Could a switch to analogue insulin reduce dangerous low blood sugar in kids with diabetes?
NCT ID NCT05614089
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This completed Phase 4 trial enrolled 400 youth aged 7-25 with type 1 diabetes in low-resource settings. It compared insulin glargine (a long-acting analogue) to standard human insulin (NPH or premixed) to see if glargine reduces serious hypoglycemia or improves time in blood sugar range over 6 months. Participants used continuous glucose monitors to track outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- insulin glargine (a long-acting insulin analogue)
- What this could lead to
- If it works, this could show that insulin glargine is safer and more effective than cheaper human insulin for managing type 1 diabetes in low-resource settings.
- What could go wrong
- This is a completed Phase 4 trial, but results may not apply broadly due to the specific low-resource setting and strict eligibility criteria. The benefits of glargine over human insulin may be modest.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
400 people
The number who actually took part.
- Started
-
Mar 2023
- Finished
-
Mar 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
7 to 25 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Children and young adults (age 7-25) 2. Have a clinical diagnosis of type 1 diabetes (T1D) Exclusion Criteria: 1. Prior use of any insulin analogue 2. Patients (or parents for children \<18 years old) who refuse to or cannot provide informed consent 3. Who are currently pregnant or plan to become pregnant over the next year 4. Who have previously used a continuous glucose monitor (CGM) for glucose monitoring 5. Who were first diagnosed with T1D less than 12 months ago 6. Who is diagnosed with severe malnutrition
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
BIRDEM Hospital
Dhaka, Bangladesh
-
Bugando Medical Center
Mwanza, Tanzania
-
Sekou-Toure Hospital
Mwanza, Tanzania
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