Aug 07,2023

The Development of Digital Therapies as a New Therapeutic Option to Treat Diseases: Focus on the International Regulatory Framework

The development of digital therapies (DTx) has attracted considerable attention in the scientific community worldwide. DTx are software-based therapeutic interventions specifically designed to prevent, manage, or treat various diseases directly in patients. Given the limited available sources on this topic in the current international scientific literature, the purpose of this review is to provide an overview of the definition and history leading up to the marketing of DTx, as well as to categorize the major DTx currently on the market on the basis of indications and mechanisms of action, with a focus on the regulatory processes that have enabled their use in clinical practice.

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#reimbursement

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Jan 26,2023

One-year follow-up comparison of two hybrid closed-loop systems in Italian children and adults with type 1 diabetes

Tandem Control-IQ and MiniMed 780G are the main Advanced Hybrid Closed Loop (AHCL) systems currently available in pediatric and adult patients with Type 1 Diabetes (T1D). The aim of this study was to evaluate glycemic control after 1-year of follow-up extending our previous study of 1-month comparison between the two systems. They retrospectively compared clinical and continuous glucose monitoring (CGM) data from the patients included in the previous study which have completed 1-year observation period. The study population consisted of 74 patients, 42 Minimed 780G users and 32 Tandem Control-IQ users. At 1-year follow-up Minimed 780G obtained better improvement in TIR (p<0.001), TAR (p=0.002), TAR>250mg/dl (p=0.001), average glucose levels (p<0.001). The use of AHCL systems led to a significant improvement of glycemic control at 1-month, which is maintained at 1-year follow-up. MiniMed is more effective than Tandem in reaching the International recommended glycemic targets.

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#closed loop

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Jul 11,2023

Real-World Performance of First- Versus Second-Generation Automated Insulin Delivery Systems on a Pediatric Population With Type 1 Diabetes: A One-Year Observational Study

The aim of this single-center observational study was to assess the real-world performance of first- and second-generation automated insulin delivery (AID) systems in a cohort of children and adolescents with type 1 diabetes over a one-year follow-up. Data on continuous glucose monitoring metrics, system settings, insulin requirements, and anthropometric parameters at three different time points (start period, six months, 12 months) were retrospectively gathered and statistically analyzed. Fifty-four individuals aged 7 to 18 years switching to AID therapy were included in the analysis. Both systems showed sustained and successful glycemic outcomes in the first year of use. However, AHCL users achieved tighter glycemic targets, without an increase of hypoglycemia risk.

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#closed loop

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Jul 08,2023

Real-World Evidence Analysis of a Hybrid Closed-Loop System

The study analyzed real-world evidence to assess the performance of the mylife CamAPS FX hybrid closed-loop system. In May 2022, the CamAPS FX app was integrated with mylife YpsoPump insulin pump and Dexcom G6 glucose sensor and launched in several countries in Europe and Australia as mylife CamAPS FX. The adaptive model predictive control algorithm residing on the app automatically calculates the insulin infusion rate every 8 to 12 minutes, which is communicated wirelessly to the insulin pump. Users from 15 countries across different age groups who used the system between May 9, 2022, and December 3, 2022, and who had ≥30 days of continuous glucose monitor data, and ≥30% of closed-loop usage were included in the current analysis (N = 1805). Glycemic outcomes from the present real-world evidence are comparable to results obtained from previous randomized controlled studies and demonstrate that users, on average, were able to achieve glycemic targets as outlined by international guidelines. 

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#closed loop

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Jul 03,2023

Economic Evaluations of mHealth Interventions for the Management of Type 2 Diabetes: A Scoping Review

There is plenty of evidence supporting the clinical benefits of mHealth interventions for type 2 diabetes, but despite often being promoted as cost-effective or cost-saving, there is still limited research to support such claims. The objective of this review was to summarize and critically analyze the current body of economic evaluation (EE) studies for mHealth interventions for type 2 diabetes. Using a comprehensive search strategy, five databases were searched for full and partial EE studies for mHealth interventions for type 2 diabetes from January 2007 to March 2022. The CHEERS 2022 checklist was used to appraise the reporting of the full EEs. Twelve studies were included in the review; nine full and three partial evaluations. All studies reported their intervention to be cost-effective or cost-saving, however, most studies’ reporting were of moderate quality with a median CHEERS score of 59%. The current literature indicates that mHealth interventions for type 2 diabetes can be cost-saving or cost-effective, however, the quality of the reporting of existing studies can be substantially improved.

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#mobile app

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Jul 28,2023

Real-World Evidence of the Cambridge Hybrid Closed-Loop App With a Novel Real-Time Continuous Glucose Monitoring System

The study evaluated the performance of the interoperable Cambridge hybrid closed-loop app with FreeStyle Libre 3 glucose sensor, and YpsoPump insulin pump in a real-world setting. Data from 100 users (63 adults, 15 children] and 22 users of unreported age) for a period of 28 days were analyzed. Time in range (3.91- 10.0mmol/L) was 72.6 ± 11.1% overall. Time below range (<3.9mmol/L) was 3.1%. Auto-mode was active for 95.8% of time. This real-world analysis suggested that the performance of Cambridge hybrid closed-loop app with this glucose sensor is comparable to other commercially available hybrid closed-loop systems.

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#closed loop

#insulin pump

#cgm

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Jul 12,2023

Association of Smartphone-Based Activity Tracking and Nocturnal Hypoglycemia in People With Type 1 Diabetes

Nocturnal hypoglycemia (NH) remains a major burden for people with type 1 diabetes (T1D). Daytime physical activity (PA) increases the risk of NH. This pilot study tested whether cumulative daytime PA measured using a smartphone-based step tracker was associated with NH. Adults with T1D for ≥ 5 years (y) on multiple daily insulin or continuous insulin infusion, not using continuous glucose monitoring and HbA1c 6 to 10% wore blinded Freestyle Libre Pro sensors and recorded total daily carbohydrate (TDC) and total daily dose (TDD) of insulin. During this time, daily step count (DSC) was tracked using the smartphone-based Fitbit MobileTrack application. The results suggested that daily PA measured by a smartphone-based step tracker was associated with the risk of NH in people with type 1 diabetes.

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#cgm

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Jul 14,2023

Prolonged Use of an Automated Insulin Delivery System Improves Sleep in Long-Standing Type 1 Diabetes Complicated by Impaired Awareness of Hypoglycemia

This study assessed changes in actigraphy-estimated sleep and glycemic outcomes after initiating automated insulin delivery (AID) Minimed 670G system. Ten adults with long-standing type 1 diabetes and impaired awareness of hypoglycemia (IAH) participated in an 18-month clinical trial assessing an AID intervention on hypoglycemia and counter-regulatory mechanisms. Data from eight participants (median age = 58 years) with concurrent wrist actigraph and continuous glucose monitoring (CGM) data were used in the present analyses. Sleep improvements were evident from 12 to 15 months after AID initiation and were preceded by improved hypoglycemia awareness , reduced hypoglycemia severity, reduced sleep-associated hypoglycemia, and reduced glucose variability.

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#closed loop

#cgm

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Jul 14,2023

First Generation of a Modular Interoperable Closed-Loop System for Automated Insulin Delivery in Patients With Type 1 Diabetes: Lessons From Trials and Real-Life Data

DBLG1 (Diabeloop Generation 1) stands as one of the five commercially available closed-loop solution worldwide for patients with type 1 diabetes as of 2023. This study aims to provide an overview of all data obtained with this system regarding outcomes and populations, with an emphasis on interoperability. Data collection ran from March 3, 2017 to April 30, 2022  (three randomized control trials and five surveys on real-life data). Overall, all sources of data (n=6859 adult patients) showed that time in range (TIR) 70 to 180 mg/dL, starting from 47.4% to 56.6%, improved from 12.2 to 17.3 percentage points. Time in hypoglycemia was reduced by 48% in average (range: 26%-70%) and reached a level of 1.3% in the largest and most recent cohort. These data obtained in different European countries were consistent throughout all reports, showing that this closed-loop system is efficient (high improvement in TIR), safe (remarkably low level of TBR), and interoperable (three pump settings so far).

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#closed loop

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Jul 27,2023

Treatment Satisfaction and Well-Being With CGM in People With T1D: An Analysis Based on the GOLD Randomized Trial

The GOLD trial was a randomized crossover trial comparing CGM versus self-monitored blood glucose (SMBG) over 16 months. Endpoints included well-being measured by the World Health Organization–Five Well-Being Index (WHO-5) and treatment satisfaction by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) as well as glucose metrics. A total of 139 participants were included. The GOLD trial demonstrated that continuous glucose monitoring (CGM) in people with type 1 diabetes (T1D) managed with multiple daily insulin injections (MDI) improved not only glucose control but also overall well-being and treatment satisfaction.

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#cgm

#bgm

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