Performance of a Novel Continuous Glucose Monitoring Device in People With Diabetes.

Background: In this multicenter study, performance of a novel continuous glucose monitoring (CGM) system was evaluated.

Methods: Adult participants with diabetes were included in the study. They each wore three sensors of the CGM system on the upper arms for up to 14 days.

Characteristics of Nocturnal Hypoglycaemic Events and Their Impact on Glycaemia.

Background: Nocturnal hypoglycaemia is a burden for people with diabetes, particularly when treated with multiple daily injections (MDI) therapy. However, the characteristics of nocturnal hypoglycaemic events in this patient group are only poorly described in the literature.

Method: Continuous glucose monitoring (CGM) data from 185 study participants with type 1 diabetes using MDI therapy were collected under everyday conditions for up to 13 weeks.

A Critical Discussion of Alert Evaluations in the Context of Continuous Glucose Monitoring System Performance.

Many continuous glucose monitoring (CGM) systems provide functionality which alerts users of potentially unwanted glycemic conditions. These alerts can include glucose threshold alerts to call the user's attention to hypoglycemia or hyperglycemia, predictive alerts warning about impeding hypoglycemia or hyperglycemia, and rate-of-change alerts. A recent review identified 129 articles about CGM performance studies, of which approximately 25% contained alert evaluations.

Clinical Performance Evaluation of Continuous Glucose Monitoring Systems: A Scoping Review and Recommendations for Reporting.

The use of different approaches for design and results presentation of studies for the clinical performance evaluation of continuous glucose monitoring (CGM) systems has long been recognized as a major challenge in comparing their results. However, a comprehensive characterization of the variability in study designs is currently unavailable. This article presents a scoping review of clinical CGM performance evaluations published between 2002 and 2022.

Comment on Hochfellner et al. Accuracy Assessment of the GlucoMen Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study. 2022, , 106.

In their recent article entitled "Accuracy Assessment of the GlucoMen Day CGM System in Individuals with Type 1 Diabetes: A Pilot Study" [...

Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA): A Novel Approach for the Statistical Accuracy Assessment of Continuous Glucose Monitoring Systems.

Background: The accuracy of continuous glucose monitoring (CGM) systems is crucial for the management of glucose levels in individuals with diabetes mellitus. However, the discussion of CGM accuracy is challenged by an abundance of parameters and assessment methods. The aim of this article is to introduce the Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA), a new approach for a comprehensive characterization of CGM point accuracy which is based on the U.

A Statistical Approach for Assessing the Compliance of Integrated Continuous Glucose Monitoring Systems with Food and Drug Administration Accuracy Requirements.

To assess the compliance of "integrated" continuous glucose monitoring (CGM) systems with U.S. Food and Drug Administration requirements, the calculation of confidence intervals (CIs) on agreement rates (ARs), that is, the percentage of CGM measurements lying within a certain deviation of a comparator method, is stipulated.

Continuous Glucose Profiles in Healthy People With Fixed Meal Times and Under Everyday Life Conditions.

Background: The increased use of continuous glucose monitoring (CGM) and automated insulin delivery systems raises the question about therapeutic targets for glucose profiles in people with diabetes. This study aimed to assess averaged pre- and postprandial glucose profiles in people without diabetes to provide guidance for normal glucose patterns in clinical practice. For that, number and timing of meal intake were predefined.

Accuracy Evaluation of a Novel Reusable Patch Pump Prototype.

A prototype of an insulin patch pump that operates with a double pump mechanism was tested. Accuracy of bolus delivery of 0.2 U and 1.

Patch Pumps: Periodic Insulin Delivery Patterns.

Recent in vitro experiments with patch pumps (PP) Omnipod (OP), Omnipod DASH (OP-D), A6 TouchCare (A6), and Accu-Chek Solo (ACS) have observed periodic fluctuations in the delivered amount of insulin during basal rate and consecutive bolus delivery in some PP, calling for a more systematic characterization of these periodic delivery patterns. Here, it was found that during basal rate delivery of 1 U/h, some devices of OP, OP-D, and A6 showed deviations of up to ±30% from target delivery that consistently repeated every 5 hours, whereas ACS showed no clear periodicity with considerably lower deviations. Similar results were found during consecutive bolus delivery of 1 U, where deviations repeated consistently every five boluses in some devices of OP, OP-D, and A6.

Evaluation of Meal Carbohydrate Counting Errors in Patients with Type 1 Diabetes.

Aim: Correct estimation of meal carbohydrate content is a prerequisite for successful intensified insulin therapy in patients with diabetes. In this survey, the counting error in adult patients with type 1 diabetes was investigated.

Methods: Seventy-four patients with type 1 diabetes estimated the carbohydrate content of 24 standardized test meals.

Therapy adjustments in people with type 1 diabetes with impaired hypoglycemia awareness on multiple daily injections using real-time continuous glucose monitoring: a mechanistic analysis of the HypoDE study.

Introduction: Studies have shown beneficial effects of real-time continuous glucose monitoring (rtCGM) usage on clinical outcomes. The objective of this analysis was to identify which therapy adjustments were made by people with type 1 diabetes with impaired hypoglycemia awareness during rtCGM usage enabling reductions in the number of low glucose events observed in the HypoDE (Hypoglycemia in Deutschland) study.

Research Design And Methods: In the multicenter randomized controlled trial in people with type 1 diabetes on multiple daily injections with impaired hypoglycemia awareness, participants recorded their diabetes therapy in 7-day logbooks at baseline and at 6-month follow-up.

Mean Absolute Relative Difference of Blood Glucose Monitoring Systems and Relationship to ISO 15197.

Background: The analytical quality of a blood glucose monitoring system (BGMS) is often assessed according to the requirements described in the international standard ISO 15197. However, the mean absolute relative difference (MARD) is sometimes used as well. This analysis aims at providing empirical data from BGMS evaluation studies conducted according to ISO 15197 and at providing an estimation of how MARD and percentage of measurement results within ISO accuracy limits are related.

Choice of Continuous Glucose Monitoring Systems May Affect Metrics: Clinically Relevant Differences in Times in Ranges.

Background: Continuous glucose monitoring-derived parameters are becoming increasingly important in the treatment of people with diabetes. The aim of this study was to assess whether these parameters, as calculated from different continuous glucose monitoring systems worn in parallel, are comparable. In addition, clinical relevance of differences was investigated.

Diabetes management intervention studies: lessons learned from two studies.

Introduction: Several clinical studies investigated improvements of patient outcomes due to diabetes management interventions. However, chronic disease management is intricate with complex multifactorial behavior patterns. Such studies thus have to be well designed in order to allocate all observed effects to the defined intervention and to exclude effects of other confounders as well as possible.

Evaluation of the Accuracy of Current Tubeless Pumps for Continuous Subcutaneous Insulin Infusion.

Recently two new tubeless pumps for insulin therapy were introduced. They were tested for accuracy and occlusion detection and compared with the established patch pump Omnipod (OP). Using a modified setup for tubeless pumps based on IEC 60601-2-24, the basal rate and bolus delivery of the Accu-Chek Solo micropump system (ACS) and the A6 TouchCare System (A6) were measured with a microgravimetric method.

Time in Specific Glucose Ranges, Glucose Management Indicator, and Glycemic Variability: Impact of Continuous Glucose Monitoring (CGM) System Model and Sensor on CGM Metrics.

Background: International consensus recommends a set of continuous glucose monitoring (CGM) metrics to assess quality of diabetes therapy. The impact of individual CGM sensors on these metrics has not been thoroughly studied yet. This post hoc analysis aimed at comparing time in specific glucose ranges, coefficient of variation (CV) of glucose concentrations, and glucose management indicator (GMI) between different CGM systems and different sensors of the same system.

Insulin Pump Therapy for Patients With Type 2 Diabetes Mellitus: Evidence, Current Barriers, and New Technologies.

An increasing number of patients with type 2 diabetes mellitus (T2DM) use insulin pumps. The first insulin pumps especially designed for patients with T2DM have recently become available. However, national guidelines do not primarily recommend the use of continuous subcutaneous insulin infusion (CSII) for this patient group.

Skin Reaction Report Form: Development and Design of a Standardized Report Form for Skin Reactions Due to Medical Devices for Diabetes Management.

Background: Skin reactions due to medical devices for diabetes management have become a common problem in diabetes technology. There is a varying degree in how detailed skin reactions are described in scientific literature and diabetes practice, and no uniform structured documentation is given. Whereas most articles only describe findings, some others already document final diagnoses, such as contact dermatitis.

A Prospective Study of Insulin Infusion Set Use for up to 7 Days: Early Replacement Reasons and Impact on Glycemic Control.

There is limited evidence supporting a replacement interval of infusion sets for continuous subcutaneous insulin infusion (CSII). The aim of this study was to investigate if steel and soft cannula infusion sets can be used in CSII therapy for up to 7 days without negative impact on infusion sites or glycemic control. The insulin infusion sets YpsoPump Orbitmicro (steel needle) and YpsoPump Orbitsoft (soft cannula) were each used for up to 7 days by 40 adult subjects with CSII.