This 30-day study, supported by a grant from Insulet, assessed the comfort, function, and use of the OmniPod system (Pod) compared with the use of a conventional insulin pump among subjects with type 1 diabetes.
The OmniPod system features the Pod, a lightweight, watertight, self-enclosed insulin pump with automated cannula insertion. The Pod delivers insulin according to preprogrammed instructions transmitted wirelessly from the personal diabetes manager, a hand-held device that programs the pump with customized insulin instructions, monitors the operation of the pump, performs suggested bolus calculations, and contains an integrated blood glucose meter.
Twenty subjects with type 1 diabetes used the OmniPod system (Insulet, Bedford, MA) to manage their diabetes (15 female and 5 male subjects; mean age 43 years [range 27–68]; mean diabetes duration 20.8 years [4–53]). The following was the inclusion criteria: use of continuous subcutaneous insulin infusion therapy for at least 6 months, an HbA1c (A1C) ≤8.5% (mean 7.1% [range of initial A1C 5.5–8.1]), measures glucose at least four times each day, and no more than one severe hypoglycemic or ketoacidosis episode within the past year and none within the past 3 months. The following were the exclusion criteria: clinical diagnosis of hypoglycemic unawareness, known dermal hypersensitivity to products that contain Beiersdorf Hypafix medical adhesive, pregnancy, and taking prescription medications that could complicate the management of glycemic control (i.e., steroids, diuretics, β-blockers).
Subjects recorded daily activities, insulin dosages, glucose results, and observations and were required to check glucose values using the personal diabetes manager’s integrated Freestyle blood glucose meter (Abbott, Alameda, CA). Clinic visits were scheduled on days 3, 14, and 30 to reinforce the study protocol procedures and to evaluate patient status. Subjects completed an exit questionnaire. Each question required the subject to answer on a scale from 1 to 5, where 1 = most favorable, 5 = least favorable, and 3 = neutral response. The following are the results comparing the Pod with their current pump: convenience of using the OmniPod system = (means ± SD) 1.85 ± 0.93, satisfaction with wearing the OmniPod system = 1.7 ± 0.98, pain associated with automated cannula insertion = 2.0 ± 0.65, satisfaction with current insulin pump = 1.9 ± 0.45, wearing while sleeping = 1.15 ± 0.49, wearing while showering = 1.10 ± 0.45, and time involved in the OmniPod change process = 2.05 ± 0.89.
Ninety percent of subjects (18 of 20) preferred using the OmniPod’s automated cannula insertion system versus inserting with their current infusion sets. All 20 subjects completed the 30-day study. A1C values at the end were significantly lower (mean 6.8% [range 5.4–7.6]; P value <0.002).
The results suggest that the OmniPod system was well received among existing pump therapy type 1 diabetic patients. Most subjects preferred the OmniPod system to their conventional insulin pump. Preliminary A1C results, in addition to feedback supplied by patients, indicate that there may be additional benefits related to using the OmniPod system that need to be studied further.