Discussion
T1D, diabetes-related, diabetes
ADVERSE EVENTS, RECRUITMENT, ADVERSE EFFECTS, DYSFUNCTION, DIABETES
The A7+TouchCare is an insulin patch pump system recently available on the market in some European countries. The aim of the study was to determine the clinical performance and patients’ satisfaction of the A7+TouchCare compared to the Omnipod insulin patch pump, which was the only patch pump available in France to date. Here, we demonstrated similar performance to achieve glycemic control with the A7+TouchCare.This is the first report of clinical data on this new device, through a randomized study that included middle aged adult patients (mean age: 50 years-old), mostly with T1D and a long duration of diabetes (> 20 years). Glycemic control was suboptimal at baseline (mean A1c: 7.8%, 62 mmol/mol), considering that participants were already users of an insulin pump and a flash CGM device. Moreover, it is interesting to note a mean BMI of 25.4 and 26.5 kg/m2 for Omnipod and A7+Touchcare group, respectively, despite a total daily dose of insulin limited to 60 units per day. Therefore, these baseline characteristics are representative of a real-world population [The Omnipod patch pump is known to provide improved glycemic control and preference compared to MDI or conventional insulin pumps in patients with diabetes [A1C is an important indicator of long-term glycemic control with the ability to reflect the cumulative glycemic history of the preceding two to three months. For this study, we made the choice of A1C evaluation obtained from sensor measurements (GMI), which is considered as a reliable estimation of the average glucose value [An important aspect of continuous insulin infusion device is to ensure that people interact properly with technology [During the study period, some device errors were reported. Dysfunction reported are consistent with feedback from patients using this type of device in real life [Patch pumps adheres to the skin with adhesives which can induce more or less harmless skin reactions compared to conventional insulin pumps, as they require a larger adhesive area. In this study, adverse events related to the study devices were relatively frequent in both patch pump groups, but as is the case in current practice and reported by patients in real-life use [One major limitation of this study is that patients were experienced in using insulin patch pump. They were equipped with an insulin pump since several years and all patients were familiar with diabetes-related technology; thus, results should be generalized with caution to other novice diabetes populations. In order to facilitate the recruitment, we decided to include all patients who already used the Omnipod pump before randomization (and thus without a change of their pump). On the other hand, patients in the A7+TouchCare group had only minimal training in using the new insulin patch pump system. This may have an impact on the study outcomes including performance, notification of malfunctions or adverse effects, satisfaction, or preference. This also draws the attention on being more specific in patients training and for the train-the-trainer programmes [