Nov 27,2023
A Randomized Trial of Closed-Loop Insulin Delivery Postpartum in Type 1 Diabetes
This study aimed to evaluate the efficacy of closed-loop insulin delivery postpartum. In this open-label, randomized controlled trial, postpartum individuals with type 1 diabetes were randomized to hybrid closed-loop insulin delivery with the MiniMed 670G/770G system in automode or sensor-augmented pump therapy in the first 12-weeks postpartum followed by a continuation phase with closed-loop insulin delivery for all until 24 weeks postpartum. Eighteen participants completed 24 weeks of postpartum follow-up. In the randomized phase, percent time in range did not differ between groups. Participants randomized to closed-loop insulin delivery spent less time <70 mg/dL and <54 mg/dL. Time >180 mg/dL was not different between groups. In the continuation phase, those initially randomized to sensor-augmented pump therapy had less time <70 mg/dL after initiation of closed-loop insulin delivery. The closed-loop group maintained similar glycemic metrics in both study phases. In conclusion, women randomized to closed-loop insulin delivery postpartum had less hypoglycemia than those randomized to sensor-augmented pump therapy.
CLINICAL STUDY
#closed loop
#insulin pump
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Nov 27,2023
Safety and Efficacy of Sustained Automated Insulin Delivery Compared With Sensor and Pump Therapy in Adults With Type 1 Diabetes at High Risk for Hypoglycemia: A Randomized Controlled Trial
The objective of this study is to assess the safety and efficacy of automated insulin delivery (AID) in adults with type 1 diabetes (T1D) at high risk for hypoglycemia. Participants were 72 adults with T1D who used an insulin pump with Clarke Hypoglycemia Perception Awareness scale score >3 and/or had severe hypoglycemia during the previous 6 months confirmed by time below range of at least 5% during 2 weeks of blinded CGM. Parallel-arm, randomized trial (2:1) of AID (Tandem t:slim ×2 with Control-IQ technology) versus CGM sensor and pump therapy for 12 weeks. The primary outcome was TBR change from baseline. An optional 12-week extension with AID was offered to all participants. Compared with the sensor and pump (S&P), AID resulted in significant reduction of TBR by 3.7%; an 8.6% increase in TIR; and a 5.3% decrease in time above range. Mean sensor glucose reading remained similar in the AID and Sensor & Pump groups. These results show that in adults with T1D at high risk for hypoglycemia, AID reduced the risk for hypoglycemia more than twofold, as quantified by TBR, while improving TIR and reducing hyperglycemia.
CLINICAL STUDY
#closed loop
#cgm
#insulin pump
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Nov 27,2023
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Automated Insulin Delivery Systems in Children and Adolescents With Type 1 Diabetes: A Systematic Review and Meta-analysis of Outpatient Randomized Controlled Trials
The glycemic control of automated insulin delivery (AID) systems in outpatient children and adolescents with type 1 diabetes (T1D) has not been systematically evaluated. To evaluate the efficacy and safety of AID systems in children and adolescents in outpatient settings, this meta analysis looks at randomized controlled trials that compared AID systems with conventional insulin therapy in outpatient children and adolescents with T1D and reported continuous glucose monitoring outcomes. Twenty-five trials (1,345 participants) were included in the meta-analysis. AID systems were associated with an increased percentage of TIR. The favorable effect was consistent whether AID was used over 3 months or 6 months. AID systems had a favorable effect on the proportion of time below range (TBR) compared with control treatment.
CLINICAL STUDY
#closed loop
#cgm
#insulin pump
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Nov 27,2023
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Technological Integration Boosts Patient Engagement & Control in Diabetes: 1st of its kind, evidence-based India centric study from Roche Diabetes Care
A landmark analysis conducted by Roche Diabetes Care including approximately 40,000 people with diabetes living in India, highlights a statistically significant reduction in eHbA1c in Type II Diabetes (T2DM) when the mySugr® application was used in conjunction with a blood glucose meter. The purpose of this analysis was to describe how people with T2DM use the mySugr mobile application and to assess the impact on glycemic management using estimated HbA1c (eHbA1c) and Points In Range (PIR). The analysis found that integration enhanced patient engagement significantly, and users reported greater frequency of blood glucose monitoring, improved medication adherence, and increased overall awareness of their diabetes care. Between January 2022 and July 2023, people with T2DM used the mySugr app with 76.1% of them connecting their mySugr app to Bluetooth-enabled glucose meters like Accu-Chek® Guide and Accu-Chek® Instant. These users who connected their meters to the mySugr app were more engaged, automatically recording 90.8 blood glucose values on average, compared to 48.75 for non-connected users.
CLINICAL STUDY
#bgm
#mobile app
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Nov 27,2023
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Dario Contracts with New Employer for Cardiometabolic Solution
DarioHealth announced today a new contract to provide its cardiometabolic solution to an employer beginning in January 2024. The Employer, a national financial and business services company, selected Dario to improve the cardiometabolic health of its population with an integrated solution for diabetes, pre-diabetes, weight management and hypertension along with tailored support for employees taking a GLP-1, or anti-obesity, medications. "Dario is seeing increased interest in our proven ability to help people achieve better cardiometabolic health through sustained behavior change, a requirement for people using medications such as GLP-1s. We are excited to support our new client's business goals with effective and easy-to-use solutions which we believe employees will love," said Rick Anderson, President of Dario.
PRODUCT
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#dtx
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Nov 28,2023
Better Therapeutics Strengthens Financial Position Through Amendment to Debt Facility and Implementation of Cost Reductions
Better Therapeutics disclosed several initiatives aimed at extending the company's cash runway sufficiently to demonstrate commercial traction with its lead product, AspyreRx. Better Therapeutics successfully negotiated an amendment to its debt facility with Hercules Capital,Inc., granting the company the opportunity to extend the Interest Only (IO) period until mid-2024, redeem up to $2.5 million of debt without prepayment penalties. In addition, to further strengthen its financial position and maintain investments to support the commercial launch of AspyreRx, the company is implementing various cost-saving measures, including company-wide salary reductions for the first quarter of 2024. These measures, along with other operational plans, are expected to improve the company’s financial position by approximately $5 million through the first quarter of 2024.
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Nov 25,2023
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Digital health application integrating wearable data and behavioral patterns improves metabolic health
The study explores the effectiveness of the remote programfrom January AI, utilizing continuous glucose monitoring (FreeStyle Libre CGM) and wearables (HR monitor (Apple Watch or Fitbit)) to provide lifestyle recommendations for preventing Type 2 Diabetes (T2D). The program enrolled 2,217 participants with varying glucose levels over 28 days, incorporating CGM data, food intake, physical activity, and wearables information through a smartphone app. The app offered daily insights and personalized recommendations based on user preferences and observed glycemic patterns. Significant improvements in hyperglycemia, glucose variability, and hypoglycemia were observed, particularly in non-diabetic individuals. Body weight decreased across all groups, and healthy eating habits improved, indicating that integrating behavior logging, CGM data, and lifestyle recommendations through a mobile app can enhance metabolic health in both nondiabetic and T2D individuals, serving as a valuable tool for T2D prevention and treatment.
CLINICAL STUDY
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#mobile app
#virtual care
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Nov 21,2023
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Kaleido launches cutting-edge Hybrid Closed Loop system with Diabeloop and Dexcom for people with diabetes
ViCentra B.V., the company behind Kaleido, one of the world's smallest, lightest insulin patch pump systems for managing type 1 diabetes, is pleased to announce the launch of a Hybrid Closed Loop system for automated insulin delivery. This system delivers insulin by using the DBLG1 algorithm from Diabeloop, which receives input from the Dexcom G6 Continuous Glucose Monitoring (CGM) sensor. Kaleido users can wear their pump as a patch or place it in their pocket at their own discretion. The system comes with two durable pumps that are rechargeable, eliminating the need to dispose of the pump every 3 days as other patch pumps do. DBLG1 algorithm considers the user's glucose levels provided by the Dexcom G6 Continuous Glucose Monitor (CGM) alongside inputs on meals and activities to determine the insulin delivery. Users and healthcare professionals have real-time access to their data insights via automated transfer to the cloud platform YourLoops. ViCentra is launching the Hybrid Closed Loop system in Germany, the Netherlands and France with its commercial partner Diabeloop. Roll-out to additional countries which include the UK and Italy is planned for 2024.
COLLABORATION
PARTNERSHIP
#connected device
#cgm
#closed loop
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