Jan 25,2024

Assessment of Glycemic Control by Continuous Glucose Monitoring, Hemoglobin A1c, Fructosamine, and Glycated Albumin in Patients With End-Stage Kidney Disease and Burnt-Out Diabetes

Patients with diabetes and end-stage kidney disease (ESKD) may experience “burnt-out diabetes,” defined as having an HbA1c value <6.5% without antidiabetic therapy for >6 months. The research aims to assess glycemic control by continuous glucose monitoring (Dexcom G6 CGM) metrics and glycemic markers in ESKD patients on hemodialysis with burnt-out diabetes. In this pilot prospective study, glycemic control was assessed by continuous glucose monitoring (CGM), HbA1c measures, and glycated albumin and fructosamine measurements in patients with burnt-out diabetes (n = 20) and without a history of diabetes (n = 20). Patients with burnt-out diabetes had higher CGM-measured daily glucose levels, lower percent time in the range 70–180 mg/dL, higher percent time above range (>250 mg/dL), and longer duration of hyperglycemia >180 mg/dL (hours/day) compared with patients without diabetes. The use of CGM demonstrated that patients with burnt-out diabetes have significant undiagnosed hyperglycemia. CGM and glycated albumin provide better assessment of glycemic control than do values of HbA1c and fructosamine in patients with ESKD.

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Jan 15,2024

Patients with diabetes need more than glucose monitoring systems

Patients with diabetes increasingly use continuous glucose monitoring systems (CGMs), but Arti Masturzo of CCS, a chronic care management company, emphasizes that technology alone is insufficient. In an interview, Masturzo highlights the importance of education and support for patients and providers. She discusses the 2023 guidelines from the American Diabetes Association, noting that only half of CGM users receive diabetes education. Masturzo suggests personalized care, combining CGMs with education and coaching, to simplify diabetes management. She also addresses the role of primary care providers, the need for ongoing support, and challenges in underserved communities. Additionally, Masturzo emphasizes the importance of clinician training to ensure accurate CGM usage and overall diabetes care.

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Jan 11,2024

Veri Releases New Metabolic Health Program

Veri announced the release of its new in-app metabolic health program, leveraging personal biomarkers from a continuous glucose monitor (CGM) with behavior change science. Built by Veri's health team in coordination with advisors from Stanford, Duke, and Harvard, the new four-stage program gives members a personalized metabolic health coach in their pocket, including daily guidance to help members understand their metabolic health, daily goals to keep on track and lifestyle change support. Veri program package delivers 14-day wearable CGM from FreeStyle Libre and mobile app based software experience starting from €139/month, or just the app subscription for €39/month. Veri for Coaches is also offered by the company for the practitioners and coaches to keep track of their clients via coaching dashboards, and bundle their services with sensors offer by Veri.

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Jan 10,2024

Kakao Healthcare aims to go global with diabetes management

Kakao Healthcare CEO Hwang Hee took the stage at the J.P. Morgan Healthcare Conference (JPMHC) 2024 in San Francisco, unveiling ambitious plans for PASTA, its new mobile-based blood sugar management service utilizing continuous glucose monitoring (CGM) devices and smartphones. The service includes AI-based food recognition and nutrient analysis, real-time blood sugar measurement, real-time guidance, analytical reports, and a community feature for sharing blood sugar data among family and friends. Kakao Healthcare will also be providing a separate system called "PASTA Connect" to medical institutions to facilitate patient treatment and education by integrating patient data with the hospital's electronic medical record system to support patient treatment continuously. The company is set to launch the platform in Korea in February. He mentioned plans for the PASTA service to enter Japan within the year and in the U.S. by the end of next year and noted that discussions with partners for joint ventures in each region are progressing, with concrete overseas business plans expected to be revealed soon.

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Jan 08,2024 TOP STORY

Tandem Diabetes Care’s t:slim X2 Insulin Pump Integrates Automated Insulin Delivery System with Abbott’s New FreeStyle Libre 2 Plus Sensor

Abbott and Tandem Diabetes Care announced that the t:slim X2 insulin pump with Control-IQ technology is the first automated insulin delivery (AID) system to integrate with the newly available FreeStyle Libre 2 Plus sensor, Abbott’s latest continuous glucose monitoring (CGM) technology. For the first time, FreeStyle Libre technology users in the United States are now able to experience the therapeutic benefits of a hybrid closed-loop system that helps predict and prevent high and low blood sugar. Tandem’s t:slim X2 insulin pump connects wirelessly to the FreeStyle Libre 2 Plus sensor, which sends automatic glucose readings every minute to the pump. The pump’s Control-IQ technology predicts glucose levels 30 minutes into the future, automatically adjusting insulin delivery every five minutes based on CGM readings and can deliver automatic correction boluses to help prevent hyperglycemia. Abbott’s latest addition to the FreeStyle Libre portfolio is the FreeStyle Libre 2 Plus sensor, which is the modified FreeStyle Libre 2 sensor cleared in 2023 by the U.S. FDA for use with AID systems. 

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Jan 08,2024 TOP STORY

Medtronic Diabetes announces the approval for MiniMed 780G System with Simplera Sync disposable, all-in-one sensor

Medtronic announced CE Mark approval for the MiniMed 780G system with Simplera Sync, a disposable CGM requiring. Simplera Sync features a two-step insertion process and is half the size of previous Medtronic sensors. The MiniMed 780G system with Simplera Sync sensor will be available in Europe via limited release in spring 2024. Medtronic will begin the phased commercial launch in Europe in the summer of 2024. Today, the MiniMed 780G system can be used with the Guardian 4 sensor. The MiniMed 780G system is an advanced insulin delivery system, automatically adjusting and correcting glucose levels every 5 minutes, and features with a Meal Detection feature to reduce post-meal hyperglychemia. The system with Simplera Sync sensor is not approved by the FDA and is limited to investigational use in the U.S. Simplera Sync sensor is designed to leverage Medtronic's advanced AID algorithm as part of its MiniMed 780G system while having a similar look and feel as the Simplera CGM which is for integrated use with the InPen smart insulin pen.

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Jan 08,2024 TOP STORY

Dexcom Reports Preliminary, Unaudited Revenues and Announces Its New Sensor Stelo

Dexcom reported that it expects preliminary, unaudited revenue for the fourth quarter ended December 31, 2023 to be at least $1.030 billion, an increase of 26% over the fourth quarter of 2022. U.S. revenue is expected to be approximately $765 million, representing growth of 26% over the fourth quarter of 2022. International revenue is expected to be approximately $265 million, an increase of 27% over the fourth quarter of 2022. For 2024, Dexcom currently anticipates total revenue of approximately $4.15 billion to $4.35 billion, representing expected organic growth of approximately 16% to 21% over 2023. The company also announced today that Stelo, its new glucose sensor designed specifically for people with type 2 diabetes who do not use insulin, was submitted to the FDA for review in Q4 2023. Stelo will offer 15-day sensor wear, a cash-pay option and a software experience tailored specifically for non-insulin users. The system is expected to launch in the U.S. in summer 2024. Dexcom will report its audited full fourth quarter and fiscal 2023 financial results on Thursday, February 8, 2024 after the close of market.

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Dec 29,2023

PharmaSens submits insulin patch pump for FDA approval

PharmaSens announced today that it submitted an application for FDA approval for its Niia Essential insulin patch pump system. FDA submission follows the pump’s recent ISO 13485 certification for the Switzerland-based company. Niia Essential, the first of three patch pumps from PharmaSens, features a patient-centric design aimed at enhancing ease of use. PharmaSens designed its basal-bolus patch pump to combine the ease of an insulin pen with the advantages of a sophisticated pump. It features a 3 mL reservoir, offering extended usage periods and access to reimbursed patch pump therapy. PharmaSens CEO Marcel Both expects a favorable review from the FDA, with the company gearing up for a market launch. He also said the company has ongoing trade sale partnership discussions to ensure successful market entry. A sale would also allow the company to advance its product pipeline, which includes a closed-loop system and an integrated CGM sensor and pump.

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Jan 02,2024

Glucotrack Announces Early Accuracy Data For Its Implantable Continuous Glucose Monitor

GlucoTrack provides updates on initial and long-term preclinical testing for the implantable Continuous Blood Glucose Monitor™ (CBGM). The Company announces the successful completion of their first preclinical study of the implantable CBGM. The study’s objective was to assess implant technique and device safety. In addition, a small sample size of sensors was used to determine device functionality. Although not intended to be an accuracy study, the sensor demonstrates a Mean Absolute Relative Difference (MARD) of 8.1% at Day 30 and 4.5% at Day 60. The study was completed with no significant adverse effects.

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Dec 21,2023

Association of Continuous Glucose Monitoring Metrics With Pregnancy Outcomes in Patients With Preexisting Diabetes

Continuous glucose monitoring (CGM) improves maternal glycemic control and neonatal outcomes in type 1 diabetes pregnancies compared with self-monitoring of blood glucose. However, CGM targets for pregnancy are based on expert opinion. The study aimed to evaluate the association between CGM metrics and perinatal outcomes and identify evidence-based targets to reduce morbidity. This was a retrospective cohort study of pregnant patients with type 1 or 2 diabetes who used real-time CGM and delivered at a U.S. tertiary center (2018–2021). Multiple gestations, fetal anomalies, and early pregnancy loss were excluded. Exposures included time in range (TIR; 65–140 mg/dL), time above range (TAR), time below range (TBR), glucose variability, average glucose, and glucose management indicator. The primary outcome was a composite of fetal or neonatal mortality, large or small for gestational age at birth, neonatal intensive care unit admission, hypoglycemia, shoulder dystocia or birth trauma, and hyperbilirubinemia. Of 117 patients, 16 (13.7%) used CGM before pregnancy and 68 (58.1%) had type 1 diabetes. Overall, 98 patients (83.8%) developed the composite neonatal outcome. All CGM metrics, except TBR, were associated with neonatal morbidity. The statistically optimal TIR was 66–71%. Nearly all CGM metrics were associated with adverse neonatal morbidity and mortality and may aid management of preexisting diabetes in pregnancy. The findings support the American Diabetes Association recommendation of 70% TIR.

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