Type 2 Diabetes Mellitus (T2DM)DM4PHC-pilotNCT06907472
Diabetes Management for Primary Healthcare Centers.
A study testing Protocol-based treatment in people with Type 2 Diabetes Mellitus (T2DM), run by University of Abuja at 2 sites in Nigeria.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Protocol-based treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 2 sitesNigeria
- Study dates
- 15 Sep 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults 18 years and older
- Uncomplicated type 2 diabetes mellitus
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Nigeria2 sites
Kagini PHC, Abuja Municipal Area council (AMAC)
Abuja, Federal Capital Territory, 900106
Deidei PHC, Bwari Area Council
Abuja, Federal Capital Territory, 901101
About this study
Official title: 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.
Read the 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:
- Healthy lifestyle counseling on clinic visits (Patient level).
- Simplified treatment protocol for diabetes management (National policy level).
- Access to functioning glucometers, test strips, and essential medicines (Health systems level).
- Team-based care and trained Community health extension workers/nurses to provide Diabetes management and follow up care (Health workers \& National Policy level).
- Information system to support performance and quality reporting and Health facility improvement (Health facility level).
- Diabetes patient registry and empanelment (Health system level).
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Protocol-based treatment
- Keywords
- Integrating Diabetes care, Primary Healthcare Center, pilot study, Abuja, Nigeria
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protocol-based treatmentDrug
Also called 1. Metformin 500mg [brand; Diamet 500mg by MAY & BAKER Nigeria PLC] 2. Glibenclamide 5mg [brand; Diatab 5mg by MAY & BAKER Nigeria PLC]
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
| Study group | Role | What they receive |
|---|---|---|
| Single arm diabetes management in Primary Healthcare Centers [PHCs] | Experimental | 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. Receives: Drug: Protocol-based treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reach (Recruitment rate): defined as the proportion of patients enrolled per month per the monthly recruitment target.
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%
Measured: Six months.
Adoption (adherence to protocol): defined as the proportion of diagnosed patients with diabetes started on treatment.
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%.
Measured: Six months.
Maintenance (retention rate): defined as the proportion of patients who complete the six-month final visit of the implementation phase
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%.
Measured: Six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start15 Sep 2025
- Primary completion30 Jun 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is a single-arm pilot trial.
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Abuja
- Sponsor type
- University, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Northwestern University, Washington University School of Medicine
- Responsible party
- Principal investigator, Ikechukwu Anthony Orji, University of Abuja
- Investigators
- Ikechukwu A. Orji, MBBS, PhD, Principal investigator, University of AbujaDike B. Ojji, MBBS, PhD, Study chair, University of AbujaLisa R. Hirschhorn, MD, MPH, Study director, Northwestern University Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907472
- Sponsor's protocol ID
- UATH/HREC/PR/505
- Other IDs
- D43TW011976, FHREC/2024/01/190/06-08-24
- Acronym
- DM4PHC-pilot
- Status last verified
- Jul 2026
- First submitted
- 14 Mar 2025
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual patient data will be shared through NHLBI BioLINCC.
Publications
Baldridge AS, Aluka-Omitiran K, Orji IA, Shedul GL, Ojo TM, Eze H, Shedul G, Ugwuneji EN, Egenti NB, Okoli RCB, Ale BM, Nwankwo A, Osagie S, Ye J, Chopra A, Sanuade OA, Tripathi P, Kandula NR, Hirschhorn LR, Huffman MD, Ojji DB. Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial. Implement Sci Commun. 2022 Aug 2;3(1):84. doi: 10.1186/s43058-022-00328-9.
PubMed 35918703Orji IA, Baldridge AS, Omitiran K, Guo M, Ajisegiri WS, Ojo TM, Shedul G, Kandula NR, Hirschhorn LR, Huffman MD, Ojji DB. Capacity and site readiness for hypertension control program implementation in the Federal Capital Territory of Nigeria: a cross-sectional study. BMC Health Serv Res. 2021 Apr 9;21(1):322. doi: 10.1186/s12913-021-06320-8.
PubMed 33836719Orji IA, Baldridge AS, Ikechukwu-Orji MU, Banigbe B, Eze NC, Chopra A, Omitiran K, Iyer G, Odoh D, Alex-Okoh M, Reng R, Hirschhorn LR, Huffman MD, Ojji DB. Evaluation of Primary Healthcare Centers' Service Availability and Readiness for Implementing Diabetes Care in Abuja, Nigeria: A Cross-Sectional, Formative Assessment. Res Sq [Preprint]. 2024 Mar 26:rs.3.rs-3959541. doi: 10.21203/rs.3.rs-3959541/v1.
PubMed 38585872
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Diabetes Care Into Primary Healthcare Centers in Abuja, Nigeria: A Pilot Study
- ClinicalTrials.gov ID
- NCT06907472
- Acronym / sponsor ID
- DM4PHC-pilot / UATH/HREC/PR/505
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Integrating Diabetes care, Primary Healthcare Center, pilot study, Abuja, Nigeria
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University of AbujaUniversity, hospital or other
- Collaborators
- Fogarty International Center of the National Institute of Health, Northwestern University, Washington University School of Medicine
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- Healthy lifestyle counseling on clinic visits (Patient level).
- Simplified treatment protocol for diabetes management (National policy level).
- Access to functioning glucometers, test strips, and essential medicines (Health systems level).
- Team-based care and trained Community health extension workers/nurses to provide Diabetes management and follow up care (Health workers \& National Policy level).
- Information system to support performance and quality reporting and Health facility improvement (Health facility level).
- Diabetes patient registry and empanelment (Health system level).
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is a single-arm pilot trial.
| Arm | Type | Receives |
|---|---|---|
| Single arm diabetes management in Primary Healthcare Centers [PHCs] | Experimental | Drug: Protocol-based treatmentSingle-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. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults 18 years and older
- Uncomplicated type 2 diabetes mellitus
Key exclusion criteria (8 listed)
- Minors (younger than 18 years),
- Type 1 diabetes mellitus
- Prisoners
- Other detained individuals
- Severe hypertension (SBP ≥180 mmHg and DBP ≥ 110 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Protocol-based treatmentAlso: 1. Metformin 500mg [brand; Diamet 500mg by MAY & BAKER Nigeria PLC] 2. Glibenclamide 5mg [brand; Diatab 5mg by MAY & BAKER Nigeria PLC]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 | Drug | Single arm diabetes management in Primary Healthcare Centers [PHCs] |
Primary outcome
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%
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%.
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%.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Results publication: PubMed 35918703Baldridge AS, Aluka-Omitiran K, Orji IA, Shedul GL, Ojo TM, Eze H, Shedul G, Ugwuneji EN, Egenti NB, Okoli RCB, Ale BM, Nwankwo A, Osagie S, Ye J, Chopra A, Sanuade OA, Tripathi P, Kandula NR, Hirschhorn LR, Huffman MD, Ojji DB. Hypertension Treatment in Nigeria (HTN) Program: rationale and design for a type 2 hybrid, effectiveness, and implementation interrupted time series trial. Implement Sci Commun. 2022 Aug 2;3(1):84. doi: 10.1186/s43058-022-00328-9.
- Results publication: PubMed 33836719Orji IA, Baldridge AS, Omitiran K, Guo M, Ajisegiri WS, Ojo TM, Shedul G, Kandula NR, Hirschhorn LR, Huffman MD, Ojji DB. Capacity and site readiness for hypertension control program implementation in the Federal Capital Territory of Nigeria: a cross-sectional study. BMC Health Serv Res. 2021 Apr 9;21(1):322. doi: 10.1186/s12913-021-06320-8.
- Results publication: PubMed 38585872Orji IA, Baldridge AS, Ikechukwu-Orji MU, Banigbe B, Eze NC, Chopra A, Omitiran K, Iyer G, Odoh D, Alex-Okoh M, Reng R, Hirschhorn LR, Huffman MD, Ojji DB. Evaluation of Primary Healthcare Centers' Service Availability and Readiness for Implementing Diabetes Care in Abuja, Nigeria: A Cross-Sectional, Formative Assessment. Res Sq [Preprint]. 2024 Mar 26:rs.3.rs-3959541. doi: 10.21203/rs.3.rs-3959541/v1.
- Individual participant dataSharing planned: Yes. Individual patient data will be shared through NHLBI BioLINCC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ikechukwu A. Orji, MBBS, PhD principal investigator
University of Abuja
Dike B. Ojji, MBBS, PhD study chair
University of Abuja
Lisa R. Hirschhorn, MD, MPH study director
Northwestern University Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Protocol-based treatment in people with Type 2 Diabetes Mellitus (T2DM), run by University of Abuja at 2 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reach (Recruitment rate): defined as the proportion of patients enrolled per month per the monthly recruitment target. (time frame: Six months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06907472, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.