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Could a switch to analogue insulin reduce dangerous low blood sugar in kids with diabetes?

NCT ID NCT05614089

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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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