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

Use of smartphone application versus written titration charts for basal insulin titration in adults with type 2 diabetes and suboptimal glycaemic control (My Dose Coach) : multicentre, open-label, parallel, randomised controlled trial

Background The majority of people with type 2 diabetes who require insulin therapy use only basal insulin in combination with other anti-diabetic agents. We tested whether using a smartphone application to titrate insulin could improve glycaemic control in people with type 2 diabetes who use basal insulin. Methods This was a 12-week, multicentre, open-label, parallel, randomised controlled trial conducted in 36 diabetes practices in Germany. Eligible participants had type 2 diabetes, a BMI ≥25.0 kg/m2, were on basal insulin therapy or were initiating basal insulin therapy, and had suboptimal glycaemic control (HbA1c >7.5%; 58.5 mmol/mol). Block randomisation with 1:1 allocation was performed centrally. Participants in the intervention group titrated their basal insulin dose using a smartphone application (My Dose Coach) for 12 weeks. Control group participants titrated their basal insulin dose according to a written titration chart. The primary outcome was the baseline-adjusted change in HbA1c at 12 weeks. The intention-to-treat analysis included all randomised participants. Results Between 13 July 2021 and 21 March 2022, 251 study participants were randomly assigned (control group: n = 123; intervention group: n = 128), and 236 completed the follow-up phase (control group: n = 119; intervention group: n = 117). Regarding the HbA1c a model-based adjusted between-group difference of −0.31% (95% CI: 0.01%–0.69%; p = 0.0388) in favour of the intervention group was observed. There were 30 adverse events reported: 16 in the control group, 14 in the intervention group. Of these, 15 adverse events were serious. No event was considered to be related to the investigational device. Interpretation Study results suggest that utilizing this digital health smartphone application for basal insulin titration may have resulted in a comparatively greater reduction in HbA1c levels among individuals with type 2 diabetes, as compared to basal insulin titration guided by a written titration schedule. No negative effect on safety outcomes was observed. Funding Sanofi-Aventis Deutschland GmbH

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

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

Quality assessment of glucose measurement with regard to epidemiology and clinical management of diabetes mellitus in Germany

Background:During the last decade, Germany has seen an increased prevalence and a redistribution from undetected to diagnosed diabetes mellitus. Due to this substantial epidemiological development, the number of people with documented type 2 diabetes was 8.7 million in 2022. An estimated two million undiagnosed subjects are to be added. Beyond that, the life expectancy of diabetic subjects is increasing due to more responsive health systems in terms of care. Possible reasons include improved screening of at-risk individuals, the introduction of HbA1c for diagnosis in 2010, and the higher use of risk scores. Additionally, quality aspects of the laboratory methodology should be taken into consideration.Methods:Epidemiology and clinical management of diabetes in Germany are presented in the light of publications retrieved by a selective search of the PubMed database. Additionally, the data from German external quality assessment (EQA) surveys for the measurands glucose in plasma and HbA1c in whole blood, reviewed from 2010 until 2022, were evaluated. Above this, data concerning the analytical performance of near-patient glucometer devices, according to the ISO norm 15197:2013, were analyzed.Results:Two laboratory aspects are in good accordance with the observation of an increase in the diabetes mellitus prevalence when retrospectively reviewing the period 2010 to 2022: First, the analytical performance according to the ISO norm 15197:2013 of the glucometer devices widely used by patients with diabetes for the glucose self-testing, has improved during this period. Secondly, concerning the EQA program of INSTAND, the number of participating laboratories raised significantly in Germany. The spreads of variations of the specified results for plasma glucose remained unchanged between 2010 and 2022, whereas for HbA1c a significant decrease of the result scattering could be observed.Conclusion:These retrospectively established findings testify to an excellent analytical quality of laboratory diagnostics for glucose and HbA1c throughout Germany which may be involved in a better diagnosis and therapy of previously undetected diabetes mellitus

The Need for Standardization of Continuous Glucose Monitoring Performance Evaluation: An Opinion by the International Federation of Clinical Chemistry and Laboratory Medicine Working Group on Continuous Glucose Monitoring.

Metrics derived from continuous glucose monitoring (CGM) systems are often discordant between systems. A major cause is that CGM systems are not standardized; they use various algorithms and calibration methods, leading to discordant CGM readings across systems. This discordance can be addressed by standardizing CGM performance assessments: If manufacturers aim their CGM systems at the same target, then CGM readings will align across systems. This standardization should include the comparator device, sample origin, and study procedures. With better aligned CGM readings, CGM-derived metrics will subsequently also align better between systems

The Use of Continuous Glucose Monitoring to Diagnose Stage 2 Type 1 Diabetes.

This consensus report evaluates the potential role of continuous glucose monitoring (CGM) in screening for stage 2 type 1 diabetes (T1D). CGM offers a minimally invasive alternative to venous blood testing for detecting dysglycemia, facilitating early identification of at-risk individuals for confirmatory blood testing. A panel of experts reviewed current evidence and addressed key questions regarding CGMs diagnostic accuracy and screening protocols. They concluded that while CGM cannot yet replace blood-based diagnostics, it holds promise as a screening tool that could lead to earlier, more effective intervention. Metrics such as time above range &gt;140 mg/dL could indicate progression risk, and artificial intelligence (AI)-based modeling may enhance predictive capabilities. Further research is needed to establish CGM-based diagnostic criteria and refine screening strategies to improve T1D detection and intervention

Consensus Considerations and Good Practice Points for Use of Continuous Glucose Monitoring Systems in Hospital Settings.

Continuous glucose monitoring (CGM) systems provide frequent glucose measurements in interstitial fluid and have been used widely in ambulatory settings for diabetes management. During the coronavirus disease 2019 (COVID-19) pandemic, regulators in the U.S. and Canada temporarily allowed for CGM systems to be used in hospitals with the aim of reducing health care professional COVID-19 exposure and limiting use of personal protective equipment. As such, studies on hospital CGM system use have been possible. With improved sensor accuracy, there is increased interest in CGM usage for diabetes management in hospitals. Laboratorians and health care professionals must determine how to integrate CGM usage into practice. The aim of this consensus guidance document is to provide an update on the application of CGM systems in hospital, with insights and opinions from laboratory medicine, endocrinology, and nursing

Continuous Glucose Monitors and Automated Insulin Dosing Systems in the Hospital Consensus Guideline.

This article is the work product of the Continuous Glucose Monitor and Automated Insulin Dosing Systems in the Hospital Consensus Guideline Panel, which was organized by Diabetes Technology Society and met virtually on April 23, 2020. The guideline panel consisted of 24 international experts in the use of continuous glucose monitors (CGMs) and automated insulin dosing (AID) systems representing adult endocrinology, pediatric endocrinology, obstetrics and gynecology, advanced practice nursing, diabetes care and education, clinical chemistry, bioengineering, and product liability law. The panelists reviewed the medical literature pertaining to five topics: (1) continuation of home CGMs after hospitalization, (2) initiation of CGMs in the hospital, (3) continuation of AID systems in the hospital, (4) logistics and hands-on care of hospitalized patients using CGMs and AID systems, and (5) data management of CGMs and AID systems in the hospital. The panelists then developed three types of recommendations for each topic, including clinical practice (to use the technology optimally), research (to improve the safety and effectiveness of the technology), and hospital policies (to build an environment for facilitating use of these devices) for each of the five topics. The panelists voted on 78 proposed recommendations. Based on the panel vote, 77 recommendations were classified as either strong or mild. One recommendation failed to reach consensus. Additional research is needed on CGMs and AID systems in the hospital setting regarding device accuracy, practices for deployment, data management, and achievable outcomes. This guideline is intended to support these technologies for the management of hospitalized patients with diabetes