Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06532461
NA

A Trial of Three- and Seven-days Insulin Infusions Set

Sponsor: Steno Diabetes Center Copenhagen

View on ClinicalTrials.gov

Summary

More and more children and adolescents are using diabetes devices attached to the skin. The attachment of infusions sets to the skin provoke allergenic or toxic eczema, the continous infusion of insulin provoke subcutaneous changes and prolonged wear time seems to increase the risk of these complication. On the other site fewer skin stripping episodes with longer wear time and filtration of the insulin may be beneficial for the skin, therefore comparing the occurrence of subcutaneous hyper echogenicity, eczema and the skin barrier in users of 3 and 7 days infusions set is highly relevant. The primary aim of present study is to investigate if the use of three days insulin infusion set is superior to seven days in preventing the occurrence of hyperechogenicity in areas recently used for insulin infusion and if the type of insulin matter comparing insulin aspart - Novo Rapid, or insulin lispro - Humalog

Official title: A Randomized Controlled Trial Testing the Influence of Three- and Seven-days Insulin Infusions and Two Types of Insulin on Hyperechogenicity in Subcutis and Glycemic Variables in Children and Adolescents With Type 1 Diabetes

Key Details

Gender

All

Age Range

7 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2024-07-20

Completion Date

2026-12-31

Last Updated

2024-08-06

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Mio Advanced infusions set

Insulin infusionsset fitting Medtronic 780 G insulin pump

DRUG

Novorapid

Randomized to either Novorapid or Humalog

DEVICE

Extended wear insulin infusion (EWIS)

Insulin infusionsset fitting Medtronic 780 G insulin pump

DRUG

Humalog

Randomized to either Novorapid or Humalog

Locations (1)

Steno Diabetes Center Copenhagen

Herlev, Capital, Denmark