Insulin-treated Diabetes Research Articles

A Telehealth Program Using Continuous Glucose Monitoring and a Connected Insulin Pen Cap in Nursing Homes for Older Adults with Insulin-Treated Diabetes: The Trescasas Study.

Objective: To assess the impact and feasibility of a telehealth program using continuous glucose monitoring (CGM) and a connected insulin pen cap (CIPC) in nursing homes for older adults with insulin-treated diabetes. Research Methods: This multicenter, prospective, sequential, single-arm study consisted of three phases: (1) baseline, blind CGM (Freestyle Libre Pro®); (2) intervention 1, CGM (Freestyle Libre2®) without alarms; and (3) intervention 2, CGM with alarms for hypo and hyperglycemia. Two telehealth visits from reference diabetes units were conducted to adjust antidiabetic treatments. Insulin treatment was tracked using the Insulclock® CIPC. The study's primary objective was to evaluate the reduction of hypoglycemia rate. Results: Of 82 eligible patients at seven nursing homes, 54 completed the study (age: 87.7 ± 7.1, 68-102 years, 56% women, duration of diabetes: 18.7 years, baseline glycated hemoglobin: 6.9% [52 mmol/mol]). The mean number of hypoglycemic events was significantly reduced from baseline (4.4) to intervention 1 (2.8; P = 0.060) and intervention 2 (2.1; P = 0.023). The time below range 70 mg/dL (3.9 mmol/L) significantly decreased from 3.7% at baseline to 1.4% at intervention 2 (P = 0.036). The number of insulin injections significantly decreased from baseline to intervention 1 (1.2 to 0.99; P = 0.027). Nursing home staff expressed a positive view of the program, greater convenience, and potential to reduce hypoglycemia with the Freestyle Libre2® CGM versus the glucometer. Conclusions: A telehealth program using CGM and a CIPC was associated with improved glycemic profiles among institutionalized older individuals with diabetes receiving insulin and was well perceived by professionals.

Effects of atmospheric pressure change during flight on insulin pump delivery and glycaemic control of pilots with insulin-treated diabetes: an in vitro simulation and a retrospective observational real-world study.

Glycaemic control and clinical outcomes in diabetes are improved by continuous subcutaneous insulin infusion (CSII). Atmospheric pressure changes during flights may affect insulin delivery from pumps and cause unintended metabolic consequences, including hypoglycaemia, in people with type 1 diabetes. The present report evaluates both hypobaric flight simulation and real-world data in pilots using insulin pumps while flying. In the flight simulation part of this study, an in vitro study of insulin pumps was conducted in a hypobaric chamber, de-pressurised to 550 mmHg to mimic the atmospheric pressure changes in airliner cabins during commercial flights. Insulin delivery rates and bubble formation were recorded for standard flight protocol. Insulin infusion sets, without pumps, were tested in a simulated rapid decompression scenario. The real-world observational study was a 7.5-year retrospective cohort study in which pre- and in-flight self-monitored blood glucose (SMBG) values were monitored in pilots with insulin-treated diabetes. Commercial and private pilots granted a medical certificate to fly within the European Union Aviation Safety Agency approved protocol and receiving insulin either by pump or multiple daily injections (MDI) were included. In the flight simulation study, full cartridges over-delivered 0.60 U of insulin during a 20 min ascent and under-delivered by 0.51 U during descent compared with ground-level performance. During emergency rapid decompression, 5.6 U of excess insulin was delivered. In the real-world study, seven pilots using CSII recorded 4656 SMBG values during 2345 h of flying across 1081 flights. Only 33 (0.7%) values were outside an acceptable safe range (5.0-15.0 mmol/l [90-270 mg/dl]). No clinically significant fall in the median SMBG concentration was observed after aircraft ascent and no in-flight SMBG values were within the hypoglycaemic range (<4.0 mmol/l [<72 mg/dl]). Compared with pilots receiving MDI therapy, pilots using CSII recorded more SMBG values within the acceptable range (99.3% vs 97.5%), fewer values in the low red range (0.02% vs 0.1%), fewer in-flight out-of-range values (0.2% vs 1.3%) and maintained stricter glycaemic control during flight. Ambient pressure reduction during simulated flights results in bubble formation and expansion within insulin cartridges. This causes unintended delivery of small insulin doses independent of pre-determined delivery rates and represents the maximum amount of insulin that could be delivered and retracted. However, in vivo, pilots using CSII in-flight did not experience a fall in blood glucose or episodes of hypoglycaemia during these atmospheric pressure changes and the use of insulin pumps can be endorsed in view of their clinical benefits.

Predicting the Risk of Adverse Neonatal Outcomes in Women With Insulin-Treated Diabetes: Is It Time for a Pregnancy-Specific Glycemic Risk Index (GRI)?

The Glycemia Risk Index (GRI) describes the quality of glycemic control, emphasizing extreme hypoglycemia and hyperglycemia more than less extreme values. However, a pregnancy-specific GRI (pGRI), tailored to the tighter target glucose range required during pregnancy, has not been established. We retrospectively evaluated clinical, metabolic, and Continuous Glucose Monitoring (CGM) data across pregnancy in women with insulin-treated diabetes, managed between September 2021 and March 2024 at the University Hospital of Pisa. First and second levels of hyperglycemia (TAR1: 140-180 mg/dL, TAR2: >180 mg/dL) and hypoglycemia (TBR1: 63-54 mg/dL, TBR2: <54 mg/dL) were used to calculate the pGRI at each trimester. Logistic regression analysis investigated the association between pGRI and risk of at least one adverse neonatal outcome (among preterm delivery, macrosomia, large for gestational age, small for gestational age, neonatal hypoglycemia, neonatal jaundice, and neonatal intensive care unit admission). Of 45 pregnant women, 25 (56%) experienced at least one adverse neonatal outcome. In the third trimester, women with adverse outcomes had significantly higher total TAR (26 [12-32]% vs 10 [4-23]%, P = .018) and lower TIR (71 [64-83]% vs 88 [75-92]%, P = .007). Specifically, the difference was notable in TAR2 (6 [2-15]% vs 1 [0-4]%, P = .004), whereas TAR1 was comparable between the 2 groups. Accordingly, third trimester pGRI was higher in women with adverse neonatal outcomes (38 [18-49]% vs 18 [10-31]%, P = .013) and, at logistic regression, slightly but significantly increased the risk of adverse neonatal outcomes (1.044 [1.004-1.086], P = .024). Pregnant women with insulin-treated diabetes reporting adverse neonatal outcomes spent more time in hyperglycemia, particularly in extreme hyperglycemia. Therefore, the level of hyperglycemia should always be assessed during pregnancy. The pGRI, emphasizing extreme hyperglycemia, may be a novel comprehensive tool for assessing the risk of adverse neonatal outcomes.

Characterization of human placental fetal vessels in gestational diabetes mellitus.

Gestational diabetes mellitus is one of the most common complications during pregnancy. Its prevalence is rapidly increasing worldwide. Gestational diabetes mellitus is leading to an elevated risk for the development of endothelial dysfunction and cardiovascular diseases both in the mother and the child in later life. The underlying pathophysiological mechanisms are not well-understood. Therefore, we aimed to characterize the endothelial function in fetal placental vessels from mothers with gestational diabetes mellitus. In this study, we distinguished between insulin-treated and diet-controlled gestational diabetes mothers and compared them to a normoglycemic control group. The clinical data confirmed pre-conceptional overweight as a risk factor in women with insulin-treated gestational diabetes mellitus. The insulin-treated gestational diabetes group was also characterized by a recent family history of diabetes compared to mothers of the control or diet-controlled gestational diabetes group. Analyses of blood serum from umbilical cords suggested a reduced fetal insulin metabolism in the insulin-treated gestational diabetes group. Vascular function analysis in fetal placental vessels revealed an altered substance P-induced vasorelaxation in vessels from patients with insulin-dependent gestational diabetes. Inhibition of nitric oxide synthase affected only fetal vessel segments from the control group or diet-controlled gestational diabetes group, but not from insulin-dependent gestational diabetes. Finally, we found a significantly decreased substance P receptor (TACR1) mRNA expression in fetal vessel segments from patients with insulin-treated gestational diabetes. In conclusion, we provide evidence that different pathophysiological mechanisms might be responsible for the development of insulin-treated versus diet-controlled gestational diabetes. Only in fetal vessels from patients with insulin-treated gestational diabetes were we able to detect an endothelial dysfunction and a reduced fetal insulin conversion. This provides novel insights into the pathophysiology of the subtypes of gestational diabetes.

Associations between diabetes and risk of short-term and long-term nursing home stays among older people receiving home care services: A nationwide registry study

BackgroundOlder people with diabetes who live at home and receive home care services (HCS) are vulnerable, which may result in a need for more care than the HCS can provide. In this study we aimed to explore associations between pharmacologically treated diabetes and the risk of short-term and long-term nursing home stays (NHS) among older people receiving HCS.MethodsThis nationwide registry study included older people ≥ 65 years receiving HCS, as registered in the Norwegian Information System for the Nursing and Care Sector (IPLOS) (2010–2014). Data from IPLOS were merged with data from the Norwegian Prescription Database and the Norwegian Patient Registry. Pharmacologically treated diabetes (hereafter referred to as diabetes) was defined based on prescriptions of glucose-lowering drugs (GLD) (≥ 1 prescription in the current or previous year). Persons not prescribed GLD were defined as not having diabetes. Based on Anatomical Therapeutic Chemical (ATC) codes we identified the following subgroups: persons without diabetes, persons using “non-insulin GLD only”, “insulin and non-insulin GLD” and “insulin only”. An NHS was defined as at least one stay during a given calendar year, where a short-term NHS is temporary, and a long-term NHS is permanent. Log-binomial regression was used to test for differences in NHS and results are reported as risk ratios (RR) with 95% CIs.ResultsBoth insulin-treated subgroups had a higher risk of a short-term NHS (“insulin only” users RR 1.06 (CI 1.03–1.09) and “insulin and non-insulin GLD” users RR 1.04 (CI 1.02–1.06)) compared to those without diabetes. In general, persons with diabetes had a lower risk of a long-term NHS than those without diabetes (RR 0.92 (CI 0.89–0.94)). The subgroup using “insulin and non-insulin GLD” had the lowest risk of a long-term NHS (RR 0.86 (CI 0.81–0.91)).ConclusionDespite a lower risk of a long-term NHS among older people with diabetes, we found an increased risk of a short-term NHS among persons with insulin-treated diabetes who live at home and receive HCS. This calls for attention when planning health care, in order to provide coordinated and individualized care to prevent short-term NHS’s.

6810 Successful Insulin Allergy Desensitization To Humalog During The Second Trimester Of Pregnancy

Abstract Disclosure: J. Noreña: None. S. Seav: None. S. Jiang: None. S. McGhee: None. M. Tan: None. M. Basina: None. Background: Insulin allergy is rare, occurring in only 0.1 to 3% of people with insulin-treated diabetes. During pregnancy, this incidence is even lower due to a relative immunosuppressive state. Currently, there are no standardized insulin allergy desensitization protocols for this specific patient population. Clinical Case: A 39-year-old female (G4P3003) with T2DM and multiple prior medication allergies presented to the antepartum unit in her 17th week of pregnancy due to hyperglycemia and reported insulin allergy to NPH insulin.Patient was initially diagnosed with gestational diabetes during her third pregnancy, requiring NPH insulin which she seemed to tolerate well at the time. She remained medication-free for two years post-delivery but later developed T2DM with an A1c of 6.8%. Metformin and Jardiance, previously prescribed, were discontinued upon confirmation of her current pregnancy. She opted to manage her diabetes through diet and exercise alone, but her A1c rose to 7.0%, prompting the initiation of NPH.Following the first dose of NPH at home, she experienced a localized burning sensation at the injection site associated with facial flushing, followed by a diffuse, pruritic, erythematous rash on her face, chest, abdomen, and bilateral arms. Due to her history of anaphylaxis to other drugs (mainly antibiotics), she was admitted to the hospital for monitoring. Inpatient attempts with lower doses of NPH and then a trial of glargine triggered new rash episodes. Work-up revealed negative insulin antibodies, low IgG, and a normal CBC. She was started on Humalog to cover basal dose administered every 6 hours and additional prandial injections, which she tolerated prior to discharge. One week later, she developed a new local erythematous reaction at the Humalog injection site followed by a generalized rash which led to her readmission.Allergy was consulted and facilitated a successful desensitization protocol to Humalog. The protocol included escalating doses of insulin administered every 30 minutes (0.1u, 0.2u, 0.4u, 0.8u, 1u, 2u, 3u, 3u) to achieve a pre-determined cumulative dose of 10.5 units. Patient tolerated the protocol well and was discharged with q6h Humalog for basal coverage in addition to prandial doses with plan to transition to insulin pump therapy with Humalog soon. Conclusion: This unique case demonstrates how insulin desensitization can be a safe and successful strategy to help achieve insulin tolerance and glycemic control during pregnancy. Election of an insulin, such as Humalog, that can achieve the one-hour post-prandial glucose target during pregnancy and also provide effective basal coverage should be considered as desensitization can only be done with one insulin type at a time. Presentation: 6/2/2024

Long-term clinical outcomes of drug-coated balloon angioplasty for de novo coronary lesions in patients with diabetes mellitus.

We investigated whether drug-coated balloon (DCB) treatment is effective for all de novo cases of coronary artery disease (CAD) in patients with diabetes mellitus. Furthermore, we also investigated the relationship between the degree of diabetes mellitus and clinical outcomes after DCB treatment. In this study, we included 516 consecutive patients with de novo CAD who were treated with DCB. The patients were divided into the diabetic and non-diabetic groups. Patients with diabetes mellitus were further classified into non-insulin-treated diabetes mellitus (NITDM) and insulin-treated diabetes mellitus (ITDM). The primary endpoints were major adverse cardiovascular ischemic events (MACE) and clinically driven target lesion revascularization (CD-TLR). Within a mean clinical follow-up period of 2.5years, the incidence of MACE among patients with diabetes mellitus (22.1%) was almost twice that of non-diabetic patients (11.9%) with a relative risk of 1.86 (95% CI 1.24-2.79, p = 0.002). The 3-year CD-TLR occurred in 28 patients with diabetes mellitus (10.6%) and 13 non-diabetic patients (5.1%, p = 0.02). ITDM patients had a significantly higher rate of MACE compared with non-diabetic patients with a relative risk of 2.86 (95% CI 1.76-4.63, p = 0.0002). ITDM remained an independent predictor of 3-year MACE with an odd ratio of 1.96 (95% CI 1.00-3.83, p = 0.05). In patients undergoing DCB, the presence of DM was associated with a higher risk of MACE and CD-TLR. Particularly in DCB, treatment was still inadequately effective for ITDM patients.

Velagliflozin, a once-daily, liquid, oral SGLT2 inhibitor, is effective as a stand-alone therapy for feline diabetes mellitus: the SENSATION study.

To investigate safety and effectiveness of velagliflozin oral solution as sole therapy in naïve and previously insulin-treated diabetic cats. 252 client-owned cats receiving ≥ 2 doses of velagliflozin; 214 (85%) naïve diabetics and 38 (15%) insulin-treated diabetics. Prospective, baseline-controlled, open-label clinical field trial. Cats received velagliflozin orally, once daily. Physical examinations and blood collections were performed days 0, 3, 7, 30, 60, 120, and 180. Data are median (range). Screening blood glucose (BG) was 436 mg/dL (272 to 676 mg/dL). On days 30, 60, 120, and 180, single BG after receiving velagliflozin was 153 mg/dL (62 to 480 mg/dL), 134 mg/dL (64 to 414 mg/dL), 128 mg/dL (55 to 461 mg/dL), and 125 mg/dL (77 to 384 mg/dL), respectively. Screening fructosamine was 538 µmol/L (375 to 794 µmol/L). On the same recheck days, fructosamine was 310 µmol/L (204 to 609 µmol/L), 286 µmol/L (175 to 531 µmol/L), 269 µmol/L (189 to 575 µmol/L), and 263 µmol/L (203 to 620 µmol/L). At day 180, 81% of 158 cats remaining had BG and/or fructosamine within reference ranges; 88.6% (124 of 140) and 87.7% (121 of 138) showed improvement in polyuria and polydipsia, respectively. Ketonuria developed in 35 cats (13.9%), including 18 (7.1%) that had ketoacidosis. Ketoacidosis was less common in naïve diabetic cats (11 of 214 [5.1%]) compared to insulin-treated diabetic cats (7 of 38 [18.4%]). At ketoacidosis diagnosis, 14 of 18 cats (77.8%) were euglycemic (ie, BG < 250 mg/dL). Most episodes of ketosis or ketoacidosis (30 of 35 [85.7%]) occurred within the first 14 days of treatment. Insulin-treated diabetic cats were less likely to complete the trial. No clinical hypoglycemia occurred. Velagliflozin improved glycemic parameters and clinical signs in diabetic cats. Velagliflozin provides an alternative to insulin as a stand-alone treatment of diabetic cats.

Automating insulin delivery through pump and continuous glucose monitoring connectivity: Maximizing opportunities to improve outcomes.

The development of automated insulin delivery (AID) systems, which connect continuous glucose monitoring (CGM) systems with algorithmic insulin delivery from an insulin pump (continuous subcutaneous insulin infusion, [CSII]), has led to improved glycaemia and quality of life benefits in those with insulin-treated diabetes. This review summarizes the benefits gained by the connectivity between insulin pumps and CGM devices. It details the technical requirements and advances that have enabled this, and highlights the clinical and user benefits of such systems. Clinical trials and real-world outcomes from the use of AID systems in people with type 1 diabetes (T1D)will be the focus of this article; outcomes in people with type 2 diabetes (T2D) and other diabetes subtypes will also be discussed. We also detail the limitations of current technological approaches for connectivity between insulin pumps and CGM devices. While recognizing the barriers, we discuss opportunities for the future.

Use of continuous glucose monitoring when initiating glucagon-like peptide-1 receptor agonist therapy in insulin-treated diabetes.

Glucagon-like peptide-1 receptor agonist (GLP-1RA) medications have been shown to be effective in achieving optimal glucose control and reducing all-cause death, cardiovascular death, nonfatal myocardial infarction, hospitalization for heart failure, and end-stage kidney disease in individuals with type 1 (T1D) and type 2 diabetes (T2D). However, use of these medications has been associated with increased hypoglycaemia risk in patients treated with concomitant antihyperglycaemic medications. The risk is particularly high in patients with T1D due to their loss of glucagon counter-regulatory response. This article reviews the effect of GLP-1RA formulations on the development of hypoglycaemia in individuals with T1D and T2D treated with insulin therapy, discusses the benefits of continuous glucose monitoring with GLP-1RA treatment, and presents strategies for safely initiating GLP-1RA therapy in these individuals.

Diffuse pulmonary hemorrhage as a rare presentation of pheochromocytoma: a case report with review of the literature

A 37-year-old male patient with a past history of fluctuating hypertension and insulin-treated diabetes mellitus presented to our clinic with a 1-year history of sudden-onset cough, dyspnea, and frank hemoptysis. Examination showed asthenia, moderate anemia, uncontrolled blood pressure, and a past history of one admission for management of hemoptysis and cardiac failure. The evaluation showed mild anemia, azotemia, low ejection fraction, contrast-enhanced computed tomography (CECT) of the chest, and sputum suggestive of pulmonary hemorrhage. Investigation during current admission revealed proteinuria, left suprarenal mass on USG, and clear lung parenchyma on chest X-ray and CECT. Autoimmune workup for vasculitis was negative and 24-h urinary catecholamine levels were elevated with CECT abdomen confirming pheochromocytoma. His blood pressure was controlled and he underwent laparoscopic left adrenalectomy with confirmation on histopathology. Postoperatively he is doing well with minimal requirement of antihypertensive, and diabetes is controlled with diet and exercise only. This case highlights diffuse alveolar hemorrhage as a rare presentation of pheochromocytoma. This case also highlights that secondary cause of hypertension should always be ruled out in case of uncontrolled hypertension in young patients to prevent devastating complications.

Long-term albumin improves the outcomes of patients with decompensated cirrhosis and diabetes mellitus: Post hoc analysis of the ANSWER trial.

Type-2 diabetes mellitus is a frequent comorbidity of cirrhosis independently associated with cirrhosis-related complications and mortality. This post hoc analysis of the ANSWER trial database assessed the effects of long-term human albumin (HA) administration on top of the standard medical treatment (SMT) on the clinical outcomes of a subgroup of 85 outpatients with liver cirrhosis, uncomplicated ascites and insulin-treated diabetes mellitus type 2 (ITDM). Compared to patients in the SMT arm, the SMT + HA group showed a better overall survival (86% vs. 57%, p = .016) and lower incidence rates of paracenteses, overt hepatic encephalopathy, bacterial infections, renal dysfunction and electrolyte disorders. Hospital admissions did not differ between the two arms, but the number of days spent in hospital was lower in the SMT + HA group. In conclusion, in a subgroup of ITDM outpatients with decompensated cirrhosis and ascites, long-term HA administration was associated with better survival and a lower incidence of cirrhosis-related complications.

Glucose Targets Using Continuous Glucose Monitoring Metrics in Older Adults With Diabetes: Are We There Yet?

The older population is increasing worldwide and up to 30% of older adults have diabetes. Older adults with diabetes are at risk of glucose-related acute and chronic complications. Recently, mostly in type 1 diabetes (T1D), continuous glucose monitoring (CGM) devices have proven beneficial in improving time in range (TIR glucose, 70-180 mg/dL or glucose 3.9-10 mmol/L), glycated hemoglobin (HbA1c), and in lowering hypoglycemia (time below range [TBR] glucose <70 mg/dL or glucose <3.9 mmol/L). The international consensus group formulated CGM glycemic targets relating to older adults with diabetes based on very limited data. Their recommendations, based on expert opinion, were aimed at mitigating hypoglycemia in all older adults. However, older adults with diabetes are a heterogeneous group, ranging from healthy to very complex frail individuals based on chronological, biological, and functional aging. Recent clinical trial and real-world data, mostly from healthy older adults with T1D, demonstrated that older adults often achieve CGM targets, including TIR recommended for non-vulnerable groups, but less often meet the recommended TBR <1%. Existing data also support that hypoglycemia avoidance may be more strongly related to minimization of glucose variability (coefficient of variation [CV]) rather than lower TIR. Very limited data are available for glucose goals in older adults adjusted for the complexity of their health status. Herein, we review the bidirectional associations between glucose and health status in older adults with diabetes; use of diabetes technologies, and their impact on glucose control; discuss current guidelines; and propose a new set of CGM targets for older adults with insulin-treated diabetes that are individualized for health and living status.

The Human Phospholipase B-II Precursor (HPLBII-P) in Urine as a Novel Biomarker of Increased Glomerular Production or Permeability in Diabetes Mellitus?

Background: A previous report showed that the urine output of HPLBII-P in patients with diabetes mellitus and SARS-CoV-2 infection was increased as a sign of glomerular dysfunction. The aim of this report was to investigate the relation of the urine output of HPLBII-P to diabetes mellitus in two large community-based elderly populations, i.e., the ULSAM and PIVUS cohorts. Methods: HPLBII-P was measured by an ELISA in the urine of a community-based cohort of 839 men (ULSAM) collected at 77 years of age and in the urine of a community-based cohort of 75-year-old men, n = 387, and women, n = 401 (PIVUS). KIM-1, NGAL, and albumin were measured in urine and cathepsin S and cystatin C in serum. Results: HPLBII-P was significantly raised among males with diabetes in the ULSAM (p < 0.0001) and PIVUS cohorts (p ≤ 0.02), but not in the female cohort of PIVUS. In the female subpopulation of insulin-treated diabetes, HPLBII-P was raised (p = 0.02) as compared to women treated with oral antidiabetics only. In the ULSAM cohort, HPLBII-P was correlated to NGAL, KIM-1, and albumin in urine both in non-DM (all three biomarkers; p < 0.0001) and in DM (NGAL; p = 0.002, KIM-1; p = 0.02 and albumin; p = 0.01). Plasma glucose and HbA1c in blood showed correlations to U-HPLBII-P (r = 0.58, p < 0.001 and r = 0.42, p = 0.004, respectively). U-HPLBII-P and cathepsin S were correlated in the ULSAM group (r = 0.50, p < 0.001). No correlations were observed between U-HPLBII-P and serum creatinine or cystatin C. Conclusions: The urine measurement of HPLBII-P has the potential to become a novel and useful biomarker in the monitoring of glomerular activity in diabetes mellitus.

Accuracy and Feasibility of Using a Smartphone Application for Carbohydrate Counting Versus Traditional Carbohydrate Counting for Adults With Insulin-Treated Diabetes.

Patients with insulin-treated diabetes struggle with performing accurate carbohydrate counting for proper blood glucose control. Little is known about the comparative accuracy and feasibility of carbohydrate counting methods. The purpose of this study was to determine whether carbohydrate counting using a smartphone application is more accurate and feasible than a traditional method. Based on a conceptual model derived from the Technology Acceptance Model, feasibility was defined as usefulness, ease of use, and behavioral intention to use each method. A standardized meal was presented to 20 adults with insulin-treated diabetes who counted carbohydrates using traditional and smartphone methods. Accuracy was measured by comparing carbohydrate counting estimates with the standardized meal values. Perceived feasibility (usefulness, ease of use, behavioral intention) was measured using rating forms derived from the Technology Acceptance Model. The number of training and estimation minutes were significantly higher for the traditional method than the smartphone method (Z = -3.83, P < .05; Z = -2.30, P < .05). The traditional method took an additional 1.4 minutes for estimation and 12.5 minutes for training. There were no significant differences in accuracy between traditional and smartphone methods for carbohydrate counting (Wilcoxon signed-rank test, Z = -1.10, P = .28). There were no significant differences between traditional and smartphone methods for feasibility (usefulness, Z = -.10, P = .95; ease of use, Z = -.36, P = .72; or behavioral intention, Z = -.94, P = .35). While both traditional and smartphone methods were found to be similar in terms of accuracy and feasibility, the smartphone method took less time for training and for carbohydrate estimation.

Continuous Glucose Monitor Metrics Are Associated with Emergency Department Visits and Hospitalizations for Hypoglycemia and Hyperglycemia, but Have Low Predictive Value.

Objective: Determine whether continuous glucose monitor (CGM) metrics can provide actionable advance warning of an emergency department (ED) visit or hospitalization for hypoglycemic or hyperglycemic (dysglycemic) events. Research Design and Methods: Two nested case-control studies were conducted among insulin-treated diabetes patients at Kaiser Permanente, who shared their CGM data with their providers. Cases included dysglycemic events identified from ED and hospital records (2016-2021). Controls were selected using incidence density sampling. Multiple CGM metrics were calculated among patients using CGM >70% of the time, using CGM data from two lookback periods (0-7 and 8-14 days) before each event. Generalized estimating equations were specified to estimate odds ratios and C-statistics. Results: Among 3626 CGM users, 108 patients had 154 hypoglycemic events and 165 patients had 335 hyperglycemic events. Approximately 25% of patients had no CGM data during either lookback; these patients had >2 × the odds of a hypoglycemic event and 3-4 × the odds of a hyperglycemic event. While several metrics were strongly associated with a dysglycemic event, none had good discrimination. Conclusion: Several CGM metrics were strongly associated with risk of dysglycemic events, and these can be used to identify higher risk patients. Also, patients who are not using their CGM device may be at elevated risk of adverse outcomes. However, no CGM metric or absence of CGM data had adequate discrimination to reliably provide actionable advance warning of an event and thus justify a rapid intervention.

Accuracy of intermittently scanned continuous glucose monitoring during caesarean delivery in pregnant women with insulin-treated diabetes

AimContinuous Glucose Monitoring (CGM) systems are not currently recommended to guide intrapartum glucose and insulin infusion, due to insufficient data. In this study, intrapartum accuracy of intermittently scanned CGM (isCGM), compared to simultaneously measured capillary glucose (CG), was evaluated. MethodsPaired isCGM (Freestyle Libre 2) - CG data during caesarean delivery in pregnant women with insulin-treated diabetes were prospectively collected. The isCGM accuracy was assessed by MARD and Clarke Error Grid analysis. Moreover, the impact on intrapartum management was evaluated. ResultsSixty-eight paired isCGM-CG data of 19 women were evaluated. The overallMARD was 9.28 %. All values were in A and B zones of Clarke Error Grid. Forty-six (68 %) isCGM-CG pairs were in the same glycemic range, meaning the same intrapartum management. All discordant data were identified by checking CG in case of isCGM above 110 mg/dL or less than 70 mg/dL [chi-square 21.76, p < 0.001]. At ROC curve, isCGM above 110 mg/dL was associated with 100 % sensitivity to discordant result at CG (AUC 0.859, p < 0.001). ConclusionThe accuracy of isCGM during caesarean delivery was good, particularly for glucose values between 70 and 110 mg/dL, when CG confirmation could be safely avoided.

S2I2N0-3 score predicts short- and long-term mortality and morbidity in HFrEF: a post-hoc analysis of the GUIDE-IT trial.

This study investigated the S2I2N0-3 score, a simple tool comprising stroke history, insulin-treated diabetes, and N-terminal pro-brain natriuretic peptide, for forecasting mortality and morbidity in heart failure (HF) with reduced ejection fraction (HFrEF). Analysing 890 GUIDE-IT HFrEF trial participants, we stratified them by baseline S2I2N0-3 risk score into three risk groups. We examined the score's association with five adverse outcomes over short (90days) and extended periods (median follow-up of 15months) using Cox and competing risk models. Our analysis revealed significant positive associations between the S2I2N0-3 strata and adverse outcomes. When analysed as a continuous variable, each point increment of the S2I2N0-3 score was associated with a higher risk of short- and long-term cardiovascular death [short term: hazard ratio (HR) 1.43, 95% confidence interval (CI) 1.03-1.98; long term: HR 1.18, 95% CI 1.02-1.38], all-cause death (HR 1.52, 95% CI 1.12-2.07; HR 1.18, 95% CI 1.03-1.36), HF hospitalization (HR 1.39, 95% CI 1.20-1.62; HR 1.18, 95% CI 1.06-1.31), any hospitalization (HR 1.19, 95% CI 1.06-1.34; HR 1.09, 95% CI 1.00-1.19), and the composite outcome of cardiovascular death and HF hospitalization (HR 1.39, 95% CI 1.21-1.60; HR 1.17, 95% CI 1.06-1.30). The S2I2N0-3 demonstrated reliable prognostic value, with C-indices ranging from 0.619 to 0.753 across outcomes and time points. When compared with the Meta-Analysis Global Group in Chronic Heart Failure (MAGGIC) score using Z-statistics, net reclassification index, and integrated discrimination improvement, the S2I2N0-3 showed comparable predictive power for all outcomes during both short- and long-term follow-ups. The S2I2N0-3 risk score had modest predictive values for both short- and long-term clinical outcomes in HFrEF patients, offering equivalent performance to the established MAGGIC score.

Driving-Related Glucose Patterns Among Older Adults with Type 1 Diabetes.

Older adults with type 1 diabetes may face challenges driving safely. Glucose "above-5-to-drive" is often recommended for insulin-treated diabetes to minimize hypoglycemia while driving. However, the effectiveness of this recommendation among older adults has not been evaluated. Older drivers with type 1 diabetes were assessed while using sensor-augmented insulin pumps during a 2-week clinical trial run-in. Twenty-three drivers (median age 69 years [interquartile range; IQR 65-72]; diabetes duration 37 years [20-45]) undertook 618 trips (duration 10 min [5-21]). Most trips (n = 535; 87%) were <30 min duration; 9 trips (1.5%) exceeded 90 min and 3 trips (0.5%) exceeded 120 min. Pre-trip continuous glucose monitoring (CGM) was >5.0 mmol/L for 577 trips (93%) and none of these had CGM <3.9 mmol/L during driving (including 8 trips >90 min and 3 trips >120 min). During 41 trips with pre-trip CGM ≤5.0 mmol/L, 11 trips had CGM <3.9 mmol/L. Seventy-one CGM alerts occurred during 60 trips (10%), of which 54 of 71 alerts (76%) were unrelated to hypoglycemia. Our findings support a glucose "above-5-to-drive" recommendation to avoid CGM-detected hypoglycemia among older drivers, including for prolonged drives, and highlight the importance of active CGM low-glucose alerts to prevent hypoglycemia during driving. Driving-related CGM usability and alert functionality warrant investigation. Clinical trial ACTRN1261900515190.

Abstract TMP117: Exposure to Single or Recurrent Hypoglycemia Increases Stroke Risk in Insulin-Treated Female Diabetic Rats

Stroke is a serious complication of diabetes. Intensive treatment of diabetes increases the risk of recurrent hypoglycemia (RH). Hypoglycemia exposure causes prothrombotic effects. Earlier, we demonstrated that exposure to single hypoglycemia (SH), 5-day RH (once every day), and twice-a-week RH for 6 weeks increases stroke risk in male insulin-treated diabetic (ITD) rats. In the present study, we determined the effect of SH and RH on stroke risk/thrombosis in female rats. Streptozotocin diabetic female rats were treated for hyperglycemia using insulin pellets (Figure A). Rats were randomly assigned to either hyperinsulinemic euglycemia (ITD+RH+Glucose, control) or hyperinsulinemic hypoglycemia (ITD+RH) groups (3 h duration) (Figure B). Separate groups tested the effect of SH, RH for 5 days, or RH for 6 weeks. Based on the results of the male studies, stroke risk after SH, 5-day RH, and 6-week RH were assessed on days 1, 7, and 3 post-last hypoglycemia, respectively. Groups were balanced (confirmed by Chi square test) in terms of the proportion of animals at different stages of the estrous cycle. To assess the risk of stroke, the carotid artery and jugular vein were linked with a shunt containing a suture, and the weight of the clot accumulated on the suture following 15 min of blood flow was quantified as a measure of stroke risk/thrombosis. The clot weight in the SH-exposed ITD group was significantly higher by 47% (22±3 mg, n=9, p&lt;0.05) when compared to its respective control (15±1 mg, n=8). The clot weight determined 7 days after the 5-day ITD+RH group (18±1 mg, n=7) was significantly (p&lt;0.05) higher than its control group (15±1 mg, n=9). The clot weight in the 6-week ITD+RH group was significantly higher by 47% (20±2 mg, n=9, p&lt;0.01) when compared to its control (14±1 mg, n=7) (Figure C). Our results show that similar to male rats, SH and RH increase stroke risk in female ITD rats. We are currently evaluating the underlying mechanisms. Acknowledgment: NIH (NS122808).