BMJ Open Diabetes Research & Care最新文献

Introduction: Painful diabetic peripheral neuropathy (pDPN), a common complication of diabetes, is challenging to treat and negatively impacts quality of life (QoL). Many patients either fail to achieve adequate pain relief with current treatments or suffer from systemic side effects with oral options. This study used data from the German Pain e-Registry (GPeR) to evaluate the high-concentration capsaicin topical system (HCCTS) for treating pDPN of the feet.

Research design and methods: This retrospective, non-interventional cohort study (CASPAR) included patients with pDPN of the feet who received ≥1 HCCTS treatment (~3-month treatment intervals) and contributed data to the GPeR for ≥12 months. Data were collected on pain intensity, QoL, sleep, mood, concomitant medication, and tolerability.

Results: Overall, 365 patients with pDPN of the feet were included. Significant reductions in 24-hour average pain intensity (API) were observed from baseline to month 3 (following one HCCTS treatment). Further reductions in mean API score were seen over 12 months with ongoing treatments, whereas API increased in patients who discontinued treatment (baseline to month 12 mean API scores: 61.4 to 8.8 for four HCCTS [∆ -52.6], 59.3 to 16.7 for three HCCTS [∆ -42.6], 56.3 to 31.9 for two HCCTS [∆ -24.4], 57.5 to 51.4 for one HCCTS [∆ -6.1]). Similar trends were seen for sleep, mood, and QoL outcomes. There was a significant reduction in concomitant pain medication use in patients receiving ongoing HCCTS treatments. The most common adverse events were local application-site reactions.

Conclusions: This real-world study in patients with pDPN of the feet demonstrates that ongoing HCCTS treatments continue to improve pain intensity, mood, and QoL, while concomitant medication use decreases. Benefits from treatment were lost following HCCTS discontinuation. These findings emphasize the importance of ongoing treatments to achieve the potential of HCCTS in improving outcomes for patients with pDPN.

Background: Previous studies have demonstrated disparities in the utilization of diabetes technology among youth with type 1 diabetes (T1D) based on race and socioeconomic status (SES). Few studies have examined these differences on a national scale or among youth with commercial health insurance.

Aim: To investigate differences in the fill rates of insulin pumps and continuous glucose monitors (CGMs) among commercially insured children with T1D across diverse racial and SES groups.

Methods: Using medical and pharmacy claims included in the OptumLabs Data Warehouse, we calculated the proportion of youth <18 years with T1D who had a fill for an insulin pump or a CGM, overall and stratified by race/ethnicity and annual household income, between 2011 and 2021.

Results: Among 13,246 youth with T1D, 36.1% had CGM and 30.9% had pump fills. White youth had higher CGM and pump fills than black (CGMs: 35.8% vs 22.5%; pumps: 31.9% vs 21.2%, p<0.001) and Hispanic (CGMs: 35.8% vs 32.6%, p=0.047; pumps: 31.9% vs 25.0%, p<0.001). Youth from households with income

Conclusions: In a cohort of commercially insured youth with T1D, both race and income are important factors that can independently influence the use of diabetes technology. Racial disparities decrease with higher income and disappear at incomes ≥US$200,000. Black youth with income

Introduction: To compare carotid intima-media thickness (cIMT) and liver fat content in subjects who maintained good glycemic control for 6 years on initial triple therapy with metformin/exenatide/pioglitazone versus sequential add-on therapy with metformin followed with glipizide and basal insulin in subjects with new-onset diabetes.

Research design and methods: Liver fat content and cIMT were compared among patients with T2DM who received initial triple therapy with metformin/pioglitazone/exenatide (n=29) versus metformin, followed by stepwise addition of glipizide and then insulin glargine (n=26) and who maintained HbA1c<6.5% for 6 years in Efficacy and Durability of Initial Combination Therapy for Type 2 Diabetes.

Results: After 6 years in subjects receiving initial triple therapy with metformin/pioglitazone/exenatide and subjects receiving sequential addition of metformin followed by glipizide and insulin glargine had a mean HbA1c of 5.7% vs 6.0%, respectively, p=NS. Nonetheless, subjects receiving sequential add-on therapy experienced a greater increase in cIMT and manifested greater liver fat content and fibrosis than subjects receiving initial triple therapy.

Conclusions: Including pioglitazone plus exenatide in the glucose-lowering regimen slows the progression of cIMT and was associated with lower hepatic fat content and fibrosis compared with subjects receiving sequential add-on therapy without pioglitazone and exenatide despite comparable optimal glycemic control.

Trial registration number: NCT01107717.

Introduction: Glucagon-like peptide-1 receptor agonists (GLP-1 RA) and dual glucose insulinotropic polypeptide (GIP)/GLP-1 RA are widely prescribed, but their effectiveness in different subtypes of maturity-onset diabetes of the young (MODY) is unknown.

Research design and methods: We present a descriptive case series of individuals from two MODY cohorts who used GLP-1 RA or dual GIP/GLP-1 RA. Paired t tests were used to compare HbA1c, body mass index (BMI), and sulfonylurea (SU) dose before and after GLP-1 RA or dual GIP/GLP-1 RA therapy.

Results: 10 individuals (4 hepatocyte nuclear factor-1α (HNF1A)-MODY, 4 hepatocyte nuclear factor-4α (HNF4A)-MODY, 1 ATP-binding cassette transporter subfamily C member 8 (ABCC8)-MODY, 1 hepatocyte nuclear factor-1β (HNF1B)-MODY) were identified who used GLP-1 RA or dual GIP/GLP-1 RA. In patients with HNF1A-MODY and HNF4A-MODY, GLP-1 RA reduced HbA1c by 1.3% (p=0.010), BMI by 2.90 kg/m² (p=0.008), and total daily dose of SU by 66.6% (p=0.005). Dual GIP/GLP-1 RA treatment led to a non-statistically significant decrease in HbA1c of 1.8% (p=0.104), a statistically significant reduction in BMI of 8.73 kg/m² (p=0.010), and all patients discontinued SU (n=2) and one discontinued insulin. In patients with ABCC8-MODY and HNF1B-MODY, GLP-1 RA reduced HbA1c by 1.2% and 1.8%, BMI by 1.1 kg/m² and 1.2 kg/m², and the patients no longer required treatment with SU or insulin, respectively.

Conclusions: GLP-1 RA and dual GIP/GLP-1 RA lowered HbA1c, BMI, and SU dose in patients with MODY.

Introduction: About one-third of adults in the USA have some grade of hepatic steatosis. Coronary artery calcium (CAC) scans contain more information than currently reported. We previously reported new artificial intelligence (AI) algorithms applied to CAC scans for opportunistic measurement of bone mineral density, cardiac chamber volumes, left ventricular mass, and other imaging biomarkers collectively referred to as AI-cardiovascular disease (CVD). In this study, we investigate a new AI-CVD algorithm for opportunistic measurement of liver steatosis.

Methods: We applied AI-CVD to CAC scans from 5702 asymptomatic individuals (52% female, age 62±10 years) in the Multi-Ethnic Study of Atherosclerosis. Liver attenuation index (LAI) was measured using the percentage of voxels below 40 Hounsfield units. We used Cox proportional hazards regression to examine the association of LAI with incident CVD and mortality over 15 years, adjusted for CVD risk factors and the Agatston CAC score.

Results: A total of 751 CVD and 1343 deaths accrued over 15 years. Mean±SD LAI in females and males was 38±15% and 43±13%, respectively. Participants in the highest versus lowest quartile of LAI had greater incidence of CVD over 15 years: 19% (95% CI 17% to 22%) vs 12% (10% to 14%), respectively, p<0.0001. Individuals in the highest quartile of LAI (Q4) had a higher risk of CVD (HR 1.43, 95% CI 1.08 to 1.89), stroke (HR 1.77, 95% CI 1.09 to 2.88), and all-cause mortality (HR 1.36, 95% CI 1.10 to 1.67) compared with those in the lowest quartile (Q1), independent of CVD risk factors.

Conclusion: AI-enabled liver steatosis measurement in CAC scans provides opportunistic and actionable information for early detection of individuals at elevated risk of CVD events and mortality, without additional radiation.

Introduction: Ringer's lactate (RL), a balanced crystalloid by regenerating bicarbonate ion, may lead to early diabetic ketoacidosis (DKA) resolution and reduced hyperchloremia as compared with 0.9% saline (NS).

Research design and methods: This was a double-blind randomized controlled trial conducted in the pediatric emergency and intensive care units of a teaching hospital. Children with type 1 diabetes mellitus (T1DM) aged 9 months to 12 years who presented in DKA were included. Participants were randomized to receive either NS or RL as initial fluid (used for both resuscitation and replacement). The primary outcome was time to resolution of DKA. Secondary outcomes included change in serum chloride and bicarbonate from baseline, total fluid received and incidence of acute kidney injury.

Results: The study was conducted between December 2020 and December 2021, and 67 children were recruited (34 in the NS group and 33 in the RL group). The mean time to DKA resolution was shorter in the RL group compared with the NS group (12.9±7.9 vs 16.8±9 hours). The mean difference and HR for time to DKA resolution in the RL group compared with the NS group were 3.85 hours (95% CI 0.3 to 8) and 1.39 hours (95% CI 1.25 to 1.56), respectively. The rise in chloride from baseline was higher in the NS group as compared with the RL group at 4 and 8 hours (8.7±5.6 vs 3.9±5.1 mmol/L) and (10.8±7.7 vs 4.4±8.3 mmol/L), respectively. On the contrary, the rise in bicarbonate from baseline to 12 hours was significantly higher in the RL group as compared with the NS group (14.7±1.6 vs 12.9±3.1).

Conclusions: The time to resolution of DKA was shorter in RL group as compared with the NS group. Regeneration of bicarbonate from lactate ion in the RL forms a strong physiological basis for this outcome as compared with hyperchloremia induced by NS. This makes RL a favorable option in children with DKA.

Introduction: Recent post hoc analyses indicate that patients with normal or low body mass index (BMI) benefit from sodium-glucose cotransporter-2 (SGLT2) inhibitor use. We aimed to evaluate the effects of SGLT2 inhibitors on renal and patient outcomes in patients with diabetes and normal or low BMI.

Research design and methods: This single-center retrospective cohort study included 5,842 adult patients with type 2 diabetes and BMI<23 kg/m² from 2016 to 2020. Patients were divided into control and SGLT2 inhibitor groups and matched using propensity scores. The primary outcome was the annual change in the estimated glomerular filtration rate (eGFR). Secondary outcomes included change in BMI, a composite renal outcome (eGFR decline of ≥40% from baseline or end-stage kidney disease), all-cause mortality, and cardiovascular disease (CVD).

Results: Overall, 648 patients were selected for propensity score matching, of whom 216 (33.3%) were receiving SGLT2 inhibitors. The mean age and eGFR were 61.6 years and 84.7 mL/min/1.73 m², respectively. The median urine albumin-to-creatinine ratio was 11.6 mg/gCr. The control group showed relatively unchanged eGFR over time, whereas the SGLT2 inhibitor group showed an increase in eGFR over time (0.0 vs +0.3 mL/min/1.73 m²/year, p=0.0398). SGLT2 inhibitor use was associated with a lower risk of mortality (HR 0.171, 95% CI 0.041 to 0.718, p=0.0159) and composite renal outcome (HR 0.223, 95% CI 0.052 to 0.952; p=0.0426), but not with the risk of CVD.

Conclusions: SGLT2 inhibitor use may reduce the risk of eGFR decline and all-cause mortality even in low-risk patients with diabetes and normal or low BMI.

Introduction: Several factors influence individuals' confidence to perform diabetes-related self-care activities, including perceived patient-provider communication, diabetes duration and age at diagnosis. It has been well-documented that patient-provider communication is essential when managing chronic diseases such as diabetes; however, the impact of this communication with diabetes duration and age at diabetes diagnosis on confidence in performing self-care behaviors is obscure.

Research design and methods: We utilized data from the 2021 Household Component of the Medical Expenditure Survey among participants 18 years or older who had completed the Diabetes Care Survey. Ordinal logistic regression models were utilized to assess the association between confidence in performing diabetes self-care (outcome) and perceived communication with healthcare providers (exposure). Age at diabetes diagnosis and diabetes duration were secondary exposures of interest.

Results: 1231 participants were included in the analyses. In primary analyses, we observed that greater perceived healthcare provider communication resulted in greater confidence in diabetes self-care (OR (95% CI) 1.14 (1.08, 1.21)). Results also showed that patients who were diagnosed at older ages have less confidence in managing their diabetes than patients diagnosed at younger ages (OR (95% CI) 0.93 (0.88, 0.99)); correspondingly, longer diabetes duration was associated with greater confidence in diabetes self-care (OR (95% CI) 1.09 (1.01, 1.17)).

Conclusions: Confidence in self-care is greatly influenced by perceptions of patient-provider communication, age at diagnosis and diabetes duration. Specifically, having healthcare providers clearly explain things to patients is vital to increasing diabetes self-care. Because self-care is important when managing chronic diseases such as diabetes, future studies should tailor interventions for optimal outcomes.

Introduction: Roux-en-Y gastric bypass (RYGB) increases the risk of postprandial hypoglycemia, whereas pregnancy decreases insulin sensitivity, which could be expected to counteract hypoglycemia. We examined if RYGB performed prior to pregnancy altered the postprandial glucose metabolism and enteropancreatic hormone responses to a mixed meal test (MMT).

Research design and methods: Twenty-three women with RYGB and 23 women matched on prepregnancy body mass index and parity underwent a 4-hour MMT in the first and third trimester of pregnancy with measurement of circulating levels of glucose, insulin, C-peptide, glucose-dependent insulin peptide (GIP), glucagon-like peptide 1 (GLP-1), glucagon, free fatty acids, and lactate. Biochemical hypoglycemia was defined as plasma glucose <3.5 mmol/L.

Results: Women with RYGB had earlier and higher peak glucose, lower nadir glucose levels, and a higher frequency of biochemical hypoglycemia compared with women without RYGB in both the first and third trimester. The lower glucose levels were preceded by markedly elevated total GLP-1 and insulin levels in women with RYGB, whereas total GIP levels were unaltered. The glucagon levels were lower in women with RYGB. In the first trimester MMT, peak and area under the curve of total plasma GLP-1 and serum insulin levels were negatively associated with nadir plasma glucose, while the early postmeal response of plasma glucagon was positively associated with nadir plasma glucose in the third trimester.

Conclusions: These results provide novel insights into the combined effects of RYGB and pregnancy on postmeal glucose metabolism and enteropancreatic hormone responses during pregnancy, and how these changes associate with an increased risk of postprandial hypoglycemia.

Trial registration number: NCT03713060.