Table 2

Hypoglycemia rates and gastrointestinal side effects during artificial pancreas visits

Rapid insulin-alone (n = 28)Rapid insulin-and-pramlintide (n = 27)Regular insulin-and-pramlintide (n = 26)
Number of patients with at least one hypoglycemic event requiring treatment9 (32%)8 (30%)13 (50%)
Number of hypoglycemic events requiring treatments11 (1 per 2.5 days)12 (1 per 2.3 days)18 (1 per 1.4 days)
Number of hypoglycemic events requiring multiple treatments4 (36%)3 (25%)12 (62%)
Number of nocturnal hypoglycemic events requiring treatments117
Number of mild hypoglycemic events <3.9 mmol/L262532
MildModerateModerate to severeSevereMildModerateModerate to severeSevereMildModerateModerate to severeSevere
Number of patients experiencing any gastrointestinal symptom0 (0%)0 (0%)0 (0%)0 (0%)2 (7%)3 (11%)0 (0%)0 (0%)1 (4%)3 (12%)2 (8%)0 (0%)
Number of meals followed by*
 Any gastrointestinal symptom0 (0%)0 (0%)0 (0%)0 (0%)3 (3%)3 (3%)¥0 (0%)¥0 (0%)2 (2%)6 (6%)¥3 (3%)¥0 (0%)
 Nausea0 (0%)0 (0%)0 (0%)0 (0%)2 (2%)1 (1%)0 (0%)0 (0%)1 (1%)3 (3%)2 (2%)0 (0%)
 Vomiting0 (0%)0 (0%)0 (0%)0 (0%)0 (0%)0 (0%)0 (0%)0 (0%)0 (0%)0 (0%)0 (0%)0 (0%)
 Bloating0 (0%)0 (0%)0 (0%)0 (0%)1 (1%)0 (0%)0 (0%)0 (0%)1 (1%)1 (1%)0 (0%)0 (0%)
 Heartburn0 (0%)0 (0%)0 (0%)0 (0%)0 (0%)2 (2%)0 (0%)0 (0%)1 (1%)2 (2%)1 (1%)0 (0%)
  • Data are displayed as number (%) or numbers.

  • Hypoglycemic events are defined as plasma glucose concentration <3.3 mmol/L with symptoms or <3.0 mmol/L irrespective of symptoms, and were treated with 16 g oral carbohydrate (Fig. 2 shows the times of hypoglycemia events).

  • * There were a total of 112, 108, and 104 meals during insulin-alone artificial pancreas, rapid insulin-and-pramlintide artificial pancreas, and regular insulin-and-pramlintide artificial pancreas visits, respectively.

  • The three participants that reported moderate gastrointestinal symptoms on the rapid insulin-and-pramlintide artificial pancreas visits also reported symptoms on the regular insulin-and-pramlintide artificial pancreas visits.

  • ¥ The meals that were followed by moderate or moderate-to-severe symptoms on the rapid and regular insulin-and-pramlintide artificial pancreas visits had a median pramlintide prandial bolus of 22 and 59 µg, respectively.