NCT05614089CompletedPhase 4
Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings
Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 10 Sept 2025
Brief summary (registry, in English)
The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g. NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 400 (actual)
- First submitted
- 28 Oct 2022
- Start date
- 15 Mar 2023
- Primary completion date
- 13 Aug 2024
- Lead sponsor
- Jing Luo
- Diseases
- Type 1 diabetes
- NCT number
- NCT05614089
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 400
- From 15 Mar 2023 to the primary completion date, 13 Aug 2024
- 3 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior use of any insulin analogue
Lab values
- Who have previously used a continuous glucose monitor (CGM) for glucose monitoring
Age
- Patients (or parents for children \<18 years old) who refuse to or cannot provide informed consent
Other
- Who are currently pregnant or plan to become pregnant over the next year
- Who were first diagnosed with T1D less than 12 months ago
- Who is diagnosed with severe malnutrition
Who the study is looking for
- Children and young adults (age 7-25)
- Have a clinical diagnosis of type 1 diabetes (T1D)
Age in the registry: 7 years to 25 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BIRDEM Hospital Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Unknown status |
| Sekou-Toure Hospital Coordinator of this site? Confirm its status | Mwanza | Tanzania | Unknown status |
| Bugando Medical Center Coordinator of this site? Confirm its status | Mwanza | Tanzania | Unknown status |
Related publications
- Human versus analogue insulin for children and young adults with type 1 diabetes in low-resource settings (HumAn-1): a multicentre, open-label, randomised controlled trial.Lancet Diabetes Endocrinol · 2026 · PMID 42409045
This page is information, not medical advice. Discuss any trial with your doctor.