| 1. |
- Adolfsson, Peter, et al.
(författare)
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Automated Insulin Delivery Systems in Pediatric Type 1 Diabetes : A Narrative Review
- 2024
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Ingår i: Journal of Diabetes Science and Technology. - : Diabetes Technology Society. - 1932-2968.
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Forskningsöversikt (refereegranskat)abstract
- This narrative review assesses the use of automated insulin delivery (AID) systems in managing persons with type 1 diabetes (PWD) in the pediatric population. It outlines current research, the differences between various AID systems currently on the market and the challenges faced, and discusses potential opportunities for further advancements within this field. Furthermore, the narrative review includes various expert opinions on how different AID systems can be used in the event of challenges with rapidly changing insulin requirements. These include examples, such as during illness with increased or decreased insulin requirements and during physical activity of different intensities or durations. Case descriptions give examples of scenarios with added user-initiated actions depending on the type of AID system used. The authors also discuss how another AID system could have been used in these situations.
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| 2. |
- Adolfsson, Peter, 1963, et al.
(författare)
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Automated Insulin Delivery Systems in Pediatric Type 1 Diabetes: A Narrative Review
- 2024
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Ingår i: JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY. - : Diabetes Technology Society. - 1932-2968.
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Tidskriftsartikel (refereegranskat)abstract
- This narrative review assesses the use of automated insulin delivery (AID) systems in managing persons with type 1 diabetes (PWD) in the pediatric population. It outlines current research, the differences between various AID systems currently on the market and the challenges faced, and discusses potential opportunities for further advancements within this field. Furthermore, the narrative review includes various expert opinions on how different AID systems can be used in the event of challenges with rapidly changing insulin requirements. These include examples, such as during illness with increased or decreased insulin requirements and during physical activity of different intensities or durations. Case descriptions give examples of scenarios with added user-initiated actions depending on the type of AID system used. The authors also discuss how another AID system could have been used in these situations.
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| 3. |
- Battelino, T, et al.
(författare)
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Guideline Development for Medical Device Technology: Issues for Consideration
- 2023
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Ingår i: Journal of diabetes science and technology. - : SAGE Publications. - 1932-2968. ; 17:6, s. 1698-1710
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Tidskriftsartikel (refereegranskat)abstract
- Advances in the development of innovative medical devices and telehealth technologies create the potential to improve the quality and efficiency of diabetes care through collecting, aggregating, and interpreting relevant health data in ways that facilitate more informed decisions among all stakeholder groups. Although many medical societies publish guidelines for utilizing these technologies in clinical practice, we believe that the methodologies used for the selection and grading of the evidence should be revised. In this article, we discuss the strengths and limitations of the various types of research commonly used for evidence selection and grading and present recommendations for modifying the process to more effectively address the rapid pace of device and technology innovation and new product development.
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| 4. |
- Benhalima, Katrien, et al.
(författare)
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Automated Insulin Delivery for Pregnant Women With Type 1 Diabetes : Where do we stand?
- 2024
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Ingår i: Journal of Diabetes Science and Technology. - : Diabetes Technology Society. - 1932-2968.
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Tidskriftsartikel (refereegranskat)abstract
- Automated insulin delivery (AID) systems mimic an artificial pancreas via a predictive algorithm integrated with continuous glucose monitoring (CGM) and an insulin pump, thereby providing AID. Outside of pregnancy, AID has led to a paradigm shift in the management of people with type 1 diabetes (T1D), leading to improvements in glycemic control with lower risk for hypoglycemia and improved quality of life. As the use of AID in clinical practice is increasing, the number of women of reproductive age becoming pregnant while using AID is also expected to increase. The requirement for lower glucose targets than outside of pregnancy and for frequent adjustments of insulin doses during pregnancy may impact the effectiveness and safety of AID when using algorithms for non-pregnant populations with T1D. Currently, the CamAPS® FX is the only AID approved for use in pregnancy. A recent randomized controlled trial (RCT) with CamAPS® FX demonstrated a 10% increase in time in range in a pregnant population with T1D and a baseline glycated hemoglobin (HbA1c) ≥ 48 mmol/mol (6.5%). Off-label use of AID not approved for pregnancy are currently also being evaluated in ongoing RCTs. More evidence is needed on the impact of AID on maternal and neonatal outcomes. We review the current evidence on the use of AID in pregnancy and provide an overview of the completed and ongoing RCTs evaluating AID in pregnancy. In addition, we discuss the advantages and challenges of the use of current AID in pregnancy and future directions for research.
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| 5. |
- Eichenlaub, Manuel, et al.
(författare)
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Continuous Glucose Deviation Interval and Variability Analysis (CG-DIVA) : A Novel Approach for the Statistical Accuracy Assessment of Continuous Glucose Monitoring Systems
- 2022
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Ingår i: Journal of Diabetes Science and Technology. - : Diabetes Technology Society. - 1932-2968.
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Tidskriftsartikel (refereegranskat)abstract
- 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.S. Food and Drug Administration requirements for "integrated" CGM systems.METHODS: The statistical concept of tolerance intervals and data from two approved CGM systems was used to illustrate the CG-DIVA.RESULTS: The CG-DIVA characterizes the expected range of deviations of the CGM system from a comparison method in different glucose concentration ranges and the variability of accuracy within and between sensors. The results of the CG-DIVA are visualized in an intuitive and straightforward graphical presentation. Compared with conventional accuracy characterizations, the CG-DIVA infers the expected accuracy of a CGM system and highlights important differences between CGM systems. Furthermore, it provides information on the incidence of large errors which are of particular clinical relevance. A software implementation of the CG-DIVA is freely available (https://github.com/IfDTUlm/CGM_Performance_Assessment).CONCLUSIONS: We argue that the CG-DIVA can simplify the discussion and comparison of CGM accuracy and could replace the high number of conventional approaches. Future adaptations of the approach could thus become a putative standard for the accuracy characterization of CGM systems and serve as the basis for the definition of future CGM performance requirements.
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| 6. |
- Ekberg, N. R., et al.
(författare)
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Smart Pen Exposes Missed Basal Insulin Injections and Reveals the Impact on Glycemic Control in Adults With Type 1 Diabetes
- 2024
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Ingår i: Journal of Diabetes Science and Technology. - : SAGE Publications. - 1932-2968. ; 18:1, s. 66-73
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Tidskriftsartikel (refereegranskat)abstract
- Background: Adherence to basal insulin injections and the effects of missed basal insulin injections in adults with type 1 diabetes (T1D) were investigated using data from continuous glucose monitoring (CGM) and smart insulin pen devices in a real-world study. Methods: This was a post hoc analysis of a prospective, real-world study conducted in Sweden. Adults with T1D who were using CGM received a smart insulin pen device (NovoPen 6) for insulin injections. Missed basal insulin doses (≥40 hours between doses) were evaluated over 14-day periods, and the probability of missing basal insulin doses was estimated. Associations between missed basal insulin doses and glycemic outcomes were also explored. Results: Thirty-two patients with 4410 acceptable CGM days (315 14-day periods) were included. The number of missed basal insulin doses ranged from 0 to 4 over 315 14-day periods. The estimated probability of missing at least one basal insulin dose over any given 14-day period was 22% (95% confidence interval: 10%-40%). Missed basal insulin doses were significantly associated with higher mean glycemic levels, higher glucose management indicator, and lower time in range (70-180 mg/dL [3.9-10.0 mmol/L]). Similar results were observed when adjusted for missed bolus insulin doses; age and sex had no statistically significant effect on any glycemic parameter. Conclusions: This is the first study, based on accurate real-world injection data, to demonstrate the challenge of adherence to basal insulin injections in patients with T1D, and document that just one missed basal injection per week can result in clinically significant changes in glycemic control. © 2022 Diabetes Technology Society.
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| 7. |
- Freckmann, Guido, et al.
(författare)
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Clinical Performance Evaluation of Continuous Glucose Monitoring Systems : A Scoping Review and Recommendations for Reporting
- 2023
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Ingår i: Journal of Diabetes Science and Technology. - : Sage Publications. - 1932-2968. ; 17:6, s. 1506-1526
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Forskningsöversikt (refereegranskat)abstract
- 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. Specifically, this review quantifies the prevalence of numerous options associated with various aspects of study design, including subject population, comparator (reference) method selection, testing procedures, and statistical accuracy evaluation. We found that there is a large variability in nearly all of those aspects and, in particular, in the characteristics of the comparator measurements. Furthermore, these characteristics as well as other crucial aspects of study design are often not reported in sufficient detail to allow an informed interpretation of study results. We therefore provide recommendations for reporting the general study design, CGM system use, comparator measurement approach, testing procedures, and data analysis/statistical performance evaluation. Additionally, this review aims to serve as a foundation for the development of a standardized CGM performance evaluation procedure, thereby supporting the goals and objectives of the Working Group on CGM established by the Scientific Division of the International Federation of Clinical Chemistry and Laboratory Medicine.
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| 8. |
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| 9. |
- Hidefjäll, P, et al.
(författare)
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Patient Controlled, Off-label Use of Continuous Glucose Monitoring: Real-World Medical Costs and Effects of Patient Controlled Sensor Augmented Pump Therapy in Adult Patients Type 1 Diabetes
- 2021
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Ingår i: Journal of diabetes science and technology. - : SAGE Publications. - 1932-2968. ; 15:3, s. 575-581
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Tidskriftsartikel (refereegranskat)abstract
- Continuous glucose monitoring (CGM) has shown promise to reduce glycated hemoglobin (HbA1c) levels, but its cost-effectiveness is seen as uncertain by reimbursement agencies. The aim of this study was to explore the impact of real-world, off-label, patient controlled CGM use in combination with continuous subcutaneous insulin infusion (CSII) on costs and effects in patients with type 1 diabetes in a Swedish clinic.Methods:A real-world, retrospective study with questionnaire on CGM use by adult patients with type 1 diabetes on CSII (Animas Vibe) were offered sensor augmented pump therapy (SAPT) (Dexcom G4) as part of hospital innovation funding program. Direct medical costs, HbA1c, and complications following switch from CSII with self-monitoring of blood glucose (SMBG) to SAPT were calculated.Results:Questionnaire data showed that CGM sensors were on average used 92% of the time for 22 days. One hundred and thirty-nine (95%) of 146 respondents used each sensor for longer than one week. Data analysis showed a statistically significant HbA1c decrease of 0.56% (6.1 mmol/mol) after change to SAPT. In patients using the sensor 100%, the decrease was 0.89% (9.8 mmol/mol). The analysis showed that SAPT led to higher costs (5500 USD/year) than CSII + SMBG (3680 USD/year), with incremental costs being 1815 USD per year to achieve an HbA1c decrease of 0.56% (6.1 mmol/mol). The incidence of all complications declined after switch to SAPT.Conclusion:The primary data analysis showed a decrease in HbA1c values following switch to SAPT, corresponding to previous cost-effectiveness studies, but at substantially lower costs due to longer sensor off-label use.
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| 10. |
- Hilmarsdóttir, Eva, et al.
(författare)
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A Digital Lifestyle Program in Outpatient Treatment of Type 2 Diabetes : A Randomized Controlled Study
- 2021
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Ingår i: Journal of Diabetes Science and Technology. - : Sage Publications. - 1932-2968. ; 15:5, s. 1134-1141
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND: Lifestyle is important in type 2 diabetes mellitus (T2DM). This study's aim was to investigate whether a healthy-lifestyle-supporting smartphone application could affect treatment outcomes at an endocrinology outpatient clinic.METHODS: Consecutively invited patients were randomly assigned to an intervention or control group after age and gender stratification. In addition to standard care, intervention group participants used a smartphone application to access a lifestyle program (SidekickHealth) through which they received personalized recommendations and education about healthy lifestyles. Tests at baseline and every other month for six months included body weight and blood tests for glycated hemoglobin (HbA1c) and blood lipids, as well as questionnaires about distress related to diabetes, health-related quality of life, depression, and anxiety. Statistics included comparisons both within and between groups.RESULTS: A total of 37 patients (23 women) were included, whereof 30 finished, 15 in each group (19% dropout); the average age was 51.2 ± 10.6 (25-70) years. No significant differences emerged between groups, but within the intervention group, there was a significant decrease in HbA1c from 61 ± 21.4 to 52.7 ± 15.2 mmol/mol, in disease-specific distress from 19.5 ± 16.5 to 11.7 ± 13.4, and in anxiety symptoms from 5.4 ± 4.0 to 4.1 ± 3.8. No significant changes occurred within the control group. The application usage was most frequent during the first months and differed interpersonally.CONCLUSIONS: Our results indicate that the SidekickHealth digital lifestyle program could potentially enhance outpatient treatment in T2DM, in terms of both glycemic control and psychological well-being but larger confirmative studies are needed.
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