Could a faster insulin improve blood sugar control in teens with type 1 diabetes?
NCT ID NCT06948760
First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This completed trial tested whether a faster-acting insulin (Lyumjev) used with a special conversion factor in an automated insulin pump (Control-IQ) could improve blood sugar control in 11 adolescents with type 1 diabetes. Participants were randomly assigned to use Lyumjev with the new settings or their usual insulin (Humalog or Novolog) with optimized settings. The main goal was to see if the Lyumjev group spent more time in the target blood sugar range (70-180 mg/dL).
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lyumjev insulin (ultra-rapid-acting insulin)
- What this could lead to
- If successful, this could help adolescents with type 1 diabetes achieve better blood sugar control using a faster-acting insulin in an automated pump.
- What could go wrong
- This was a very small trial (11 participants) with no phase designation, so results may not be generalizable. Faster insulin also carries a risk of hypoglycemia.
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
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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11 people
The number who actually took part.
- Started
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Jul 2025
- Finished
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Mar 2026
- Lead sponsor
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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
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12 to 22 years
- Sex
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Anyone
- Healthy volunteers
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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. Age ≥12.0 and ≤22 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year 3. HbA1c \>6.5 - 12% 4. Currently using insulin for at least six months 5. Currently using the Tandem t:slim insulin pump with Control-IQ Technology® for at least two months 6. Using insulin parameters such as carbohydrate ratio and correction factors consistently on their pump in order to dose insulin for meals or corrections 7. Access to internet and willingness to upload data during the study as needed, including data generated prior to the start of the study 8. For females, not currently known to be pregnant or breastfeeding 9. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. 10. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, prior to the insulin Optimization Phase and for the duration of the study 11. Willingness to use Lyumjev if randomized to the experimental treatment arm 12. Total daily insulin dose (TDD) at least 10 U/day and not more than 100 U/day 13. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, biguanides, sulfonylureas and nutraceuticals) 14. Willingness to eat at least 1 g/kg of carbohydrate per day 15. Willingness to check ketones per study protocol using home urine ketone strips 16. An understanding and willingness to follow the protocol and signed informed consent Exclusion Criteria: 1. History of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment 2. Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment 3. Current HbA1c \<6.5 or \>12 4. Pregnancy or intent to become pregnant during the trial 5. Currently being treated for a seizure disorder 6. Planned surgery during study duration 7. Need for treatment with oral steroid 8. Treatment with any non-insulin glucose-lowering agent (including metformin, GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and nutraceuticals) 9. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol.
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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
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University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903, United States
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