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

NCT06532461 | Recruiting

• 1 other identifier: Steno-SSS-RCT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Type 1 Diabetes

Keywords

Ultrasound; Electric Bioimpedance Spectroscopy; tissue viability imaging; Hyperechogenicity; Lipohypertrophy

Outcome Measures

Primary Outcomes (1)

• Occurence of hyperchogenicity at last two positions for infusions sets

  Ultrasound scan of skin area for last two positions

  2 weeks

Secondary Outcomes (4)

• Time-in-range (3.9 - 10 mmol/l)

  2 weeks data

• Insulin need per kg

  2 weeks data

• Electric impedance Spectrocopy (EIS)

  2 weeks

• Tissue red blood cell count

  2 weeks

Study Arms (4)

Starting 3-days infusion set and Novorapid

ACTIVE COMPARATOR

Start first 3-days infusion set for 4 months then cross-over to 7-days infusions set for 4 months - allocated to Novorapid

Device: Mio Advanced infusions set; Drug: Novorapid

Starting 3-days infusion set and Humalog

ACTIVE COMPARATOR

Start first 3-days infusion set for 4 months then cross-over to 7-days infusions set for 4 months - allocated to Humalog

Device: Mio Advanced infusions set; Device: Extended wear insulin infusion (EWIS)

Starting 7-days infusion set and Novorapid

ACTIVE COMPARATOR

Start first 7-days infusion set for 4 months then cross-over to 3-days infusions set for 4 months - allocated to Novorapid

Drug: Novorapid; Drug: Humalog

Starting 7-days infusion set and Humalog

ACTIVE COMPARATOR

Start first 7-days infusion set for 4 months then cross-over to 3-days infusions set for 4 months - allocated to Humalog

Device: Extended wear insulin infusion (EWIS); Drug: Humalog

Interventions

Mio Advanced infusions set DEVICE

Insulin infusionsset fitting Medtronic 780 G insulin pump

Also known as: Extended wear insulin infusions (EWIS)

Starting 3-days infusion set and Humalog; Starting 3-days infusion set and Novorapid

Novorapid DRUG

Randomized to either Novorapid or Humalog

Also known as: Humalog

Starting 3-days infusion set and Novorapid; Starting 7-days infusion set and Novorapid

Extended wear insulin infusion (EWIS) DEVICE

Insulin infusionsset fitting Medtronic 780 G insulin pump

Also known as: Mio Advanced infusions set

Starting 3-days infusion set and Humalog; Starting 7-days infusion set and Humalog

Humalog DRUG

Randomized to either Novorapid or Humalog

Also known as: Novorapid

Starting 7-days infusion set and Humalog; Starting 7-days infusion set and Novorapid

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with T1D
• 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.
• Insulin needs per day above 8 units

You may not qualify if:

• 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

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, Capital, 2730, Denmark

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Jannet Svensson

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jannet Svensson, Professor

CONTACT

25488355; jannet.svensson@regionh.dk

Julian Bjerrekær, MD

CONTACT

24966836; julian.bjerrekaer@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized to start first with 3 or 7 days infusionsset and cross-over after 4 months. Further they are randomized to either Novorapid og humalog insulin

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 1, 2024
• Study Start: July 20, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 6, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)