Glycaemia In People Research Articles

Modifying the timing of breakfast improves postprandial glycaemia in people with type 2 diabetes: A randomised controlled trial

AimsInvestigate the effects of breakfast timing on postprandial glycaemia in adults with type 2 diabetes (T2D), and the impact of a 20-min walk after breakfast. MethodsEleven adults with T2D (57±7y; HbA1c 7.4±1%) participated in a six-week randomised crossover controlled trial comprising three 4-day conditions: Early (0700h), Mid (0930h) and Delayed (1200h). After each condition, a second 4-day intervention of 20-min walk after each condition was undertaken. Standardised breakfast was provided. Interstitial glucose and physical activity were measured. Incremental area under the curve (iAUC) 2-h post-breakfast, 24-h iAUC, and fasting glucose were analysed with linear mixed-effects models. Cohen’s d of the 2-h iAUC post-breakfast 20-min walk was calculated. ResultsMid and Delayed had lower 2-h post-breakfast iAUC (p<0.002, -57 mmol/L×2h; p<0.02, -41 mmol/L×2h) compared to Early. There were no differences in fasting (0600h) glucose or 24-h iAUC. There was a small effect of the 20-min walk on lowering 2-h post-breakfast iAUC for Early (d=0.35) and Delayed (d=0.37), with no effect in Mid. ConclusionIn people with T2D, delaying breakfast from 0700 h to mid-morning or midday reduced postprandial glycaemia. Additional post-meal walking for 20 minutes had a small effect in lowering postprandial glycaemia when breakfast was at 0700 h or midday, but provided no additional benefit when breakfast was at mid-morning.

Expansion of Medicaid Coverage of Continuous Glucose Monitor Reduces Health Disparity in Children and Young Adults With Type 1 Diabetes.

Continuous glucose monitor (CGM) usage improves glycemia in people with type 1 diabetes (PWD) and is accepted as the standard of care. The CGM utilization is lower in patients with public insurance and minorized ethnicities. In 2022, California Medicaid reduced its barriers to obtaining CGM coverage for PWD. It is unknown whether this policy change is sufficient to increase CGM usage. We hypothesize that the change in Medicaid coverage improved CGM uptake in children and young adults with T1D. Data were extracted from electronic medical record of a large urban children's hospital in 2021 and 2022. The CGM usage was determined based on clinician documentation or the presence of CGM downloads. Kruskal-Wallis tests, Wald tests, and χ2 tests were used to test hypothesis (P < .05). Mixed effects logistical regression analyses were performed. We included 878 and 892 PWD (age ≤ 21 years) in 2021 and 2022, respectively. In 2022, Medicaid insured 59.3% of patients. Between 2021 and 2022, CGM usage did not change for privately insured patients (84%) but increased from 41% to 58% for patients receiving Medicaid. In our mixed effects logistic regression model, CGM usage was higher in 2022 and in English speakers. Public insurance, black race, and patients' age were negatively associated with CGM usage. Our results suggest that Medicaid expansion of CGM coverage increases its utilization for pediatric PWD but did not eliminate the disparity. Future studies are needed to identify barriers that preclude equity in technology uptake.

Is It Time for a New Algorithm for the Pharmacotherapy of Steroid-Induced Diabetes?

Glucocorticoids (GS) are widely used in multiple medical indications due to their anti-inflammatory, immunosuppressive, and antiproliferative effects. Despite their effectiveness in treating respiratory, skin, joint, renal, and neoplastic diseases, they dysregulate glucose metabolism, leading to steroid-induced diabetes (SID) or a significant increase of glycemia in people with previously diagnosed diabetes. The risk of adverse event development depends on the prior therapy, the duration of the treatment, the form of the drug, and individual factors, i.e., BMI, genetics, and age. Unfortunately, SID and steroid-induced hyperglycemia (SIH) are often overlooked, because the fasting blood glucose level, which is the most commonly used diagnostic test, is insufficient for excluding both conditions. The appropriate control of post-steroid hyperglycemia remains a major challenge in everyday clinical practice. Recently, the most frequently used antidiabetic strategies have been insulin therapy with isophane insulin or multiple injections in the basal-bolus regimen. Alternatively, in patients with lower glycemia, sulphonylureas or glinides were used. Taking into account the pathogenesis of post-steroid-induced hyperglycemia, the initiation of therapy with glucagon-like peptide 1 (GLP-1) analogs and dipeptidyl peptidase 4 (DPP-4) inhibitors should be considered. In this article, we present a universal practical diagnostic algorithm of SID/SIH in patients requiring steroids, in both acute and chronic conditions, and we present a new pharmacotherapy algorithm taking into account the use of all currently available antidiabetic drugs.

SARS-CoV-2 booster vaccination does not worsen glycemia in people with type 1 diabetes using insulin pumps: an observational study.

Despite an increased risk for adverse outcomes from SARS-CoV-2 infection among individuals with type 1 diabetes (T1D), vaccine hesitancy persists due to safety concerns including dysglycemia. The impact of booster vaccination on individuals using automated insulin delivery (AID) systems remains unclear. We used continuous glucose monitoring (CGM) data from 53 individuals with T1D using insulin pump therapy who received their third and/or fourth COVID-19 vaccination. CGM data from the 14 days before and 3 and 7 days after each vaccination were compared. The primary outcome was glucose time in range (TIR) (70-180mg/dL) 3 and 7 days post-vaccination compared with the 14 days prior. Secondary outcomes included other CGM metrics such as time below range (< 70mg/dL), time above range (> 180mg/dL), mean glucose, co-efficient of variation and average total daily insulin. The cohort comprised 53 adults (64% women, 64% AID), totaling 74 vaccination periods (84% Pfizer-BioNTech boosters), mean ± SD age 40.0 ± 15.9 years, duration of diabetes 26.0 ± 15.4 years. There was no significant difference between pre-vaccination TIR (61.0%±18.5) versus 3 (60.5%±22.8) and 7 days post-vaccination (60.2%±21.8; p = 0.79). Level 1 hypoglycemia, time in range 54-69mg/dL, was lower 3 (1.1%±1.7) and 7 days post-vaccination (1.1%±1.6), compared with 14 days pre-vaccination (1.4%±1.4; p = 0.021). The study provides evidence that SARS-CoV-2 booster vaccination does not acutely worsen glycemia in people with T1D receiving insulin pump therapy.

Use of a decision support tool and quick start onboarding tool in individuals with type 1 diabetes using advanced automated insulin delivery: a single-arm multi-phase intervention study

BackgroundMultiple clinician adjustable parameters impact upon glycemia in people with type 1 diabetes (T1D) using Medtronic Mini Med 780G (MM780G) AHCL. These include glucose targets, carbohydrate ratios (CR), and active insulin time (AIT). Algorithm-based decision support advising upon potential settings adjustments may enhance clinical decision-making.MethodsSingle-arm, two-phase exploratory study developing decision support to commence and sustain AHCL. Participants commenced investigational MM780G, then 8 weeks Phase 1-initial optimization tool evaluation, involving algorithm-based decision support with weekly AIT and CR recommendations. Clinicians approved or rejected CR and AIT recommendations based on perceived safety per protocol. Co-design resulted in a refined algorithm evaluated in a further identically configured Phase 2. Phase 2 participants also transitioned to commercial MM780G following “Quick Start” (algorithm-derived tool determining initial AHCL settings using daily insulin dose and weight). We assessed efficacy, safety, and acceptability of decision support using glycemic metrics, and the proportion of accepted CR and AIT settings per phase.ResultsFifty three participants commenced Phase 1 (mean age 24.4; Hba1c 61.5mmol/7.7%). The proportion of CR and AIT accepted by clinicians increased between Phases 1 and 2 respectively: CR 89.2% vs. 98.6%, p < 0.01; AIT 95.2% vs. 99.3%, p < 0.01. Between Phases, mean glucose percentage time < 3.9mmol (< 70mg/dl) reduced (2.1% vs. 1.4%, p = 0.04); change in mean TIR 3.9-10mmol/L (70-180mg/dl) was not statistically significant: 72.9% ± 7.8 and 73.5% ± 8.6. Quick start resulted in stable TIR, and glycemic metrics compared to international guidelines.ConclusionThe co-designed decision support tools were able to deliver safe and effective therapy. They can potentially reduce the burden of diabetes management related decision making for both health care practitioners and patients.Trial registrationProspectively registered with Australia/New Zealand Clinical Trials Registry(ANZCTR) on 30th March 2021 as study ACTRN12621000360819.

519-P: Association of Circulating Sphingolipids with Glycemia in People without Diabetes

519-P: Association of Circulating Sphingolipids with Glycemia in People without Diabetes

Time to unshackle the medical treatment of obesity in the NHS

Obesity affects one in four people in the United Kingdom and costs the National Health Service (NHS) ∼£6.5 billion annually. The glucagon-like peptide-1 (GLP-1) receptor analogues, such as once-daily subcutaneous Liraglutide 3.0 mg (Saxenda®) and once-weekly subcutaneous Semaglutide 2.4 mg (Wegovy®), were approved by the National Institute of Health and Care Excellence (NICE) as a treatment for obesity and funded by the NHS for 2 years. Our local data shows that Saxenda is effective at reducing body weight and glycaemia in people with obesity and diabetes; however, the supply issues of GLP-1 receptor analogues have contributed to the unavailability of Saxenda and Wegovy in our service. Our patients are devastated that they cannot access NICE-approved GLP-1 receptor analogues for obesity. The 2-year GLP-1 receptor analogue treatment limit for obesity alongside a lack of funded NHS services and supply issues represent barriers to treatment for people living with obesity who have clear medical indications.

Glucagon-based therapy for people with diabetes and obesity: What is the sweet spot?

People with obesity and type 2 diabetes have a high prevalence of metabolic-associated steatotic liver disease, hyperlipidemia and cardiovascular disease. Glucagon increases hepatic glucose production; it also decreases hepatic fat accumulation, improves lipidemia and increases energy expenditure. Pharmaceutical strategies to antagonize the glucagon receptor improve glycemic outcomes in people with diabetes and obesity, but they increase hepatic steatosis and worsen dyslipidemia. Co-agonism of the glucagon and glucagon-like peptide-1 (GLP-1) receptors has emerged as a promising strategy to improve glycemia in people with diabetes and obesity. Addition of glucagon receptor agonism enhances weight loss, reduces liver fat and ameliorates dyslipidemia. Prior to clinical use, however, further studies are needed to investigate the safety and efficacy of glucagon and GLP-1 receptor co-agonists in people with diabetes and obesity and related conditions, with specific concerns regarding a higher prevalence of gastrointestinal side effects, loss of muscle mass and increases in heart rate. Furthermore, co-agonists with differing ratios of glucagon:GLP-1 receptor activity vary in their clinical effect; the optimum balance is yet to be identified.

Association of food insecurity with changes in diet quality, weight, and glycemia over two years in adults with prediabetes and type 2 diabetes on medicaid

Little is known about longitudinal associations between food insecurity (FI) and diet, weight, and glycemia in people with prediabetes and type 2 diabetes (T2D). In a secondary analysis of Medicaid-enrolled health center patients with prediabetes or T2D in Boston, Massachusetts (N = 188), we examined associations between food security (FS) and measures of diet quality, weight, and hyperglycemia. FS (10-item USDA FS module) was ascertained at baseline, 1-year, and 2-year follow-up and categorized as persistently secure, intermittently insecure, or persistently insecure. Associations between FS category and changes in Healthy Eating Index-2020 (HEI-20), body mass index (BMI), and hemoglobin A1c (A1c) from baseline to year 2 were assessed using multivariate generalized linear models. Participants had median (p25, p75) age of 52 (42, 57); 71.8% were female and 62.8% Hispanic. Over follow-up, 32.4% were persistently food secure, 33.0% intermittently insecure, and 34.5% persistently insecure. Baseline mean (SD) HEI-20, BMI, and A1c were 55.8 (14.5), 35.9 (8.7) kg/m2, 7.1% (1.6) and did not differ by FS category. FS category was not associated with changes in HEI-20, BMI, and A1c at 2 years (all p > 0.05). Results suggest that Medicaid-enrolled adults with prediabetes or T2D, regardless of FS status, would benefit from dietary and weight management interventions.

Effects of statin therapy on diagnoses of new-onset diabetes and worsening glycaemia in large-scale randomised blinded statin trials: an individual participant data meta-analysis

Previous meta-analyses of summary data from randomised controlled trials have shown that statin therapy increases the risk of diabetes, but less is known about the size or timing of this effect, or who is at greatest risk. We aimed to address these gaps in knowledge through analysis of individual participant data from large, long-term, randomised, double-blind trials of statin therapy. We conducted a meta-analysis of individual participant data from randomised controlled trials of statin therapy that participated in the CTT Collaboration. All double-blind randomised controlled trials of statin therapy of at least 2 years' scheduled duration and with at least 1000 participants were eligible for inclusion in this meta-analysis. All recorded diabetes-related adverse events, treatments, and measures of glycaemia were sought from eligible trials. Meta-analyses assessed the effects of allocation to statin therapy on new-onset diabetes (defined by diabetes-related adverse events, use of new glucose-lowering medications, glucose concentrations, or HbA1c values) and on worsening glycaemia in people with diabetes (defined by complications of glucose control, increased use of glucose-lowering medication, or HbA1c increase of ≥0·5%). Standard inverse-variance-weighted meta-analyses of the effects on these outcomes were conducted according to a prespecified protocol. Of the trials participating in the CTT Collaboration, 19 trials compared statin versus placebo (123 940 participants, 25 701 [21%] with diabetes; median follow-up of 4·3 years), and four trials compared more versus less intensive statin therapy (30 724 participants, 5340 [17%] with diabetes, median follow-up of 4·9 years). Compared with placebo, allocation to low-intensity or moderate-intensity statin therapy resulted in a 10% proportional increase in new-onset diabetes (2420 of 39 179 participants assigned to receive a statin [1·3% per year] vs 2214 of 39 266 participants assigned to receive placebo [1·2% per year]; rate ratio [RR] 1·10, 95% CI 1·04-1·16), and allocation to high-intensity statin therapy resulted in a 36% proportional increase (1221 of 9935 participants assigned to receive a statin [4·8% per year] vs 905 of 9859 participants assigned to receive placebo [3·5% per year]; 1·36, 1·25-1·48). For each trial, the rate of new-onset diabetes among participants allocated to receive placebo depended mostly on the proportion of participants who had at least one follow-up HbA1c measurement; this proportion was much higher in the high-intensity than the low-intensity or moderate-intensity trials. Consequently, the main determinant of the magnitude of the absolute excesses in the two types of trial was the extent of HbA1c measurement rather than the proportional increase in risk associated with statin therapy. In participants without baseline diabetes, mean glucose increased by 0·04 mmol/L with both low-intensity or moderate-intensity (95% CI 0·03-0·05) and high-intensity statins (0·02-0·06), and mean HbA1c increased by 0·06% (0·00-0·12) with low-intensity or moderate-intensity statins and 0·08% (0·07-0·09) with high-intensity statins. Among those with a baseline measure of glycaemia, approximately 62% of new-onset diabetes cases were among participants who were already in the top quarter of the baseline distribution. The relative effects of statin therapy on new-onset diabetes were similar among different types of participants and over time. Among participants with baseline diabetes, the RRs for worsening glycaemia were 1·10 (1·06-1·14) for low-intensity or moderate-intensity statin therapy and 1·24 (1·06-1·44) for high-intensity statin therapy compared with placebo. Statins cause a moderate dose-dependent increase in new diagnoses of diabetes that is consistent with a small upwards shift in glycaemia, with the majority of new diagnoses of diabetes occurring in people with baseline glycaemic markers that are close to the diagnostic threshold for diabetes. Importantly, however, any theoretical adverse effects of statins on cardiovascular risk that might arise from these small increases in glycaemia (or, indeed, from any other mechanism) are already accounted for in the overall reduction in cardiovascular risk that is seen with statin therapy in these trials. These findings should further inform clinical guidelines regarding clinical management of people taking statin therapy. British Heart Foundation, UK Medical Research Council, and Australian National Health and Medical Research Council.

Morning exercise and pre-breakfast metformin interact to reduce glycaemia in people with type 2 diabetes: a randomized crossover trial.

Exercise is recommended in the treatment of type 2 diabetes and can improve insulin sensitivity. However, previous evidence suggests that exercise at different times of the day in people with type 2 diabetes may have opposing outcomes on glycaemia. Metformin is the most commonly prescribed initial pharmacological intervention in type 2 diabetes, and may alter adaptions to exercise. It is unknown if there is an interaction between metformin and diurnal exercise outcomes. We aimed to investigate glycaemic outcomes of moderate intensity morning vs. evening exercise in people with type 2 diabetes being prescribed metformin monotherapy. In this study, nine males and nine females with type 2 diabetes undergoing metformin monotherapy (age 61±8.2years, mean±SD) completed a 16-week crossover trial including 2-week baseline recording, 6weeks randomly assigned to a morning exercise (07.00-10.00h) or evening exercise (16.00-19.00h) and a 2-week wash-out period. Exercise arms consisted of 30min of walking at 70% of estimated max heart rate every other day. Glucose levels were measured with continuous glucose monitors and activity measured by wrist-worn monitors. Food-intake was recorded by 4-day food diaries during baseline, first and last 2weeks of each exercise arm. There was no difference in exercise intensity, total caloric intake or total physical activity between morning and evening arms. As primary outcomes, acute (24h) glucose area under the curve (AUC), was lower (P=0.02) after acute morning exercise (180.6±68.4mmol/l) compared to baseline (210.3±76.7mmol/l); and there were no differences identified for glucose (mmol/l) between baseline, morning and evening exercise at any specific time point when data were analysed with two-way ANOVA. As secondary outcomes, acute glucose AUC was significantly lower (P=0.01) in participants taking metformin before breakfast (152.5±29.95mmol/l) compared with participants taking metformin after breakfast (227.2±61.51mmol/l) only during the morning exercise arm; and during weeks 5-6 of the exercise protocol, glucose AUC was significantly lower (P=0.04) for participants taking metformin before breakfast (168.8±15.8mmol/l), rather than after breakfast (224.5±52.0mmol/l), only during morning exercise. Our data reveal morning moderate exercise acutely lowers glucose levels in people with type 2 diabetes being prescribed metformin. This difference appears to be driven by individuals that consumed metformin prior to breakfast rather than after breakfast. This beneficial effect upon glucose levels of combined morning exercise and pre-breakfast metformin persisted through the final 2weeks of the trial. Our findings suggest that morning moderate intensity exercise combined with pre-breakfast metformin intake may benefit the management of glycaemia in people with type 2 diabetes. KEY POINTS: Morning moderate exercise acutely lowers glucose levels in people with type 2 diabetes being prescribed metformin. This difference appears to be driven by individuals that consumed metformin prior to breakfast rather than after breakfast. Morning exercise combined with pre-breakfast metformin persistently reduced glucose compared to morning exercise combined with post-breakfast metformin through the final week (week 6) of the intervention. Our study suggests it may be possible to make simple changes to the time that people with type 2 diabetes take metformin and perform exercise to improve their blood glucose.

Dynamic Changes in Brain Perfusion after Cognitive Rehabilitation in Patients with Type 1 and Type 2 Diabetes Mellitus

INTRODUCTION: The results of numerous studies indicate a high prevalence of cognitive impairment among patients with diabetes mellitus (DM).&#x0D; AIM: To evaluate the effectiveness of computerized training in cognitive rehabilitation in individuals with type 1 and type 2 DM, taking into account the dynamics of brain perfusion.&#x0D; MATERIALS AND METHODS: A randomized controlled study. The study group consisted of 25 patients with type 1 DM and 30 patients with type 2 DM aged 23 to 67 years. The comparison group included 20 patients with type 1 DM (mean age 28.4 years) and 20 patients with type 2 DM (mean age 56.0 years). Before and after the rehabilitation course, the patients of the study group underwent a general clinical examination, a blood test for carbohydrate metabolism, cognitive function testing using the Montreal Scale (MoCA test), contrast-free perfusion magnetic resonance imaging (MRI) of the brain. Active rehabilitation lasted 6 month; it was based on a computerized training, including exercises on verbal and nonverbal intelligence.&#x0D; RESULTS: On the initial examination, all the subjects did not have the achieved target level of glycated hemoglobin. After completion of the training program, a decrease in the parameter in both groups was noted, as well as a decrease in the mean level of fasting glycemia in people with type 1 DM. The result of neuropsychological testing in all patients at the initial stage corresponded to the diagnosis of ‘cognitive dysfunction’. The control test revealed an improvement in cognitive status according to the overall score, the abstraction scale, speech, memory and visual-constructive skills. Correlation analysis in the group with type 1 DM showed that the result of exercises on visual attention and auditory perception was influenced by memory function. In individuals with type 2 DM, increased glycated hemoglobin was associated with a decrease in cognitive functions according to the overall score of the MoCA test, as well as in tasks for speech, memory, visual-constructive skills. Dynamic analysis of changes in the MRI picture revealed hypoperfusion in the area of the right and left thalamus in patients with type 1 and type 2 DM, respectively, as well as increased perfusion of the white matter of the right parietal lobe in the group with type 1 DM, and in the putamen area on the left in the group with type 2 DM.&#x0D; CONCLUSION: In patients with type 1 and type 2 DM, as well as with cognitive deficit, who underwent a course of cognitive rehabilitation using computerized training, an improvement in cognitive status was noted, which was confirmed by the results of contrast-free perfusion MRI. to evaluate the effectiveness of computerized training in cognitive rehabilitation in people with type 1 and type 2 diabetes mellitus, taking into account the dynamics of brain perfusion.

1486-P: Effects of the COVID-19 Booster Vaccine on Glycemia and Insulin Resistance in People with Type 1 Diabetes—A Prospective Pilot Study

Background: Inflammation is well-known to worsen glycemia in people with type 1 diabetes (T1D). COVID-19 vaccines are vital for protection against SARS-CoV-2 infection, but by necessity trigger an acute immune response. Case reports have described hyperglycemic crises shortly after a booster dose. However, effects of COVID-19 vaccines on glycemic control in T1D is poorly understood. Methods: This was a prospective cohort study of adults with T1D receiving a COVID-19 booster dose. At the baseline visit a blinded Dexcom G6 Pro CGM was placed, subjects received COVID-19 booster vaccine 3-4 days later, and returned 6 days post-vaccination to have the CGM removed. Primary outcome was change in mean daily glucose level from baseline. Secondary outcomes included total daily insulin dose (TDI), total daily insulin resistance (TDIR = mean glucose * TDI), and time in range (TIR = %glucose readings between 70-180mg/dL). Data were transformed as necessary to maintain normality. Results: We enrolled 20 adults with T1D; one subject was excluded for nonadherence with study procedures. Baseline characteristics included (mean±SD) age: 48.9±19.4y, sex: 68.4%F, BMI: 29.6±6.2kg/m2, A1c: 7.0±1.0%. 42% received a Moderna and 58% Pfizer-BioNTech booster. Mean glucose on Day#2 post-vaccination was significantly greater than baseline (165.1±27.4 vs 154.5±30.2 mg/dL, p=0.04), as was TDIR (7970±4113 vs 7036±3999; p=0.02). No other days had significant differences in glycemic metrics as compared to baseline. There were no differences in any outcome metrics between booster vaccine manufacturers. Conclusions: These results suggest that adults with T1D may experience transient glycemic elevations after receiving a COVID-19 booster. Clinicians may need to warn people with T1D to be more vigilant with glucose testing and insulin dosing temporarily after vaccination. Larger studies are warranted to corroborate these findings. Disclosure M.Zilbermint: Consultant; EMD Serono, Other Relationship; American Association of Clinical Endocrinologists. M.Motevalli: None. K.Batty: None. J.Venner-walcott: None. A.Edwards: None. T.Burley: None. K.Jackson: None. M.Akhtar: None. A.Demidowich: Research Support; Dexcom, Inc. Funding Dexcom, Inc. (IIS-2021-136)

151-LB: Expansion of Medicaid Coverage of Continuous Glucose Monitor Reduces Health Disparity

Background: Continuous glucose monitor (CGM) usage improves glycemia in people with type 1 diabetes (PWT1D) and is accepted as the standard of care. CGM utilization is lower in patients with public insurance and minorized ethnicities. In 2022, California Medicaid expanded CGM coverage to all PWT1D without requiring a minimum number of glucose tests per day. It is unknown if this policy change is sufficient to increase CGM usage. We hypothesize that Medicaid expansion narrowed but did not eliminate the disparity in CGM usage. Methods: Data was extracted from electronic medical record of a large urban children's hospital in 2021 and 2022. CGM usage was determined based on clinician documentation or the presence of CGM downloads. We limited the data query to PWT1D who were seen at least once in the diabetes clinic each year. Chi-square and student T-tests were used to determine statistical significance (P&amp;lt;0.05). Results: We included 1471 and 1355 PWT1D in 2021 and 2022, respectively. Medicaid insured 66.8% and 62.2% of the patients in 2021 and 2022, respectively. CGM usage increased 1.4-fold in the entire patient population (2021: 52.2%, 2022: 71.1%). Between 2021 and 2022, CGM usage increased 1.6-fold (39% to 63%) and 1.1-fold (77% to 85%) for those with Medicaid and private insurances, respectively. CGM usage increased in all race/ethnicities, with the largest increase seen in patients who identify as Black and Latino (2021 vs 2022: White 69% vs 83%, Latino 38% vs 60%, Black 15% to 50%, P≤ 0.0001 for all comparisons). CGM usage increased 1.3-fold (58% to 74%) in English speakers and 2.1-fold (29% to 59%) in non-English speakers. Conclusion: Our results demonstrate that Medicaid expansion of CGM coverage increases its utilization for pediatric PWT1D. Despite increased CGM usage in marginalized community, disparity persists among patients with public insurance, minority races/ethnicities, and non-English language. Future studies are needed to identify barriers that preclude equity in technology uptake. Disclosure B. Miyazaki: None. T. Zeier: None. R. O. Barber: None. J. C. Espinoza: Consultant; Sanofi, Research Support; NIH - National Institutes of Health, FDA, Speaker's Bureau; Glooko, Inc. L. C. Chao: None. Funding U.S. Food and Drug Administration (P50FD006425 to J.C.E.)

Glucagon-like peptide-1 agonists combined with sodium-glucose cotransporter-2 inhibitors reduce weight in type 1 diabetes.

This study evaluated whether adding sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide-1 receptor agonists (GLP1-RA) to insulin reduced weight and glycemia in people with type 1 diabetes. This retrospective analysis of electronic health records evaluated 296 people with type 1 diabetes over 12 months after medications were first prescribed. Four groups were defined: control n= 80, SGLT2i n= 94, GLP1-RA n= 82, and combination of drugs (Combo) n= 40. We measuredchanges at 1year in weight and glycated hemoglobin (HbA1c). The control group did not have changes in weight or glycemic control. The mean (SD) percentage weight loss after 12 months was 4.4%(6.0%), 8.2% (8.5%), and 9.0%(8.4%) in the SGLT2i, GLP1-RA, and Combo groups, respectively (p< 0.001). The Combo group lost the most weight (p <0.001). The HbA1c reduction was 0.4% (0.7%), 0.3% (0.7%), and 0.6% (0.8%) in the SGLT2i, GLP1-RA, and Combo groups, respectively (p< 0.001). The Combo group had the biggest improvements in glycemic control and total and low-density lipoprotein cholesterol compared with baseline (all p <0.01). Severe adverse events were similar between all the groups, with no increased risk of diabetic ketoacidosis. The SGLT2i and GLP1-RA agents on their own improved body weight and glycemia, but combining the medications resulted in more weight loss. Treatment intensification appears to result in benefits with no difference in severe adverse events.

559-P: The Advancing Care for T1D Obesity Network (ACT1ON) Sequential Multiple Assignment Randomized Trial Pilot Results for Effect on Weight and Glycemia

Background: People with T1D commonly struggle with co-managing weight and glycemia, which increases cardiovascular disease risk. We evaluated the effect of an adaptive Sequential, Multiple Assignment, Randomized Trial (SMART) pilot on weight and glycemia in people with T1D. Methods: The SMART pilot tested the hypocaloric Look AHEAD (Low Fat) or Low Carbohydrate (Low Carb) ; or Mediterranean (Med, not calorie restricted) diets among young adults with T1D ages 19-30 (BMI 27-39.9 kg/m²) . We report data from the first 3-month diet period pre-pandemic before a shift to a virtual protocol for primary (weight, HbA1c, and % time below range [TBR, 54-69 mg/dl]) and secondary outcomes (body fat % and % time in range [70-180 mg/dl]) . We computed descriptive within-group changes in outcomes. Adjusted models tested diet differences. Results: Overall weight change was -2.0 kg (95% CI -3.0, -1.1, p&amp;lt;0.0001, n=38) and did not vary by diet. Body fat % decreased overall. Per adjusted models, HbA1c decreased on Low Fat vs. Low Carb (-0.60% [95% CI -1.5, -0.3], p=0.049) and TBR trended towards a decrease on Med vs. Low Carb (-3.1% [95% CI -6.4, 0.083], p=0.056) . Conclusions: Our intervention decreased adiposity and maintained glycemia in young adults with T1D. We will use these results to power an efficacy trial to co-optimize weight and glycemia among individuals with T1D. Disclosure D.Igudesman: None. R.E.Pratley: Other Relationship; Bayer AG, Corcept Therapeutics, Dexcom, Inc., Hanmi Pharm. Co., Ltd., Merck &amp; Co., Inc., Metavention, Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. M.R.Kosorok: n/a. D.M.Maahs: Advisory Panel; Abbott Diabetes, Eli Lilly and Company, Medtronic, Novo Nordisk, Sanofi, Consultant; Aditx Therapeutics, Inc., Biospex. E.J.Mayer-davis: None. J.Crandell: n/a. T.Pokaprakarn: None. K.Corbin: None. D.P.Zaharieva: Research Support; Insulet Corporation, International Society for Pediatric and Adolescent Diabetes, Leona M. and Harry B. Helmsley Charitable Trust. A.Addala: None. J.Thomas: None. A.Casu: None. M.Riddell: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Consultant; Eli Lilly and Company, Jaeb Center for Health Research, Speaker's Bureau; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk. Funding National Institutes of Health 1DP3DK113358

614-P: Fear of Hypoglycemia, Hypoglycemia Confidence, and Time in Range in Adolescents and Young Adults with Type 1 Diabetes (T1D)

Fear of hypoglycemia (FOH) and low hypoglycemia confidence (HC) can lead to hypoglycemia avoidance behaviors which may influence glycemia in people with T1D. Despite links with A1c, there are limited data on the correlation of FOH or HC with time in range (TIR) , which represents a more complete picture of glycemia. We explored FOH and HC in relation to CGM-derived glycemic metrics. Methods: Participants (n=20, M age 16.3 ± 2.5y, 45% female, M A1c 7.3 ± 1.3%, 100% CGM use; 70% pump use) completed questionnaires assessing FOH and HC, and CGM data were collected over the next 12 weeks. Data were analyzed using Pearson correlations. Results: Table 1 presents correlations between FOH, HC and glycemic metrics. FOH in young adults, specifically Worry, was associated with less time below range (&amp;lt;70 mg/dl; r = -0.75, p =.05) . No other statistically significant correlations between FOH, HC and TIR were detected. Conclusion: Young adults’ worries related to FOH correlate with less level 1 hypoglycemia (&amp;lt;70 mg/dL) due to reasons other than hypoglycemia avoidance behaviors, which merits further study. The small sample size limited the power to detect additional significant associations of FOH/HC with TIR, though patterns suggest several possible links. Advanced technology such as closed-loop systems coupled with psychosocial interventions aimed at reducing FOH and improving HC may help optimize TIR. Disclosure S.Menon: None. D.Desalvo: Consultant; Dexcom, Inc., Insulet Corporation, Research Support; Insulet Corporation. M.Erraguntla: None. K.Pamidimukkala: None. S.Mckay: None. C.Villegas: None. M.E.Hilliard: None. Funding Food and Drug Administration (FDA)

Design of the Advancing Care for Type 1 Diabetes and Obesity Network energy metabolism and sequential multiple assignment randomized trial nutrition pilot studies: An integrated approach to develop weight management solutions for individuals with type 1 diabetes

Young adults with type 1 diabetes (T1D) often have difficulty co-managing weight and glycemia. The prevalence of overweight and obesity among individuals with T1D now parallels that of the general population and contributes to dyslipidemia, insulin resistance, and risk for cardiovascular disease. There is a compelling need to develop a program of research designed to optimize two key outcomes—weight management and glycemia—and to address the underlying metabolic processes and behavioral challenges unique to people with T1D. For an intervention addressing these dual outcomes to be effective, it must be appropriate to the unique metabolic phenotype of T1D, and to biological and behavioral responses to glycemia (including hypoglycemia) that relate to weight management. The intervention must also be safe, feasible, and accepted by young adults with T1D. In 2015, we established a consortium called ACT1ON: Advancing Care for Type 1 Diabetes and Obesity Network, a transdisciplinary team of scientists at multiple institutions. The ACT1ON consortium designed a multi-phase study which, in parallel, evaluated the mechanistic aspects of the unique metabolism and energy requirements of individuals with T1D, alongside a rigorous adaptive behavioral intervention to simultaneously facilitate weight management while optimizing glycemia. This manuscript describes the design of our integrative study—comprised of an inpatient mechanistic phase and an outpatient behavioral phase—to generate metabolic, behavioral, feasibility, and acceptability data to support a future, fully powered sequential, multiple assignment, randomized trial to evaluate the best approaches to prevent and treat obesity while co-managing glycemia in people with T1D.Clinicaltrials.gov identifiers: NCT03651622 and NCT03379792. The present study references can be found here:https://clinicaltrials.gov/ct2/show/NCT03651622https://clinicaltrials.gov/ct2/show/NCT03379792?term=NCT03379792&draw=2&rank=1Submission Category: “Study Design, Statistical Design, Study Protocols”.

The potential of GLP-1 receptor agonists in type 2 diabetes and chronic kidney disease: from randomised trials to clinical practice.

Chronic kidney disease (CKD) affects around 10% of the global population and is most often caused by diabetes. Diabetes with CKD (diabetic kidney disease, DKD) is a progressive condition that may cause kidney failure and which contributes significantly to the excess morbidity and mortality in these patients. DKD is treated with direct disease-targeting therapies like blockers of the renin–angiotensin system, sodium–glucose cotransporter-2 (SGLT-2) inhibitors and non-steroidal mineralocorticoid receptor antagonists as well as indirect therapies impacting hyperglycaemia, dyslipidaemia, obesity and hypertension, which all together reduce disease progression. While no glucagon-like peptide-1 (GLP-1) receptor agonists (RAs) are currently indicated to improve kidney outcomes, accumulating evidence from cardiovascular outcomes trials (CVOTs) corroborates a kidney-protective effect in people with T2D and CKD, and GLP-1 RAs are now mentioned in international treatment guidelines for type 2 diabetes (T2D) with CKD. GLP-1 RAs are indicated to improve glycaemia in people with T2D; certain GLP-1 RAs are also approved for weight management and to reduce cardiovascular risk in T2D. Ongoing pivotal trials are assessing additional indications, including T2D with CKD. In this article, we review and discuss kidney outcomes from a multitude of completed clinical trials as well as real-world evidence and ongoing clinical trials.

A Systematic Review to Assess the Impact of Hyperbaric Oxygen Therapy on Glycaemia in People with Diabetes Mellitus.

Background and Objectives: Hyperbaric oxygen is a recognised treatment for a range of medical conditions, including treatment of diabetic foot disease. A number of studies have reported an impact of hyperbaric oxygen treatment on glycaemic control in patients undergoing treatment for diabetic foot disease. There has been no systematic review considering the impact of hyperbaric oxygen on glycaemia in people with diabetes. Materials and Methods: A prospectively PROSPERO-registered (PROSPERO registration: CRD42021255528) systematic review of eligible studies published in English in the PUBMED, MEDLINE, and EMBASE databases, based on the following search terms: hyperbaric oxygen therapy, HBO2, hyperbaric oxygenation, glycaemic control, diabetes, diabetes Mellitus, diabetic, HbA1c. Data extraction to pre-determined piloted data collection form, with individual assessment of bias. Results: In total, 10 eligible publications were identified after screening. Of these, six articles reported a statistically significant reduction in blood glucose from hyperbaric oxygen treatment, while two articles reported a statistically significant increase in peripheral insulin sensitivity. Two articles also identified a statistically significant reduction in HbA1c following hyperbaric oxygen treatment. Conclusions: There is emerging evidence suggesting a reduction in glycaemia following hyperbaric oxygen treatment in patients with diabetes mellitus, but the existing studies are in relatively small cohorts and potentially underpowered. Additional large prospective clinical trials are required to understand the precise impact of hyperbaric oxygen treatment on glycaemia for people with diabetes mellitus.