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

Abstract

Objective Artificial pancreas (AP) systems have been shown to improve glycemic control throughout the day and night in adults, adolescents, and children. However, AP testing remains limited during intense and prolonged exercise in adolescents and children. We present the performance of the Tandem Control‐IQ AP system in adolescents and children during a winter ski camp study, where high altitude, low temperature, prolonged intense activity, and stress challenged glycemic control. Methods In a randomized controlled trial, 24 adolescents (ages 13‐18 years) and 24 school‐aged children (6‐12 years) with Type 1 diabetes (T1D) participated in a 48 hours ski camp (∼5 hours skiing/day) at three sites: Wintergreen, VA; Kirkwood, and Breckenridge, CO. Study participants were randomized 1:1 at each site. The control group used remote monitored sensor‐augmented pump (RM‐SAP), and the experimental group used the t: slim X2 with Control‐IQ Technology AP system. All subjects were remotely monitored 24 hours per day by study staff. Results The Control‐IQ system improved percent time within range (70‐180 mg/dL) over the entire camp duration: 66.4 ± 16.4 vs 53.9 ± 24.8%; P = .01 in both children and adolescents. The AP system was associated with a significantly lower average glucose based on continuous glucose monitor data: 161 ± 29.9 vs 176.8 ± 36.5 mg/dL; P = .023. There were no differences between groups for hypoglycemia exposure or carbohydrate interventions. There were no adverse events. Conclusions The use of the Control‐IQ AP improved glycemic control and safely reduced exposure to hyperglycemia relative to RM‐SAP in pediatric patients with T1D during prolonged intensive winter sport activities.

Efficacy of the Diabeloop closed‐loop system to improve glycaemic control in patients with type 1 diabetes exposed to gastronomic dinners or to sustained physical exercise

“…Moreover, the percentage gain with the Diabeloop device is also higher than values obtained with commercially available hybrid CL devices in outpatients (14% gain found by Messer et al with the MiniMed670G, 10.3% reported by Lee et al with an enhanced version of the MiniMed670G, and 6.7% found by Biester et al with the DreaMed GlucoSitter) and in inpatients (5.7% found by Buckingham et al with a modified version of the OmniPod; see also the 10.8% gain with Tandem's Control‐IQ system as well as the clinical experience with the Medtronic 670G “hybrid” closed‐loop system presented at the American Diabetes Association's 79th Scientific Sessions). It also compares well with data obtained in settings of physical activity (6.6% gain found by Breton et al during intense prolonged outdoor exercise in a ski camp, and the 12.5% gain reported Ekhlaspour et al during winter sports). The overnight time spent in the range of 4.4 to 7.8 mmol/L was 22% longer with the Diabeloop system than it was with OL systems. This value is higher than the 4% reported by Reddy et al and the 11% reported by Kovatchev et al in previous adult inpatient short‐term studies.…”

7. Diabetes Technology: Standards of Medical Care in Diabetes—2021

“…A so-called hybrid approach, hybrid closed-loop, has been adopted in first-generation closed-loop systems and requires users to bolus for meals and snacks. Multiple studies, using a variety of systems with varying algorithms, pump, and sensors, have been performed in adults and children (163)(164)(165)(166)(167)(168)(169)(170)(171)(172)(173). Evidence suggests such systems may reduce A1C levels and improve time in range (174)(175)(176)(177)(178).…”

Current treatment options and challenges in patients with Type 1 diabetes: Pharmacological, technical advances and future perspectives

“…Other devices have been evaluated and authorized for commercial use such as Tandem Control IQ, which proved its efficacy with a sensor that needs no calibrations, by increasing time in the target (from 61 ± 17% at baseline to 71 ± 12% at the end of 6 months study period), by reducing HBA1c values (-0.33% in CLC group) and hypoglycemic events [117]. This AP model was also assessed in the pediatric population [118] during a winter camp and showed its efficacy also in this specific population and during physical activity (percent time within range was 66.4 ± 16.4 vs 53.9 ± 24.8% with P-value 0.01). Since this system is available in the US from the beginning of 2020, the first real-life data have been published, confirming results obtained in clinical trials with improvements also in psychosocial outcomes [119].…”