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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

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Study Record Versions

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12026-09-24Current
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Viewing V1 (2026-09-24)

Study Details

Study Identification

Unique Protocol IDBMU-MED-2026-011
Brief TitleLow-cost Insulin Delivery for Type 2 Diabetes in Rural Primary Care
Official TitleA Randomised Trial of a Nurse-led Insulin Initiation Pathway Versus Standard Referral for Type 2 Diabetes in Rural Primary Care
Secondary IDs

Study Status

Record Verification2026-09
Overall StatusNot yet recruiting
Study Start2026-11-01
Primary Completion2027-11-30
Study Completion2028-02-28
First Submitted
First Submitted that Met QC Criteria2026-09-21
First Posted2026-09-21 [Actual]
Last Update Submitted that Met QC Criteria2026-09-24
Last Update Posted2026-09-24 [Actual]

Oversight

U.S. FDA-regulated Drug
U.S. FDA-regulated Device
Product manufactured in and exported from the U.S.
Data MonitoringYes

Study Description

Brief SummaryThis trial evaluates a nurse-led insulin initiation pathway in rural primary care against standard referral, measuring glycaemic control and access to treatment.
Detailed DescriptionParticipants 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.

Conditions

ConditionType 2 Diabetes Mellitus
Keywordsdiabetes insulin primary care task shifting

Study Design

Study TypeInterventional
Primary PurposeTreatment
Study Phase
Interventional Study ModelParallel Assignment
Number of Arms2
MaskingNone (Open Label)
AllocationRandomized
Enrollment640 [Estimated]

Arms and Interventions

ArmsAssigned Interventions
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)

Outcome Measures

Primary Outcome MeasuresChange in HbA1c from baseline Time Frame: 12 months
Secondary Outcome MeasuresProportion achieving HbA1c below 7% Time Frame: 12 months Time to insulin initiation Time Frame: From enrolment to 12 months

Eligibility

Minimum Age30 Years
Maximum Age70 Years
Ages30 Years to 70 Years (Adult, Older Adult)
SexAll
Gender-based Eligibility
Gender Eligibility Description
Accepts Healthy VolunteersNo
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>

Contacts/Locations

Central Contact PersonDr Kamrul Hasan +8802550000138 diabetes-care@bmu.ac.bd
Study Officials
LocationMymensingh, Mymensingh, Bangladesh, 2200 Status: Not yet recruiting Facility: Mymensingh Medical College Hospital Contact: Dr Kamrul Hasan

IPD Sharing

IPD informationPlan to Share IPD: Not provided

References

Citations
Links
Available IPD/Information

Document Section

Documents