Four-Week SkinSiteStudy in Type 1 Diabetes

NCT06177054 | Completed

• 1 other identifier: Steno-SSS-4WK
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Using insulin pumps and sensors to monitor blood glucose has become standard of care for children with diabetes. The continous infusion of insulin in the subcutaneous tissue leads to increased risk of lipohypertrophy that might influence insulin absorption. We are in this study using ultrasound to detect subcutaneous hyperechogenicity to guide rotation of insulin infusion and investigate if avoidance of areas with hyperechogenicity improve insulin absorption seen as decrease in insulin needs.

Conditions

Type 1 Diabetes

Keywords

Ultrasound; Children; Skin; Lipohypertrophy; echogenicity

Outcome Measures

Primary Outcomes (1)

• insulin need per kg

  upload data from insulin pump with insulin need comparing last two weeks with previous two weeks and the two weeks at baseline

  6 weeks

Secondary Outcomes (2)

• Time-in-range

  6 weeks

• Hyperechogenicity detected by ultrasound

  4 weeks

Study Arms (1)

Rotation of sites

OTHER

Each participants is first included with no instruction of rotation and then after 2 weeks instructed to avoid areas with hyperechogenicity

Behavioral: Rotation guided by ultrasound

Interventions

Rotation guided by ultrasound BEHAVIORAL

Instruction to avoid areas with hyperechogenicity - after two weeks observation

Rotation of sites

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• type 1 diabetes,
• using CE marked automatic insulin delivery system,
• using insulin pump for at least 6 months

You may not qualify if:

• Do not use bolusguide (entering carbs),
• not trained in carbohydrate counting,
• unable to understand and read Danish

Sponsors & Collaborators

• Steno Diabetes Center Copenhagen: lead

Study Sites (1)

Steno Diabetes Center Copenhagen

Herlev, Capital, 2730, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Officials

• Jannet Svensson

  Steno Diabetes Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: First two weeks observational, then instruction to avoid areas with hyperechogenicity for better absorption of insulin

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: December 8, 2023
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: July 31, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)