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Low-cost Insulin Delivery for Type 2 Diabetes in Rural Primary Care
- BDCTR ID
- BDCTR-2026-000138
- Sponsor
- Bangladesh Medical University
- Information provided by
- Dr Kamrul Hasan, Professor (Responsible Party)
- Last Update Posted
- 2026-09-24
Not yet recruiting
Study Overview
Brief Summary
This trial evaluates a nurse-led insulin initiation pathway in rural primary care against standard referral, measuring glycaemic control and access to treatment.
Detailed Description
Participants with poorly controlled type 2 diabetes are randomised to a nurse-led insulin initiation pathway or standard specialist referral. The primary endpoint is change in HbA1c at 12 months.
Official Title
Conditions
- Type 2 Diabetes Mellitus
Intervention/Treatment
- Behavioral: Nurse-led insulin initiation pathway
- Drug: Human insulin (NPH and regular)
Other Study ID Numbers
BMU-MED-2026-011
Study Start
Primary Completion
Study Completion
Enrollment (Estimated)
Study Type
Resource links provided by the National Library of Medicine
- MedlinePlus related topics: Type 2 Diabetes Mellitus
- Genetic and Rare Diseases Information Center resources: Type 2 Diabetes Mellitus
- Drug Information available for: Human insulin (NPH and regular)
- FDA Drug and Device Resources
Contacts and Locations
This section provides contact details for people who can answer questions about joining this study, and information on where this study is taking place.
To learn more, please see the Contacts and Locations section in How to Read a Study Record.
Study Contact
Name: Dr Kamrul Hasan
Phone Number: +8802550000138
Email: diabetes-care@bmu.ac.bd
This study has 1 location
Bangladesh
Mymensingh, Mymensingh, Bangladesh, 2200
Not yet recruiting
Mymensingh Medical College Hospital
Contact: Dr Kamrul Hasan
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.
For general information about clinical research, read Learn About Studies.
Eligibility Criteria
<p>Inclusion Criteria:</p><ul><li>Adults aged 30 to 70 years with type 2 diabetes.</li><li>HbA1c above 9% on oral therapy.</li></ul><p>Exclusion Criteria:</p><ul><li>Type 1 diabetes.</li><li>Pregnancy.</li></ul>
Ages Eligible for Study
Sexes Eligible for Study
Accepts Healthy Volunteers
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:
- Treatment
- Allocation:
- Randomized
- Interventional Model:
- Parallel Assignment
- Masking:
- None (Open Label)
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimental: Nurse-led pathway Structured nurse-led insulin initiation and titration. | Behavioral: Nurse-led insulin initiation pathway Protocolised initiation and titration delivered by trained nurses. Drug: Human insulin (NPH and regular) |
Active Comparator: Standard referral Referral to a specialist clinic for insulin initiation. | Drug: Human insulin (NPH and regular) |
What is the study measuring?
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
| Change in HbA1c from baseline | 12 months |
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
| Proportion achieving HbA1c below 7% | 12 months | |
| Time to insulin initiation | From enrolment to 12 months |
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study Record Dates
These dates track the progress of study record and summary results submissions to the registry. Study records and reported results are reviewed by the Registry Office to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted that Met QC Criteria
First Posted
Study Record Updates
Last Update Submitted that Met QC Criteria
Last Update Posted
Last Verified
More Information
Terms related to this study
Keywords Provided by Bangladesh Medical University
- diabetes
- insulin
- primary care
- task shifting
Plan for Individual Participant Data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents, and helpful links
Data Monitoring Committee