Adolescents and young adults with type 1 diabetes exhibit the worst glycemic control among individuals with type 1 diabetes across the lifespan. Although continuous glucose monitoring (CGM) has been ...shown to improve glycemic control in adults, its benefit in adolescents and young adults has not been demonstrated.
To determine the effect of CGM on glycemic control in adolescents and young adults with type 1 diabetes.
Randomized clinical trial conducted between January 2018 and May 2019 at 14 endocrinology practices in the US including 153 individuals aged 14 to 24 years with type 1 diabetes and screening hemoglobin A1c (HbA1c) of 7.5% to 10.9%.
Participants were randomized 1:1 to undergo CGM (CGM group; n = 74) or usual care using a blood glucose meter for glucose monitoring (blood glucose monitoring BGM group; n = 79).
The primary outcome was change in HbA1c from baseline to 26 weeks. There were 20 secondary outcomes, including additional HbA1c outcomes, CGM glucose metrics, and patient-reported outcomes with adjustment for multiple comparisons to control for the false discovery rate.
Among the 153 participants (mean SD age, 17 3 years; 76 50% were female; mean SD diabetes duration, 9 5 years), 142 (93%) completed the study. In the CGM group, 68% of participants used CGM at least 5 days per week in month 6. Mean HbA1c was 8.9% at baseline and 8.5% at 26 weeks in the CGM group and 8.9% at both baseline and 26 weeks in the BGM group (adjusted between-group difference, -0.37% 95% CI, -0.66% to -0.08%; P = .01). Of 20 prespecified secondary outcomes, there were statistically significant differences in 3 of 7 binary HbA1c outcomes, 8 of 9 CGM metrics, and 1 of 4 patient-reported outcomes. The most commonly reported adverse events in the CGM and BGM groups were severe hypoglycemia (3 participants with an event in the CGM group and 2 in the BGM group), hyperglycemia/ketosis (1 participant with an event in CGM group and 4 in the BGM group), and diabetic ketoacidosis (3 participants with an event in the CGM group and 1 in the BGM group).
Among adolescents and young adults with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in glycemic control over 26 weeks. Further research is needed to understand the clinical importance of the findings.
ClinicalTrials.gov Identifier: NCT03263494.
This study analyzed narratives about experiences of real-time continuous glucose monitoring (CGM) in people with type 1 diabetes.
People with type 1 diabetes using CGM and caregivers completed an ...online survey. Questions included duration of CGM, frequency of sensor wear, funding, and a free narrative about experiences or views about CGM. We used qualitative framework analysis to analyze 100 responses; 50% of participants were aged ≥ 18 years.
Most participants (87%) used CGM with insulin pump therapy, 71% used sensors ≥ 75% of the time, and 66% received funding for CGM from the National Health Service. Four themes were identified: 1) metabolic control, 2) living with CGM (work and school, sleep, exercise, nutrition, frequency of self-monitoring of blood glucose SMBG), 3) psychological issues and patient/caregiver attitudes, and 4) barriers to CGM use (technical issues, financial issues, attitudes of healthcare professionals toward CGM). Despite some hassles, experiences were overwhelmingly positive, with improved glycemic control, diet and exercise management, quality of life, and physical and psychological well-being, as well as reduced frequency of SMBG. Technical problems included sensor inaccuracy and unreliability, and "alarm fatigue." The advantages of CGM used with an insulin pump with automatic suspension of insulin delivery during hypoglycemia were recorded by several participants, noting reduced hypoglycemia frequency and fear of nocturnal hypoglycemia.
Patient and caregiver narratives indicate that CGM is a valuable addition to diabetes care for many with type 1 diabetes.
Aims
This is a meta‐synthesis of extant qualitative literature related to impact of continuous glucose monitoring (CGM). CGM has been available for a decade for the management of Type 1 diabetes and ...is the lynchpin of future artificial pancreas technologies. Clinical uptake of CGM is an important area of inquiry. The purpose of this meta‐synthesis is to understand the impact of CGM on individuals with Type 1 diabetes and others (parents, significant others, providers) in order to design appropriate clinical interventions for adherence.
Methods
Studies published in English between 2007 and 2017 were included, reflecting commercial CGM availability. PubMed, PsychINFO, CINALH, Web of Science and EMBASE databases were queried using search terms related to CGM, qualitative, experience and Type 1 diabetes. Included articles contained original qualitative or mixed‐method research on CGM, sensor‐augmented pump or closed‐loop therapies. Articles underwent quality appraisal and thematic interpretive integration by a multidisciplinary team.
Results
Nine articles (343 participants) met the inclusion criteria and were included in the synthesis. Six novel themes emerged: interacting with CGM, burden of living with CGM, feeling different from others, feeling empowered, interacting with glucose information and impact on relationships.
Conclusion
CGM affects physical, emotional and relational aspects of life. Clinicians can help minimize the burden of CGM with carefully delivered education and expectation‐setting with individuals. Empowerment and relational partnerships in diabetes care can be explored to maximize satisfaction with CGM. Systematic interpretive synthesis of qualitative studies provides a comprehensive, contextual understanding of the impact of CGM on daily life and relationships.
What's new?
Continuous glucose monitoring (CGM) is the cornerstone of future diabetes technologies, and it is essential that healthcare providers comprehend the user experience with CGM in order to promote sustained use.
This qualitative meta‐synthesis synthesizes nine studies (343 participants) to provide a meaningful picture of the impact of CGM: interacting with CGM, emotional burden, feeling different, feeling empowered, using glucose information and affecting relationships.
This synthesis identifies targets for intervention including optimizing CGM settings, discussing empowerment strategies, and forming partnerships with parents, significant others and providers.
The purpose of the study was to evaluate the performance and usability of the FreeStyle(®) Libre™ Flash glucose monitoring system (Abbott Diabetes Care, Alameda, CA) for interstitial glucose results ...compared with capillary blood glucose results.
Seventy-two study participants with type 1 or type 2 diabetes were enrolled by four U.S. clinical sites. A sensor was inserted on the back of each upper arm for up to 14 days. Three factory-only calibrated sensor lots were used in the study. Sensor glucose measurements were compared with capillary blood glucose (BG) results (approximately eight per day) obtained using the BG meter built into the reader (BG reference) and with the YSI analyzer (Yellow Springs Instrument, Yellow Springs, OH) reference tests at three clinic visits (32 samples per visit). Sensor readings were masked to the participants.
The accuracy of the results was demonstrated against capillary BG reference values, with 86.7% of sensor results within Consensus Error Grid Zone A. The percentage of readings within Consensus Error Grid Zone A on Days 2, 7, and 14 was 88.4%, 89.2%, and 85.2%, respectively. The overall mean absolute relative difference was 11.4%. The mean lag time between sensor and YSI reference values was 4.5±4.8 min. Sensor accuracy was not affected by factors such as body mass index, age, type of diabetes, clinical site, insulin administration, or hemoglobin A1c.
Interstitial glucose measurements with the FreeStyle Libre system were found to be accurate compared with capillary BG reference values, with accuracy remaining stable over 14 days of wear and unaffected by patient characteristics.
The artificial pancreas is now a viable treatment option for people with Type 1 diabetes and has demonstrated improved glycaemic outcomes while also reducing the onus of self‐management of Type 1 ...diabetes. Closed‐loop glucose‐responsive insulin delivery guided by real‐time sensor glucose readings can accommodate highly variable day‐to‐day insulin requirements and reduce the hypoglycaemia risk observed with tight glycaemic control in Type 1 diabetes. In 2011, the James Lind Alliance research priorities for Type 1 diabetes were produced and priority 3 was to establish whether an artificial pancreas (closed‐loop system) for Type 1 diabetes is effective. This review focuses on the progress that has been made in the evolution of closed‐loop systems as an effective treatment option for Type 1 diabetes. Development of closed‐loop systems has advanced from feasibility evaluations in highly supervised settings over short periods, to clinical studies in free‐living, unsupervised conditions lasting several months. The approval in the USA of the first hybrid closed‐loop system (MiniMed® 670G pump, Medtronic, Northridge, CA, USA) in 2016 for use in Type 1 diabetes reflects these advancements. We discuss the evidence from clinical studies that closed‐loop systems are effective with improved glycaemic outcomes, reduced hypoglycaemia and had positive end‐user acceptance in children, adolescents, adults and pregnant women with Type 1 diabetes. We also present the outlook for future closed‐loop systems in the treatment of Type 1 diabetes and identify the challenges facing the wide‐spread clinical adoption of this technology.
What's new?
Attainment of near normoglycaemia in Type 1 diabetes is challenging with currently available treatment options.
The artificial pancreas (closed‐loop) is an efficacious and safe approach for management of Type 1 diabetes in children and adults.
For widespread clinical adoption of artificial pancreas systems, challenges of cost‐effectiveness, user acceptance, and user and healthcare professional training need to be addressed.
There is a pressing need for new treatment regimens that enable improved glycaemic control and reduced diabetes self‐management burdens. Closed‐loop, or artificial pancreas, systems represent one of ...the most promising avenues in this regard. Closed‐loop systems connect wearable continuous glucose monitor (CGM) sensors to smartphone‐ or tablet‐mounted algorithms that process and model CGM data to deliver precise and frequently updated doses of fast‐acting insulin (and glucagon in dual‐hormone systems) to users via wearable pumps. Recent studies have demonstrated that closed‐loop systems offer significant benefit in terms of improved glycaemic control. However, less attention has been paid to the psychosocial impact on users of closed‐loop systems. This article reviews recent research on psychosocial aspects of closed‐loop usage in light of preceding research on user experience of currently available technologies such as insulin pumps and CGM sensors. The small, but growing body of research in this field reports generally positive user experience and a number of experienced benefits including: reassurance and reduced anxiety, improved sleep and confidence, and ‘time off’ from diabetes demands. However, these benefits are counterbalanced by important challenges, ranging from variable levels of trust to concerns about physical bulk, technical glitches and difficulties incorporating closed‐loop systems into everyday life. Future research should explore psychosocial aspects of closed‐loop usage in more diverse groups and with regard to clinicians, as well as users, to ensure that the clinical benefits of closed‐loop systems are realized at scale in routine medical care.
What's new?
Whereas most studies of closed‐loop overlook psychosocial issues, there is growing recognition of the need to evaluate user experience of new diabetes technologies.
This review evaluates research carried out on the psychosocial aspects of closed‐loop system usage across paediatric, pregnant and adult populations, using qualitative and/or quantitative methodologies.
Existing research identifies both benefits and burdens arising from the use of varied closed‐loop systems. Future studies should be carried out with more consistent methodological rigour in addition to exploring psychosocial experiences in more diverse patient groups and in clinicians.
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.
New closed-loop insulin systems Boughton, Charlotte K.; Hovorka, Roman
Diabetologia,
05/2021, Letnik:
64, Številka:
5
Journal Article
Recenzirano
Odprti dostop
Advances in diabetes technologies have enabled the development of automated closed-loop insulin delivery systems. Several hybrid closed-loop systems have been commercialised, reflecting rapid ...transition of this evolving technology from research into clinical practice, where it is gradually transforming the management of type 1 diabetes in children and adults. In this review we consider the supporting evidence in terms of glucose control and quality of life for presently available closed-loop systems and those in development, including dual-hormone closed-loop systems. We also comment on alternative ‘do-it-yourself’ closed-loop systems. We remark on issues associated with clinical adoption of these approaches, including training provision, and consider limitations of presently available closed-loop systems and areas for future enhancements to further improve outcomes and reduce the burden of diabetes management.
Graphical abstract
Continuous glucose monitoring (CGM) provides important information to aid in achieving glycemic targets in people with diabetes.
We performed a meta-analysis of randomized controlled trials (RCTs) ...comparing CGM with usual care for parameters of glycemic control in both type 1 and type 2 diabetes.
Many electronic databases were searched for articles published from inception until 30 June 2019.
We selected RCTs that assessed both changes in HbA
and time in target range (TIR), together with time below range (TBR), time above range (TAR), and glucose variability expressed as coefficient of variation (CV).
Data were extracted from each trial by two investigators.
All results were analyzed by a random effects model to calculate the weighted mean difference (WMD) with the 95% CI. We identified 15 RCTs, lasting 12-36 weeks and involving 2,461 patients. Compared with the usual care (overall data), CGM was associated with modest reduction in HbA
(WMD -0.17%, 95% CI -0.29 to -0.06,
= 96.2%), increase in TIR (WMD 70.74 min, 95% CI 46.73-94.76,
= 66.3%), and lower TAR, TBR, and CV, with heterogeneity between studies. The increase in TIR was significant and robust independently of diabetes type, method of insulin delivery, and reason for CGM use. In preplanned subgroup analyses, real-time CGM led to the higher improvement in mean HbA
(WMD -0.23%, 95% CI -0.36 to -0.10,
< 0.001), TIR (WMD 83.49 min, 95% CI 52.68-114.30,
< 0.001), and TAR, whereas both intermittently scanned CGM and sensor-augmented pump were associated with the greater decline in TBR.
Heterogeneity was high for most of the study outcomes; all studies were sponsored by industry, had short duration, and used an open-label design.
CGM improves glycemic control by expanding TIR and decreasing TBR, TAR, and glucose variability in both type 1 and type 2 diabetes.
Previous studies on telemedicine interventions have shown that older diabetic patients experience difficulty in using computers, which is a barrier to remote communication between medical teams and ...older diabetic patients. However, older people in China tend to find it easy to use mobile phones and personal messaging apps that have a user-friendly interface. Therefore, we designed a mobile health (mHealth) system for older people with diabetes that is based on mobile phones, has a streamlined operation interface, and incorporates maximum automation.
The goal of the research was to investigate the use of mobile phone-based telemedicine apps for management of older Chinese patients with type 2 diabetes mellitus (T2DM). Variables of interest included efficacy and safety.
A total of 91 older (aged over 65 years) patients with T2DM who presented to our department were randomly assigned to one of two groups. Patients in the intervention group (n=44) were provided glucometers capable of data transmission and received advice pertaining to medication, diet, and exercise via the mHealth telemedicine system. Patients assigned to the control group (n=47) received routine outpatient care with no additional intervention. Patients in both groups were followed up at regular 3-month intervals.
After 3 months, patients in the intervention group showed significant (P<.05) improvement in postprandial plasma glucose level. After 6 months, patients in the intervention group exhibited a decreasing trend in postprandial plasma glucose and glycated hemoglobin levels compared with the baseline and those in the control group (P<.05).
Mobile phone-based telemedicine apps help improve glycemic control in older Chinese patients with T2DM.
China Clinical Trial Registration Center ChiCTR 1800015214; http://www.chictr.org.cn/showprojen.aspx?proj=25949 (Archived by WebCite at http://www.webcitation.org/73wKj1GMq).
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