Closed‐loop driven by control‐to‐range algorithm outperforms threshold‐low‐glucose‐suspend insulin delivery on glucose control albeit not on nocturnal hypoglycaemia in prepubertal patients with type 1 diabetes in a supervised hotel setting

Abstract

This randomized control trial investigated glucose control with closed-loop (CL) versus threshold-low-glucose-suspend (TLGS) insulin pump delivery in pre-pubertal children with type 1 diabetes in supervised hotel conditions. The patients [n = 24, age range: 7-12, HbA1c: 7.5 ± 0.5% (58 ± 5 mmol/mol)] and their parents were admitted twice at a 3-week interval. CL control to range or TLGS set at 3.9 mmoL/L were assessed for 48 hour in randomized order. Admissions included three meals and one snack, and physical exercise. Meal boluses followed individual insulin/carb ratios. While overnight (22:00-08:00) per cent continuous glucose monitoring (CGM) time below 3.9 mmol/L (primary outcome) was similar, time in ranges 3.9 to 10.0 and 3.9 to 7.8 mmoL/L and mean CGM were all significantly improved with CL (P < 0.001). These results were confirmed over the whole 48 hour. Disconnections between devices and limited accuracy of glucose sensors in the hypoglycaemic range appeared as limiting factors for optimal control. CL mode was well accepted while fear of hypoglycaemia was unchanged. CL did not minimize nocturnal hypoglycaemia exposure but improved time in target range compared to TLGS. Although safe and well-accepted, CL systems would benefit from more integrated devices.

Closed loop control in adolescents and children during winter sports: Use of the Tandem Control‐IQ AP system

“…However, the significant improvement in the primary outcomes was shown using the CLC system despite these four systems potentially under‐delivering insulin in these four participants. Our ski camp study confirmed the results of two of the previous studies testing the DiAs system in prepubertal children . The only study testing a CLC system during ski camp by this group resulted in significant improvement in both time in range and hypoglycemia in an adolescent cohort .…”

“…In another randomized, crossover trial, the AP system resulted in increased time in range (73% vs 47%) with no significant change in time with hypoglycemia in 12 children with T1D age 5 to 8 years using the DiAs system . In a 48 hour randomized cross‐over study in 24 children 5 to 9 years old using either the DiAs system (CL) or a low glucose suspend system (LGS), there was a significant improvement in both overall mean CGM (160.2 in CL vs 180 mg/dL in LGS) and time in range (63.8 in CL vs 48.5% in LGS) with no significant reduction in hypoglycemia . In another camp study by Ly et al testing the DiAs system in 10 to 20 year old participants time in range improved during closed loop at 92% vs 80% during SAP ( P = .022) .…”

“…35 In a 48 hour randomized cross-over study in 24 children 5 to 9 years old using either the DiAs system (CL) or a low glucose suspend system (LGS), there was a significant improvement in both overall mean CGM (160.2 in CL vs 180 mg/dL in LGS) and time in range (63.8 in CL vs 48.5% in LGS) with no significant reduction in hypoglycemia. 36 In another camp study by Ly et al testing the DiAs system in 10 to 20 year old participants time in range improved during closed loop at 92% vs 80% during SAP (P = .022). 20 Using the same In randomized, crossover 5-day camp studies, both younger children (aged 6-11 years) and adolescents used a bi-hormonal closed loop system (insulin and glucagon) that was associated with a lower mean CGM glucose in both groups.…”

“…Our ski camp study confirmed the results of two of the previous studies testing the DiAs system in prepubertal children. 35,36 The only study testing a CLC system during ski camp by this group resulted in significant improvement in both time in range and hypoglycemia in an adolescent cohort. 28 Both groups were supervised remotely through CGM by a physician.…”

An adaptive technique based blood glucose control in type‐1 diabetes mellitus patients

“…Some recent research works for the diabetes mellitus system is overviewed as follows. In supervised learning conditions, the type‐1 diabetes affected prepubertal children is analyzed using threshold‐low‐glucose‐suspend (TLGS) insulin pump delivery vs glucose control with closed‐loop (CL) system of Renard et al 26 Kumari and Mathana 27 have suggested no exercise and changes in eating habits for the diabetic patients to control their glycemic index. Thereby, the patients are recommended only to change their chewing style, food size and time of swallowing.…”