NCT02914886

Beneficial Effect of Insulin Glulisine by Lipoatrophy and Type 1 Diabetes (LAS)

Lipoatrophy in Children, Adolescents and Adults With Modern Treatment Modalities: is There a Beneficial Effect of Insulin Glulisine?

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Kinderkrankenhaus auf der Bult · Academic / Other
• Sex: All
• Age: 6 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to investigate whether a zinc-free insulin is an effective treatment option for lipoatrophy in patients with type 1 Diabetes (T1D) and insulin pump (CSII, continuous subcutaneous insulin infusion) therapy.

Detailed description

Randomized, controlled, open-label parallel study. Clinical Study Phase IV After being included in the study, subjects are getting an extensive dermatological examination by a pediatric dermatologist familiar with cutaneous complications of T1D, additionally pathological results will be documented by photography and, if necessary, videodermoscopy. Additionally, an evaluation of their lipoatrophic areas using imaging methods like ultrasound (USG) and MRI will be performed. After randomization, half of the included children switch their pump insulin into insulin glulisine (intervention group) for 6 months. The others continue their current treatment (control group) and switch to insulin glulisine 6 months later. Both groups are followed-up until month 12. Hence, after the 4th visit at 6 months, all enrolled patients are on insulin glulisine pumps for a further period of 6 months.

Conditions

• Type 1 Diabetes
• Lipoatrophy

Interventions

Type	Name	Description
DRUG	Apidra	Half of patients with lipoatrophy will be switched randomly to insulin Apidra for 12 months. Any site other than the lipoatrophic site would be used for delivering the insulin for the purpose of this study.
DRUG	current insulin	Half of patients with lipoatrophy will still use their current Insulin for 6 months. After 6 months the current insulin will be switched to insulin Apidra for the next 6 months.

Timeline

• Start date: 2016-09-01
• Primary completion: 2019-04-01
• Completion: 2019-04-01
• First posted: 2016-09-26
• Last updated: 2024-10-15