects have received diabetes education services performed by the registered nurse from UPDI
  • Subjects are treated with exercise and diet only
  • Subjects are participating or will participate in other research studies
  • Subjects do not have insurance or cannot afford payments for diabetes care/treatment
  • Subjects are unable to read and comprehend English
  • Subjects are unable to provide informed consent
  • Other medical conditions for which these protocols are deemed inappropriate by the physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Medical Center Community Medicine Inc. (UPMC CMI) Primary Care Practices

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (1)

  • Zgibor JC, Maloney MA, Malmi M Jr, Fabio A, Kuo S, Solano FX, Tilves D, Tu L, Davidson MB. Effectiveness of certified diabetes educators following pre-approved protocols to redesign diabetes care delivery in primary care: Results of the REMEDIES 4D trial. Contemp Clin Trials. 2018 Jan;64:201-209. doi: 10.1016/j.cct.2017.10.003. Epub 2017 Oct 6.

    PMID: 28993287DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Janice Zgibor, RPh PhD

    University of South Florida

    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

May 15, 2012

First Posted

June 4, 2012

Study Start

April 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

June 2, 2023

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)