Health TrialsbyHealthPanel

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

ConditionType 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age7-18
SponsorSteno Diabetes Center Copenhagen

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Those who are unable to read and understand Danish

Those with impaired cognitive development that may interfere with the ability to answer questionnaires in Danish and/or be reached by phone or videocall

Trial design

Design model

Crossover

Treatments tested in this trial

  • Mio Advanced infusions set

    Device

    Insulin infusionsset fitting Medtronic 780 G insulin pump

  • Novorapid

    Drug

    Randomized to either Novorapid or Humalog

  • Extended wear insulin infusion (EWIS)

    Device

    Insulin infusionsset fitting Medtronic 780 G insulin pump

  • Humalog

    Drug

    Randomized to either Novorapid or Humalog

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Starting 3-days infusion set and NovorapidActive comparator 2 interventions
Group B: Starting 3-days infusion set and HumalogActive comparator 2 interventions
Group C: Starting 7-days infusion set and NovorapidActive comparator 2 interventions
Group D: Starting 7-days infusion set and HumalogActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Occurence of hyperchogenicity at last two positions for infusions sets

Ultrasound scan of skin area for last two positions

Time frame
2 weeks

Secondary outcomes

1

Time-in-range (3.9 - 10 mmol/l)

Download data from continous glucose platform (Carelink or Stenopool) for the last two weeks before visits

Time frame
2 weeks data
2

Insulin need per kg

Download of data from insulin pump platform (Carelink or Stenopool) for the last 2 weeks

Time frame
2 weeks data
3

Electric impedance Spectrocopy (EIS)

Measures of electric impedans at last two sites for infusion

Time frame
2 weeks
4

Tissue red blood cell count

Imaging with TiVI (tissue viability imaging) showing microcirculation

Time frame
2 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Steno Diabetes Center Copenhagen

Lead sponsor

Source ClinicalTrials.gov
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