Study outcomes
redness, pain
ADVERSE EVENTS
The primary study outcome was the glucose management indicator (GMI), an estimation of the laboratory A1C based on glucose parameters collected from CGM, on the last 10 weeks [An auto-questionnaire developed for the study was filled out by the patient at each visit to determine their satisfaction when using the insulin pump device. Existing validated questionnaires did not a priori allow sufficient exploration of the differences between the two pump models. The questionnaire was composed of 16 items (one question per item, except for item 10 that included 5 questions) concerning overall satisfaction and feelings about the blood glucose control (4 items); on the start-up and placement of the system (3 items); on the daily use of the system (3 items); on the management of the system with the PDM (4 items); and on the withdrawal/replacement of the system (2 items). For each question, the satisfaction scale went from 1 (very unsatisfied) to 5 (very satisfied), except for question 7 about pain for which 5 was painful and 1 was not painful at all.At Visit 3, patients randomized in the A7+TouchCare group were also asked to indicate their preference for the insulin management system, insulin patch and the PDM on a scale from 1 to 5 where 1 indicated the preference for the A7+TouchCare pump and 5 the preference for Omnipod pump.Local skin tolerability at the site of the pump (irritation/itching and redness) and other adverse events related to the study devices were recorded at each visit.