By providing blood glucose (BG) concentration measurements in an almost continuous-time fashion for several consecutive days, wearable minimally-invasive continuous glucose monitoring (CGM) sensors ...are revolutionizing diabetes management, and are becoming an increasingly adopted technology especially for diabetic individuals requiring insulin administrations. Indeed, by providing glucose real-time insights of BG dynamics and trend, and being equipped with visual and acoustic alarms for hypo- and hyperglycemia, CGM devices have been proved to improve safety and effectiveness of diabetes therapy, reduce hypoglycemia incidence and duration, and decrease glycemic variability. Furthermore, the real-time availability of BG values has been stimulating the realization of new tools to provide patients with decision support to improve insulin dosage tuning and infusion. The aim of this paper is to offer an overview of current literature and future possible developments regarding CGM technologies and applications. In particular, first, we outline the technological evolution of CGM devices through the last 20 years. Then, we discuss about the current use of CGM sensors from patients affected by diabetes, and, we report some works proving the beneficial impact provided by the adoption of CGM. Finally, we review some recent advanced applications for diabetes treatment based on CGM sensors.
Technology has long been used to carry out self-management as well as to improve adherence to treatment in people with diabetes. However, most technology-based apps do not meet the basic requirements ...for engaging patients.
This study aimed to evaluate the effect of use frequency of a diabetes management app on glycemic control.
Overall, 2 analyses were performed. The first consisted of an examination of the reduction of blood glucose (BG) mean, using a randomly selected group of 211 users of the SocialDiabetes app (SDA). BG levels at baseline, month 3, and month 6 were calculated using the intercept of a regression model based on data from months 1, 4, and 7, respectively. In the second analysis, the impact of low and high BG risk was examined. A total of 2692 users logging SDA ≥5 days/month for ≥6 months were analyzed. The highest quartile regarding low blood glucose index (LBGI) and high blood glucose index (HBGI) at baseline (t1) was selected (n=74 for group A; n=440 for group B). Changes in HBGI and LBGI at month 6 (t2) were analyzed.
For analysis 1, baseline BG results for type 1 diabetes mellitus (T1DM) groups A and B were 213.61 (SD 31.57) mg/dL and 206.43 (SD 18.65) mg/dL, respectively, which decreased at month 6 to 175.15 (SD 37.88) mg/dL and 180.6 (SD 40.47) mg/dL, respectively. For type 2 diabetes mellitus (T2DM), baseline BG was 218.77 (SD 40.18) mg/dL and 232.55 (SD 46.78) mg/dL, respectively, which decreased at month 6 to 160.51 (SD 39.32) mg/dL and 173.14 (SD 52.81) mg/dL for groups A and B, respectively. This represents a reduction of estimated A
(eA
) of approximately 1.3% (P<.001) and 0.9% (P=.001) for T1DM groups A and B, respectively, and 2% (P<.001) for both A and B T2DM groups, respectively. For analysis 2, T1DM baseline LBGI values for groups A and B were 5.2 (SD 3.9) and 4.4 (SD 2.3), respectively, which decreased at t2 to 3.4 (SD 3.3) and 3.4 (SD 1.9), respectively; this was a reduction of 34.6% (P=.005) and 22.7% (P=.02), respectively. Baseline HBGI values for groups A and B were 12.6 (SD 4.3) and 10.6 (SD 4.03), respectively, which decreased at t2 to 9.0 (SD 6.5) and 8.6 (SD 4.7), respectively; this was a reduction of 30% (P=.001) and 22% (P=.003), respectively.
A significant reduction in BG was found in all groups, independent of the use frequency of the app. Better outcomes were found for T2DM patients. A significant reduction in LBGI and HBGI was found in all groups, regardless of the use frequency of the app. LBGI and HBGI indices of both groups tend to have similar values after 6 months of app use.
Regular self-monitoring of blood glucose levels, and ketones when indicated, is an essential component of type 1 diabetes (T1D) management. Although fingerstick blood glucose monitoring has been the ...standard of care for decades, ongoing rapid technological developments have resulted in increasingly widespread use of continuous glucose monitoring (CGM). This article reviews recommendations for self-monitoring of glucose and ketones in pediatric T1D with particular emphasis on CGM and factors that impact the accuracy and real-world use of this technology.
Self-monitoring blood glucose (SMBG) systems have the potential to play an important role in the management of diabetes and in the reduction of risk of serious secondary clinical complications. This ...review describes the transition from simple urine sugar screening tests to sophisticated meter and reagent strip systems to monitor blood glucose. Significant developments in design and technology over the past four decades are described since the first meter was introduced in 1970. Factors that have influenced this evolution and the challenges to improve analytical performance are discussed. Current issues in the role of SMBG from the clinical, patient and manufacturer perspectives, notably adherence, costs and regulations, are also considered.
We present a sensing system operating at millimetre (mm) waves in transmission mode that can measure glucose level changes based on the complex permittivity changes across the signal path. The ...permittivity of a sample can change significantly as the concentration of one of its substances varies: for example, blood permittivity depends on the blood glucose levels. The proposed sensing system uses two facing microstrip patch antennas operating at 60 GHz, which are placed across interrogated samples. The measured transmission coefficient depends on the permittivity change along the signal path, which can be correlated to the change in concentration of a substance. Along with theoretical estimations, we experimentally demonstrate the sensing performance of the system using controlled laboratory samples, such as water-based glucose-loaded liquid samples. We also present results of successful glucose spike detection in humans during an in-vivo Intravenous Glucose Tolerance Test (IVGTT). The system could eventually be developed into a non-invasive glucose monitor for continuous monitoring of glucose levels for people living with diabetes, as it can detect as small as 1.33 mmol/l (0.025 wt%) glucose concentrations in the controlled water-based samples satisfactorily, which is well below the typical human glucose levels of 4 mmol/l.
Glycemic control often deteriorates during adolescence and the transition to young adulthood for patients with type 1 diabetes. The inability to manage type 1 diabetes effectively during these years ...is associated with poor glycemic control and complications from diabetes in adult life.
To determine the effect of daily financial incentives on glucose monitoring adherence and glycemic control in adolescents and young adults with type 1 diabetes.
The Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults With Type 1 Diabetes (BE IN CONTROL) study was an investigator-blinded, 6-month, 2-arm randomized clinical trial conducted between January 22 and November 2, 2016, with 3-month intervention and follow-up periods. Ninety participants (aged 14-20) with suboptimally controlled type 1 diabetes (hemoglobin A1c HbA1c >8.0%) were recruited from the Diabetes Center for Children at the Children's Hospital of Philadelphia.
All participants were given daily blood glucose monitoring goals of 4 or more checks per day with 1 or more level within the goal range (70-180 mg/dL) collected with a wireless glucometer. The 3-month intervention consisted of a $60 monthly incentive in a virtual account, from which $2 was subtracted for every day of nonadherence to the monitoring goals. During a 3-month follow-up period, the intervention was discontinued.
The primary outcome was change in HbA1c levels at 3 months. Secondary outcomes included adherence to glucose monitoring and change in HbA1c levels at 6 months. All analyses were by intention to treat.
Of the 181 participants screened, 90 (52 57.8% girls) were randomized to the intervention (n = 45) or control (n = 45) arms. The mean (SD) age was 16.3 (1.9) years. The intervention group had significantly greater adherence to glucose monitoring goals in the incentive period (50.0% vs 18.9%; adjusted difference, 27.2%; 95% CI, 9.5% to 45.0%; P = .003) but not in the follow-up period (15.3% vs 8.7%; adjusted difference, 3.9%; 95% CI, -2.0% to 9.9%; P = .20). The change in HbA1c levels from baseline did not differ significantly between groups at 3 months (adjusted difference, -0.08%; 95% CI, -0.69% to 0.54%; P = .80) or 6 months (adjusted difference, 0.03%; 95% CI, -0.55% to 0.60%; P = .93).
Among adolescents and young adults with type 1 diabetes, daily financial incentives improved glucose monitoring adherence during the incentive period but did not significantly improve glycemic control.
clinicaltrials.gov Identifier: NCT02568501.
The self-monitoring of blood glucose (SMBG), traditionally performed by “point-of-care” (POC) devices called portable glucose monitors (PGM) is now considered an integral part of managed care of ...diabetic patients, especially type 1 diabetics and those on insulin therapy. In patients with type 2 diabetes, SMBG can help to achieve a better glycaemic control, although there is not sufficient evidence to attest that strict monitoring in these patients is associated with an improved outcome. The outcome of several clinical studies, especially in diabetics on insulin therapy, has shown that SMBG plays a key role in preventing complications in the short, medium and long term. According to the current recommendations, SMBG is aimed to achieve and maintain glycaemic control, prevent and identify hypoglycaemia, prevent severe hyperglycaemia, adjust lifestyle changes and establish the need to begin treatment with insulin in gestational diabetes mellitus. However, as clearly highlighted by the American Diabetes Association (ADA) and the National Academy of Clinical Biochemistry (NACB), patients and healthcare personnel should be trained on the appropriate use of the device, as well as on the correct interpretation of data. Moreover, definite analytical targets and appropriate acceptance criteria for performance should be fulfilled before a new device is introduced in the hospital environment, or recommended to the patients. Performance limitations such as hematocrit extremes and analytical interferences should be clearly acknowledged by the operators, before taking test results for granted. The current article aims to review the current indications for SMGB and highlight the most important criteria for the appropriate use of PGMs.
Hypertension is a widespread chronic disease, and its effective treatment requires self-management by patients. Health-related apps provide an effective way of supporting hypertension ...self-management. However, the increasing range and variety of hypertension apps available on the market, owing to the global growth in apps, creates the need for patients and health care professionals to be informed about the effectiveness of these apps and the levels of privacy and security that they provide.
This study aimed to describe and assess all available apps supporting hypertension self-management in the most popular app stores and investigate their functionalities.
In January 2018, the UK Apple and Google Play stores were scanned for all free and paid apps supporting hypertension self-management. Apps were included if they were in English, had functionality supporting hypertension self-management, and targeted adult users with hypertension. The included apps were downloaded and their functionalities were investigated. Behavior change techniques (BCTs) linked with the theoretical domain framework (TDF) underpinning potentially effective apps were independently coded by two reviewers. The data privacy and security of the apps were also independently assessed.
A total of 186 hypertension apps that met the inclusion criteria were included in this review. The majority of these apps had only one functionality (n=108), while the remainder offered different combinations of functionalities. A small number of apps had comprehensive functionalities (n=30) that are likely to be more effective in supporting hypertension self-management. Most apps lacked a clear theoretical basis, and 24 BCTs identified in these 30 apps were mapped to 10 TDF mechanisms of actions. On an average, 18.4 BCTs were mapped to 6 TDF mechanisms of actions that may support hypertension self-management behaviors. There was a concerning absence of evidence related to the effectiveness and usability of all 186 apps, and involvement of health care professionals in the app development process was minimal. Most apps did not meet the current standards of data security and privacy.
Despite the widespread accessibility and availability of smartphone apps with a range of combinations of functionalities that can support the self-management of hypertension, only a small number of apps are likely to be effective. Many apps lack security measures as well as a clear theoretical basis and do not provide any evidence concerning their effectiveness and usability. This raises a serious issue, as health professionals and those with hypertension have insufficient information to make decisions on which apps are safe and effective.
Currently available semiautomated insulin-delivery systems require individualized insulin regimens for the initialization of therapy and meal doses based on carbohydrate counting for routine ...operation. In contrast, the bionic pancreas is initialized only on the basis of body weight, makes all dose decisions and delivers insulin autonomously, and uses meal announcements without carbohydrate counting.
In this 13-week, multicenter, randomized trial, we randomly assigned in a 2:1 ratio persons at least 6 years of age with type 1 diabetes either to receive bionic pancreas treatment with insulin aspart or insulin lispro or to receive standard care (defined as any insulin-delivery method with unblinded, real-time continuous glucose monitoring). The primary outcome was the glycated hemoglobin level at 13 weeks. The key secondary outcome was the percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter; the prespecified noninferiority limit for this outcome was 1 percentage point. Safety was also assessed.
A total of 219 participants 6 to 79 years of age were assigned to the bionic-pancreas group, and 107 to the standard-care group. The glycated hemoglobin level decreased from 7.9% to 7.3% in the bionic-pancreas group and did not change (was at 7.7% at both time points) in the standard-care group (mean adjusted difference at 13 weeks, -0.5 percentage points; 95% confidence interval CI, -0.6 to -0.3; P<0.001). The percentage of time that the glucose level as assessed by continuous glucose monitoring was below 54 mg per deciliter did not differ significantly between the two groups (13-week adjusted difference, 0.0 percentage points; 95% CI, -0.1 to 0.04; P<0.001 for noninferiority). The rate of severe hypoglycemia was 17.7 events per 100 participant-years in the bionic-pancreas group and 10.8 events per 100 participant-years in the standard-care group (P = 0.39). No episodes of diabetic ketoacidosis occurred in either group.
In this 13-week, randomized trial involving adults and children with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction than standard care in the glycated hemoglobin level. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and others; ClinicalTrials.gov number, NCT04200313.).
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