Reduced burden of diabetes and improved quality of life: Experiences from unrestricted day‐and‐night hybrid closed‐loop use in very young children with type 1 diabetes
Abstract:Objective
To evaluate the experiences of families with very young children aged 1 to 7 years (inclusive) with type 1 diabetes using day‐and‐night hybrid closed‐loop insulin delivery.
Methods
Parents/caregivers of 20 children aged 1 to 7 years with type 1 diabetes completed a closed‐loop experience survey following two 3‐week periods of unrestricted day‐and‐night hybrid closed‐loop insulin therapy using Cambridge FlorenceM system at home. Benefits, limitations, and improvements of closed‐loop technology were ex… Show more
“…Furthermore, it has been shown that the use of CGM systems 9 might be a main driver of improvement in terms of glycemic control and that the method of insulin delivery (pen vs. CSII) might be of lesser importance in all age groups 10,11 . As part of a future development, for the implementation of hybrid closed‐loop systems, both compartments – sensor and pump are a must 12 …”
The aim of this study was to assess accuracy of the three most commonly used continuous glucose monitoring (CGM) systems in almost real‐life situation during a diabetes camp in children with type 1 diabetes (T1D) aged 9–14 years. Data was gathered during a 2‐week summer camp under physicians' supervision. Out of 38 participating children with T1D (aged: 11.0 [9.9; 12.1] years; 57% girls, mean HbA1c 7.2 [6.9; 7.7] %,) 37 wore a CGM system (either Abbott FreeStyle Libre (FSL), Dexcom G6 (DEX) or Medtronic Enlite (ENL)) throughout the camp. All concomitantly available data pairs of capillary glucose measurements and sensor values were used for the analysis. Mean absolute relative difference (MARD) was calculated and Parkes Error Grid analyses were done for all three systems used. In total 2079 data pairs were available for analysis. The overall MARDs of CGM systems used at the camp was FSL: 13.3% (6.7;21.6). DEX: 10.3% (5.8; 16.7) and ENL 8.5% (3.6; 15.6). During eu‐, hypo‐ and hyperglycemia MARDs were lowest in ENL. Highest MARDs were seen in hypoglycemia, where all three systems exhibited MARDs above 15%. Overnight MARDs of all systems was higher than during daytime. All sensors performed worst in hypoglycemia. Performance of the adequately calibrated Medtronic system outperformed the factory‐calibrated sensors. For clinical practice, it is important to adequately train children with T1D and families in the correct procedures for sensors that require calibrations.
“…Furthermore, it has been shown that the use of CGM systems 9 might be a main driver of improvement in terms of glycemic control and that the method of insulin delivery (pen vs. CSII) might be of lesser importance in all age groups 10,11 . As part of a future development, for the implementation of hybrid closed‐loop systems, both compartments – sensor and pump are a must 12 …”
The aim of this study was to assess accuracy of the three most commonly used continuous glucose monitoring (CGM) systems in almost real‐life situation during a diabetes camp in children with type 1 diabetes (T1D) aged 9–14 years. Data was gathered during a 2‐week summer camp under physicians' supervision. Out of 38 participating children with T1D (aged: 11.0 [9.9; 12.1] years; 57% girls, mean HbA1c 7.2 [6.9; 7.7] %,) 37 wore a CGM system (either Abbott FreeStyle Libre (FSL), Dexcom G6 (DEX) or Medtronic Enlite (ENL)) throughout the camp. All concomitantly available data pairs of capillary glucose measurements and sensor values were used for the analysis. Mean absolute relative difference (MARD) was calculated and Parkes Error Grid analyses were done for all three systems used. In total 2079 data pairs were available for analysis. The overall MARDs of CGM systems used at the camp was FSL: 13.3% (6.7;21.6). DEX: 10.3% (5.8; 16.7) and ENL 8.5% (3.6; 15.6). During eu‐, hypo‐ and hyperglycemia MARDs were lowest in ENL. Highest MARDs were seen in hypoglycemia, where all three systems exhibited MARDs above 15%. Overnight MARDs of all systems was higher than during daytime. All sensors performed worst in hypoglycemia. Performance of the adequately calibrated Medtronic system outperformed the factory‐calibrated sensors. For clinical practice, it is important to adequately train children with T1D and families in the correct procedures for sensors that require calibrations.
“…A multicenter trial with 20 very young children between 1 and 7 years of age using an experimental closed loop system containing a modified Medtronic ™ 640G insulin pump (investigational use only; Medtronic, Northridge, California), a real‐time continuous glucose sensor (Enlite 3, Medtronic), and the FlorenceM CL system control algorithm version 0.3.46 reported similar results. Responders especially emphasized the improvement in quality of sleep with CL for both caregivers and users [ 32 ]. We could reproduce these findings.…”
Continuous glucose monitoring (CGM) improves treatment with lower blood glucose levels and less patient effort. In combination with continuous insulin application, glycemic control improves and hypoglycemic episodes should decrease. Direct feedback of CGM to continuous subcutaneous insulin application, using an algorithm is called a closed-loop (CL) artificial pancreas system. Commercial devices stop insulin application by predicting hypoglycemic blood glucose levels through direct interaction between the sensor and pump. The prediction is usually made for about 30 minutes and insulin delivery is restarted at the previous level if a rise in blood glucose is predicted within the next 30 minutes (hybrid closed loop system, HCL this is known as a predictive low glucose suspend system (PLGS)). In a fully CL system, sensor and pump communicate permanently with each other. Hybrid closed-loop (HCL) systems, which require the user to estimate the meal size and provide a meal insulin basis, are commercially available in Germany at the moment. These systems result in fewer hyperglycemic and hypoglycemic episodes with improved glucose control. Open source initiatives have provided support by building do-it-yourself CL (DIYCL) devices for automated insulin application since 2014, and are used by a tech-savvy subgroup of patients. The first commercial hybrid CL system has been available in Germany since September 2019. We surveyed 1054 patients to determine which devices are currently used, which features would be in demand by potential users, and the benefits of DIYCL systems. 9.7% of these used a DIYCL system, while 50% would most likely trust these systems but more than 85% of the patients would use a commercial closed loop system, if available. The DIYCL users had a better glucose control regarding their time in range (TIR) and glycated hemoglobin (HbA1c).
“…The Omnipod Horizon system [124] uses a patch pump and both its safety and efficacy were demonstrated in both adults and pediatric T1Ds even also in an outpatient setting [125,126]. CLCs equally allow a better QoL, by reducing the burden related to diabetes by demonstrating a significant reduction of the time spent in diabetes management [127,128]. These results need to be confirmed in real life since the effectiveness of clinical trials in selected subjects could have impacted the results.…”
Type 1 diabetes mellitus imposes a significant burden of complications and mortality, despite important advances in treatment: subjects affected by this disease have also a worse quality of life-related to disease management. To overcome these challenges, different new approaches have been proposed, such as new insulin formulations or innovative devices. The introduction of insulin pumps allows a more physiological insulin administration with a reduction of HbA1c level and hypoglycemic risk. New continuous glucose monitoring systems with better accuracy have allowed, not only better glucose control, but also the improvement of the quality of life. Integration of these devices with control algorithms brought to the creation of the first artificial pancreas, able to independently gain metabolic control without the risk of hypo- and hyperglycemic crisis. This approach has revolutionized the management of diabetes both in terms of quality of life and glucose control. However, complete independence from exogenous insulin will be obtained only by biological approaches that foresee the replacement of functional beta cells obtained from stem cells: this will be a major challenge but the biggest hope for the subjects with type 1 diabetes. In this review, we will outline the current scenario of innovative diabetes management both from a technological and biological point of view, and we will also forecast some cutting-edge approaches to reduce the challenges that hamper the definitive cure of diabetes.
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