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RecruitingNCT06372392Updated Apr 18, 2024

Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps

An interventional study of Universal meal coefficient utilization in Type1diabetes, sponsored by Tartu University Hospital. Recruiting at 1 site in Estonia. Open to participants aged 7 Years to 19 Years. Per ClinicalTrials.gov, last updated 2024-04-18.

Sponsored by Tartu University Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 3 months ago, but the record still lists the study as recruiting.
  • Registered 6 months after the study started (first participant enrolled Oct 2023, registered Apr 2024).
  • Started Oct 2023; still recruiting 2 years 11 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
7 Years to 19 Years
Sex
All
01

Study summary

Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport.

02

Conditions studied

  • Type1diabetes
03

In context

Diabetes Mellitus, Type 1

3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.

This study's planned enrollment of 20 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Tartu University Hospital is the lead sponsor of 24 studies on the registry; 10 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years to 19 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age 7-19
  • type 1 diabetes diagnosed at least 1 year ago
  • insulin in the dose 0,5-1,0 units/day/kg
  • MiniMed 780G pump usage at least 1 month.

Exclusion criteria

Exclusion Criteria:

  • Active coeliac disease
  • Chronic disease possible to influence diabetes treatment
  • Acute disease at the moment of recruitment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    Universal coefficient

    With fixed meal bolus coefficients (TDD/300 breakfast and TDD/400 other meals)

    Device: Universal meal coefficient utilization

  • Active comparator
    Individualized coefficient

    With meal bolus coefficient individualized according to physician judgment's

    Device: Universal meal coefficient utilization

Interventions

  • DeviceUniversal meal coefficient utilization

    Usage of universal fixed meal bolus coefficients for the control of postprandial hyperglycemia compared to individualized coefficients n the users of Medtronic Minimed 780G pumps

06

What researchers measure

Primary outcomes

  1. Time in range (TIR)

    Comparision of TIR between groups

    Time frame: 4 weeks

Secondary outcomes

  1. TBR

    Comparision of TBR between groups

    Time frame: 4 weeks

  2. TAR

    Comparision of TAR between groups

    Time frame: 4 weeks

  3. auto-corrections %

    auto-corrections % between groups

    Time frame: 4 weeks

  4. coefficient of variability

    coefficient of variability between groups

    Time frame: 4 weeks

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06372392
Lead sponsor
Tartu University Hospital
Collaborators
Estonia Research Council
Responsible party
Aleksandr Peet (Pediatric endocrinologist (PI), Tartu University Hospital) — Principal investigator
First posted
Apr 18, 2024
Start date
Oct 10, 2023
Primary completion
Jun 10, 2024 (estimated)
Completion
Dec 1, 2024 (estimated)
Last update
Apr 18, 2024

Study contacts

Aleksandr Peet, MD, PhD
Contact
aleksandr.peet@kliinikum.ee
5532256
Aleksandr Peet, MD, PhD
Contact
alekspt@hotmail.com
5532256
Aleksandr Peet
principal investigator · Tartu University Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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