TABLE 2.

Within-trial results in costs, health care use, health self-care, staff time, and clinical outcomes

Outcomes	Intervention, n = 44		Control, n = 42		p Valuea
	Mean ± SD or n (%)	Median (IQR or Range)	Mean ± SD or n (%)	Median (IQR or Range)
Per patient costs, $
Nonstudy health care use	31 ± 104	0 (0–0)	18 ± 77	0 (0–0)	.52
Trial staff for intervention/control	227 ± 71	234 (183–253)	76 ± 64	96(0–108)	< .01
Strip test use	943 ± 414	881 (624–1,148)	1,024 ± 464	978(643–1,212)	.58
Continuous glucose monitoring use	176 ± 597	0 (0–0)	800 ± 1,140	0 (0–2,584)	< .01
Pump use	1,859 ± 747	2,152(2,152–2,152)	1,563 ± 957	2,152(0–2,152)	.10
Total costs	3,343 ± 1,137	3,407(3,046–3,781)	3,481 ± 1,860	3,279(2,148–4,727)	.84
Health care use because ofT1D for 6 months
911 calls	0±0	0 (0–0)	0±0	0 (0–0)	1.00
Ambulance use	0±0	0 (0–0)	0±0	0 (0–0)	1.00
Emergency department visits	0.05 ± 0.21	0 (0–2)	0.02 ± 0.15	0(0–1)	.57
Urgent care visits	0±0	0 (0–0)	0±0	0 (0–0)	1.00
Hospitalizations	0±0	0 (0–0)	0±0	0 (0–0)	1.00
Nonstudy outpatient visits	0.09 ± 0.29	0(0–1)	0.07 ± 0.26	0 (0–2)	.72
Health self-care for 6 months
No. of clinic visits	2.41 ± 0.62	2(1–3)	1.52 ± 1.19	2 (0–3)	< .01
Daily strip tests	4.92 ± 2.26	4.7(1.5–11)	5.59 ± 2.79	5.1 (1.7–16)	.33
Pump use, yes	38 (86)		30(71)		.11b
Continuous glucose monitoring use, yes	2(5)		14 (33)		< .01b
Staff time per patient per visit
Total staff time, hrc	2.42 ± 0.82	2.13(1.58–5.17)	0.74 ± 0.12	0.68(0.67–1.18)	< .01
Clinician time, hr	0.72 ± 0.11	0.67(0.67–1.22)	0.74 ± 0.12	0.68(0.67–1.18)	.18
Other clinician time, hrd	–	–	0.02 ± 0.05	0(0–0.11)
Clinical outcomes at 6 months
Hemoglobin A1c at 6 monthse	8.99 ± 1.25	9.0(6.5–11.7)	8.96 ± 1.69	8.8(6.8–15)	.70f
Systolic blood pressuree	105.7 ± 8.4	107(90–122)	106.6 ± 8.5	105.5(93–125)	.06f
No. of patients having severe hypoglycemic events, %	0		0 ± 0		1.00b
No. of patients having severe hypergycemic events, %	1 ± 2		0 ± 0		1.00b
Subgroup analyses
In the subgroup with high baseline Hemoglobin A1c(≥ 9.0%; n = 41)
Hemoglobin A1cat6 monthse	9.92 ± 0.89	9.85(8.4–11.7)	10.07 ± 1.64	9.6(8.4–15)	.49f
Systolic blood pressure	106.3 ± 9.2	107.5(90–122)	108.2 ± 8.8	107(93–125)	.08f
Daily strip tests	4.20 ± 1.80	4.1 (1.5–7.0)	5.26 ± 3.15	4.6(2.5–16)	.28f
No. of clinical visits	2.38 ± 0.67	2(1–3)	1.7 ± 1.1	2 (0–3)	.06
Pump use—yes, %	18 (86)		13 (65)		.16b
Continuous glucose monitoring use—yes, %	1 (5)		4 (20)		.18b
In the subgroupwith low baseline HbA1c (< 9.0%; n = 45)
Hemoglobin A1cat6 monthse	8.00 ± 0.68	8.0 (6.5–9.1)	7.86 ± 0.77	7.9 (6.8–9.6)	.03f
Systolic blood pressure	105.2 ± 7.7	106(93–120)	104.9 ± 8.1	103(94–123)	.57f
Daily strip tests	5.75 ± 2.50	6.0(2.7–11.2)	5.90 ±2.45	5.4(1.7–10.3)	.09f
No. of clinical visits	2.43 ± 0.59	2(1–3)	1.36 ± 1.26	2 (0–3)	<.01
Pump use, yes	20 (87)		17(77)		.46b
Continuous glucose monitoring use, yes	1 (4)		10(45)		<.01b

Note. T1D, type 1 diabetes.

IQR used to summarize costs data and Range used to summarize the other outcomes.

^aThe default statistical method was Wilcoxon’s test.

^bFisher exact test was used to compare the groups.

^cTotal staff time includes (1) patients’ group appointments with a facilitator and (2) parents/caregivers’ group discussion with a facilitator. Time was calculated by dividing the total amount of time over the total number of patients at a group visit.

^dIn addition to receiving usual care (seeing a nurse and primary care provider), some in the usual care group might see additional providers such as a psychologist, dietitian, and social worker.

^eBased on observed data at 6 months, basic descriptive statistics were provided per group, but the p value was from a linear mixed model (Footnote b).

^fA linear mixed model was used to compare the groups, adjusting its baseline outcome and other covariates such as age, gender, and duration of diabetes.

The p value is the smaller p value for either the main group effect or the interaction effect between group and visit.