MiniMed 780G™ in 2- to 6-Year-Old Children: Safety and Clinical Outcomes After the First 12 Weeks
Authors' conclusion
MiniMed 780G™ AHCL is a safe system and 12-week use was associated with improvements in glycemic control in 2- to 6-year-old children with type 1 diabetes. In addition, AHCL is associated with a reduction in parental diabetes distress after 12-week use.
Study context
- Population
- Children aged 2–6 years with T1D >6 months, total daily insulin ≥8 U/day, HbA1c <10% (85 mmol/mol), able to use insulin pump and CGM
- Participants
- 35 children
- Exposure
- MiniMed 780G advanced hybrid closed-loop (AHCL) in SmartGuard Mode for 12 weeks; change from baseline
- MiniMed 780G AHCLn = 35
- Outcome
- Change in glycemic outcomes
- Follow-up
- 0 to 12 weeks
Methodological detailshistorical controls matched by treatment unit, diabetes duration, age, gender and baseline treatment modality
- Historical controls matched by treatment unit, diabetes duration, age, gender and baseline treatment modality
Main finding
As reported in the abstract
HbA1c mean change (SD 5.7), P = 0.010
−2.7 mmol/mol
Mean sensor glucose change ([1.0]), P < 0.001
−0.8 mmol/L
Time above range (TAR) change ([9.5]), P < 0.001
−8.6%
Time in range (TIR) increase ([9.3]), P < 0.001
8.3%
Observational data: associations, not effects.
Further findings
Parental diabetes distress (Problem Areas In Diabetes-Parent, revised (PAID-PR) score) · 0 to 12 weeks
- PAID-PR score decreased from 37.5 (18.2) to 27.5 (14.8), P = 0.006
Safety
Diabetic ketoacidosis or severe hypoglycemia
- No events of DKA or severe hypoglycemia occurred
Original publication
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