Brief Summary:

Many people with diabetes in Nigeria have trouble controlling their blood sugar. This can lead to serious health problems such as heart disease, kidney damage, eye problems, and nerve pain. Medicines alone are often not enough if patients do not take them correctly, understand how to use them, or make healthy lifestyle changes.

This study looks at whether extra support from a pharmacist can help patients with type 2 diabetes mellitus get better health results. The study is being done at Yobe State University Teaching Hospital in Nigeria.

What the study is about:

The investigators want to find out if a special "pharmaceutical care" program run by a pharmacist can improve participants' blood sugar control and overall health compared to the usual care they receive in the hospital.

What participants will do:

Participants who agree to join the study will be divided into two groups by chance.

One group will receive the normal diabetes care from doctors and nurses. The other group will receive normal care plus regular meetings with a trained pharmacist.

In the pharmacist sessions, participants will get:

Clear explanations about their diabetes medicines (why they are needed, how and when to take them, and possible side effects).

Help to solve any problems with taking medicines correctly. Simple advice on healthy eating, physical activity, and checking blood sugar at home.

Regular follow-up to answer questions and check progress.

No new or experimental drugs are being tested. No injections, surgeries, or invasive procedures are involved. Patients continue with their usual diabetes medicines prescribed by their doctors.

Why this matters:

If the pharmacist support helps patients control their blood sugar better and feel healthier, it could be a simple and useful way to improve diabetes care in hospitals like ours. Better control can reduce the risk of serious complications and improve quality of life for patients and their families.

The study will measure changes in blood sugar levels (HbA1c), blood pressure, how well patients take their medicines, and how they feel about their health. Investigators will compare the two groups after several months.

This research does not involve any risk beyond the usual care patients already receive. Participation is voluntary, and patients can leave the study at any time without affecting their normal treatment.

Background:

Type 2 diabetes mellitus remains a major public health challenge in Nigeria, with many patients experiencing poor glycemic control despite standard medical care. This often results in increased risk of microvascular and macrovascular complications, reduced quality of life, and higher healthcare costs. Pharmaceutical care is a patient-centered, collaborative practice where pharmacists work with patients and other healthcare providers to optimize medication use, improve adherence, resolve drug-related problems, and support lifestyle modifications.

Although "type 3 diabetes" is sometimes used in literature to describe brain insulin resistance linked to cognitive decline (as seen in Alzheimer's disease), this study focuses on patients with type 2 diabetes mellitus. The term "type 3 diabetes" in the study title reflects emerging research interest in the broader metabolic and neurological effects of chronic hyperglycemia.

Study Rationale:

Standard diabetes care in many resource-limited settings is primarily physician-led and may not provide sufficient time for detailed medication counseling, adherence assessment, or individualized education. This study evaluates whether adding structured pharmaceutical care by a clinical pharmacist can lead to better health outcomes compared with usual care alone.

Study Design:

This is a prospective, randomized, controlled interventional study conducted at the Diabetes Clinic of Yobe State University Teaching Hospital, Damaturu, Nigeria. Eligible patients with type 2 diabetes mellitus were randomized into two parallel groups:

Control group: Received usual standard care provided by physicians and nurses (including prescription of antidiabetic medications, basic counseling, and routine follow-up).

Intervention group: Received usual standard care plus pharmaceutical care intervention delivered by a trained clinical pharmacist.

Pharmaceutical Care Intervention:

The intervention consisted of regular, structured pharmacist-patient sessions (face-to-face) scheduled at baseline and follow-up visits. Each session included:

1. Comprehensive medication review and reconciliation.
2. Patient education on the purpose, correct dosing, administration, storage, and potential side effects of prescribed antidiabetic, antihypertensive, and other medications.
3. Identification and resolution of drug-related problems (e.g., adherence barriers, drug interactions, adverse effects).
4. Personalized counseling on diet, physical activity, self-monitoring of blood glucose (where applicable), and foot care.
5. Goal-setting and motivational interviewing techniques to improve medication adherence and lifestyle behaviors.
6. Documentation of interventions and communication of recommendations to the attending physician when necessary.

No new or investigational therapeutic agents were introduced. No invasive procedures, additional laboratory tests beyond routine clinical care, or experimental devices were used. All patients continued their physician-prescribed treatment regimens.

Objectives:

The primary objective was to assess the impact of the pharmaceutical care intervention on glycemic control (measured by HbA1c) and other key clinical outcomes. Secondary objectives included evaluating effects on medication adherence, blood pressure control, body mass index, and patient-reported quality of life.

Duration and Follow-up:

Participants were followed for 12 months, with assessments at baseline, 6 months, and end of study. The study did not alter routine clinical management beyond the added pharmacist support in the intervention arm.

Expected Impact:

This study aims to provide evidence on the value of integrating clinical pharmacists into the multidisciplinary diabetes care team in a tertiary hospital setting in northern Nigeria. Positive findings could support the expansion of pharmaceutical care services to improve health outcomes for patients with type 2 diabetes in similar resource-constrained environments.

All procedures were conducted in accordance with the Declaration of Helsinki and approved by the institutional ethics committee. Participation was voluntary, and patients could withdraw at any time without affecting their access to standard care.

Inclusion Criteria:

• 1. Patients diagnosed with type 2 diabetes mellitus, confirmed by clinical documentation.

  2. Patients who have received oral antidiabetic and/ or insulin therapy within the 30 days prior to recruitment.

  3. Patients who have demonstrated consistent attendance at clinic visits for three consecutive months before recruitment.

  4. Patients who are proficient in either English or Hausa 5. Patients who provided written consent to participate in the study in accordance with ethical standards.

  6. Patients aged 18 years or older.

Exclusion Criteria:

• 1. Critically ill patients 2. Pregnant women

No, there is no plan to share individual participant data (IPD). This is a small, single-centre study conducted in a resource-limited setting. Participant-level data will not be made available to other researchers in order to protect participant privacy and confidentiality.