A Feasibility Study of a 3-Day Basal-Bolus Insulin Delivery Device in Individuals With Type 2 Diabetes

Mader, Julia K.; Lilly, Leslie C.; Aberer, Felix; Korsatko, Stefan; Strock, Ellie S.; Mazze, Roger S.; Damsbo, P.; Pieber, Thomas R.

doi:10.2337/dc13-2238

Cited by 14 publications

(19 citation statements)

References 10 publications

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“…This increased satisfaction may have contributed to the participants taking more mealtime insulin administrations than at baseline, which could also have been a factor in better HbA 1c control. The observation of increased mealtime bolus administration with the PAQ was also seen in the first PAQ proof‐of‐concept study .…”

Section: Discussionmentioning

confidence: 58%

Improved glycaemic control and treatment satisfaction with a simple wearable 3‐day insulin delivery device among people with Type 2 diabetes

et al. 2018

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AimTo 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.MethodAdults 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.ResultsA 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.ConclusionsAdults 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)

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Section: Discussionmentioning

confidence: 58%

Improved glycaemic control and treatment satisfaction with a simple wearable 3‐day insulin delivery device among people with Type 2 diabetes

et al. 2018

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“…24 Prior studies have used CGM to evaluate glycemic measures with insulin pump therapy for T2D; however, these studies have not assessed the use of RHI. [25][26][27][28] Lane et al 29 used periodic 72-h CGM during their 1-year study of 20 patients with severe insulin-resistant T2D who were administered U500 insulin by CSII. They found that the percentage of time spent in the glycemic range improved significantly, and there was no increase in hypoglycemia, compared with prior MDI regimens.…”

Section: 011mentioning

confidence: 99%

Safety and Effectiveness of an Investigational Insulin Delivery Device Providing Basal/Bolus Therapy with Rapid-Acting or Regular Human Insulin in Adults with Type 2 Diabetes

Aronson

Mahoney

Saliu

et al. 2020

Diabetes Technology & Therapeutics

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Background: This study undertook to assess usability, 24-h glycemic profiles, and safety of an investigational basal/bolus insulin delivery device (IDD) providing rapid-acting or regular human insulin (RHI) for people with type 2 diabetes (T2D) transitioning from multiple daily insulin injections (MDIs). Methods: This prospective, single-center, open-label two-period study enrolled adults with T2D and glycated hemoglobin (HbA1c) 7%-11% (53-97 mmol/M). Participants continued the usual MDI therapy during a 2-to 3-day in-clinic MDI period and then within 7 days were switched to the IDD, using current insulin dose, for a 6-day in-clinic IDD period, with blinded continuous glucose monitoring throughout the in-clinic periods. Results: We enrolled 21 participants (meanstandard deviation age 57-8 years; HbA1c 8.2%-0.9% [66-9.8 mmol/M]) using U-100 insulin lispro (n = 11) or who switched to U-100 RHI (n = 10). Glycemic measures improved from the MDI to IDD period, including fasting blood glucose (BG), 141.2-38.3 mg/dL (7.8-2.1 mmol/L) versus 121.2-35.0 mg/dL (6.7-1.9 mmol/L; P = 0.002), respectively; 24-h mean BG, 137.0-20.5 mg/dL (7.6-1.1 mmol/L) versus 125.0-16.5 mg/dL (6.9-0.9 mmol/L; P = 0.004); and time in range (at 70-180 mg/dL; 3.9-10 mmol/L), 81.0%-14.4% versus 87.5%-10.6% (P = 0.008). No significant differences between MDIs and IDD use were recorded for time <70 mg/dL (1.6%-2.7% vs. 3.1%-2.7%, P = 0.08), CV%, or mean of daily differences. Mean amplitude of glycemic excursions was significantly lower with the IDD (P = 0.011). There were no significant differences between insulin lispro and RHI for any glycemic measure. No serious adverse events were recorded. Conclusions: In the context of this exploratory study, the IDD was safe and effective to administer insulin lispro and RHI for adults with T2D.

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“…A semi-disposable insulin device called PaQ (Cequr SA, Montreux, Switzerland) incorporates an electronic messenger with an infuser unit to alert patients when it is time to replace the device. PaQ, which has been approved in Europe, is designed to administer basal-bolus therapy and is intended to be worn for 3 days ( 21 ). The timeline for filing with the FDA to secure approval in the United States is not available.…”

Section: Practical Considerations and Perceptionsmentioning

confidence: 99%

Clinical Insights Into a New, Disposable Insulin Delivery Device

Knutsen

Voelker

Nikkel³

2015

Diabetes Spectrum

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A Feasibility Study of a 3-Day Basal-Bolus Insulin Delivery Device in Individuals With Type 2 Diabetes

Cited by 14 publications

References 10 publications

Improved glycaemic control and treatment satisfaction with a simple wearable 3‐day insulin delivery device among people with Type 2 diabetes

Improved glycaemic control and treatment satisfaction with a simple wearable 3‐day insulin delivery device among people with Type 2 diabetes

Safety and Effectiveness of an Investigational Insulin Delivery Device Providing Basal/Bolus Therapy with Rapid-Acting or Regular Human Insulin in Adults with Type 2 Diabetes

Clinical Insights Into a New, Disposable Insulin Delivery Device

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