Performance and Acceptability of a Combined Device for Insulin Infusion and Glucose Sensing in the Home Setting

Abstract

For many patients who require insulin, continuous subcutaneous insulin infusion (CSII) offers significant advantages compared to multiple daily injections (MDI). In part because CSII can more closely match the endogenous insulin profile of normal pancreatic β cells, it offers reduced rates of severe hypoglycemia, better metabolic control, and improved quality of life compared to MDI. 1Pumps are often used in conjunction with continuous glucose monitoring (CGM) systems that provide real-time data on glucose concentrations in the interstitial fluid; the CGM data can be displayed on the pump itself, or on a separate device. As shown in the STAR 3 study 2 and in the Eurythmics study, 3 sensor-augmented pump (SAP) therapy offers rapid, significant, and durable improvements in metabolic control compared to MDI therapy. A significant "dose effect" of CGM use was noted in STAR 3, with increasing frequencies of sensor use being associated with greater reductions in A1C levels at 1 year. The incremental advantage of CGM was more recently demonstrated in the INTERPRET study, in which factors associated with A1C reductions included more frequent sensor use. The use of sensor-augmented insulin pump (SAP) therapy is increasing. Currently, glucose sensors and insulin infusion cannulas are inserted separately. A new device, MiniMed Duo, combines sensing and infusion capabilities on the same platform and is intended to simplify device insertion and site management. We evaluated the device's performance with respect to insulin delivery and glucose sensing, and its acceptability with patients.

Duration of Infusion Set Survival in Lipohypertrophy Versus Nonlipohypertrophied Tissue in Patients with Type 1 Diabetes

“…27 In fact, the MiniMed Duo combined system achieved adequate clinical CGM accuracy on subjects in a home setting. 28 CGM survival is minimally affected by LH tissue, and CGM sites last longer than infusion sets.…”

A comprehensive microbiological safety approach for agarose encapsulated porcine islets intended for clinical trials

“…The ultimate goal for the treatment of type 1 diabetes is the restoration of physiological blood glucose regulation without the requirement for lifelong therapy such as immunosuppression or immunoregulation. There are numerous challenges for the attainment of this goal, and diverse approaches ranging from insulin pumps to gene therapy to stem cell strategies are all being pursued . In another approach, the replacement of lost islet cells through human islet allotransplantation has established the clinical utility of islet grafting .…”

Diabetes Technology

“…29 In clinical trials of SAP, participants rated the device as acceptable. 56 Those on SAP have reported lower diabetes distress, 31,36 higher treatment satisfaction, 31,36 and reduced fear of hypoglycemia. 33 Even in a trial where average use of SAP was roughly 30%, those who stayed with SAP found increased treatment satisfaction and less fear of hypoglycemia.…”