New Zealand study: More data in youth show AHCL benefits
Unlike the US study populations of just teens aged 14 and older, and adults, the study data used for approval in the EU — from New Zealand — included a total of 60 patients with 20 children aged 7-15 years. It, too, was a 10-week randomized crossover clinical trial comparing the AHCL to a sensor-augmented pump system with an algorithm only for predictive low-glucose management (PLGM) and no adjustments for high blood glucose.
Time-in-range was 59% at baseline and 58% with PLGM, compared to 70.4% with AHCL, and most of the time-in-range improvement occurred at night. Time below 70 mg/dL dropped from 3.1% to 2.5% to 2.1%, respectively.
Similar to the US studies, participants spent 96% of the time in closed-loop mode with only 1.2 exits per week. On a questionnaire, 95% of patients agreed that the system was easy to use and 85% that the system improved their quality of life.
De Bock showed a slide with some quotes, including one from a parent saying, “We didn’t have to be fearful at night or have that thought when we opened her bedroom door in the morning that she might not be conscious,” and from a patient, “I forgot I had diabetes today.”
Bailey commented: “Of course these devices are not free. So, the challenge is how do we make them available, less expensive, and easy to use? We have our work cut out for us, but this is heartening data. Everything has gotten better but we’re not out of a job yet.”
Bailey has reported receiving research support from Abbott, Capillary Biomedical, Dexcom, Diasome, Eli Lilly, Kowa, Lexicon, Medtronic, Medtrum, Novo Nordisk, REMD, Sanofi, Senseonics, ViaCyte, vTv Therapeutics, Zealand Pharma, and consulting or speaking honoraria from Abbott, LifeScan, Novo Nordisk, Sanofi, and Medtronic. Bode has reported receiving consulting and speaker fees from Medtronic. Bergenstal has reported participating in clinical research, being an advisory board member, and/or serving as a consultant for Abbott Diabetes Care, Ascensia, CeQure, Dexcom, Eli Lilly, Hygieia, Senseonics, and United Healthcare. De Bock has reported receiving honoraria or expenses from Novo Nordisk, Sanofi, Pfizer, Medtronic, and Lilly, and research funds from Novo Nordisk and Medtronic.
This article first appeared on Medscape.com.