Table 5.

Total Daily Insulin Requirements, Infiltrates, and Hypoglycemic Events (Secondary Endpoints) for 31 Participants with Type 1 Diabetes.

Metric	Baseline		Intervention week 1			Intervention week 12
	n	Median [range]	Median [range]	Median change [CI]a	P-valueb	Median [range]	Median change [CI]a	P-valueb
Total daily dose (IU)	22	39 [19; 206]	38 [20; 227]	−1 [–1.1; 3.5]	.286	35 [22; 228]	−4 [–7.8; 4.2]	.543
Infiltrates, count	12	1 [1; 2]	NA			1 [0; 2]	0 [–0.6; –0.0]	.039
Infiltrates, area (cm2)	15	9.2 [0.9; 29.4]	NA			5.4 [0.0; 26.8]	−3.8 [–7.2; –0.2]	.041
Hypoglycemic events, one-week comparison	28	0 [0; 4]	0.5 [0; 5]	0.5 [–0.5; 0.9]	.613	0 [0; 7]	0 [–0.9; 0.4]	.922
Hypoglycemic events, pretrial vs trial	28	2 [0; 30]	NA			4 [0; 44]	2 [–2.5; 5.7]	.218

^a95% CI, paired z test, compared with baseline.

^bPaired z test, compared with baseline.

CI, confidence interval.

Total daily insulin requirement is reported only for participants, who filled and returned their insulin diaries. Infiltrates area and count are reported only for participants, who had at least one infiltrate at trial start. Hypoglycemic events are reported only for participants, who filled and returned their hypoglycemic event diary.