A smart insulin calculator may give kids with diabetes more freedom at mealtimes
NCT ID NCT06141629
First seen Aug 28, 2026 · Last updated Aug 28, 2026
Summary
This trial tests whether using the Accu-Chek Aviva Expert, a bolus calculator, helps children and adolescents with type 1 diabetes achieve better blood sugar control and a better quality of life. Participants, who already count carbohydrates and use multiple daily insulin injections, will use either the bolus calculator or a standard glucometer. The study measures changes in HbA1c, glucose variability, and quality of life to see if the calculator offers benefits.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Accu-Chek Aviva Expert, a bolus calculator device that estimates insulin doses based on blood glucose, carbohydrate intake, and other parameters
- What this could lead to
- If it works, this device could help children with type 1 diabetes achieve better blood sugar control and enjoy more flexibility in their meals, improving their quality of life.
- What could go wrong
- This is a small trial, and the device may not lead to significant improvements for all users. It also requires careful carbohydrate counting, which can be challenging.
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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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30 people
The number who actually took part.
- Started
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Jan 2015
- Finished
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Jan 2017
- 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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1 year to 18 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: * \- Patients with type 1 diabetes (n=120) Age \> 1 year and \< 18 years * Diabetes duration \>12 months * MDI therapy (fast acting analog for meals; long acting analog as basal) * HbA1c \> 7.0% and \<11% Exclusion Criteria: * Insulin pump therapy * Missing consent declaration
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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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UZLeuven
Leuven, Leuven, 3000, Belgium
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