Diabetes Management for Primary Healthcare Centers. (DM4PHC-pilot)

March 25, 2026 updated by: Ikechukwu Anthony Orji, University of Abuja

Integrating Diabetes Care Into Primary Healthcare Centers in Abuja, Nigeria: A Pilot Study

The purpose of this study, "Integrating diabetes care into Primary Healthcare Centers (PHCs) in Abuja, Nigeria: a pilot study," is to screen, diagnose, treat, and educate diabetes patients in two selected PHCs in Abuja. This single-arm pilot trial will test the feasibility of integrated diabetes care, measure the implementation outcomes, and explore the effectiveness of the strategy bundle using the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The pilot study involves the use of non-physician health workers (e.g., community health extension workers [CHEWs], nurses, and laboratory technicians) to implement a diabetes care program in alignment with the HEARTS diabetes-specific module, also known as HEARTS-D. The study adapted strategies from the Transforming Hypertension Treatment in Nigeria (HTN) Program, originally based on the Kaiser Permanente Northern California hypertension program and HEARTS technical package. The adapted intervention is informed by experience from the successful HTN program and findings from the investigators' formative assessment for this diabetes integration in the PHC setting.

The investigators used an adapted Service Availability and Readiness Assessment (SARA) instrument for the formative assessment and evaluated the PHC's availability and readiness for diabetes care across various domains. These domains include staffing, training, equipment, medications, clinical guidelines, health management information systems, and diabetes care services. The formative study also assessed health workers' knowledge, attitudes, and practices related to diabetes care and explored barriers and facilitators of implementing diabetes treatment programs at the PHC setting. The findings from the formative work informed the development and adaptation of strategies for this pilot implementation. The investigators are leveraging the available non-physician health workers and paper-based health management information systems, strengthening diabetes screening and counselling services, providing adequate training and re-training of health workers to provide comprehensive diabetes care services, providing diabetes education materials and job aids, and improving access to diabetes medications. The strategy is designed to overcome modifiable barriers at patient and system levels in the cascade of care for diabetes care at the PHC setting in Nigeria.

This pilot study will deliver a multi-level implementation package for diabetes care, which includes:

  1. Healthy lifestyle counseling on clinic visits (Patient level).
  2. Simplified treatment protocol for diabetes management (National policy level).
  3. Access to functioning glucometers, test strips, and essential medicines (Health systems level).
  4. Team-based care and trained Community health extension workers/nurses to provide Diabetes management and follow up care (Health workers & National Policy level).
  5. Information system to support performance and quality reporting and Health facility improvement (Health facility level).
  6. Diabetes patient registry and empanelment (Health system level).

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Nigeria
    • Federal Capital Territory
      • Abuja, Federal Capital Territory, Nigeria, 900106
        • Kagini PHC, Abuja Municipal Area council (AMAC)
      • Abuja, Federal Capital Territory, Nigeria, 901101
        • Deidei PHC, Bwari Area Council

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults 18 years and older
  • Uncomplicated type 2 diabetes mellitus

Exclusion Criteria:

  • Minors (younger than 18 years),
  • Type 1 diabetes mellitus
  • Prisoners
  • Other detained individuals
  • Severe hypertension (SBP ≥180 mmHg and DBP ≥ 110 mmHg)
  • Prior history of complications: stroke, heart failure, chronic kidney disease, diabetic foot ulcer.
  • Pregnant women.
  • Older patients above 60 years of age with uncontrolled plasma glucose at the maximum dose of metformin (2 g/day) and maximum dose of glibenclamide (5mg/day) at entry to the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm diabetes management in Primary Healthcare Centers [PHCs]
Single-arm diabetes treatment in two PHCs. The two PHCs will implement a contextually and culturally adapted package based on the WHO HEARTS-D package for screening, diabetes diagnosis, patient education, and treatment using a HEARTS-D-adapted treatment protocol.
Drug: Protocol-based treatment

PROTOCOL:

Step 1: Metformin 500 mg daily Step 2: Metformin 1000 mg daily Step 3: Metformin 1000 mg twice daily Step 4: Metformin 1000 mg twice daily + glibenclamide 5 mg daily Step 5: Metformin 1000 mg twice daily + glibenclamide 5 mg twice daily

Other Names:
  • 1. Metformin 500mg [brand; Diamet 500mg by MAY & BAKER Nigeria PLC] 2. Glibenclamide 5mg [brand; Diatab 5mg by MAY & BAKER Nigeria PLC]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adoption (adherence to protocol): defined as the proportion of diagnosed patients with diabetes started on treatment.
Time Frame: Six months.
BENCHMARK: Achieving 80% treatment rate MEASUREMENT: The number of diagnosed patients with diabetes started on treatment divided by the total number of enrolled diabetes patients in the study x 100%.
Six months.
Maintenance (retention rate): defined as the proportion of patients who complete the six-month final visit of the implementation phase
Time Frame: Six months.
BENCHMARK: Achieving a 50% retention rate. MEASUREMENT: The total number of patients who complete the six-month final visit divided by the total number of enrolled patients during the six months of implementation x 100%.
Six months.
Reach (Recruitment rate): defined as the proportion of patients enrolled per month per the monthly recruitment target.
Time Frame: Six months.

BENCHMARK: Achieving 50% of the monthly recruitment target of 18 participants per month.

MEASUREMENT: Number of eligible patients recruited by participating PHCs per month divided by Monthly recruitment target x 100%
Six months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Abuja

Collaborators

Washington University School of Medicine
Northwestern University
Fogarty International Center of the National Institute of Health

Investigators

  • Principal Investigator: Ikechukwu A. Orji, MBBS, PhD, University of Abuja
  • Study Chair: Dike B. Ojji, MBBS, PhD, University of Abuja
  • Study Director: Lisa R. Hirschhorn, MD, MPH, Northwestern University Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2025

Primary Completion (Estimated)

June 15, 2026

Study Completion (Estimated)

December 14, 2026

Study Registration Dates

First Submitted

March 14, 2025

First Submitted That Met QC Criteria

March 26, 2025

First Posted (Actual)

April 2, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UATH/HREC/PR/505
  • D43TW011976 (U.S. NIH Grant/Contract)
  • FHREC/2024/01/190/06-08-24 (Other Identifier: FCT Health Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual patient data will be shared through NHLBI BioLINCC.

IPD Sharing Time Frame

Data will be available within 1 year of study's conclusion.

IPD Sharing Access Criteria

Access to study data will be managed through NHLBI BioLINCC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Study Data/Documents

  1. Individual Participant Data Set
    Information comments: University of Abuja REDCap link to participant data set.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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