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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
Trial Contacts
| ContactsICMJE | Dr Kamrul Hasan +8802550000138 diabetes-care@bmu.ac.bd |
|---|
Study Record Dates
| First SubmittedICMJE | Not provided |
|---|---|
| First PostedICMJE | 2026-09-21 |
| Last Update Posted | 2026-09-24 |
| Last Verified* | 2026-09 |
Outcome Measures
| Primary Outcome Measures*ICMJE | Change in HbA1c from baseline [Time Frame: 12 months] |
|---|---|
| Secondary Outcome Measures[*]ICMJE | Proportion achieving HbA1c below 7% [Time Frame: 12 months] Time to insulin initiation [Time Frame: From enrolment to 12 months] |
| Other Pre-specified Outcome Measures | Not provided |
Trial Description
| Brief Title*ICMJE | Low-cost Insulin Delivery for Type 2 Diabetes in Rural Primary Care |
|---|---|
| Official Title*§ICMJE | A Randomised Trial of a Nurse-led Insulin Initiation Pathway Versus Standard Referral for Type 2 Diabetes in Rural Primary Care |
| Acronym[*] | Not provided |
| 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. |
| Study Type*ICMJE | Interventional |
| Study Phase*ICMJE | Not provided |
| Study Design*§ICMJE | Allocation: Randomized Interventional Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
| Condition*ICMJE | Type 2 Diabetes Mellitus |
| Keywords | diabetes insulin primary care task shifting |
| Intervention*ICMJE | Behavioral: Nurse-led insulin initiation pathway — Protocolised initiation and titration delivered by trained nurses. Drug: Human insulin (NPH and regular) |
| Study Arms*ICMJE | Experimental: Nurse-led pathway — Structured nurse-led insulin initiation and titration. Interventions: Behavioral: Nurse-led insulin initiation pathway; Drug: Human insulin (NPH and regular) Active Comparator: Standard referral — Referral to a specialist clinic for insulin initiation. Interventions: Drug: Human insulin (NPH and regular) |
| Publications | Not provided |
Recruitment Information
| Recruitment Status*ICMJE | Not yet recruiting |
|---|---|
| Enrollment (Anticipated)*§ICMJE | 640 |
| Study Start Date*§ICMJE | 2026-11-01 |
| Primary Completion Date* | 2027-11-30 (Final data collection date for primary outcome measure) |
| Study Completion Date*§ICMJE | 2028-02-28 |
| Eligibility Criteria*ICMJE | <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> |
| Sex/Gender*ICMJE | Sexes Eligible for Study: All |
| Ages*ICMJE | 30 Years to 70 Years (Adult, Older Adult) |
| Accepts Healthy Volunteers*§ICMJE | No |
| Location CountriesICMJE | Bangladesh |
Administrative Information
| BDCTR NumberICMJE | BDCTR-2026-000138 |
|---|---|
| Other Study ID Numbers[*]ICMJE | BMU-MED-2026-011 |
| Has Data Monitoring Committee | Yes |
| Studies a U.S. FDA-regulated Drug Product | Not provided |
| Studies a U.S. FDA-regulated Device Product | Not provided |
| Device Product Not Approved or Cleared by U.S. FDA | Not provided |
| Pediatric Postmarket Surveillance of a Device Product | Not provided |
| Product Manufactured in and Exported from the U.S. | Not provided |
| IPD Sharing StatementICMJE | Plan to Share IPD: Not provided |
| Current Responsible Party* | Dr Kamrul Hasan, Professor |
| Current Study Sponsor*ICMJE | Bangladesh Medical University |
| CollaboratorsICMJE | Not provided |
| InvestigatorsICMJE | Not provided |
| Registry Account | Imported legacy public registry |
Symbol Legend
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- *§
- Required if Study Start Date is on or after January 18, 2017 — required for every BMU study
- [*]
- Conditionally required
- No Symbol
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- ICMJE
- Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP