Hybrid Closed Loop Systems Improve Glycemic Control and Quality of Life in Historically Minoritized Youth with Diabetes
Authors' conclusion
Improvements in glycemic control and quality of life exceeding pivotal trial findings without increased safety risks among historically minoritized youth
Study context
- Population
- Publicly insured, insulin pump-naïve, non-Hispanic Black youth aged 6 to <21 years with T1D and hemoglobin A1c (HbA1c) ≥10%13 completed
- Participants
- 15 participants
- Exposure
- T:slim X2 insulin pump with Control-IQ technology, change from baseline
- Hybrid closed loop (HCL)n = 15
- Outcome
- Absolute change in TIR (70-180 mg/dL)
- Follow-up
- 6 months
Methodological detailssingle-arm
- Single-arm
Main finding
As reported in the abstract
Baseline time in range (TIR)
12.3%
6.3–27.1%
TIR increase
23.7%-points
16.9, 30.5%P < 0.001
TIR increase in hours per day
5.7 h per day
Observational data: associations, not effects.
Secondary outcomes
Percent time >250 mg/dL
- Baseline
- 69.4% (51.6, 84.0%)
- Decrease
- 33.9%-points (−44.8, −23.1%; P < 0.001)
- Decrease in hours per day
- 8.1 h per day
HCL use and boluses
- Median time in HCL
- 78.3% (59.7, 87.3%)
- Boluses per day
- 10.1 (9.2, 11.9)
- HCL-initiated autoboluses
- 71.7% (63.8, 79.3%)
Person-reported outcome measures (PROMs)
- Diabetes-specific quality of life increased among parents
- P < 0.001
- Diabetes-specific quality of life increased among youth
- P = 0.004
- Diabetes distress decreased in both groups
- P < 0.001, P = 0.005
- Improvements in glycemia did not correlate with any baseline youth or parent PROMs
Safety
Diabetic ketoacidosis (DKA) incidence
- DKA at baseline
- 67 episodes/100-person years
- DKA during intervention (did not increase)
- 72 episodes/100-person years, P = 0.78
Original publication
Hybrid Closed Loop Systems Improve Glycemic Control and Quality of Life in Historically Minoritized Youth with Diabetes. Diabetes Technol Ther. Published 1 February 2024. doi:10.
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