Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
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Mader, JK; Lilly, LC; Aberer, F; Poettler, T; Johns, D; Trautmann, M; Warner, JL; Pieber, TR.
Improved glycaemic control and treatment satisfaction with a simple wearable 3-day insulin delivery device among people with Type 2 diabetes.
Diabet Med. 2018; 35(10):1448-1456
Doi: 10.1111/dme.13708
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- Führende Autor*innen der Med Uni Graz
- Mader Julia
- Co-Autor*innen der Med Uni Graz
- Aberer Felix
- Pieber Thomas
- Pöttler Tina
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- Abstract:
- AIM: To evaluate the PAQ® (CeQur SA, Horw, Switzerland), a wearable 3-day insulin delivery device that provides set basal rates and bolus insulin on demand, in people with Type 2 diabetes. METHOD: Adults with Type 2 diabetes with HbA1c concentrations ≥53 and ≤97 mmol/mol (7.0 and 11.0%) while treated with ≥2 insulin injections/day were enrolled in two single-arm studies comprising three periods: a baseline (insulin injections), a transition and a PAQ treatment period (12 weeks). Endpoints included HbA1c , seven-point self-monitored blood glucose, total daily dose of insulin and body weight. Safety was assessed according to examination, hypoglycaemic episodes and adverse device effects. RESULTS: A total of 28 adults were enrolled (age 63 ± 7 years, 86% men, BMI 32.3 ± 4.3kg/m2 , Type 2 diabetes duration 17 ± 8 years, HbA1c 70 ± 12 mmol/mol (8.6 ± 1.1%), total daily insulin dose 58.7 ± 20.7 U), of whom 24 completed the studies. When transitioned to PAQ, 75% of participants continued on the first basal rate selected. After 12 weeks of PAQ wear, significant improvements from baseline were seen [HbA1c -16 ± 9 mmol/mol (95% CI -20, -12) or -1.5 ± 0.9% (95% CI -1.8, -1.1) P<0.0001], and at all seven self-monitored blood glucose readings time points (P ≤0.03). Total daily insulin dose increased by 12.1 ± 19.5 U (95% CI 3.9, 20.4; P=0.0058), the number of meal time boluses increased by 0.9 ± 1.5/day (95% CI 0.3, 1.5; P=0.0081) and body weight remained stable. Six participants had mild to moderate catheter site reactions and one mild skin irritation occurred. No participant experienced severe hypoglycaemia. CONCLUSIONS: Adults with Type 2 diabetes were safely transitioned from insulin injections to the PAQ and had significantly improved glycaemic control and treatment satisfaction with insulin therapy. (ClinicalTrials.gov identifiers: NCT02158078 & NCT02419859).
- Find related publications in this database (using NLM MeSH Indexing)
- Adult - administration & dosage
- Aged - administration & dosage
- Blood Glucose - analysis, drug effects, metabolism
- Blood Glucose Self-Monitoring - instrumentation
- Diabetes Mellitus, Type 2 - blood, drug therapy, psychology
- Female - administration & dosage
- Humans - administration & dosage
- Insulin - administration & dosage, adverse effects
- Insulin Infusion Systems - administration & dosage
- Male - administration & dosage
- Middle Aged - administration & dosage
- Patient Satisfaction - administration & dosage
- Pilot Projects - administration & dosage
- Time Factors - administration & dosage
- Wearable Electronic Devices - administration & dosage