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

NCT ID: NCT06372392

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Type1diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Universal coefficient

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

Group Type EXPERIMENTAL

Universal meal coefficient utilization

Intervention Type DEVICE

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 coefficient

With meal bolus coefficient individualized according to physician judgment's

Group Type ACTIVE_COMPARATOR

Universal meal coefficient utilization

Intervention Type DEVICE

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

Interventions

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Universal 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

Intervention Type DEVICE

Eligibility Criteria

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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

* Active coeliac disease
* Chronic disease possible to influence diabetes treatment
* Acute disease at the moment of recruitment
Minimum Eligible Age

7 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Estonia Research Council

UNKNOWN

Sponsor Role collaborator

Tartu University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Aleksandr Peet

Pediatric endocrinologist (PI)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aleksandr Peet

Role: PRINCIPAL_INVESTIGATOR

Tartu University Hospital

Locations

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TartuUH

Tartu, Tartu, Estonia

Site Status RECRUITING

Countries

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Estonia

Central Contacts

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Aleksandr Peet, MD, PhD

Role: CONTACT

Aleksandr Peet, MD, PhD

Role: CONTACT

Facility Contacts

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Aleksandr Peet

Role: primary

Other Identifiers

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1.0

Identifier Type: -

Identifier Source: org_study_id

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