Intensive Insulin Treatment Research Articles

Quality of life, diabetes-related stress and treatment satisfaction are correlated with glycemia risk index (GRI), time in range and hypoglycemia/hyperglycemia components in type 1 diabetes

IntroductionTo evaluate the relationship between the GRI -component of hypoglycemia (CHypo) and hyperglycemia (CHyper)- with diabetes quality of life (DQoL), diabetes-related stress (DDS), perception of hypoglycemia (Clarke Test), visual analogic scale (VAS) and diabetes-knowledge (DKQ2) in T1D.MethodsCross-sectional study in 92 patients with T1D under intensive insulin treatment (21.7% CSII) and flash glucose monitoring (isCGM). Clinical, metabolic and glycometric parameters and quality of life/satisfaction questionnaires were analyzed.Results92 patients (54.3% male, BMI 25.4 ± 4.5 kg/m2, HbA1c 7.5 ± 1.0%, TIR 53.9 ± 15.9%) with mean age 36.1 ± 12.6years and 17.8 ± 11.3 T1D duration. The mean GRI was 60.6 ± 22.2 with a CHypo and CHyper of 5.9 ± 4.8 and 27.3 ± 14.4, respectively. 19.1% presented a pathological Clarke’s test. Patients with TIR > 70% and GRI < 40 showed better VAS (8.8 ± 1.3 vs 9.3 ± 0.9, p < 0.05) and DDS (46.4 ± 22.1 vs 36.7 ± 16.6, p < 0.05) scores, showing no differences between groups. CHyper > 15 and Chypo > 3.4 were related to worse levels of DQoL (91.1 ± 23.9 vs 76.6 ± 18.6 and 94.6 ± 24.8 vs 79.8 ± 20.1, p < 0.01), DDS(49.8 ± 22.4 vs 35.7 ± 16.5 and 49.8 ± 22.4 vs 35.7 ± 16.5, p < 0.01),and DKQ2 (24.4 ± 4.3 vs 26.8 ± 5.2 and 24.1 ± 4.8 vs 26.0 ± 4.6, p < 0.05), respectively. Worse metabolic control defined by GRI correlated with worse scores in VAS (r = −0.209, p < 0.05), DQoL (r = 0.205, p < 0.05), and DDS (r = 0.205, p < 0.05). No difference was observed in knowledge´s scale. CHyper correlated with worse scores in VAS (r = −0.231, p < 0.05), DQoL (r = 0.422, p < 0.01), and DDS (r = 0.341, p < 0.01) and lower degree of knowledge DKQ2 (r = −0.231, p < 0.05). When analyzing DQoL as a dependent variable in a multiple lineal regression, only age (β = 0.747; p < 0.001) and CHyper (β = 0.717; p < 0.001) maintained statistical significance.ConclusionsHigher GRI was related to worse quality of life, diabetes-related stress and satisfaction with treatment, analogous to the TIR results.CHyper an Chypo were related to a greater decline in quality of life, diabetes-related stress, and lower satisfaction with treatment.However, in a multiple linear regression, only CHyper maintained statistical significance.

Clinical Trial Protocol for Porcine Islet Xenotransplantation in South Korea.

Islet transplantation holds promise for treating selected type 1 diabetes mellitus patients, yet the scarcity of human donor organs impedes widespread adoption. Porcine islets, deemed a viable alternative, recently demonstrated successful longterm survival without zoonotic risks in a clinically relevant pig-to-non-human primate islet transplantation model. This success prompted the development of a clinical trial protocol for porcine islet xenotransplantation in humans. A single-center, open-label clinical trial initiated by the sponsor will assess the safety and efficacy of porcine islet transplantation for diabetes patients at Gachon Hospital. The protocol received approval from the Gachon Hospital Institutional Review Board (IRB) and the Korean Ministry of Food and Drug Safety (MFDS) under the Investigational New Drug (IND) process. Two diabetic patients, experiencing inadequate glycemic control despite intensive insulin treatment and frequent hypoglycemic unawareness, will be enrolled. Participants and their family members will engage in deliberation before xenotransplantation during the screening period. Each patient will receive islets isolated from designated pathogen-free pigs. Immunosuppressants and systemic infection prophylaxis will follow the program schedule. The primary endpoint is to confirm the safety of porcine islets in patients, and the secondary endpoint is to assess whether porcine islets can reduce insulin dose and the frequency of hypoglycemic unawareness. A clinical trial protocol adhering to global consensus guidelines for porcine islet xenotransplantation is presented, facilitating streamlined implementation of comparable human trials worldwide.

Clinical and Laboratory Characteristics of MODY Cases, Genetic Mutation Spectrum and Phenotype-genotype Relationship

Maturity onset diabetes of the young (MODY) occurs due to mutations in genes involved in pancreatic beta cell function and insulin secretion, has heterogeneous clinical and laboratory features, and account for 1-5% of all diabetes cases. The prevalence and distribution of MODY subtypes vary between countries. The aim of this study was to evaluate the clinical and laboratory characteristics, mutation distribution, and phenotype-genotype relationship in a large case series of pediatric Turkish patients genetically diagnosed with MODY. MODY cases from 14 different pediatric endocrinology departments were included. Diagnosis, treatment, follow-up data, and results of genetic analysis were evaluated. A total of 224 patients were included, of whom 101 (45%) were female, and the mean age at diagnosis was 9.4±4.1 years. Gene variant distribution was: 146 (65%) GCK; 43 (19%) HNF1A; 8 (3.6%) HNF4A, 8 (3.6%) KLF11 and 7 (3.1%) HNF1B. The remaining 12 variants were: PDX (n=1), NEUROD1 (n=3), CEL (n=1), INS (n=3), ABCC8 (n= 3) and KJNC11 (n=1). Of the cases, 197 (87.9%) were diagnosed with incidental hyperglycemia, 16 with ketosis (7%) and 7 (3%) with diabetic ketoacidosis (DKA), while 30% presented with classical symptoms of diabetes. Two-hundred (89%) had a family history of diabetes. Anti-GAD antibody was detected in 13 cases, anti-islet antibody in eight and anti-insulin antibody in four. Obesity was present in 16. Distribution of therapy was: 158 (71%) diet only; 23 (11%) intensive insulin treatment; 17 (7.6%) sulfonylureas; 10 (4.5%) metformin; and 6 (2.7%) insulin and oral anti-diabetic treatment. This was the largest genetically diagnosed series from Turkey. The most common gene variants were GCK and HNF1A with much lower proportions for other MODY types. Hyperglycemia was the most common presenting symptom while 11% of patients had diabetes-associated autoantibodies and 7% were obese. The majority of patients received dietary management only.

Psychodiabetology: The Challenge of the Future?

The number of people suffering from diabetes, including type 1, is constantly increasing both in Poland and worldwide. Type 1 diabetes is a chronic disease characterized by uncertain prognosis and relapses, as well as permanent, irreversible, and progressive changes in health status. The ongoing disease results in dysfunction or disability, and the patient requires specialized supervision, care, and rehabilitation. However, the success of therapy does not depend solely on the perfection of treatment, but also on the patient's readiness to change their lifestyle and cooperate with the therapeutic team. The patient's constant alertness in making therapeutic decisions does not always lead to expected treatment results, and the risk of hypoglycemia associated with intensive insulin treatment depletes the patient's motivation for treatment, leading over time to the development of 'therapeutic burnout' and psychiatric disorders. This narrative review is an attempt to summarize the knowledge and possible future solutions in diabetes type 1 in Poland as well as highlight the importance of comprehensive care, including psychological care, which appears fundamental in a chronic disease such as type 1 diabetes. Therefore, the aim of the study was to present generational changes and psychosocial problems of patients with type 1 diabetes and to identify urgent challenges in diabetic care. Attention should be paid to the deteriorating mental condition of the young generations, who, in the course of diabetes, are exposed to additional psychological and psychiatric health problems. The next generation of patients will require more psychological care, which is why the challenge of the future is to create psychodiabetology centers.

The effect of bolus advisors on glycaemic parameters in adults with diabetes on intensive insulin therapy: A systematic review with meta-analysis.

To conduct a systematic review with meta-analysis to provide a comprehensive synthesis of randomized controlled trials (RCTs) and prospective cohort studies investigating the effects of currently available bolus advisors on glycaemic parameters in adults with diabetes. An electronic search of PubMed, Embase, CINAHL, Cochrane Library and ClinicalTrials.gov was conducted in December 2022. The risk of bias was assessed using the revised Cochrane Risk of Bias tool. (Standardized) mean difference (MD) was selected to determine the difference in continuous outcomes between the groups. A random-effects model meta-analysis and meta-regression were performed. This systematic review was registered on PROSPERO (CRD42022374588). A total of 18 RCTs involving 1645 adults (50% females) with a median glycated haemoglobin (HbA1c) concentration of 8.45% (7.95%-9.30%) were included. The majority of participants had type 1 diabetes (N = 1510, 92%) and were on multiple daily injections (N = 1173, 71%). Twelve of the 18 trials had low risk of bias. The meta-analysis of 10 studies with available data on HbA1c showed that the use of a bolus advisor modestly reduced HbA1c compared to standard treatment (MD -011%, 95% confidence interval -0.22 to -0.01; I2 = 0%). This effect was accompanied by small improvements in low blood glucose index and treatment satisfaction, but not with reductions in hypoglycaemic events or changes in other secondary outcomes. Use of a bolus advisor is associated with slightly better glucose control and treatment satisfaction in people with diabetes on intensive insulin treatment. Future studies should investigate whether personalizing bolus advisors using artificial intelligence technology can enhance these effects.

An estimate of the need for continuous glucose monitoring in type 2 diabetes with intensive insulin treatment in secondary healthcare.

To estimate the proportion of persons with type 2 diabetes (T2DM) receiving intensive insulin treatment in the secondary healthcare who could be candidates for continuous glucose monitoring (CGM), based on different HbA1c criteria. For comparison, the results are also presented as proportion of persons with type 1 diabetes (T1DM) in the same region. In the Central Denmark Region, we identified all persons with T1DM (n = 6179) and T2DM (n = 4315) who had a minimum of one contact to a diabetes outpatient clinic from September 2021 to September 2022. Insulin regimen and HbA1c measured after a minimum of 2 months with a stable insulin regimen were retrieved from the healthcare administrative electronic platform used in the region. The numbers of persons with T1DM and T2DM with HbA1c meeting the criteria were 5145 and 3090, respectively. The fraction of T2DM with basal-bolus insulin was 35.3%, and the fraction with basal-bolus insulin and HbA1c >53 (7%) mmol/mol or >58 (7.5%) mmol/mol was 20.5% and 16.6%, respectively. These proportions correspond to 19.4%, 14.4% and 11.7% of the persons with T1DM in the same geographical area. The proportion of persons with T2DM in secondary healthcare undergoing intensive insulin treatment who could be candidates for CGM corresponded to only a minor fraction of persons with T1DM in the same region, irrespective of any HbA1c criteria applied.

Impact of glucose variability on the assessment of the glycemia risk index (GRI) and classic glycemic metrics

ObjectiveTo evaluate the impact of glucose variability on the relationship between the GRI and other glycemic metrics in a cohort of pediatric and adult patients with type 1 diabetes (T1D) using intermittent scanning continuous glucose monitoring (isCGM).MethodsWe performed a cross-sectional study of 202 patients with T1D under intensive insulin treatment (25.2% CSII) using isCGM. Clinical, metabolic, and glycemic metrics were collected, and the GRI was calculated with its hypoglycemia (CHypo) and hyperglycemia (CHyper) components. The correlation between the GRI and other classical glycometrics in relation to the coefficient of variation (CV) was evaluated.ResultsA total of 202 patients were included (53% male; 67.8% adults) with a mean age of 28.6 ± 15.7 years and 12.5 ± 10.9 years of T1D evolution (TIR 59.0 ± 17.0%; CV 39.8 ± 8.0%; GMI 7.3 ± 1.1%). The mean GRI was 54.0 ± 23.3 with a CHypo and CHyper component of 5.7 ± 4.8 and 23.4 ± 14.3, respectively. A strong negative correlation was observed between the GRI and TIR (R = −0.917; R2 = 0.840; p < 0.001), showing differences when dividing patients with low glycemic variability (CV < 36%) (R = −0.974; R2 = 0.948; p < 0.001) compared to those with greater CV instability (≥36%) (R = −0.885; R2 = 0.784; p < 0.001). The relationship of GRI with its two components was strongly positive with CHyper (R = 0.801; R2 = 0.641; p < 0.001) and moderately positive with CHypo (R = 0.398; R2 = 0.158; p < 0.001). When the GRI was evaluated with the rest of the classic glycemic metrics, a strong positive correlation was observed with HbA1c (R = 0.617; R2 = 0.380; p < 0.001), mean glucose (R = 0.677; R2 = 0.458; p < 0.001), glucose standard deviation (R = 0.778; R2 = 0.605; p < 0.001), TAR > 250 (R = 0.801; R2 = 0.641; p < 0.001), and TBR < 54 (R = 0.481; R2 = 0.231; p < 0.001).ConclusionsThe GRI correlated significantly with all the glycemic metrics analyzed, especially with the TIR. Glycemic variability (GV) significantly affected the correlation of the GRI with other parameters and should be taken into consideration.

A self-controlled, cross-over study of intensive insulin treatment with needle-based injection versus needle-free injection in hospitalized patients with type 2 diabetes.

Needle injection and needle-free injection were proven effective in improving glycated hemoglobin (HbA1c) in type 2 diabetes mellitus (T2DM) patients. However, it is unclear if needle-free and needle injections of insulin during intensive insulin therapy in hospitalized patients provide similar efficacy and safety benefits. A self-controlled cross-over study was conducted on 62 patients with T2DM who received intensive long-acting and short-acting insulin injections with or without needles. The 7-point blood glucose test was performed on the 6th day after insulin administration and the injection method switched on the 7th day of hospitalization. The difference was compared in 7-point blood glucose levels. The blood glucose levels at fasting (mean difference=-1.09 ± 2.38mmol/L, 95% CI, -1.69 to -0.48, p=0.0007) and post-breakfast (-1.14 ± 3.02mmol/L, 95%CI, -1.91 to -0.37, p=0.004) were better when patients were receiving needle-free injections compared to when receiving a needle injection. Indeed, daily blood glucose fluctuation, which presented as the area under the curve of glycemia, was decreased in needle-free injection periods (-0.3.48 ± 9.64, 95%CI, -5.95 to -1.01, p=0.0065). There was no significant difference in the dose of long-acting insulin between the two injection methods (-0.32 ± 2.69, 95%CI, -0.99 to 0.37, p>0.05). The dose of fast-acting insulin during the needle-free period was lower than that of when patients received needle injections (-1.66 ± 6.45, 95%CI, -3.29 to -0.025, p<0.05). There was no significant difference in satisfaction between the two regimens (-0.59 ± 1.55,95%CI, -0.938 to 0.509, p=0.557), but there was a significant difference in pain experience, favoring needle-free injections (p < 0.001). Glycemia was better controlled by needle-free insulin injections in hospitalized T2DM patients subjected to intensive glycemic control. These patients also experienced less pain than when insulin was injected with a needle.

1371-P: Factors Influencing the Development of Polycystic Ovary Syndrome in Premenopausal Women with Type 1 Diabetes

Objective: Polycystic ovary syndrome (PCOS) is common in women with type 1 diabetes (T1D). Reported prevalence rates vary according to diagnostic criteria used for PCOS. However, not all women with T1D develop hyperandrogenic traits and factors that influence the occurrence of PCOS have not been well stablished yet. We aim to assess the factors associated to the occurrence of PCOS in premenopausal women with T1D. Methods: Cross-sectional study. For this analysis, we included 110 patients with T1D, 24 diagnosed with PCOS by ESHRE/ASRM-Rotterdam criteria (prevalence: 22%, 95%CI: 15-30%). Women aged 18 to 45 years were consecutively recruited from a Diabetes Clinic at a tertiary hospital in Madrid, Spain. All participants were under intensive insulin treatment, had been diagnosed with T1D at least 1 year ago, and had a gynecological age of at least 2 years. A comparison between both groups T1D-PCOS and T1D-without PCOS was performed. We used Stata software v23 (StataCorp LLC) for statistical analysis. Results: Mean age was 30.3 ± 8.7 yrs and mean HbA1c was 7.31 ± 1.4%. Three-quarters (75%) of these patients were on multiple insulin doses. Women with T1D and PCOS were younger than those without PCOS (26.3 ± 7.4 in DM1-PCOS vs 31.2 ± 8.7, P &amp;lt; 0.05). Total daily insulin dose (TDI) was higher in T1D-PCOS group compared to T1D-without PCOS (0.71 ± 0.35 vs 0.58 ± 0.19, P = 0.025). There was a trend towards a more common premenarcheal diagnosis of T1D in T1D-PCOS (62.5% vs 46.5%, P = 0.116). Age (OR: 0.93, P = 0.016) and TDI (OR: 7.84; P = 0.043) were significant predictors of PCOS in the univariate logistic regression analysis. After introducing these variables in a multivariate regression analysis, only age was retained as a significant predictor factor of PCOS in women with T1D (OR: 0.93; P = 0.040). Conclusions: In this study, premenopausal women with T1D and PCOS were younger, used higher daily insulin doses and tend to have a more common premenarcheal diagnosis of T1D as compared to T1D women without PCOS. Disclosure A.Bayona: None. L.Nattero-chávez: None. M.De la calle de la villa: None. E.F.Durán: None. B.Dorado avendaño: None. M.Luque-ramírez: None. H.F.Escobar-morreale: None.

981-P: Transition from Standard Time to Daylight Saving Time and Vice Versa—Effects on FGM Metrics in Patients with Autoimmune Diabetes

Circadian rhythm variations, including transition from standard time (ST) to daylight saving time (DST), are associated with measurable effects on health. It is not known whether the transition from ST to DST and vice versa could affect glucose control in patients with autoimmune diabetes on intensive insulin treatment. This was a single center observational study. All FGM users sharing their glucose readings on the LibreView platform were evaluated for eligibility. Pittsburgh Sleep Quality Index (PSQI) questionnaire was administered to all patients on the day before and one week after the transition to DST. In addition, FGM metrics from two weeks before and two weeks after DST transition were acquired. Seven months later, the same evaluation was performed for the transition from DST to ST. Thirty-six patients with autoimmune diabetes were included for transition from ST to DST; sixty-five patients for transition from DST to ST. After DST transition, 16 patients reported worsening of PSQI, along with significant increase of GMI, mean glucose and TAR level 1, and reduction of TIR and CV. Conversely, FGM metrics were unchanged in the 20 patients who reported no variation or amelioration of PSQI. On the contrary, after returning to ST, no variation in FGM metrics was recorded neither for the 16 patients who reported worsening of PSQI, nor for the 49 patients with no variation or amelioration of PSQI. Consistently, after transition to DST, at linear regression analyses PSQI variation was found to be significantly related with variation of mean glucose, GMI, TIR, TAR level 2 and TBR level 1. On the other hand, after returning to ST, no relation between variations of PSQI and FGM metrics was detected. These results were confirmed for 22 patients whose data were collected for both transitions. In conclusion, transition from ST to DST, but not vice versa, is associated with glucose control derangement and could require a more intensive diabetes management. Disclosure L.Di gioia: None. S.Di molfetta: Consultant; Roche Diabetes Care, Ascensia Diabetes Care, Lilly Diabetes, Movi SpA. F.Giordano: None. M.Caporusso: None. G.Sorice: None. A.Cignarelli: Speaker's Bureau; Eli Lilly and Company, Novo Nordisk, Sanofi. A.Natalicchio: Other Relationship; AstraZeneca, Novo Nordisk, Sanofi, Boehringer-Ingelheim, Lilly. L.Laviola: Advisory Panel; A. Menarini Diagnostics, Boehringer Ingelheim Inc., Eli Lilly and Company, Novo Nordisk, Roche Diabetes Care, Sanofi, Other Relationship; Medtronic, Speaker's Bureau; Abbott, Terumo Corporation. F.Giorgino: Advisory Panel; Boehringer-Ingelheim, Amarin Corporation, Medtronic, Roche Diabetes Care, Sanofi, Bayer Inc., Novo Nordisk, Consultant; Novo Nordisk, Lilly, Research Support; Lilly, Roche Diabetes Care, AlfaSigma, Speaker's Bureau; Abbott, Boehringer-Ingelheim, Lilly, Sanofi, Medscape.

Sustained low-grade inflammation in young participants with childhood onset type 1 diabetes: The Norwegian atherosclerosis and childhood diabetes (ACD) study

Background and aimsPersons with type 1 diabetes (T1D) have increased mortality from cardiovascular disease. Early inflammation is important in the development of atherosclerosis. We aimed to evaluate the extent of inflammation and difference in mean over a five-year period in young persons with T1D compared to healthy controls. MethodsThe Norwegian Atherosclerosis and Childhood Diabetes (ACD) study is a prospective population-based cohort study on atherosclerosis development in childhood-onset T1D compared to healthy controls, with follow-ups every fifth year. The original study cohort consisted of 314 children with T1D on intensive insulin treatment and 120 healthy controls of similar age. Circulating levels of VCAM-1, TNA-α, P-selectin, E-selectin, CRP, IL-6, IL-18, MCP-1, MMP-9 and TIMP-1 were measured by ELISAs at baseline and at the five-year follow-up. ResultsThe group with T1D had mean age 13.7 (SD = 2.8) years, disease duration 5.6 (SD = 3.4) years and HbA1c 68 (SD = 13.1) mmol/mol at baseline. Levels of almost all inflammatory markers were significantly increased in the group with T1D compared to controls, and significant mean-difference between the two groups over the five-year period was observed in four markers: IL-18, P-selectin, E-selectin and TIMP-1. ConclusionsThe early low-grade inflammation present in young individuals with T1D five years after diagnosis is sustained at ten-year disease duration, with moderate changes for most markers of inflammation over time. The evolving inflammatory profile indicates an accelerated chain of events in the progression of early atheromatosis in T1D.

Abstract #1493875: Efficacy and Safety of Short-term Continuous Subcutaneous Native GLP-1 Infusion Versus Intensive Insulin (CSII) Treatment in Patients with Newly Diagnosed Type 2 diabetes

Abstract #1493875: Efficacy and Safety of Short-term Continuous Subcutaneous Native GLP-1 Infusion Versus Intensive Insulin (CSII) Treatment in Patients with Newly Diagnosed Type 2 diabetes

Parental Resilience and Physical Health in Parents of Children With Type 1 Diabetes in Northern Greece.

Type 1 diabetes mellitus (T1DM) is the most common endocrine and metabolic disorder in children. On the other hand, little is known regarding the health of parents whose children suffer from T1DM. The study aims to investigate the mental resilience and physical health of parents of children with type 1 diabetes. The sample consisted of 80 parents of children and adolescents with T1DM.The study was conducted with the contribution of associations of parents of children with type 1 diabetes in a large hospital in Northern Greece between April 2021 and September 2021. A demographic and clinical questionnaire, the Wagnild and Young Resilience Scale-14(RS-14), and the General Health 28 Physical Health Measurement Questionnaire(GHQ-28) were used to collect the research data. Of the parents,18.8% were male while 65% were female. The mean age of the parents was 44.02±6.71 years while the age of their children with diabetes was 13.13±6.05 years. Almost half of the children followed intensive insulin treatment (47.5%) whereas 22,5% reported that their children received insulin via a pump. A higher percentage of parents reported measuring their children's blood sugar more than six times a day (46,3%) and having their glycated hemoglobin (HbA1c) levels checked four times a year (51.2%). Finally, statistically significant effects on the physical symptoms and severe depression of parents of children with type 1 diabetes were observed. Additional research is needed to assess the Greek parent population's resilience and physical health. This study will help healthcare providers to expand their knowledge and meet parents' needs.

Status of Hypoglycemia in Insulin Intensive Treatment

Status of Hypoglycemia in Insulin Intensive Treatment

Reduced Carbohydrate Diet Influence on Postprandial Glycemia-Results of a Short, CGM-Based, Interventional Study in Adolescents with Type 1 Diabetes.

Therapy for type 1 diabetes (T1DM) focuses on maintaining optimal blood glucose levels, achieved with intensive insulin treatment, proper nutrition, and physical activity. The aim of this study was to investigate postprandial glycemic changes under low (30%) and standard (50%) carbohydrate diets in adolescents with T1DM. A single-center cross-over nutritional study was conducted, during which 26 adolescent patients provided 220 continuous glucose-monitored (CGM) meals data from the two consecutive 3-day nutritional plans. Overall, the 50% carbohydrate diet was associated with higher postprandial glucose variability in the small meals (afternoon snacks, second breakfast) and greater postprandial peaks for other meals (breakfast, dinner, supper). Nevertheless, after the adjustment of a patient's individual clinical variables (age, Tanner classification, glucose disposal rate), we observed that mean postprandial glucose was higher for afternoon snacks and lower for suppers in the 30% carbohydrate diet. Although a 30% carbohydrate diet seems to offer better postprandial glycemia, it requires additional attention from the physician and patient when it comes to modifying daily carbohydrate intake. Increased fat/protein content and size of the main meal lead to a prolonged postprandial glycemic response, which may affect the insulin treatment and result in suboptimal glycemic control.

RF28 | PSUN184 New American Diabetes Association Definition of Diabetes Remission Does not Correlate with Time in Remission in Ketosis-Prone Diabetes

Abstract Introduction Approximately 50% of obese Black patients presenting with diabetic ketoacidosis (DKA) at new-onset of diabetes have immunologic and metabolic features of type 2 diabetes, also called ketosis-prone diabetes (KPDM). With intensive insulin treatment, ∼70% have improvements in beta-cell function and insulin sensitivity and achieve diabetes remission. The definition of remission in KPDM has been heterogeneous with our group defining remission as HbA1c &amp;lt; 7%, fasting blood glucose (BG) &amp;lt; 130 mg/dl and random BG &amp;lt; 180 mg/dl while off insulin injections for at least 1 week. In 2021, the American Diabetes Association (ADA) consensus recommended that the definition of diabetes remission as HbA1c &amp;lt; 6.5% or a fasting BG &amp;lt; 126 mg/dl while off medications for &amp;gt; 3 months. We hypothesized that patients who achieved the more intensive ADA definition of remission (HbA1c &amp;lt; 6.5%) will have longer time in remission compared to our previous non-intensive definition of remission (HbA1c 6.5-7%). Methods Forty obese Black patients (BMI ≥ 28 kg/m2) with newly diagnosed diabetes and unprovoked DKA had intensive insulin therapy until HbA1c &amp;lt; 7% without insulin therapy for at least one week. Patients were followed until hyperglycemia relapse (HbA1c &amp;gt; 6.5% or fasting BG &amp;gt; 126 mg/dl and/or requiring antidiabetic medications). Baseline characteristics and clinical time to hyperglycemia relapse-free survival were compared between patients with HbA1c &amp;lt; 6.5 (n= 24) and HbA1c 6.5-7% (n=16). Results Age, sex, family history of type 2 diabetes, BMI, HbA1C, weight change and insulin doses received between the two groups (HbA1c &amp;lt; 6.5 vs 6.5-7%) did not differ significantly. Median follow-up overall was 404 days with a range of 7-1099 days. In patients that experienced a hyperglycemia relapse, bivariate analysis shows that median days to hyperglycemia relapse was longer in HbA1c &amp;lt; 6.5% (411 days, range (17-804) vs HbA1c 6.5-7% (126 days, range (7-391), p= 0.05) but without a statistical difference. Survival analysis showed that time in remission did not statistically differ between the two groups (log rank, p=0.6853). Conclusion In obese Black patients with KPDM, HbA1c &amp;lt; 6.5% at time of insulin discontinuation does not prolong diabetes compared to patients that achieved HbA1c 6.5-7%, suggesting that predictors of prolonged remission may differ among diverse populations with diabetes. Presentation: Sunday, June 12, 2022 12:30 p.m. - 2:30 p.m., Monday, June 13, 2022 12:44 p.m. - 12:49 p.m.

Cost-Effectiveness Analysis of Flash Glucose Monitoring System for People with Type 2 Diabetes Receiving Intensive Insulin Treatment.

AimsFor people with type 2 diabetes (T2D) on intensive insulin therapy, the use of flash continuous glucose monitoring (“flash monitoring”) is associated with improved average glucose control and/or reduced hypoglycemic exposure. This study assessed the cost-effectiveness of flash monitoring versus traditional blood glucose monitoring (BGM) in people with T2D using intensive insulin in the United Kingdom (UK).MethodsThe IQVIA CORE Diabetes Model (IQVIA CDM; v9.0) was used to analyze the impact of flash monitoring versus BGM over a 40-year time horizon from the UK payer perspective. Model inputs included baseline characteristics, intervention effects, resource utilization, costs, and utilities, based on recently published literature and national databases. UK National Health Service reimbursed costs of flash monitoring and BGM were used. An intervention-related health utility was obtained from a time trade-off study. Alternative scenarios were explored to assess the impact of key assumptions on base case results.ResultsIn base-case analysis, flash monitoring compared with BGM resulted in an incremental cost of £5781 and an additional 0.47 quality-adjusted life years (QALYs). This provides an incremental cost-effectiveness ratio (ICER) of £12,309/QALY. HbA1c and the intervention-related health utility were the key drivers of differentiation. All scenario analyses, including different discount rates, time horizons, effects on HbA1c and on the intervention-related health utility, as well as glycemic emergencies, generated ICERs of less than £20,000 per QALY.ConclusionsThe consistent results across base case and a range of scenario analyses indicate that long-term flash glucose monitoring use is cost-effective compared with BGM in a UK population of T2D on intensive insulin therapy based on updated clinical effects and a cost-effectiveness threshold of £20,000–30,000 per QALY. Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-022-01325-w.

Comparison of three insulin bolus calculators to increase time in range of glycemia in a group of poorly controlled adults Type 1 diabetes in a Brazilian public health service

BackgroundA main factor contributing to insufficient glycemic control, during basal/bolus insulin therapy, is poor self-management bolus. Insulin bolus administration frequency is strongly associated with glycated hemoglobin (A1c) in Type 1 Diabetes (T1D). In the present study, we analyzed the performance of two-bolus calculator’s software that could be accessible to T1D patients from a Public Health Service to improve glycemic time in range (TIR) and A1c.MethodsThis prospective, controlled, randomized, parallel intervention clinical trial was carried out with 111 T1D participants on basal/bolus therapy [multiple daily insulin injections (MDI) or subcutaneous infusion pump (CSII)] with basal A1c ≥ 8.5% for 24 weeks. Patients were divided into 3 groups: 2 interventions: COMBO® (bolus calculator) and GLIC (mobile application) and 1 control (CSII group). Anthropometrics and metabolic variables were assessed on basal, 3 and 6 months of follow-up.ResultsTIR was increased in 9.42% in COMBO group (29 ± 12% to 38.9 ± 12.7%; p < 0.001) in 8.39% in the GLIC® group (28 ± 15% to 36.6 ± 15.1%; p < 0.001) while remained stable in CSII group (40 ± 11% to 39.3 ± 10.3%). A1c decrease in 1.08% (p < 0.001), 0.64% (p < 0.001) and 0.38% (p = 0.01) at 6 months in relation to basal in the COMBO, GLIC and CSII respectively. Daily basal insulin dose was reduced by 8.8% (p = 0.01) in the COMBO group.ConclusionThe COMBO and a mobile applicative (GLIC) bolus calculator had a similar and a good performance to optimize the intensive insulin treatment of T1D in the public health system with increase in the TIR and reduction in A1C without increase hypoglycemia prevalence.

Type 1 diabetes mellitus and cardiovascular risk: A short review

The incidence of cardiovascular disease is substantially increased in patients with type 1 diabetes compared to the general population. Robust evidence from the randomized Diabetes Control and Complications Trial (DCCT) and the long-term epidemiologic surveillance of its participants suggest that tight glycemic control by means of intensive insulin treatment is efficacious both in primary and secondary prevention of cardiovascular disease. New antidiabetic agents with proven cardiorenal benefit in patients with type 2 diabetes, such as Glucagen-Like Polypeptide-1 Receptor Agonists (GLP-1RA) and Sodium-Glucose co-Transporter-2 Inhibitors (SGLT-2inh), have been tested as adjunctive to insulin treatment in a few clinical trials in patients with type 1 diabetes. Despite their favorable effect on risk factors for atherosclerotic disease, such as body weight and blood pressure, the lack of evidence for a direct effect on cardiovascular outcomes and an increased risk for serious adverse events, such as diabetic ketoacidosis, limit their use in patients with type 1 diabetes. New metrics of glycemia, alterations in diabetes classification and precision medicine may contribute in an individualized approach of cardiovascular risk prevention in patients with diabetes.

1-h Glucose During Oral Glucose Tolerance Test Predicts Hyperglycemia Relapse-Free Survival in Obese Black Patients With Hyperglycemic Crises.

ObjectiveApproximately 50% of obese Black patients with unprovoked diabetic ketoacidosis (DKA) or severe hyperglycemia (SH) at new-onset diabetes achieve near-normoglycemia remission with intensive insulin treatment. Despite the initial near-normoglycemia remission, most DKA/SH individuals develop hyperglycemia relapse after insulin discontinuation. Traditional biomarkers such as normal glucose tolerance at the time of remission were not predictive of hyperglycemia relapse. We tested whether 1-h plasma glucose (1-h PG) at remission predicts hyperglycemia relapse in Black patients with DKA/SH.MethodsSecondary analysis was performed of two prospective randomized controlled trials in 73 patients with DKA/SH at the safety net hospital with a median follow-up of 408 days. Patients with DKA/SH underwent a 5-point, 2-h 75-g oral glucose tolerance test after hyperglycemia remission. Hyperglycemia relapse is defined by fasting blood glucose (FBG) > 130 mg/dl, random blood glucose (BG) >180 mg/dl, or HbA1c > 7%.ResultsDuring the median 408 (interquartile range: 110–602) days of follow-up, hyperglycemia relapse occurred in 28 (38.4%) participants. One-hour PG value ≥199 mg/dl discriminates hyperglycemia relapse (sensitivity: 64%; specificity: 71%). Elevated levels of 1-h PG (≥199 mg/dl) were independently associated with hyperglycemia relapse (adjusted hazard ratio: 2.40 [95% CI: 1.04, 5.56]). In a multivariable model with FBG, adding 1-h PG level enhanced the prediction of hyperglycemia relapse, with significant improvements in C-index (Δ: +0.05; p = 0.04), net reclassification improvement (NRI: 48.7%; p = 0.04), and integrated discrimination improvement (IDI: 7.8%; p = 0.02) as compared with the addition of 2-h PG (NRI: 20.2%; p = 0.42; IDI: 1.32%; p = 0.41) or HbA1c (NRI: 35.2%; p = 0.143; IDI: 5.8%; p = 0.04).ConclusionOne-hour PG at the time of remission is a better predictor of hyperglycemia relapse than traditional glycemic markers among obese Black patients presenting with DKA/SH. Testing 1-h PG at insulin discontinuation identifies individuals at high risk of developing hyperglycemia relapse.