Diabetes technology & therapeutics最新文献

Aims: Real-world evidence (RWE) data on the use of automated insulin delivery (AID) systems in the MENAT region (Middle East, North Africa, Türkiye) are limited. The aim of this article is to report RWE data on the use of the MiniMed™ 780G AID system in MENAT.

Materials and methods: CareLink™ personal data as of July 01, 2024, of MENAT users from countries with more than 25 users were included. Continuous glucose monitoring-based endpoints, system usage, and insulin delivery were examined in (1) the overall cohort, (2) users who reached 12 months of system use (longitudinal cohort), and (3) users having pre- to post-AHCL (advanced hybrid closed-loop) algorithm initiation data.

Results: Seven thousand nine hundred and sixty-five users across 19 MENAT countries showed a mean glucose management index (GMI) of 6.9 ± 0.7%, time in range (TIR) of 71.7 ± 18.2%, time in tight range (TITR) of 48.9 ± 19.4%, time below range 70 mg/dL of 2.4 ± 3.9%, and time below range 54 mg/dL of 0.5 ± 1.7%. TIR and TITR were higher in users using optimal settings (glucose target = 100 mg/dL and an active insulin time = 2 h), being 76.3 ± 16.4% and 54.2 ± 18.8%, respectively. Consistent results were obtained analyzing different age groups, different countries, across the four seasons, between weekday/weekends, and day/night. Glycemic improvements began after AHCL algorithm initiation and sustained for 12 months, with a TIR and TBR70 that reached international targets in all months.

Conclusions: MiniMed 780G system RWE data in the MENAT region showed a sustained glycemic control that achieved international target criteria across different age groups, countries, and climate extremes. These findings align with RWE data from other geographies, validate the broad applicability of the MiniMed 780G benefits, and may help expand access to AID systems in the region.

Background: Continuous glucose monitoring (CGM) is increasing in insulin-treated type 2 diabetes (T2D). Yet, standardized CGM-based insulin titration is lacking. This study evaluated the feasibility of algorithmic CGM-based titration compared with self-monitoring blood glucose (SMBG) titration.

Methods: We conducted a 16-week, two-site, randomized controlled trial in adults with T2D (glycated hemoglobin 7%-9%) using degludec and adjunctive noninsulin agents, without rapid-acting insulin. Participants were assigned (2:1) to weekly algorithmic CGM-based dose changes with open CGM (EXP) or weekly SMBG-based titration with blinded CGM (CTR). Both groups received dose notifications via phone. The primary endpoint was the change in CGM-measured time in range (TIR, 70-180 mg/dL) from baseline to week 16, tested for noninferiority (-5%-percentage points [%-pt]). The trial is registered at ClinicalTrials.gov: NCT06111508.

Results: A total of 30 participants were randomized. Mean (standard deviation) TIR increased from 54.1% (22.5%) to 75.3% (19.3%) in EXP and from 50.2% (22.1%) to 55.3% (22.7%) in CTR. Mean change was +20.3%-pt versus +8.3%-pt, yielding an estimated treatment difference (EXP - CTR) of +14.6%-pt; one-sided 95% confidence interval (CI) lower bound was +4.0%-pt, exceeding the noninferiority margin (P < 0.005). Exploratory superiority analysis showed two-sided 95% CI: 1.3-27.8 (P = 0.03). CGM-measured hypoglycemia (<70 mg/dL) was low (median [interquartile range]: 0.34% [0.09-0.90] vs. 0.00% [0.00-0.41]), and level 2 episodes (SMBG <54 mg/dL) were rare (1.1 vs. 2.2 patient-year of exposure). No severe hypoglycemia or serious adverse events occurred.

Conclusions: Using CGM and receiving algorithmic CGM-based titrations were feasible, safe, and had favorable overall glycemic metrics. Long-term impact should be confirmed in broader populations.

Total pancreatectomy with islet auto-transplantation (TPIAT) treats intractable pain in patients with pancreatitis. Automated insulin delivery (AID) systems improve glycemic control in patients with diabetes, but their role in post-TPIAT glycemic management needs exploration. This case series included two patients who initiated AID after TPIAT at the Johns Hopkins Children's Center from August 2024 to June 2025. Following TPIAT, a 10-year-old male using AID met the glycemic target of 80-130 mg/dL with a mean blood glucose of 119 ± 23 mg/dL, time in range of 71%, time above range of 28%, and time below range of 1%. Similarly, in a 16-year-old female using AID after TPIAT mean blood glucose was 106 ± 15 mg/dL, time in range was 81%, time above range was 17%, and time below range was 2%. AID use after TPIAT can maintain tight glycemic control without hypoglycemia or hyperglycemia and may be considered for use in post-TPIAT glycemic management.

Objective: Missing premeal boluses negatively impacts glycemic outcomes in automated insulin delivery (AID) users. This prospective interventional study compared postprandial glycemia after missed bolus across three AID systems in children with type 1 diabetes (CwD).

Methods: CwD using MiniMed 780G (780G), Tandem Control-IQ (CIQ), or Ypsomed CamAPS (CamAPS) consumed 30 g and 50 g of carbohydrates (CH) in the form of standardized enteral nutrition, purposely omitting a premeal bolus. The mean area under the curve (AUC) of glucose concentration change and continuous glucose monitoring metrics were analyzed over 4 h postprandially and compared between the systems.

Results: Forty-three CwD completed the study (mean age = 13 years, mean HbA1c = 47 mmol/mol [6.5%]). The lowest mean AUC was reached by 780G, followed by CIQ and CamAPS (137 vs. 144 vs. 156 mmol/L·sec·10³, P < 0.01). Similar trends were seen after 50 g of CH. CamAPS users spent more time in level 2 hyperglycemia (26% for 30 g, 42% for 50 g) compared to CIQ (9.9% and 26%) and 780G (5.0% and 21%; P < 0.001).

Conclusions: AID systems differ in their capacity to compensate for missed premeal boluses. 780G and CIQ outperformed CamAPS in limiting postprandial hyperglycemia, suggesting they may be preferable for CwD prone to bolus omission.

Aims: The UNBIASED UK study is the first national study that explores disparities in access to diabetes technology among children and young people (CYP) with type 1 diabetes (T1D) from ethnic minority and low socioeconomic backgrounds in the United Kingdom. Despite the National Institute for Health and Care Excellence guidance ensuring free universal access to diabetes technologies since 2023, significant inequities persist. This article outlines key barriers and provides recommendations to improve equitable access and engagement with diabetes technologies for CYP.

Methods: A multimethod participatory approach was used, including semi-structured triad interviews with parents and CYP of underrepresented groups living in low socioeconomic areas and minority ethnic groups. Health care professionals from the National Health Service were also interviewed to explore perceived and systemic barriers to technology adoption. Thematic analysis identified key challenges and potential solutions, and new recommendations were sought from codesigned workshops and public consultations were further developed.

Results: The UNBIASED study identified key themes from parents, children, and young people, including barriers to access, experiences with diabetes technology, inconsistent services and education, intersectional challenges, communication issues, and emotional support needs. Health care professionals highlighted financial limits, language barriers, regional service differences, unconscious bias, and low awareness as major factors contributing to disparities. Key strategies and new recommendations are made to improve fair access to diabetes technologies, including systemic reforms, better communication and support, and stronger community engagement.

Conclusions: This UK UNBIASED study highlights the urgent need for standardized policies, increased awareness campaigns, culturally tailored education, peer support initiatives, and improved health care provider training to ensure equitable access to diabetes technology for all CYP with T1D in the United Kingdom.

Aims: To evaluate the impact of automated insulin delivery (AID) systems on the incidence and progression of diabetic retinopathy (DR) in adults with type 1 diabetes (T1D) compared with multiple daily injections (MDI).

Methods: This prospective cohort study followed 379 adults with T1D for a mean of 4.9 ± 1.4 years. DR was assessed via standardized retinal imaging. At baseline, 80 participants used AID, and 35 initiated AID during follow-up; 264 remained on MDI. Outcomes included baseline DR prevalence, incident DR, and DR progression. Multivariate Poisson and Cox regression models adjusted for key covariates (age, diabetes duration, pre-baseline HbA_1c) were used, with propensity score-matched and HbA1c trajectory analyses as sensitivity checks.

Results: DR prevalence at baseline was 13.9% with no group differences. Incident DR was lower among AID users (6.1% vs. 18.9% in MDI; hazard ratio = 0.33, 95% confidence interval: 0.13-0.73; P = 0.01; number needed to treat = 8). DR progression and all vision-threatening events occurred only in the MDI group (41.7% vs. 0%; P < 0.001). Use of AID systems resulted in a greater reduction in HbA_1c compared with MDI (-0.32% vs. -0.06%; P = 0.01).

Conclusions: AID systems were associated with improved glycemic control and reduced incidence and progression of DR in adults with T1D. These findings support AID use to prevent early microvascular complications.

Objective: Patients with type 1 diabetes (T1D) present early subclinical signs of vascular and endothelial dysfunction. Hybrid closed-loop systems (HCLSs) are the gold standard for glycemic management; however, their cardiovascular benefits remain unclear. The aim of this study is to determine whether HCLS improves vascular and endothelial function compared with multiple daily injections (MDIs) or sodium glucose cotransporter 2 inhibitors (SGLT-2is) in T1D.

Research design and methods: Ninety consecutive patients with poorly controlled T1D under MDI treatment were categorized into three groups according to the treatment approach: (1) HCLS or (2) SGLT-2i added to MDI or (3) intensification of MDI treatment. We assessed at baseline and 6 and 12 months posttreatment: (1) continuous glucose monitoring metrics, (2) pulse wave velocity (PWV) and central systolic blood pressure (cSBP) and central diastolic blood pressure (cDBP) as markers of vascular function, and (3) the perfused boundary region (PBR) of the sublingual arterial microvessels, as a marker of endothelial glycocalyx integrity.

Results: At 6 months, HCLS demonstrated the most significant increase in time in range (TIR) followed by SGLT-2i (+28.61 vs +10.91, P = 0.026) compared with MDI group (+2.11, P < 0.001 for all comparisons). At 12 months, patients on HCLS showed a 2-fold and a 4-fold higher increase in TIR compared with SGLT-2i (P = 0.026) and MDI group (P < 0.001), respectively. At 12 months, HCLS and SGLT-2i group displayed the most significant decrease in PWV (-15.71% and -10.14%), cSBP (-8.15% and -6.88%), and PBR (-6.98% and -8.98%) compared with MDI (+5.67%, +1.49%, and +1.99%, respectively; P < 0.05). The absolute change of PWV, PBR, and cSBP was associated with the absolute change of TIR (P < 0.05).

Conclusions: MiniMed^TM 780G HCLS demonstrated superiority over MDI or SGLT-2i in terms of glycemic control and cardiovascular function in T1D. These results support HCLS as a preferred therapeutic option for the prevention of cardiometabolic disease in individuals with T1D, in a population whose cardiovascular burden is often underrecognized in both research and clinical practice.

Diabetes is a growing public health burden across the Asia-Pacific (APAC) region. The increasing use of continuous glucose monitoring (CGM) holds significant potential to improve glycemic control and safety outcomes in individuals with diabetes. However, CGM devices in APAC vary widely in technical performance, clinical validation, and regulatory oversight, posing risks of inaccurate readings and treatment errors, especially for nonadjunctive integrated CGM (iCGM) systems. This review synthesizes the literature and regional insights on CGM regulatory frameworks, accuracy standards, and unmet needs. The authors highlight the U.S. Food and Drug Administration (FDA) iCGM standards as the most stringent global standards. Adopting FDA iCGM criteria alongside the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) reporting recommendations, with contextual modifications for diverse epidemiological, infrastructural, and socioeconomic settings in APAC, is explored. A phased, regionally coordinated approach is proposed, incorporating voluntary benchmarks, capacity-building for lower-resourced regulators, regulatory reliance mechanisms, and shared postmarketing surveillance platforms. Emphasis is placed on multistakeholder collaboration and region-specific validation studies. Harmonizing iCGM regulatory standards in APAC is anticipated to enhance device accuracy, safety, and interoperability, improve diabetes care, and streamline regulatory processes, serving as a model for regulatory excellence for other emerging medical technologies.

Background: To determine the correlation between time in tight range (TITR; 70-140 mg/dL) and prevalence of microvascular complications in patients with type 2 diabetes mellitus (T2DM).

Methods: Data of 999 patients with T2DM and negative history of cardiovascular disease were analyzed. TITR was assessed using data from a continuous glucose monitoring (CGM) system. Participants were stratified into quartiles based on TITR (Q1: ≤42.6%, Q2: >42.6 to ≤61.2%, Q3: >61.2 to ≤73.4%, Q4: >73.4%). The correlation of TITR/microvascular complications was assessed using multivariate logistic regression analysis after adjustment for potential confounders.

Results: The mean TITR was 56.8 ± 22.4%, and 51.2% of participants had at least one microvascular complication. The adjusted odds ratios for any microvascular complication across increasing TITR quartiles were 1.00 (Q1 as the reference group), 0.39 (Q2; 95% confidence interval [CI]: 0.25-0.62), 0.45 (Q3; 95% CI: 0.28-0.70), and 0.30 (Q4; 95% CI: 0.19-0.47). This indicated that the prevalence of diabetic microvasculopathies was lower in higher TITR quartiles. Similar inverse trends were observed for retinopathy, nephropathy, and peripheral neuropathy. Each 10% increase in TITR was associated with a reduced risk of each type of diabetic microvasculopathy. Receiver operating characteristic curve analysis identified 54.3% as the optimal TITR cutoff value for the identification of microvascular complications.

Conclusions: Higher TITR was significantly associated with lower prevalence of microvascular complications in patients with T2DM. CGM-derived TITR is a potentially useful clinical metric for optimizing glycemic management and reducing the risk of microvascular complications.

Trial registration number: UMIN000032325.

Excess body weight and poor metabolic control remain major contributors to cardiometabolic disease, highlighting the need for effective therapeutic options. This meta-analysis aimed to evaluate the efficacy and safety of once-daily oral orforglipron in obese adults with and without diabetes. Searches were conducted across four databases through November 2025. Five randomized controlled trials (n = 6140) were included. Orforglipron produced consistent, dose-dependent reductions in body weight, ranging from modest losses at 3 mg to more than 6 kg at 36 mg in patients with diabetes. Individuals without diabetes experienced greater weight reductions, approaching 12 kg at the highest dose. Significant improvements in body mass index, waist circumference, and glycated hemoglobin (HbA1c; -1.29%) were also observed. Gastrointestinal adverse events increased with higher dose, and no significant difference in the incidence of acute pancreatitis was identified. Overall, orforglipron demonstrated clinically meaningful metabolic benefits with an acceptable safety profile.