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

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06372392
• Other study ID #: 1.0
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Tartu University Hospital
• Contact: Aleksandr Peet, MD, PhD
• Phone: 5532256
• Email: aleksandr.peet[@]kliinikum.ee
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 1, 2024
• Est. primary completion date: June 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

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

Locations

Country	Name	City	State
Estonia	TartuUH	Tartu	Tartumaa

Sponsors (2)

Lead Sponsor	Collaborator
Tartu University Hospital	Estonia Research Council

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time in range (TIR)	Comparision of TIR between groups	4 weeks
Secondary	TBR	Comparision of TBR between groups	4 weeks
Secondary	TAR	Comparision of TAR between groups	4 weeks
Secondary	auto-corrections %	auto-corrections % between groups	4 weeks
Secondary	coefficient of variability	coefficient of variability between groups	4 weeks