Table 1.

Clinical features and metabolic control measures

	Overall			Baseline A1C >7.0%			Baseline A1C <7.0%			P *
	Baseline†	Month 6	Month 12	Baseline†	Month 6	Month 12	Baseline†	Month 6	Month 12
n	83	83	83	49	49	49	34	34	34
Body weight (kg)	77 ± 15	78 ± 16	79 ± 15	79 ± 16	80 ± 17	81 ± 17	75 ± 13	75 ± 13	76 ± 13	<0.001
Daily insulin dose (U/kg body wt)	0.5 ± 0.1	0.5 ± 0.2	0.5 ± 0.1	0.5 ± 0.2	0.6 ± 0.2	0.6 ± 0.2	0.5 ± 0.1	0.5 ± 0.1	0.5 ± 0.1	0.72
Blood glucose meter tests per day‡	7.0 ± 2.4	6.4 ± 3.1	5.7 ± 2.1	6.5 ± 2.3	5.7 ± 2.3	5.5 ± 2.0	7.6 ± 2.4	7.3 ± 3.9	6.0 ± 2.2	<0.001
A1C (%)	7.1 ± 0.8	6.8 ± 0.6	6.9 ± 0.7	7.6 ± 0.5	7.1 ± 0.5	7.2 ± 0.5	6.4 ± 0.5	6.3 ± 0.5	6.4 ± 0.6	<0.001
CGM glucose measures (n)§	81	81	81	49	49	49	32	32	32
Mean glucose (mg/dl)	151 ± 25	148 ± 21	148 ± 23	162 ± 24	157 ± 22	158 ± 23	136 ± 18	134 ± 12	133 ± 13	0.22
Glucose level (min/day)
71–180 mg/dl	983	1,026	1,066	866	962	966	1,151	1,139	1,135	0.02
≤70 mg/dl	62	55	58	53	53	49	82	65	72	0.06
≤60 mg/dl	30	16	19	23	16	14	38	13	25	0.003
≤50 mg/dl	7	4	5	7	3	4	6	6	5	0.002
>180 mg/dl	385	321	293	483	378	422	219	231	211	0.12
>200 mg/dl	246	202	188	335	252	289	133	137	116	0.05
>250 mg/dl	77	48	49	121	61	78	28	33	19	0.02
Summary values
Hypoglycemia area under the curve‖	0.5	0.3	0.3	0.4	0.3	0.3	0.6	0.3	0.4	0.002
Low blood glucose index¶	1.2	1.0	1.0	0.9	0.9	0.9	1.6	1.3	1.3	0.01
Hyperglycemia area under the curve#	11.6	8.6	8.1	16.0	11.0	12.5	5.4	5.5	4.8	0.05
High blood glucose index¶	5.6	4.8	4.6	6.6	5.5	6.2	3.3	3.7	3.4	0.08
Variability
Standard deviation (mg/dl)	56	52	52	61	57	55	46	47	45	0.02 (0.03)
Mean amplitude of glycemic excursion (mg/dl)	107	101	97	114	106	107	91	89	93	0.03 (0.04)
Mean absolute rate of change (mg · dl−1 · min−1)	0.63	0.65	0.65	0.69	0.67	0.69	0.57	0.58	0.63	0.11 (0.03)
Coefficient of variation**	0.36	0.35	0.34	0.37	0.37	0.35	0.35	0.33	0.33	0.07 (0.10)

Data are means ± SD or median.

*P values for the comparison of baseline vs. month 12 for all subjects pooled. For variability, the unadjusted and adjusted P values for mean glucose are both given: unadjusted (adjusted).

†Baseline data are from blinded CGM use for approximately 4–7 days prior to randomization.

‡Self-reported blood glucose meter monitoring.

§Subjects required to have at least 24 h of glucose data at all three time points to be included in analysis. One subject with zero use in month 12 and one subject whose CGM use in month 12 was imputed with the self-reported data at the month 12 visit as a result of a missing download data were excluded.

‖Total area under the curve <70 mg/dl reflects both percentage and severity of glucose values in the hypoglycemic range.

¶Blood glucose index (ref. 8).

#Total area under the curve above 180 mg/dl.

**SD divided by mean glucose.