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

April 13, 2024 updated by: Aleksandr Peet, Tartu University Hospital

Randomized Controlled Study of the Usage of Universal Fixed Meal Bolus Coefficients for the Control of Postprandial Hyperglycemia in the Users of Medtronic Minimed 780G Pumps

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Universal coefficient
With fixed meal bolus coefficients (TDD/300 breakfast and TDD/400 other meals)
Device: 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
Active Comparator: Individualized coefficient
With meal bolus coefficient individualized according to physician judgment's
Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time in range (TIR)
Time Frame: 4 weeks
Comparision of TIR between groups
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TBR
Time Frame: 4 weeks
Comparision of TBR between groups
4 weeks
TAR
Time Frame: 4 weeks
Comparision of TAR between groups
4 weeks
auto-corrections %
Time Frame: 4 weeks
auto-corrections % between groups
4 weeks
coefficient of variability
Time Frame: 4 weeks
coefficient of variability between groups
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tartu University Hospital

Collaborators

Estonia Research Council

Investigators

  • Principal Investigator: Aleksandr Peet, Tartu University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Estimated)

June 10, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 10, 2024

First Submitted That Met QC Criteria

April 13, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 13, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1.0

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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