Abstract
Aims
To evaluate the efficacy of an advance closed-loop (AHCL) system in restoring awareness
of hypoglycemia in patients with type 1 diabetes (T1D).
Methods
We conducted a prospective study including 46 subjects with T1D flash glucose monitoring
(FGM) or continuous glucose monitoring (CGM) switching to a Minimed 780G® system.
Patients were classified in three groups according to the therapy used before switching
to Minimed® 780G: multiple dose insulin (MDI) therapy + FGM (n = 6), continuous subcutaneous
insulin infusion + FGM (n = 21), and sensor-augmented pump with predictive low-glucose
suspend (n = 19). FGM/CGM data were analyzed at baseline, after 2 and 6 months on
AHCL. Clarke’s score of hypoglycemia awareness was compared at baseline and 6 months
recordings. We also compared the efficacy of the AHCL system in improving A1c among patients with appropriate perception of symptoms of hypoglycemia compared to
those presenting with impaired awareness of hypoglycemia (IAH).
Results
Participants had a mean age of 37 ± 15 and a diabetes duration of 20 ± 10 years. At
baseline, 12 patients (27%) showed IAH as defined by a Clarke’s score ≥ 3. Patients
with IAH were older and had lower estimated glomerular filtration rate (eGFR) compared
with those who did not have IAH; with no differences in baseline CGM metrics or A1c. An overall decrease in A1c was observed after 6 months on AHCL system (from 6.9 ± 0.5% to 6.7 ± 0.6%, P < 0.001), regardless of prior insulin therapy. The improvement in metabolic control
was greater in patients with IAH, showing a reduction in A1c from 6.9 ± 0.5 to 6.4 ± 0.4% vs 6.9 ± 0.5 to 6.8 ± 0.6% (P = 0.003), showing a parallel increase in total daily boluses of insulin and automatic
bolus correction administered by the AHCL system. In patients with IAH Clarke’s score
decreased from 3.6 ± 0.8 at baseline to 1.9 ± 1.6 after 6 months (P < 0.001). After 6 months on AHCL system, only 3 patients (7%) presented with a Clarke’s
score ≥ 3, resulting in an absolute risk reduction of 20% (95% confidence interval:
7–32) of having IAH.
Conclusions
Switching from any type of insulin administration to AHCL system improves restoration
of hypoglycemia awareness and metabolic control in patients with T1D, particularly
in adults with impaired perception of hypoglycemia symptoms.
Trial Registration
ClinicalTrial.gov ID NCT04900636.
Keywords
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Article info
Publication history
Published online: March 18, 2023
Accepted:
March 13,
2023
Received in revised form:
February 20,
2023
Received:
January 14,
2023
Identification
Copyright
© 2023 Elsevier B.V. All rights reserved.
