Product Info

to 7.5±0.6 (median 7.5) at the end of study. There was a small change in mean
total daily dose of insulin/kg (0.8±0.2 baseline to 0.9±0.2 end of study) and modest
increase in weight. Weight gain would also be expected for pediatric patients 7 to
13 years of age as part of the normal growth process.
CAUTION: Note that since this study did not include a control group,
no claims regarding effectiveness can be made. However, the study
does support that the device is relatively safe for use.
Of the 203 adverse events reported through the end of the study period, 39%
(N=80) were classified as device related. Of the 80 device-related adverse events,
65 were glycemic events (hyperglycemia, severe hyperglycemia, and severe
hyperglycemia with ketosis) and 14 were related to skin issues (cellulitis, skin
infection at the infusion set site, infection at the sensor insertion site, pump site
infection on lower abdomen, eczema, and skin irritation). Five adverse events were
classified as procedure related (these included neurocardiogenic syncope,
headache, and angioedema) and two of the adverse events (hyperglycemia and
skin irritation) were classified as both device and procedure related.
There were 104 reports of severe hyperglycemia and there was no diabetic
ketoacidosis while on the MiniMed 670G System during the study. The majority of
these severe hyperglycemic events (77/104) were mild in intensity. Ketone levels
were available for 102 of the 104 severe hyperglycemia episodes and the majority
of ketone levels (83/104) were low (10.8–27 mg/dL).
One severe hyperglycemic event was associated with an emergency room visit,
however, the ER visit was primarily due to concurrent acute gastroenteritis.
Of the 62 device related episodes of severe hyperglycemia, 51 were believed to be
due to infusion set issues such as occlusion, bent cannula or cannula pull out.
These issues are typically seen in relatively high rates in the pediatric population
(causes provided in Table D-1 and Table D-2). Unlike insulin pump therapy which
may or may not have alerts associated with infusion set failure, the MiniMed 670G
System has fixed alarms (high alerts) that serve as an additional mitigation for
subjects.
350 Chapter 17