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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 18
Healthy Volunteers: f
View:

• Diagnosed with T1D

• Diabetes duration of more than 6 months prior to inclusion.

• Currently using the CE-marked hybrid closed-loop system - Medtronic 780G pump and the corresponding sensor with automated insulin delivery.

• Planning to using the CE-marked hybrid closed-loop system - Medtronic 780G pump and the corresponding sensor with automated insulin delivery.

• Being between 7 and 18 years of age prior to inclusion

• Insulin needs per day above 8 units

Locations
Other Locations
Denmark
Steno Diabetes Center Copenhagen
RECRUITING
Herlev
Contact Information
Primary
Jannet Svensson, Professor
jannet.svensson@regionh.dk
25488355
Backup
Julian Bjerrekær, MD
julian.bjerrekaer@regionh.dk
24966836
Time Frame
Start Date: 2024-07-20
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 80
Treatments
Active_comparator: Starting 3-days infusion set and Novorapid
Start first 3-days infusion set for 4 months then cross-over to 7-days infusions set for 4 months - allocated to Novorapid
Active_comparator: Starting 3-days infusion set and Humalog
Start first 3-days infusion set for 4 months then cross-over to 7-days infusions set for 4 months - allocated to Humalog
Active_comparator: Starting 7-days infusion set and Novorapid
Start first 7-days infusion set for 4 months then cross-over to 3-days infusions set for 4 months - allocated to Novorapid
Active_comparator: Starting 7-days infusion set and Humalog
Start first 7-days infusion set for 4 months then cross-over to 3-days infusions set for 4 months - allocated to Humalog
Sponsors
Leads: Steno Diabetes Center Copenhagen

This content was sourced from clinicaltrials.gov

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