NCT06372392

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 18, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

April 18, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

April 10, 2024

Last Update Submit

April 13, 2024

Conditions

Type1diabetes

Outcome Measures

Primary Outcomes (1)

  • Time in range (TIR)

    Comparision of TIR between groups

    4 weeks

Secondary Outcomes (4)

  • TBR

    4 weeks

  • TAR

    4 weeks

  • auto-corrections %

    4 weeks

  • coefficient of variability

    4 weeks

Study Arms (2)

Universal coefficient

EXPERIMENTAL

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

Device: Universal meal coefficient utilization

Individualized coefficient

ACTIVE COMPARATOR

With meal bolus coefficient individualized according to physician judgment's

Device: Universal meal coefficient utilization

Interventions

Universal meal coefficient utilizationDEVICE

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

Individualized coefficientUniversal coefficient

Eligibility Criteria

Age7 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TartuUH

Tartu, Tartu, 50406, Estonia

RECRUITING

Study Officials

  • Aleksandr Peet

    Tartu University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandr Peet, MD, PhD

CONTACT

5532256aleksandr.peet@kliinikum.ee

Aleksandr Peet, MD, PhD

CONTACT

5532256alekspt@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric endocrinologist (PI)

Study Record Dates

First Submitted

April 10, 2024

First Posted

April 18, 2024

Study Start

October 10, 2023

Primary Completion

June 10, 2024

Study Completion

December 1, 2024

Last Updated

April 18, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)