Improving the clinical value and utility of CGM systems: issues and recommendations : a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionise the use of intensive insulin therapy in diabetes; however, progress towards that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardised format for displaying results and uncertainty on how best to use CGM data to make therapeutic decisions. This scientific statement makes recommendations for systemic improvements in clinical use and regulatory (pre- and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes

Improving the clinical value and utility of CGM systems: issues and recommendations: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group

The first systems for continuous glucose monitoring (CGM) became available over 15 years ago. Many then believed CGM would revolutionize the use of intensive insulin therapy in diabetes; however, progress toward that vision has been gradual. Although increasing, the proportion of individuals using CGM rather than conventional systems for self-monitoring of blood glucose on a daily basis is still low in most parts of the world. Barriers to uptake include cost, measurement reliability (particularly with earlier-generation systems), human factors issues, lack of a standardized format for displaying results, and uncertainty on how best to use CGM data to make therapeutic decisions. This Scientific Statement makes recommendations for systemic improvements in clinical use and regulatory (pre- and postmarketing) handling of CGM devices. The aim is to improve safety and efficacy in order to support the advancement of the technology in achieving its potential to improve quality of life and health outcomes for more people with diabetes

Patch Pumps : What are the advantages for people with diabetes?

Aim Patch pumps, i.e. insulin pumps without tubing, are an attractive alternative to conventional insulin pumps for people with type 1 diabetes and type 2 diabetes on insulin therapy. In this review, potential patient-relevant advantages and disadvantages of patch pumps are summarized and respective studies on patient-reported outcomes (PROs) are assessed. Methods Relevant studies were identified through a systematic PubMed search. Reference lists in respective articles and Google Scholar were also checked for additional references. Articles in English published before June 30, 2021, were included; no other criteria on publication dates were set. Results A total of 12 studies were included. The results of this analysis provide evidence that patch pumps improve quality of life, reduce diabetes-related distress, increase patient satisfaction, and are preferred by patients compared to conventional insulin pumps and multiple daily injection therapy (MDI). However, several methodological limitations of the studies identified constrain the significance of this analysis. Conclusions Despite the limited number of studies evaluating the benefits of patch pumps on PROs, there is increasing evidence that people with diabetes prefer patch pumps. Although there are numerous PROs for patch pumps, it is surprising that this aspect has been relatively understudied. More systematic evaluation studies of the benefits of patch pumps on PROs are needed

Diabetes Digital App Technology: Benefits, Challenges, and Recommendations. A Consensus Report by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group

Digital health technology, especially digital and health applications ("apps"), have been developing rapidly to help people manage their diabetes. Numerous health-related apps provided on smartphones and other wireless devices are available to support people with diabetes who need to adopt either lifestyle interventions or medication adjustments in response to glucose-monitoring data. However, regulations and guidelines have not caught up with the burgeoning field to standardize how mobile health apps are reviewed and monitored for patient safety and clinical validity. The available evidence on the safety and effectiveness of mobile health apps, especially for diabetes, remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore conducted a joint review of the current landscape of available diabetes digital health technology (only stand-alone diabetes apps, as opposed to those that are integral to a regulated medical device, such as insulin pumps, continuous glucose monitoring systems, and automated insulin delivery systems) and practices of regulatory authorities and organizations. We found that, across the U.S. and Europe, mobile apps intended to manage health and wellness are largely unregulated unless they meet the definition of medical devices for therapeutic and/or diagnostic purposes. International organizations, including the International Medical Device Regulators Forum and the World Health Organization, have made strides in classifying different types of digital health technology and integrating digital health technology into the field of medical devices. As the diabetes digital health field continues to develop and become more fully integrated into everyday life, we wish to ensure that it is based on the best evidence for safety and efficacy. As a result, we bring to light several issues that the diabetes community, including regulatory authorities, policy makers, professional organizations, researchers, people with diabetes, and health care professionals, needs to address to ensure that diabetes health technology can meet its full potential. These issues range from inadequate evidence on app accuracy and clinical validity to lack of training provision, poor interoperability and standardization, and insufficient data security. We conclude with a series of recommended actions to resolve some of these shortcomings

Effekte von rtCGM bei Erwachsenen mit Typ-1-Diabetes und Hypoglykämieproblemen, die mit einer multiplen Insulininjektions-Therapie behandelt werden: Ergebnisse der multizentrischen, randomisierten kontrollierten HypoDE-Studie

Fragestellung: Die Wirksamkeit von rtCGM zur Vermeidung von Hypoglykämien bei Patienten mit multiplen Insulininjektionen und Hypoglykämieproblemen wurde bisher nicht untersucht. Ziel dieser Studie war es zu zeigen, dass der Einsatz von rtCGM bei diesen Patienten zu einer Reduktion von hypoglykämischen Glukosewerten führt. Methodik: Die HypoDE-Studie war eine randomisierte, kontrollierte Studie mit 6-Monats Follow-up, die von 12 diabetologischen Schwerpunktpraxen in Deutschland durchgeführt wurde. Studienteilnehmer hatten Typ-1-Diabetes mit einer Hypoglykämiewahrnehmungsstörung und/oder schwere Unterzuckerungen im letzten Jahr. Studienteilnehmer trugen für 28 Tage ein verblindetes rtCGM-System und wurden anschließend entweder auf die Nutzung eines offenen rtCGM-Systems (Dexcom G5) für 26 Wochen (rtCGM-Gruppe), oder die Kontrollgruppe, die weiterhin die Blutzuckermessung nutzte, randomisiert. Zur Follow-up-Phase, Woche 22 – 26, bekam die Kontrollgruppe wieder ein verblindetes rtCGM-System. Primärer Endpunkt war die Verbesserung hypoglykämischer Ereignisse, definiert als Glukosewerte ≤54 mg/dl für 320 Minuten. Als sekundärer Endpunkt wurde die Anzahl schwerer Unterzuckerungen (Fremdhilfe + medizinische Intervention) analysiert. Ergebnisse: Vollständige Daten von 141 Patienten konnten ausgewertet werden. Im Durchschnitt konnte die Anzahl hypoglykämischer Ereignisse in der rtCGM-Gruppe von 10,4 ± 9,6 auf 3,4 ± 4,5 gesenkt werden; in der Kontrollgruppe von 13,5 ± 11,8 auf 13,2 ± 11,5. Die Incidence-Rate-Ratio (IRR) für hypoglykämische Ereignisse war für Teilnehmer der rtCGM-Gruppe um 72% signifikant geringer (IRR 0,28; 95% KI 0,20 – 0,39; p < 0,0001). Die Inzidenzrate schwerer Unterzuckerungen seit Randomisierung war 0,64 pro Patientenjahr in der rtCGM-Gruppe und 1,18 pro Patientenjahr in der Kontrollgruppe (IRR 0,36; 95% KI 0,15 – 0,88; p = 0,0247). Schlussfolgerungen: rtCGM führt bei Patienten mit multiplen Insulininjektionen mit Hypoglykämieproblemen zu einer signifikanten Reduktion von hypoglykämischen Werten sowie schwerer Unterzuckerungen

Combining Glucose Monitoring and Insulin Infusion in an Integrated Device: A Narrative Review of Challenges and Proposed Solutions.

The introduction of automated insulin delivery (AID) systems has enabled increasing numbers of individuals with type 1 diabetes (T1D) to improve their glycemic control largely. However, use of AID systems is limited due to their complexity and costs associated. The user must wear both a continuously monitoring glucose system and an insulin infusion pump. The glucose sensor and the insulin catheter must be inserted at two different body sites using different insertion devices. In addition, the user must pair and manage the different systems. These communicate with the AID software implemented on the pump or on a third device such as a dedicated display device or smart phone application. These components might be developed and commercialized by different manufacturers, which in turn can cause difficulties for patients seeking technical support. A possible solution to these challenges would be to integrate the glucose sensor and insulin catheter into a single device. This would allow the glucose sensor and insulin catheter to be inserted simultaneously, eliminating the need for pairing, and simplifying system management. In recent years, different technologies have been developed and evaluated in clinical investigations that combine the glucose sensor and the insulin catheter in one platform. The consistent finding of all these studies is that integration has no adverse effect on insulin infusion and glucose measurements provided that certain conditions are met. In this review, we discuss the perceived challenges of such an approach and discuss possible solutions that have been proposed

Impact of diabetic nephropathy on pharmacodynamic and pharmacokinetic properties of insulin in type 1 diabetic patients

WSTĘP. Celem pracy jest ilościowa ocena parametrów farmakodynamicznych i farmakokinetycznych krótkodziałającej insuliny ludzkiej i insuliny lispro u chorych na cukrzycę typu 1 z i/lub bez jawnej nefropatii cukrzycowej. MATERIAŁ I METODY. Badanie przeprowadzone metodą podwójnie ślepej próby miało charakter krzyżowy. Stosując technikę klamry euglikemicznej (5 mmol/l), oceniano odpowiedź metaboliczną na podskórne wstrzyknięcia insuliny krótkodziałającej i lispro (0,2 j./kg) u 12 chorych z cukrzycą typu 1 i jawną nefropatią cukrzycową (białkomocz > 500 mg/24 h i/lub stężenie kreatyniny w surowicy > 1,5 mg/dl, grupa NP) oraz u 12 chorych na cukrzycę typu 1 z prawidłową funkcją nerek, stanowiących grupę kontrolną (grupa DC). WYNIKI. Szczytowe stężenie wolnej insuliny w osoczu w przypadku lispro (359 [NP] vs. 254 pmol/l [DC]) było wyższe, a czas do osiągnięcia maksymalnego stężenia insuliny (85 [NP] vs. 99 min [DC]) był krótszy niż w przypadku ludzkiej insuliny krótkodziałającej (213 [NP] vs. 144 pmol/l [DC]; 118 [NP] vs. 153 min [DC]) w obu grupach chorych. Podsumowując, stężenia ludzkiej insuliny krótkodziałającej i lispro były wyższe u chorych z jawną nefropatią niż w grupie kontrolnej. Czas do uzyskania maksymalnego efektu metabolicznego był krótszy w przypadku insuliny lispro niż w przypadku insuliny ludzkiej w obu grupach chorych (102 vs. 191 min [NP]; 105 vs. 172 min [DC]). Całkowity efekt metaboliczny insuliny krótkodziałającej w przeciwieństwie do insuliny lispro był mniejszy u chorych z nefropatią cukrzycową niż z grupie kontrolnej (odpowiednio 967 vs. 1510 mg/kg). WNIOSKI. Chociaż stwierdzono wyższe stężenia insuliny u chorych z nefropatią cukrzycową, odpowiedź metaboliczna na ludzką insulinę krótkodziałającą pozostaje zmniejszona. Insulina lispro zachowuje swoją charakterystyczną farkmakokinetykę i farmakodynamikę u chorych z jawną nefropatią cukrzycową.INTRODUCTION. To quantify pharmacokinetic and pharmacodynamic properties of regular insulin and insulin lispro in type 1 diabetic patients with and without overt diabetic nephropathy. MATERIAL AND METHODS. In this double-blind, two- -way cross-over, euglycemic (5 mmol/l) glucose clamp study, we investigated the metabolic response to subcutaneous injections of regular insulin and insulin lispro (0.2 U/kg) in 12 type 1 diabetic patients with overt diabetic nephropathy (proteinuria > 500 mg/24 h and/or serum creatinine > 1.5 mg/dl; NP group) and in a control group of 12 type 1 diabetic patients with normal renal function (DC group). RESULTS. Peak plasma free insulin levels with insulin lispro (359 [NP] vs. 254 pmol/l [DC]) were higher and time to maximal insulin concentrations (85 [NP] vs. 99 min [DC]) shorter than with regular insulin (213 [NP] vs. 144 pmol/l [DC]; 118 [NP] vs. 153 min [DC]) in both patient groups. Overall insulin levels for regular insulin and for insulin lispro were higher in patients with overt diabetic nephropathy compared with control patients. Time to maximal metabolic effect was shorter with insulin lispro than with regular insulin in both patient groups (102 vs. 191 min [NP]; 105 vs. 172 min [DC]). The overall metabolic effect of regular insulin but not of insulin lispro was lower in patients with diabetic nephropathy than in diabetic control patients (967 vs. 1,510 mg/kg, respectively). CONCLUSIONS. Although insulin levels are higher in patients with overt diabetic nephropathy, the metabolic response to regular insulin is reduced. Insulin lispro maintains its characteristic pharmacokinetic and pharmacodynamic properties in patients with overt diabetic nephropathy

Continuous glucose monitoring in older adults with diabetes : data from the diabetes prospective follow-up (DPV) registry

Aims: To analyse predictors for continuous glucose monitoring (CGM) use in people with diabetes aged ≥60 years using insulin therapy and to assess the rates of CGM use during recent years (2019–2021). Research Design and Methods: Prospective study including 6849 individuals with diabetes and insulin therapy (type 2 diabetes: n = 5320; type 1 diabetes: n = 1529) aged ≥60 years. Data from 129 treatment centres were retrieved from the Diabetes Prospective Follow-up Registry (DPV) in March 2023. Results: Sensor use in individuals aged ≥60 years has increased in type 1 (2019: 28%, 2020: 39%, 2021: 45%) and type 2 diabetes (2019: 10%, 2020: 16%, 2021: 18%). Predictors for sensor use in older individuals with type 1 diabetes are younger age and CSII use (p < 0.001). Predictors in older individuals with type 2 diabetes are younger age, longer diabetes duration, higher BMI and CSII use (p < 0.001). Conclusions: CGM has become more common in older adults with diabetes and will presumably increase further. Age is a predictor for sensor use in older adults with diabetes. Age-related physical barriers and insufficient usability of devices, lack of interest in technologies, but possibly also effects of prejudice on the grounds of age may contribute to this finding