[Individualization of diabetes treatment by automated insulin delivery]. / Individualisierung der Diabetestherapie durch Automatisierung der Insulingabe.

Insulin pumps and glucose sensors have been shown to be effective in improving diabetes treatment and reducing acute complications according to data from registries. Therefore, in pediatric diabetology the use of at least one technical device is standard. Both devices can also be combined to form automated insulin delivery (AID) systems.Many AID systems have been tested in clinical trials and have proven to be safe and effective. The supply situation in Germany currently only allows one system to be prescribed for people insured by the statutory health insurances. Currently, children younger than 7 years of age cannot be treated with this system. The reasons for this are legal hurdles and lack of certification by the manufacturers. The CE certification can also lead to problems with insulin prescriptions. Open-source systems are non-regulated variants to circumvent existing regulatory conditions. There are risks here for both users and prescribers.For permanent use a thorough knowledge of the features of each AID system is necessary for both the user and the practitioner. Complete automation does not yet work. For the evaluation of the AID treatment, the metric data of the glucose sensors, the time in range and the glucose management index are the recognized and suitable parameters, because they allow a consultation based on real data from the daily life of people with diabetes.As all glucose sensors are read out via cloud-based software or the data are obtained directly and automatically from a telephone-linked receiver device, this provides the ideal technical basis for telemedical care, which still needs to be configured.

The impact of using a closed-loop system on food choices and eating practices among people with Type 1 diabetes: a qualitative study involving adults, teenagers and parents.

AIMS: We explored whether, how and why moving onto and using a hybrid day-and-night closed-loop system affected people's food choices and dietary practices to better understand the impact of this technology on everyday life and inform recommendations for training and support given to future users. METHODS: Twenty-four adults, adolescents and parents were interviewed before commencing use of the closed-loop system and following its 3-month use. Data were analysed thematically and longitudinally. RESULTS: While participants described preparing and/or eating similar meals to those consumed prior to using a closed-loop, many described feeling more normal and less burdened by diabetes in dietary situations. Individuals also noted how the use of this technology could lead to deskilling (less precise carbohydrate counting) and less healthy eating (increased snacking and portion sizes and consumption of fatty, energy-dense foods) because of the perceived ability of the system to deal with errors in carbohydrate counting and address small rises in blood glucose without a corrective dose needing to be administered. CONCLUSIONS: While there may be quality-of-life benefits to using a closed-loop, individuals might benefit from additional nutritional and behavioural education to help promote healthy eating. Refresher training in carbohydrate counting may also be necessary to help ensure that users are able to undertake diabetes management in situations where the technology might fail or that they take a break from using it.

Patients' and caregivers' experiences of using continuous glucose monitoring to support diabetes self-management: qualitative study.

BACKGROUND: Continuous glucose monitoring (CGM) enables users to view real-time interstitial glucose readings and provides information on the direction and rate of change of blood glucose levels. Users can also access historical data to inform treatment decisions. While the clinical and psychological benefits of CGM are well established, little is known about how individuals use CGM to inform diabetes self-management. We explored participants' experiences of using CGM in order to provide recommendations for supporting individuals to make optimal use of this technology. METHODS: In-depth interviews (n = 24) with adults, adolescents and parents who had used CGM for ≥4 weeks; data were analysed thematically. RESULTS: Participants found CGM an empowering tool because they could access blood glucose data effortlessly, and trend arrows enabled them to see whether blood glucose was rising or dropping and at what speed. This predicative information aided short-term lifestyle planning and enabled individuals to take action to prevent hypoglycaemia and hyperglycaemia. Having easy access to blood glucose data on a continuous basis also allowed participants to develop a better understanding of how insulin, activity and food impacted on blood glucose. This understanding was described as motivating individuals to make dietary changes and break cycles of over-treating hypoglycaemia and hyperglycaemia. Participants also described how historical CGM data provided a more nuanced picture of blood glucose control than was possible with blood glucose self-monitoring and, hence, better information to inform changes to background insulin doses and mealtime ratios. However, while participants expressed confidence making immediate adjustments to insulin and lifestyle to address impending hypoglycaemia and hypoglycaemia, most described needing and expecting health professionals to interpret historical CGM data and determine changes to background insulin doses and mealtime ratios. While alarms could reinforce a sense of hypoglycaemic safety, some individuals expressed ambivalent views, especially those who perceived alarms as signalling personal failure to achieve optimal glycaemic control. CONCLUSIONS: CGM can be an empowering and motivational tool which enables participants to fine-tune and optimize their blood glucose control. However, individuals may benefit from psycho-social education, training and/or technological support to make optimal use of CGM data and use alarms appropriately.

Home Use of an Artificial Beta Cell in Type 1 Diabetes.

BACKGROUND: The feasibility, safety, and efficacy of prolonged use of an artificial beta cell (closed-loop insulin-delivery system) in the home setting have not been established. METHODS: In two multicenter, crossover, randomized, controlled studies conducted under free-living home conditions, we compared closed-loop insulin delivery with sensor-augmented pump therapy in 58 patients with type 1 diabetes. The closed-loop system was used day and night by 33 adults and overnight by 25 children and adolescents. Participants used the closed-loop system for a 12-week period and sensor-augmented pump therapy (control) for a similar period. The primary end point was the proportion of time that the glucose level was between 70 mg and 180 mg per deciliter for adults and between 70 mg and 145 mg per deciliter for children and adolescents. RESULTS: Among adults, the proportion of time that the glucose level was in the target range was 11.0 percentage points (95% confidence interval [CI], 8.1 to 13.8) greater with the use of the closed-loop system day and night than with control therapy (P<0.001). The mean glucose level was lower during the closed-loop phase than during the control phase (difference, -11 mg per deciliter; 95% CI, -17 to -6; P<0.001), as were the area under the curve for the period when the glucose level was less than 63 mg per deciliter (39% lower; 95% CI, 24 to 51; P<0.001) and the mean glycated hemoglobin level (difference, -0.3%; 95% CI, -0.5 to -0.1; P=0.002). Among children and adolescents, the proportion of time with the nighttime glucose level in the target range was higher during the closed-loop phase than during the control phase (by 24.7 percentage points; 95% CI, 20.6 to 28.7; P<0.001), and the mean nighttime glucose level was lower (difference, -29 mg per deciliter; 95% CI, -39 to -20; P<0.001). The area under the curve for the period in which the day-and-night glucose levels were less than 63 mg per deciliter was lower by 42% (95% CI, 4 to 65; P=0.03). Three severe hypoglycemic episodes occurred during the closed-loop phase when the closed-loop system was not in use. CONCLUSIONS: Among patients with type 1 diabetes, 12-week use of a closed-loop system, as compared with sensor-augmented pump therapy, improved glucose control, reduced hypoglycemia, and, in adults, resulted in a lower glycated hemoglobin level. (Funded by the JDRF and others; AP@home04 and APCam08 ClinicalTrials.gov numbers, NCT01961622 and NCT01778348.).