Table of Contents
Hybrid closed-loop (HCL) systems have the potential to reduce the suffering of severe diabetes in some adults. type 1 diabetes (T1D), but not in adolescents.
- Previous research suggests that severe diabetes distress occurs in 20% to 30% of patients with T1D, impacting self-care, diabetes management, glycemic control, and quality of life (QoL) .
- IMPLIQUE, a quality of life study, tested 250 adults (mean age 42.4 years, 58.4% women) and adolescents (mean age 15.1 years, 54.5% women) with T1D from 55 centers in France using the HCL system. was evaluated.
- All patients are insulin pump Continuous glucose monitoring system for at least 6 months. The HCL system was activated at the end of a 3-week run-in period.
- Participants completed a questionnaire assessing diabetes-related distress (diabetes problem domain) [PAID]-20 or PAID-5) and QoL (diabetes dependent quality of life audit) [ADDQoL]), other stress, anxiety, depressionfatigue, fear hypoglycemia.
- The primary outcomes were PAID and ADDQoL scores assessed at baseline, 3 months, and 6 months during the study period.
- At baseline, 64% of adults had a PAID score of 40 or higher, indicating severe diabetes distress, but this decreased to 50% after six months.
- In adults, PAID scores decreased after 3 months and remained stable after 6 months with an average improvement of 16% after using the HCL system.
- ADDQoL global scores showed rapid improvement among adults during the first 3 months of HCL system use and remained stable at 6 months.
- Adolescents in the study had lower levels of diabetes distress than adults, had no change in PAID and ADDQoL scores, but increased physical activity levels.
- Fear of hypoglycemia (behavioral hypoglycemia fear survey) improved significantly in both adults (P < .001) and adolescents (P < .05) after 6 months.
Although HCL improved some psychosocial outcomes, residual risks remain, and the authors conclude that “high rates of residual distress despite HCL use suggest an unmet need.” “This should be addressed differently through a psychotherapeutic approach.”
The study was led by Yves Reznik, M.D., of the Department of Endocrinology and Diabetes, CHU Côte de Nacle, Caen-Sedex, France. Published online in Obesity and metabolism in diabetes.
This study had no comparison group.
This study was funded by VitalAire. Many of the authors declared receiving consultant/speaker fees, research support, and lecturer/scientific advisory fees from various sources, including VitalAire and other medical device, pharmaceutical, and diabetes care companies.