Patient characteristics:
Seventy-four patients using SAP were analyzed between January 2013 and August 2020. There were no losses to follow-up, and all the patients were included in the data analysis.
The median age was 36 years (IQR 27–46). The body mass index (BMI) was 24.3 (IQR 22.7-27.19). Of the total population, 41 (55%) were female, and most had a diagnosis of T1D (71; 95%), with 20 years since diagnosis (IQR 14–33). The median number of years of follow-up using the SAP was four years (IQR 2–7). Altogether, 85.1% of the patients had poor metabolic control, with a median A1C of 8.35% (IQR 7.3–9.8.) The baseline demographic and clinical characteristics are shown in Table 1.
The hospitalization and emergency room visit rates prior to SAP therapy were 0.5 events per patient-year (IQR 0.5-1.0) and 1.0 events per patient-year (IQR 0.5-2.0), respectively. All had a history of hypoglycemic episodes with an NSH rate of 20 events per patient-year (IQR 11–35) and an SH rate of 1.5 events per patient-year (IQ 1–6), with a Gold score of 4 (IQR 2–4) and the mean total daily insulin dose was 52.5 ± 21.9 international units (IU) prior to treatment .
Table 1
Baseline patient characteristics
Male sex, n (%)
|
31 (45%)
|
Female
|
41 (55%)
|
BMI, Median (IQR)
|
25 (22.7–27.2)
|
Age in years, Median (IQR)
|
36 (27–46)
|
T1D, n (%)
|
71 (95%)
|
T2D, n (%)
|
2 (2.7%)
|
Diabetes, other, n (%)
|
1 (1.35%)
|
Diabetes years, median
|
20 (14–33)
|
Total daily insulin doses, Mean
(SD)
|
52.5 ± 21.9 IU
|
Type of pump:*
|
|
Paradigm VEO
|
6 (8.82%)
|
Minimed 640
|
36 (52.96%)
|
Minimed 670
|
26 (34.24%)
|
A1c, Mean (SD)
|
8.8% (2.7)
|
A1c, Median (IQR)
|
8.35% (7.3–9.8)
|
Gold, Median (IQR) +
|
4 (2–4)
|
Non-severe hypoglycemic episodes, EPY
|
20 (11–35)
|
Severe hypoglycemic episodes
|
1.5 (1–6)
|
Hospitalization rate, EPY
|
0.5 (0.5-1.0)
|
Emergency room visit rate, EPY
|
1.0 (0.5-2.0)
|
A1C, glycated hemoglobin; BMI, body mass index; IQR, interquartile range; EPY, events per patient-year, T1D, type 1 diabetes; T2D, type 2 diabetes; IU, international units; SD, standard deviation.
* Type of pump initiated from the follow-up.
+ Gold scale, assessment tool for hypoglycemia
Metabolic control
At the established cut-off point for analysis, A1C decreased to 7.0% (IQR 6.5–7.4) compared with the initial figure of 8.35% (p = 0.0001). The percentage of patients with A1C less than 7% prior to treatment was 14.5%, and at the end of follow-up, it increased to 40.6%, p = 0.0001.
At the end of follow-up, the median time in range (TIR) was 75.5% (IQR 70-80.5), with 21% time above 180 (TIR > 180) (IQR 15–29%) and 3% time below 70 (TIR < 70) (IQR 1–3).
Hypoglycemic episodes
There was a statistically significant decrease both in the rate of NSH episodes as well as in the percentage of patients with at least one episode in the last year, going from 20 episodes per patient-year (IQR 11–20) to four episodes per patient-year (IQR 2–7) p = 0.001 and from 95.9–87.7%, p = 0.0142, respectively (OR = 0.91 [95% CI 0.083–0.99]).
Severe hypoglycemia, expressed in rates and percentage of episodes in the last year, decreased from 1.5 episodes per patient-year (IQR 1–6) to 0.5 (IQR 0.31–0.5), p 0.137, and from 28.3–14.3%, p = 0.14, respectively, but without statistical significance.
An assessment of the Gold scale changes before and after beginning SAP therapy showed a score reduction from 4 (IQR 2–4) to 2 (IQR 1–3), p = 0.0001. Likewise, the percentage of patients with a score of 4 or less prior to using this technology increased from 75–87% (p = 0.0001).
Emergency room visits and hospitalization
Significant differences were found before and after the use of SAP therapy in terms of reduced hospitalizations, with an initial rate of 0.5 events per person year (IQR 0.5-1) decreasing to 0.266 events per patient-year (IQR 0.16–0.667), p = 0.004. The percentage of patients requiring hospitalization (during the last two years) was 50% prior to and 13.79% after beginning therapy (p = 0.0001) (OR = 0.23 [95% CI 0.001–0.58]).
Likewise, prior to beginning SAP therapy, 57.5% of the patients had to be admitted to the emergency room, and at the end of the study, 6.45% of them had to be admitted, p = 0.0001 (OR = 0.11 [95% CI 0.01–0.83]. Emergency room visits went from one event per person year to 0.5 events per person year, p = 0.0022. Table 2.
Table 2
Follow-up of the variables related to glycemic control
Variable
|
Baseline
|
End of followup
|
P value
|
A1C (%) SD
|
8.35
|
7
|
0.0001
|
Severe hypoglycemia
|
28.3
|
14.3
|
0.14
|
Non-severe hypoglycemia
|
95.9
|
87.7
|
0.0142
|
Gold +
|
4
|
2
|
0.0001
|
Emergency room visits
|
57.5
|
6.45
|
0.0001
|
Hospitalizations
|
50
|
13.79
|
0.0001
|
A1C, glycated hemoglobin
+ Gold scale, assessment tool for hypoglycemia