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Technological advances have had a major effect on the management of type 1 diabetes. In addition to blood glucose meters, devices used by people with type 1 diabetes include insulin pumps, continuous glucose monitors, and, most recently, systems that combine both a pump and a monitor for algorithm-driven automation of insulin delivery. In the next 5 years, as many advances are expected in technology for the management of diabetes as there have been in the past 5 years, with improvements in continuous glucose monitoring and more available choices of systems that automate insulin delivery. Expansion of the use of technology will be needed beyond endocrinology practices to primary-care settings and broader populations of patients. Tools to support decision making will also need to be developed to help patients and health-care providers to use the output of these devices to optimise diabetes management.

In this study involving patients with type 1 diabetes, sensor-augmented insulin-pump therapy plus automated insulin suspension when glucose dropped below 70 mg per deciliter reduced nocturnal hypoglycemia, without affecting glycated hemoglobin values. Severe nocturnal hypoglycemia can be catastrophic, 1 , 2 and hypoglycemia remains one of the most formidable barriers to improving glycemic control in patients with diabetes. 3 Sensor-augmented insulin-pump therapy offers substantial glycemic benefits, as compared with multiple daily insulin injections, but has not been shown to lower the risk of severe hypoglycemia significantly. 4 The automatic suspension of insulin delivery when a preset sensor glucose threshold is reached has the potential to mitigate hypoglycemia. The low-glucose suspend feature, available in the Medtronic Paradigm Veo pump outside the United States since 2009, was used in this study in the intervention group; the feature allows . . .

Patients with type 2 diabetes and high cardiovascular risk were assigned to receive either the glucagon-like peptide 1 analogue liraglutide or placebo. The rate of first occurrence of cardiovascular death, nonfatal MI, or nonfatal stroke was lower with liraglutide. Type 2 diabetes is a complex metabolic disorder that is characterized by hyperglycemia and associated with a high risk of cardiovascular, microvascular, and other complications. 1 , 2 Although glycemic control is associated with reductions in the risk of microvascular complications, the macrovascular benefits of glycemic control are less certain. Furthermore, concern has been raised about the cardiovascular safety of antihyperglycemic therapies. 3 Consequently, regulatory authorities have mandated cardiovascular safety assessments of new diabetes treatments. 4 , 5 Liraglutide, an analogue of human glucagon-like peptide 1 (GLP-1), 6 has been approved for the treatment of type 2 diabetes. Its efficacy in lowering glucose levels has been . . .

Digital health technology, especially digital and health applications (‘apps’), have been developing rapidly to help people manage their diabetes. Numerous health-related apps provided on smartphones and other wireless devices are available to support people with diabetes who need to adopt either lifestyle interventions or medication adjustments in response to glucose-monitoring data. However, regulations and guidelines have not caught up with the burgeoning field to standardise how mobile health apps are reviewed and monitored for patient safety and clinical validity. The available evidence on the safety and effectiveness of mobile health apps, especially for diabetes, remains limited. The European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) have therefore conducted a joint review of the current landscape of available diabetes digital health technology (only stand-alone diabetes apps, as opposed to those that are integral to a regulated medical device, such as insulin pumps, continuous glucose monitoring systems, and automated insulin delivery systems) and practices of regulatory authorities and organisations. We found that, across the USA and Europe, mobile apps intended to manage health and wellness are largely unregulated unless they meet the definition of medical devices for therapeutic and/or diagnostic purposes. International organisations, including the International Medical Device Regulators Forum and WHO, have made strides in classifying different types of digital health technology and integrating digital health technology into the field of medical devices. As the diabetes digital health field continues to develop and become more fully integrated into everyday life, we wish to ensure that it is based on the best evidence for safety and efficacy. As a result, we bring to light several issues that the diabetes community, including regulatory authorities, policymakers, professional organisations, researchers, people with diabetes and healthcare professionals, needs to address to ensure that diabetes health technology can meet its full potential. These issues range from inadequate evidence on app accuracy and clinical validity to lack of training provision, poor interoperability and standardisation, and insufficient data security. We conclude with a series of recommended actions to resolve some of these shortcomings.

Once-weekly insulin efsitora alfa (efsitora) is in development for the treatment of people with diabetes. The aim of the current study was to assess the efficacy and safety of once-weekly efsitora compared with daily insulin degludec (degludec) in adults with type 2 diabetes using basal insulin. This randomised, 78-week, phase 3, parallel-design, open-label, treat-to-target, non-inferiority study (QWINT-3) was conducted at 127 sites across nine countries. Adults (aged ≥18 years) with type 2 diabetes currently treated with basal insulin, up to three non-insulin glucose-lowering medications without prandial insulin, and glycated haemoglobin A1c (HbA1c) 6·5–10·0% (48–86 mmol/mol) were eligible. Participants were randomly assigned (2:1) to receive efsitora (n=655) or degludec (n=331). The primary endpoint was the change in least-squares mean HbA1c concentration from baseline to week 26, assessed in all randomly allocated participants who took at least one dose of study drug (excluding those who discontinued due to inadvertent enrolment), with a non-inferiority margin of 0·4% for efsitora versus degludec. The completed trial is registered at ClinicalTrials.gov (NCT05275400). Between March 8, 2022, and May 15, 2024, 1229 participants were enrolled and 986 (80%) were randomly allocated: 655 to the efsitora group and 331 to the degludec group, all of whom received at least one dose of study treatment. 871 (88%) of those randomly allocated completed 78 weeks of treatment. The population comprised 431 (44%) female and 555 (56%) male patients, median age was 62·0 years (IQR 54·0–68·0), baseline BMI was 29·65 kg/m2 (IQR 26·32–34·12), and HbA1c concentration was 7·7% (7·1–8·4). The least-squares mean change from baseline to week 26 in HbA1c concentration was –0·81 percentage points (SE 0·03; –8·85 mmol/mol [0·33]) in the efsitora group and –0·72 percentage points (0·04; –7·88 mmol/mol [0·46]) in the degludec group (estimated treatment difference –0·09 percentage points [95% CI –0·19 to 0·01]), indicating non-inferiority of efsitora to degludec. Combined level 2 hypoglycaemia (glucose concentration <54 mg/dL [<3·0 mmol/L]) or level 3 (severe) hypoglycaemia events from baseline to week 78 occurred at a similar rate for efsitora (0·84 events per patient-year of exposure; 754 events in 268 [41%] participants) and degludec (0·74 per patient-year of exposure; 346 events in 123 [37%] participants; estimated rate ratio 1·14 [95% CI 0·83–1·56]; p=0·43). Serious adverse events occurred in 103 (16%; 7 [1%] related to treatment) efsitora-treated and 37 (11%; 1 [<1%] related to treatment) degludec-treated participants; the most frequent (at ∼1%) were primarily cardiovascular-related in both groups. Nine deaths (seven in the efsitora group and two in the degludec group) occurred during the trial, but none were related to study treatment. Efsitora is a well tolerated and efficacious once-weekly alternative to daily basal insulin, with a reduced injection frequency, for the treatment of adults with type 2 diabetes. Eli Lilly and Company.

Despite substantial evidence of the benefit of frequent self-monitoring of blood glucose (SMBG) in type 1 diabetes, certain insurers limit the number of test strips that they will provide. The large database of the T1D Exchange clinic registry provided an opportunity to evaluate the relationship between the number of SMBG measurements per day and HbA1c levels across a wide age range of children and adults. The analysis included 20,555 participants in the T1D Exchange clinic registry with type 1 diabetes ≥1 year and not using a continuous glucose monitor (11,641 younger than age 18 years and 8,914 18 years old or older). General linear models were used to assess the association between the number of SMBG measurements and HbA1c levels after adjusting for potential confounding variables. A higher number of SMBG measurements per day were associated with non-Hispanic white race, insurance coverage, higher household income, and use of an insulin pump for insulin delivery (P < 0.001 for each factor). After adjusting for these factors, a higher number of SMBG measurements per day was strongly associated with a lower HbA1c level (adjusted P < 0.001), with the association being present in all age-groups and in both insulin pump and injection users. There is a strong association between higher SMBG frequency and lower HbA1c levels. It is important for insurers to consider that reducing restrictions on the number of test strips provided per month may lead to improved glycemic control for some patients with type 1 diabetes.

Abstract Rationale There is uncertainty about the effects of treating obstructive sleep apnea on glycemic control in patients with type 2 diabetes. Objectives To determine whether treatment of obstructive sleep apnea in patients with type 2 diabetes improves glycemic control. Methods In this trial, we randomized patients with type 2 diabetes and no previous diagnosis of obstructive sleep apnea, with a glycated hemoglobin level of 6.5–8.5%, and an oxygen desaturation index of 15 or more events per hour to positive airway pressure therapy or to usual care. Measurements and Main Results A total of 416 patients met the entry criteria as determined by each site and were randomized. Of the 298 participants who met centrally adjudicated entry criteria, no differences between the study groups were seen for change in glycated hemoglobin. Furthermore, there were no between-group differences when analyses were restricted to those with poorer baseline glycemic control, those with more severe sleep apnea, or those who were adherent to therapy. A greater fall in diastolic blood pressure occurred in the positive airway pressure group than in the usual care group (−3.5 mm Hg vs. −1.5 mm Hg; P = 0.07). This difference was significant in those who were adherent to positive airway pressure therapy (−4.4 mm Hg vs. −1.6 mm Hg; P = 0.02). There was a significant reduction in sleepiness in the positive airway pressure therapy group (P < 0.0001). Quality of life assessment revealed improvements in vitality, mental health, and mental component summary scores in the positive airway pressure therapy group. Conclusions This trial showed no effect of positive airway pressure therapy on glycemic control in patients with relatively well-controlled type 2 diabetes and obstructive sleep apnea. Clinical trial registered with www.clinicaltrials.gov (NCT00509223).

Diabetes is a multisystem disorder associated with a nearly twofold excess risk for a broad range of adverse cardiovascular outcomes including coronary heart disease, stroke, and cardiovascular death. Liraglutide is a human glucagon-like peptide receptor analog approved for use in patients with type 2 diabetes mellitus (T2DM). To formally assess the cardiovascular safety of liraglutide, the Liraglutide Effect and Action in Diabetes: Evaluation of cardiovascular outcome Results (LEADER) trial was commenced in 2010. LEADER is a phase 3B, multicenter, international, randomized, double-blind, placebo-controlled clinical trial with long-term follow-up. Patients with T2DM at high risk for cardiovascular disease (CVD) who were either drug naive or treated with oral antihyperglycemic agents or selected insulin regimens (human NPH, long-acting analog, or premixed) alone or in combination with oral antihyperglycemics were eligible for inclusion. Randomized patients are being followed for up to 5 years. The primary end point is the time from randomization to a composite outcome consisting of the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. LEADER commenced in September 2010, and enrollment concluded in April 2012. There were 9,340 patients enrolled at 410 sites in 32 countries. The mean age of patients was 64.3 ± 7.2 years, 64.3% were men, and mean body mass index was 32.5 ± 6.3 kg/m2. There were 7,592 (81.3%) patients with prior CVD and 1,748 (18.7%) who were high risk but without prior CVD. It is expected that LEADER will provide conclusive data regarding the cardiovascular safety of liraglutide relative to the current standard of usual care for a global population of patients with T2DM.

Laboratory HbA 1c does not always predict diabetes complications and our aim was to establish a glycaemic measure that better reflects intracellular glucose exposure in organs susceptible to complications. Six months of continuous glucose monitoring data and concurrent laboratory HbA 1c were evaluated from 51 type 1 diabetes (T1D) and 80 type 2 diabetes (T2D) patients. Red blood cell (RBC) lifespan was estimated using a kinetic model of glucose and HbA 1c , allowing the calculation of person-specific adjusted HbA 1c (aHbA 1c ). Median (IQR) RBC lifespan was 100 (86–102) and 100 (83–101) days in T1D and T2D, respectively. The median (IQR) absolute difference between aHbA 1c and laboratory HbA 1c was 3.9 (3.0–14.3) mmol/mol [0.4 (0.3–1.3%)] in T1D and 5.3 (4.1–22.5) mmol/mol [0.5 (0.4–2.0%)] in T2D. aHbA 1c and laboratory HbA 1c showed clinically relevant differences. This suggests that the widely used measurement of HbA 1c can underestimate or overestimate diabetes complication risks, which may have future clinical implications.

Most patients with type 2 diabetes begin pharmacotherapy with metformin, but eventually need additional treatment. We assessed the safety and efficacy of once weekly exenatide, a glucagon-like peptide 1 receptor agonist, versus maximum approved doses of the dipeptidyl peptidase-4 inhibitor, sitagliptin, or the thiazolidinedione, pioglitazone, in patients treated with metformin. In this 26-week randomised, double-blind, double-dummy, superiority trial, patients with type 2 diabetes who had been treated with metformin, and at baseline had mean glycosylated haemoglobin (HbA 1c) of 8·5% (SD 1·1), fasting plasma glucose of 9·1 mmol/L (2·6), and weight of 88·0 kg (20·1), were enrolled and treated at 72 sites in the USA, India, and Mexico. Patients were randomly assigned to receive: 2 mg injected exenatide once weekly plus oral placebo once daily; 100 mg oral sitagliptin once daily plus injected placebo once weekly; or 45 mg oral pioglitazone once daily plus injected placebo once weekly. Primary endpoint was change in HbA 1c between baseline and week 26. Analysis was by intention to treat, for all patients who received at least one dose of study drug. This trial is registered with ClinicalTrials.gov, number NCT00637273. 170 patients were assigned to receive once weekly exenatide, 172 to receive sitagliptin, and 172 to receive pioglitazone. 491 patients received at least one dose of study drug and were included in the intention-to-treat analysis (160 on exenatide, 166 on sitagliptin, and 165 on pioglitazone). Treatment with exenatide reduced HbA 1c (least square mean −1·5%, 95% CI −1·7 to −1·4) significantly more than did sitagliptin (−0·9%, −1·1 to −0·7) or pioglitazone (−1·2%, −1·4 to −1·0). Treatment differences were −0·6% (95% CI −0·9 to −0·4, p<0·0001) for exenatide versus sitagliptin, and −0·3% (−0·6 to −0·1, p=0·0165) for exenatide versus pioglitazone. Weight loss with exenatide (−2·3 kg, 95% CI–2·9 to −1·7) was significantly greater than with sitagliptin (difference −1·5 kg, 95% CI −2·4 to −0·7, p=0·0002) or pioglitazone (difference −5·1 kg, −5·9 to −4·3, p<0·0001). No episodes of major hypoglycaemia occurred. The most frequent adverse events with exenatide and sitagliptin were nausea (n=38, 24%, and n=16, 10%, respectively) and diarrhoea (n=29, 18%, and n=16, 10%, respectively); upper-respiratory-tract infection (n=17, 10%) and peripheral oedema (n=13, 8%) were the most frequent events with pioglitazone. The goal of many clinicians who manage diabetes is to achieve optimum glucose control alongside weight loss and a minimum number of hypoglycaemic episodes. Addition of exenatide once weekly to metformin achieved this goal more often than did addition of maximum daily doses of either sitagliptin or pioglitazone. Amylin Pharmaceuticals and Eli Lilly.