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Randomized Controlled Trial
. 2020 Nov;21(7):1285-1291.
doi: 10.1111/pedi.13094. Epub 2020 Aug 19.

Lipoatrophy in children, adolescents and adults with insulin pump treatment: Is there a beneficial effect of insulin glulisine?

Olga Kordonouri  1 , Torben Biester  1 , Jürgen Weidemann  2 , Hagen Ott  3 , Kerstin Remus  1 , Julia Grothaus  3 , Nicole Pisarek  1 , Reinhard Hartmann  1 , Kerstin Adolph  1 , Karin Lange  4 , Thomas Danne  1
Affiliations
Randomized Controlled Trial

Lipoatrophy in children, adolescents and adults with insulin pump treatment: Is there a beneficial effect of insulin glulisine?

Olga Kordonouri et al. Pediatr Diabetes. 2020 Nov.

Abstract

Aim: To investigate whether zinc-free insulin is an effective treatment option for lipoatrophy.

Methods: Controlled, randomized, open-label parallel study in young people with type 1 diabetes, pump treatment and lipoatrophy at injection sites. Participants underwent dermatological examination and evaluation of affected areas using ultrasound and magnetic resonance imaging (MRI). After randomization, half of themswitched to insulin glulisine (intervention group) for 6 months. The control group continued their treatment with zinc-containing insulin and switched to insulin glulisine 6 months later. Both groups were followed-up until month 12. Primary endpoint was the increase of the relative thickness of the subcutaneous fat layer of the most atrophic site at 6 months as documented by MRI.

Results: Fourteen participants were included into the study. While relative thickness of subcutaneous fat tissue was comparable between intervention (-60% [-98.8 - -17.6], n = 7) and control group (-50% [-72.7 - -1.0], P = .511; median (range), n = 7)at baseline, it improved in the intervention (-14.3% [-85.7-83.3] vs -31.3% (-66.7-0), P = .031), but not in the control group (P = .125) after 6 months. At 12 months, relative fat thickness (P = .003), number (P = .015) and size of most atrophic sites (P = .001) were improved in the intervention group. Number (P = .018) and size of most atrophic sites (P = .008) were also reduced in the control group between 6 and 12 months.

Conclusions: Although the present pilot study is based on a small sample, the data give first hint that the use of the zinc-free insulin glulisine may be beneficial in people with diabetes, pump and lipoatrophy.

Trial registration: ClinicalTrials.gov NCT02914886.

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References

REFERENCES

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