Faster insulin in pumps may improve after-meal blood sugar in kids with diabetes
NCT ID NCT04149262
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a faster-acting insulin (Fiasp) works better than standard rapid insulin (NovoRapid) in insulin pumps for children and teens with type 1 diabetes. Researchers looked at blood sugar levels 30 minutes, 1 hour, and 2 hours after meals using real-world data from 44 participants. The goal was to see if the faster insulin leads to better post-meal glucose control.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- fast-acting insulin aspart (Fiasp)
- What this could lead to
- If it works, this could show that faster-acting insulin helps control blood sugar better after meals in children with type 1 diabetes using insulin pumps.
- What could go wrong
- This is a small, completed study with only 44 participants, so results may not apply to all children. It also looks at short-term glucose levels, not long-term outcomes.
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.
- Participants
-
44 people
The number who actually took part.
- Started
-
Nov 2019
- Finished
-
Feb 2023
- 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.
Who is studied
Children and adolescents with type 1 diabetes mellitus receiving care at the Pediatric Diabetes Outpatient Clinic of the 1st Pediatric Department of Aristotle University of Thessaloniki at Ippokratio General Hospital. The study population includes patients treated with continuous subcutaneous insulin infusion (insulin pump therapy) with available continuous glucose monitoring data during routine clinical follow-up.
- Ages
-
2 to 18 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. Informed consent obtained by parents or legal caregivers before any trial-related activities. 2. Any age, age ≥ 2 years and age \<18 years at the time of signing informed consent 3. Documented diagnoses of T1DM ≥ 3 months prior to the beginning of the study 4. Using the Medtronic MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter for at least 30 days prior to beginning of the study and willing to continue using the system throughout the trial. 5. Ability and willingness to use the same insulin infusion sets throughout the trial 6. Using the same insulin for at least 30 days prior to screening 7. HbA1c \< 9.0% as assessed by local laboratory at screening 8. Ability and willingness to adhere to the protocol including performing SMBG (Self Monitoring Blood Glucose) profiles, attending visits, uploading pump and sensor data to the CareLink platform Exclusion Criteria: 1. Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies 2. Treatment with any medication for the indication of diabetes other than stated in the inclusion criteria within 30 days before screening 3. Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial 4. Any diabetic complication including renal disease, retinopathy, etc 5. History of hospitalization for ketoacidosis ≤ 3 months prior to the day of screening 6. Any condition which, in the opinion of the Investigator, might influence patient's safety or compliance with 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
-
Aristotle University of Thessaloniki
Thessaloniki, 54246, Greece
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