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

Not Applicable

• Conditions: E10; E11; Type 1 diabetes mellitus; Type 2 diabetes mellitus

• Registration Number: DRKS00018936
• Lead Sponsor: niversitätsklinikum Düsseldorf, Zentrum für Kinder- und Jugendmedizin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-11
• Study Completion: 2023-02-04
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 61

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
onger 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.