scholarly journals Open-Source Technology for Real-Time Continuous Glucose Monitoring in the Neonatal Intensive Care Unit: Case Study in a Neonate With Transient Congenital Hyperinsulinism

10.2196/21770 ◽  
2020 ◽  
Vol 22 (12) ◽  
pp. e21770
Author(s):  
Katarina Braune ◽  
Mandy Wäldchen ◽  
Klemens Raile ◽  
Sigrid Hahn ◽  
Tebbe Ubben ◽  
...  
Keyword(s):  
Open Source ◽  
Real Time ◽  
Continuous Glucose Monitoring ◽  
Newborn Infants ◽  
Glucose Monitoring ◽  
Congenital Hyperinsulinism ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

Background Use of real-time continuous glucose monitoring (rtCGM) systems has been shown to be a low-pain, safe, and effective method of preventing hypoglycemia and hyperglycemia in people with diabetes of various age groups. Evidence on rtCGM use in infants and in patients with conditions other than diabetes remains limited. Objective This case study describes the off-label use of rtCGM and the use of an open-source app for glucose monitoring in a newborn with prolonged hypoglycemia secondary to transient congenital hyperinsulinism during the perinatal period. Methods The Dexcom G6 rtCGM system (Dexcom, Inc) was introduced at 39 hours of age. Capillary blood glucose checks were performed regularly. In order to benefit from customizable alert settings and detect hypoglycemic episodes, the open-source rtCGM app xDrip+ was introduced at 9 days of age. Results Time in range (45-180 mg/dL) for interstitial glucose remained consistently above 90%, whereas time in hypoglycemia (<45 mg/dL) decreased. Mean glucose was maintained above 70 mg/dL at 72 hours of life and thereafter. Daily sensor glucose profiles showed cyclic fluctuations that were less pronounced over time. Conclusions While off-label use of medication is both common practice and a necessity in newborn infants, there are few examples of off-label uses of medical devices, rtCGM being a notable exception. Real-time information allowed us to better understand glycemic patterns and to improve the quality of glycemic control accordingly. Severe hypoglycemia was prevented, and measurement of serum levels of insulin and further lab diagnostics were performed much faster, while the patient’s individual burden caused by invasive procedures was reduced. Greater customizability of threshold and alert settings would be beneficial for user groups with glycemic instability other than people with diabetes, and for hospitalized newborn infants in particular. Further research in the field of personal and off-label rtCGM use, efficacy studies evaluating the accuracy of low glucose readings, and studies on the differences between algorithms in translating raw sensor data, as well as customization of commercially available rtCGM systems, is needed.

scholarly journals Open-Source Technology for Real-Time Continuous Glucose Monitoring in the Neonatal Intensive Care Unit: Case Study in a Neonate With Transient Congenital Hyperinsulinism (Preprint)

2020 ◽  
Author(s):  
Katarina Braune ◽  
Mandy Wäldchen ◽  
Klemens Raile ◽  
Sigrid Hahn ◽  
Tebbe Ubben ◽  
...  
Keyword(s):  
Open Source ◽  
Real Time ◽  
Continuous Glucose Monitoring ◽  
Newborn Infants ◽  
Glucose Monitoring ◽  
Congenital Hyperinsulinism ◽  
Off Label Use ◽  
Off Label ◽  
Label Use

BACKGROUND Use of real-time continuous glucose monitoring (rtCGM) systems has been shown to be a low-pain, safe, and effective method of preventing hypoglycemia and hyperglycemia in people with diabetes of various age groups. Evidence on rtCGM use in infants and in patients with conditions other than diabetes remains limited. OBJECTIVE This case study describes the off-label use of rtCGM and the use of an open-source app for glucose monitoring in a newborn with prolonged hypoglycemia secondary to transient congenital hyperinsulinism during the perinatal period. METHODS The Dexcom G6 rtCGM system (Dexcom, Inc) was introduced at 39 hours of age. Capillary blood glucose checks were performed regularly. In order to benefit from customizable alert settings and detect hypoglycemic episodes, the open-source rtCGM app xDrip+ was introduced at 9 days of age. RESULTS Time in range (45-180 mg/dL) for interstitial glucose remained consistently above 90%, whereas time in hypoglycemia (&lt;45 mg/dL) decreased. Mean glucose was maintained above 70 mg/dL at 72 hours of life and thereafter. Daily sensor glucose profiles showed cyclic fluctuations that were less pronounced over time. CONCLUSIONS While off-label use of medication is both common practice and a necessity in newborn infants, there are few examples of off-label uses of medical devices, rtCGM being a notable exception. Real-time information allowed us to better understand glycemic patterns and to improve the quality of glycemic control accordingly. Severe hypoglycemia was prevented, and measurement of serum levels of insulin and further lab diagnostics were performed much faster, while the patient’s individual burden caused by invasive procedures was reduced. Greater customizability of threshold and alert settings would be beneficial for user groups with glycemic instability other than people with diabetes, and for hospitalized newborn infants in particular. Further research in the field of personal and off-label rtCGM use, efficacy studies evaluating the accuracy of low glucose readings, and studies on the differences between algorithms in translating raw sensor data, as well as customization of commercially available rtCGM systems, is needed.

scholarly journals Off-label innovation: characterization through a case study of rhBMP-2 for spinal fusion

2016 ◽  
Vol 25 (3) ◽  
pp. 406-414 ◽  
Author(s):  
Zane Schnurman ◽  
Michael L. Smith ◽  
Douglas Kondziolka
Keyword(s):  
Interbody Fusion ◽  
Bone Morphogenetic Protein 2 ◽  
Lumbar Interbody Fusion ◽  
Off Label Use ◽  
Off Label ◽  
Publication Patterns ◽  
Publication Data ◽  
Number Of Patients ◽  
Label Use

OBJECTIVE Off-label therapies are widely used in clinical practice by spinal surgeons. Some patients and practitioners have advocated for increased regulation of their use, and payers have increasingly questioned reimbursment for off-label therapies. In this study, the authors applied a model that quantifies publication data to analyze the developmental process from initial on-label use to off-label innovation, using as an example recombinant human bone morphogenetic protein 2 (rhBMP-2) because of its wide off-label use. METHODS As a case study of off-label innovation, the developmental patterns of rhBMP-2 from FDA-approved use for anterior lumbar interbody fusion to several of its off-label uses, including posterolateral lumbar fusion, anterior cervical discectomy and fusion, and posterior lumbar interbody fusion/transforaminal lumbar interbody fusion, were evaluated using the “progressive scholarly acceptance” (PSA) model. In this model, PSA is used as an end point indicating acceptance of a therapy or procedure by the relevant scientific community and is reached when the total number of peer-reviewed studies devoted to refinement or improvement of a therapy surpasses the total number assessing initial efficacy. Report characteristics, including the number of patients studied and study design, were assessed in addition to the time to and pattern of community acceptance, and results compared with previous developmental study findings. Disclosures and reported conflicts of interest for all articles were reviewed, and these data were also used in the analysis. RESULTS Publication data indicated that the acceptance of rhBMP-2 off-label therapies occurred more rapidly and with less evidence than previously studied on-label therapies. Additionally, the community appeared to respond more robustly (by rapidly changing publication patterns) to reports of adverse events than to new questions of efficacy. CONCLUSIONS The development of off-label therapies, including the influence of investigative methods, regulation, and changing perspectives, can be characterized on the basis of publication patterns. The approach and findings in this report could inform future off-label development of therapies and procedures as well as attempts to regulate off-label use.

scholarly journals Continuous Glucose Monitoring in the Management of Neonates with Persistent Hypoglycaemia and Congenital Hyperinsulinism

2021 ◽  
Author(s):  
Myat Win ◽  
Rowan Beckett ◽  
Lynn Thomson ◽  
Ajay Thankamony ◽  
Kathy Beardsall
Keyword(s):  
Real Time ◽  
Preterm Infants ◽  
Continuous Glucose Monitoring ◽  
Clinical Care ◽  
Neurodevelopmental Outcome ◽  
Glucose Monitoring ◽  
Relative Difference ◽  
Congenital Hyperinsulinism ◽  
Glucose Levels ◽  
Sensor Glucose

Abstract Background Persistent hypoglycaemia is common in the newborn and is associated with poor neurodevelopmental outcome. Adequate monitoring is critical in prevention, but is dependent on frequent, often hourly blood sampling. Continuous glucose monitoring (CGM) is increasingly being used in children with type 1 diabetes mellitus, but use in neonatology remains limited. We aimed to introduce real-time CGM to provide insights into patterns of dysglycaemia and to support the management of persistent neonatal hypoglycaemia. Methods This is a single centre retrospective study of real-time CGM use over a 4-year period in babies with persistent hypoglycaemia. Results CGMs were inserted in 14 babies: 8 term and 6 preterm infants, 9 with evidence of congenital hyperinsulinism (CHI). A total of 224 days of data were collected demonstrating marked fluctuations in glucose levels in babies with CHI, with a higher sensor glucose SD (1.52±0.79 mmol/l vs 0.77±0.22mmol/l) in infants with CHI compared to preterm infants. A total of 1254 paired glucose values (CGM and blood) were compared and gave a mean absolute relative difference (MARD) of 11%. Conclusion CGM highlighted the challenges of preventing hypoglycaemia in these babies when using intermittent blood glucose levels alone, and the potential application of CGM as an adjunct to clinical care.

scholarly journals 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

2020 ◽  
pp. 193229682092090
Author(s):  
Patrik Hidefjäll ◽  
Lars Berg
Keyword(s):  
Type 1 Diabetes ◽  
Data Analysis ◽  
Cost Effectiveness ◽  
Continuous Glucose Monitoring ◽  
Real World ◽  
Glucose Monitoring ◽  
Off Label Use ◽  
Pump Therapy ◽  
Off Label

Background: 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.

Indikationsfremde Anwendung von Medikamenten und Medizinprodukten in der Notfallmedizin

2019 ◽  
Vol 14 (04) ◽  
pp. 361-371
Author(s):  
Karl Peter Ittner ◽  
Joachim Koppenberg ◽  
Ute Walter
Keyword(s):  
Off Label Use ◽  
Off Label ◽  
Label Use

ZusammenfassungWenn zugelassene Arzneimittel außerhalb der in der entsprechenden Fachinformation dargelegten Beschreibungen angewendet werden, dann spricht man von einer nicht zulassungskonformen Anwendung oder von einem Off-Label-Use. Wie in fast allen medizinischen Fachgebieten gibt es auch im Rettungsdienst sogenannte Off-Label-Use-Pharmakotherapien. Sofern evidenzbasierte Informationen zu einer nicht zulassungskonformen Anwendung vorliegen, und insbesondere im konkreten Notfall keine zulassungskonforme Möglichkeit besteht, dann ist diese gerechtfertigt. Verwendet ein Notarzt aber ein Medizinprodukt außerhalb der Zulassung, dann stellt er ein neues Produkt her und haftet persönlich bei einem Patientenschaden.

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