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Optimization of metabolic control using injection site sonography for the detection of "internal lipodystrophies" in subcutaneous tissue in adults with insulin-dependent diabetes mellitus

Optimization of metabolic control using injection site sonography for the detection of "internal lipodystrophies" in subcutaneous tissue in adults with insulin-dependent diabetes mellitus - injection site sonography

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00018936
Enrollment
100
Registered
2019-11-11
Start date
2020-01-06
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

E10 E11

Interventions

Group 1: no ultrasound of injections sites, unguided recommendation for change of injection sites Group 2: ultrasound of injection sites and resulting individual recommendation to avoid/use certain in

Sponsors

Universitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Insulin-dependent diabetes mellitus, Insulin therapy as multiple daily injections (MDI), age =18 years, patient consent, HbA1c values ??between 5.5% and 11.0%, currently using or willing to use a Flash Glucose Monitoring System (FGM) or a Continuous Glucose Monitoring System (CGM) for continuous glucose measurement during the study period.

Exclusion criteria

Exclusion criteria: Hypertrophic or atrophic lipodystrophies visible or diagnosed by palpation, patch allergies that prevent wearing a CGM / FGM sensor, severe hypoglycaemia unawareness, insulin pump therapy, current cortisone therapy or medication that significantly influences the usual diabetes therapy, inadequate knowledge / experience with dose adjustment of the previously used insulin and treatment of hyper- and hypoglycaemia.

Design outcomes

Primary

MeasureTime frame
Improvement of postprandial (2h) glucose levels pre- and post ultrasound in FGM/CGM data (14 days).

Secondary

MeasureTime frame
Longer time in range (TIR, BG ??between 70 and 180 mg / dl), lower basal and average glucose levels, less glucose fluctuations, lower HbA1c level in the next visit.

Countries

Germany

Contacts

Public ContactDirk Sandig

Hospital zum Heiligen Geist Kempen

dirk.sandig@krankenhaus-kempen.deTel: 02152/142-1150

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026