In:
Diabetes Care, American Diabetes Association, Vol. 41, No. 2 ( 2018-02-01), p. 303-310
Kurzfassung:
Short-term studies with automated systems that suspend basal insulin when hypoglycemia is predicted have shown a reduction in hypoglycemia; however, efficacy and safety have not been established in long-term trials. RESEARCH DESIGN AND METHODS We conducted a 6-month, multicenter, randomized controlled trial in children and adolescents with type 1 diabetes using the Medtronic MiniMed 640G pump with Suspend before low (predictive low-glucose management [PLGM]) compared with sensor-augmented pump therapy (SAPT) alone. The primary outcome was percentage time in hypoglycemia with sensor glucose (SG) & lt;3.5 mmol/L (63 mg/dL). RESULTS In an intent-to-treat analysis of 154 subjects, 74 subjects were randomized to SAPT and 80 subjects to PLGM. At baseline, the time with SG & lt;3.5 mmol/L was 3.0% and 2.8% in the SAPT and PLGM groups, respectively. During the study, PLGM was associated with a reduction in hypoglycemia compared with SAPT (% time SG & lt;3.5 mmol/L: SAPT vs. PLGM, 2.6 vs. 1.5, P & lt; 0.0001). A similar effect was also noted in time with SG & lt;3 mmol/L (P & lt; 0.0001). This reduction was seen both during day and night (P & lt; 0.0001). Hypoglycemic events (SG & lt;3.5 mmol/L for & gt;20 min) also declined with PLGM (SAPT vs. PLGM: events/patient-year 227 vs. 139, P & lt; 0.001). There was no difference in glycated hemoglobin (HbA1c) at 6 months (SAPT 7.6 ± 1.0% vs. PLGM 7.8 ± 0.8%, P = 0.35). No change in quality of life measures was reported by participants/parents in either group. There were no PLGM-related serious adverse events. CONCLUSIONS In children and adolescents with type 1 diabetes, PLGM reduced hypoglycemia without deterioration in glycemic control.
Materialart:
Online-Ressource
ISSN:
0149-5992
,
1935-5548
Sprache:
Englisch
Verlag:
American Diabetes Association
Publikationsdatum:
2018
ZDB Id:
1490520-6
