Using Insulin Infusion Sets in CSII for Longer Than the Recommended Usage Time Leads to a High Risk for Adverse Events: Results From a Prospective Randomized Crossover Study.
BACKGROUND
Infusion sets for use with insulin pumps are recommended for use for 2 to 3 days to avoid local skin reactions, for example, to the insulin formulation and preservatives like meta-cresol. However, many patients use the catheters longer for economic reasons. We performed this study to investigate the tolerability of 2-day use of infusion sets in comparison to 4-day use in a real-world setting.


METHODS
This prospective randomized controlled crossover study with 2 × 3-month observation periods was performed with 24 type 1 patients. At baseline, patients were trained on the use of the infusion system (Medtronic /Mio® or inset™ II) and randomized to any of the 2 treatment sequences. Observation parameters included glycemic control, frequency and nature of device-related, and procedure-related adverse events and patient preference.


RESULTS
The per-protocol analysis was performed with 22 patients (5 men, 17 women, age 39 ± 11 years, BMI 27.0 ± 3.5 kg/m2). The number of catheter related adverse events was 290 with 2-day use versus 495 with 4-day use (P < .05). The overall number of treatment related events was 750 with 2-day use versus 934 with 4-day use (P < .001). There was no difference in glycemic control between the treatment arms. Treatment satisfaction was higher with 2-day use (very high/high satisfaction: 90.4% versus 4 day-use: 77.3%, P < .05).


CONCLUSIONS
Our results demonstrate that using the infusion sets for a longer usage period of 2-3 days resulted in a clinically relevant increase in treatment-related tolerability problems. Patients should be trained and encouraged not to use insulin pump infusion sets for a longer than the recommended time period.
Pfützner Science & Health Institute, Mainz, Germany Andreas.pfuetzner@pfuetzner-mainz.com.
Andreas
A
Pfützner
Pfützner Science & Health Institute, Mainz, Germany.
Daniela
D
Sachsenheimer
ClinLogix Europe GmbH, Mainz, Germany.
Marco
M
Grenningloh
Convatec/Unomedical, Lejre, Denmark.
Matthias
M
Heschel
Convatec/Unomedical, Lejre, Denmark.
Lene
L
Walther-Johannesen
Convatec/Unomedical, Lejre, Denmark.
Rabi
R
Gharabli
Mills Peninsula Health Services, San Mateo, CA, USA.
David
D
Klonoff
D000328:Adult; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism; D057785:Catheters / Q000009:adverse effects*; D018592:Cross-Over Studies; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000175:diagnosis / Q000188:drug therapy*; D004209:Disposable Equipment; D004867:Equipment Design; D005260:Female; D005858:Germany; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D055104:Infusions, Subcutaneous; D007328:Insulin / Q000008:administration & dosage*; D007332:Insulin Infusion Systems / Q000009:adverse effects*; D008297:Male; D008875:Middle Aged; D057240:Patient Preference; D011446:Prospective Studies; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
D015415:Biomarkers; D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
insulin infusion set; insulin pump treatment; skin reactions; usage time