Multiple Daily Injection Regimen Research Articles

12438 Developing A Natural Language Processing Algorithm To Identify Insulin Pump Users Using Unstructured Clinical Notes From The Electronic Health Record

Abstract Disclosure: E.M. Everett: None. R. Tiu: None. B. Zhu: None. T. Moin: None. A.T. Bui: None. Background: Insulin pumps (pump) have many benefits to patients with type 1 diabetes compared to management with multiple daily injection regimens. Unfortunately, disparities exist in pump therapy access and use, particularly in racial-ethnic minoritized groups, those of lower socioeconomic status or limited English proficiency. Given that these groups are underrepresented in pump clinical trials, evaluating data from real-world populations such as those from large health systems is critical to improve technology use in these groups that also experience disparities in diabetes outcomes. Unfortunately, it is very challenging to identify diabetes technology users using electronic health record data due to the underutilization of ICD and procedure codes for pump use and the documentation of pump use in unstructured form in clinical notes, which is more difficult to extract outside of manual chart review. Consequently, a novel approach is needed to capture this population on a large scale. We aim to develop an algorithm using the machine learning method natural language processing (NLP), to identify these technology users and non-users in health systems, which would allow us to study pump use in real-world settings. Methods: To develop the algorithm, we performed chart review and cataloged documentation styles (keywords, phrases) indicating pump use from 88 clinical notes of adults with type 1 diabetes, authored by physicians and nurse educators in UCLA endocrinology clinics from 2014-2022. After reaching saturation for documentation styles, we used a series of regular expressions (Regex) to encode the algorithm, including code to negate phrases that may lead to false positives. Results: We tested the algorithm performance in an 85 note sample that included 59 pump users and 26 non-users. The algorithm detected 56/59 pump users and 26/26 non-pump users, yielding a sensitivity of 95% (95%CI 87-99%), a specificity of 100% (95%CI 86-100%) specificity, a positive predictive value of 100% (95%CI 94-100%), and a negative predictive value of 90% (95%CI 74-96%). Conversely, an approach using ICD and procedure codes only identified 17/59 pump users with a sensitivity of 28% (95%CI 18-42%), specificity of 100% (95%CI 87-00%), positive predictive value of 100% (95%CI 81-100%), and negative predictive value of 38% (95%CI 35-42%). Incrementally, the NLP algorithm identified ∼70% more pump users than the approach using billing codes. Conclusion: NLP is a promising approach to identify pump users using unstructured electronic health record data. Next steps include testing the current algorithm in a larger sample of clinical notes, revising the algorithm as needed. The final algorithm will be used to understand patterns and disparities of pump prescribing over time and will be leveraged as a recruitment tool to identify potentially eligible patients for future studies aimed at addressing pump disparities. Presentation: 6/3/2024

6869 Endocrinologist Perceptions of the Value of Digital Health Tools to Assist in the Management of Insulin Dosing

Abstract Disclosure: M.B. Davidson: Employee; Self; Eli Lilly & Company. B. Liao: Employee; Self; Eli Lilly & Company. C. Heckman: Employee; Self; Eli Lilly & Company. Background and aims: Insulin management is complex for both people with diabetes (PwD) and the healthcare providers (HCP) who treat them. Digital tools, such as connected insulin pen (CIP) platforms may reduce burden and improve suboptimal insulin dosing, especially through automatic capture of insulin dose events and integration with glucose values. However, the acceptance and utilization of CIP platforms in clinical practice remains lower than expected, given this clinical care gap. This study attempted to ascertain beliefs of HCP leading to this finding. Methods: For this cross-sectional study, 190 members of The Endocrine Society who self-identified as “clinical endocrinologists who treat diabetes” completed a 10-question survey on their perception of digital health tools and their value in clinical practice. Results: In their patients using multiple daily injections (MDI), defined as three or more injections of insulin per day, documentation of insulin dosing data was identified as “important” or “very important’ to 81% of respondents. However, only 48% of respondents are “confident” or “very confident” in the reliability of manually captured insulin and glucose data. While 92% of respondents indicated that a digital platform that displays insulin and glucose data would be “beneficial” or “very beneficial” for making dosing recommendations, 60% have found that a CIP platforms had been “beneficial” or “very beneficial” in helping PwD improving their glycemic control. Conclusion: A group of almost 200 clinician members of the Endocrine Society, who actively treat PwD, indicated that in their PwD using MDI regimens, access to combined insulin and glucose data is important, and digital capture of this data would be beneficial. However, this data is often unavailable or unreliable. The survey revealed a gap between their belief that availability of glucose data and insulin dosing data can help them make dosing recommendations and their belief that these will translate into impacting glycemic control of patients. Further research would be helpful to determine how diabetes technology may better support these HCP and the PwD they treat in practice. Presentation: 6/1/2024

12339 Rotating Insulin Injection Sites Isn't Enough: A Challenging Case Of Insulin-Induced Lipoatrophic Panniculitis

Abstract Disclosure: J. Hand: None. S. Nemiroff: None. C. Zmijewski: None. C.J. Levy: None. Introduction: Insulin-induced localized lipoatrophy is a rare phenomenon that involves the loss of subcutaneous adipose tissue around sites of insulin injections, and it often presents as a deep, retracted scar on the skin. Its prevalence has dropped significantly given improvements in recombinant and purified insulin and its analogs, from 55% to more recently 1-2%. Lipoatrophy can cause erratic absorption of insulin, leading to suboptimal glycemic control and hypoglycemia. The pathophysiology is not completely understood but is thought to be immune-mediated. Treatment options are limited and often focus on rotating injection sites or changing the type of insulin, though some case reports alternatively describe using corticosteroid injections. Here, we report an unusual case where a patient developed a form of early, localized lipoatrophy called lipoatrophic panniculitis due to insulin. Clinical Case: A 28-year-old male with a 13-year history of type 1 diabetes presented for insulin optimization. The patient was using multiple daily injection (MDI) insulin therapy and later an insulin pump, with careful infusion site rotation. Seven years later, he experienced issues with his pump sites, developing nodules and bruises that became painful and caused labile glycemic control. He underwent dermatologic, rheumatologic, and allergic workup with two biopsies confirming insulin-induced lipoatrophic panniculitis. Immunosuppressive and varying insulin regimens were unsuccessful. Hydroxychloroquine and methotrexate showed limited improvement with intolerable gastrointestinal side effects. Trials of hydrocortisone in his insulin infusion or topical clobetasol with tacrolimus provided no benefit. Various MDI regimens with different concentrations of lispro, aspart, faster aspart, glargine, detemir, and degludec were tried; all elicited varying degrees of pain with suboptimal glycemic response. A supervised trial of inhaled insulin was associated with bronchospasms. An implantable insulin pump was sought through clinical trials but was not feasible due to eligibility. Ultimately, he was successfully referred for pancreas transplantation due to his labile and complicated diabetes, but the procedure was complicated by allograft thrombosis and failure. He is currently awaiting a second transplant. Clinical Lesson: There are few reports of patients with insulin-induced lipoatrophic panniculitis in the literature. It is an important differential to consider for a patient that is having unexpected glycemic excursions, and it is equally as challenging to select an adequate management regimen. Treatment is limited and a broad range of options need to be considered. When these patients fail mainstay immunosuppressive, corticosteroid, and insulin-based management, pancreas transplantation may be considered as an alternative feasible treatment. Presentation: 6/1/2024

Effect of Crocus sativus Extract Supplementation in the Metabolic Control of People with Diabetes Mellitus Type 1: A Double-Blind Randomized Placebo-Controlled Trial.

61 individuals with DMT-1, mean age 48 years old (48.3 ± 14.6), 26 females (42.6%) were randomized to receive a new oral supplement in sachets containing probiotics, prebiotics, magnesium, and Crocus sativus L. extract or placebo containing probiotics, prebiotics and magnesium daily for 6 months. Glycemic control was assessed with a continuous glucose monitoring system and laboratory measurement of HbA1c and lipid profile was also examined. Blood pressure at baseline and end of intervention was also measured. Individuals were either on a continuous subcutaneous insulin infusion with an insulin pump or in multiple daily injection regimens. Diabetes distress and satiety were assessed through a questionnaire and body composition was assessed with bioelectrical impedance. At the end of the intervention, the two groups differed significantly only in serum triglycerides (p = 0.049). After 6 months of treatment, a significant reduction in the active group was observed in glycated hemoglobin (p = 0.046) and serum triglycerides (p = 0.021) compared to baseline. The other primary endpoints (glycemic control, lipid profile, blood pressure) did not differ within the groups from baseline to end of intervention, and there was no significant difference between the two groups. Diabetes distress score improved significantly only in the active group (p = 0.044), suggesting an overall improvement in diabetes disease burden in these individuals but that was not significant enough between the two groups. A probiotic supplement with saffron extract improves serum triglycerides in well-controlled people with DMT-1 and may potentially be a valuable adjunct for enhancing glycemic control.

Frequency of hypoglycaemia with basal insulin treatments in adults with type 1 diabetes treated with basal-bolus insulin regimens in treat-to-target trials: A narrative review.

To summarise, in a narrative review, published data on hypoglycaemia occurrence with basal insulin therapy in adults with type 1 diabetes treated with basal-bolus insulin regimens in treat-to-target randomised controlled trials. Data were included from 21 eligible trials, which mainly used self-measured blood glucose or plasma glucose to detect hypoglycaemia. All-day self-measured blood glucose or plasma glucose level 2 (glucose threshold of 3.1 or 3.0 mmol/L) and level 3 (severe, requiring assistance) hypoglycaemic events were reported, respectively, by a range of 69.0%-97.5% and 0%-13.4% adults when receiving basal-bolus insulin therapy, with rates of 10.6-68.1 and 0.0-0.4 events per patient-year of exposure, respectively. Hypoglycaemia rates measured using continuous glucose monitoring (three studies) were numerically, yet consistently, higher than with either other method, except when limiting to symptomatic events. Nocturnal hypoglycaemia rates were generally less than 30% of the equivalent all-day rates. Differences across the studies in design (e.g., titration targets) and participant characteristics hindered comparison of hypoglycaemia rates by insulin formulation. Consequently, few trends were identified by insulin formulation, study methodology or individuals' characteristics, suggesting that further research is required to identify treatment strategies that facilitate development of individualised recommendations to lower hypoglycaemia risk. These findings are useful to understand hypoglycaemia risk with available basal insulin therapies when used in a multiple daily injection regimen, as well as to provide context for the results of ongoing and future clinical trials, including those for two once-weekly basal insulins, insulin icodec and basal insulin Fc.

Effectiveness of Insulin Pump Therapy Versus Multiple Daily Injections for Glycemic Control and Rate of Diabetic Ketoacidosis Among Children With Type 1 Diabetes Mellitus.

Background Advances in pump technology and the availability of insulin analogs, as well as the results of the Diabetes Control and Complications Trial (DCCT), which established the benefit of improved glycemic control, have all contributed to the increased use of insulin pump therapy in recent years, particularly in children. Purpose This research aims to compare the impact of insulin delivery method, i.e., continuous subcutaneous insulin infusion (CSII) or multiple daily injections (MDI) on glycemic control and the rate of diabetic ketoacidosis (DKA) among children with type 1 diabetes mellitus in Al Ahsa, Saudi Arabia. Methods A retrospective cohort study was carried out in a diabetic center in Al Ahsa, Saudi Arabia, over 24 months (2020-2022) among children with type I diabetes mellitus (age group 1-14 years). Results In total, 351patients with diabetes were induced, with 316 (90%) on MDIand 35 (10%) onCSII. After six months of diagnosis, precisely 38 (12%) ofpatients with diabetes on the MDIregimen experienced DKA, compared to 4 (11.4%) of those on the CSIIregimen, with no statistically significant difference (P=0.918). At six months and nine months of follow-up, the average hemoglobin A1c (HbA1c) was considerably higher in diabetic patients on MDI (8.9 ± 1.7% vs. 8.2 ± 1.5% and 9.1 ± 1.6% vs. 8.0 ± 1.3%, respectively, with a significant p-value ≤0.05). Conclusion In this study, we found that patients on the MDI regimen had considerably higher HbA1c levels than patients on the CSII regimen, but there was no statistically significant difference in DKA rates between them. This is a short-term follow-up study, and we recommend that patients be followed for a longer period of time for further accurate outcomes.

Splitting Mealtime Insulin Doses for Mixed Fat and Protein Meals in Children and Adolescents with Type 1 Diabetes Using Multiple Daily Injection Regimen: A Randomized Cross-Over Trial

Aims. Assessment of the glycemic outcomes of increasing and splitting mealtime insulin doses for mixed fat and protein meals in pediatric patients with type 1 diabetes mellitus (T1DM) using multiple daily injection regimen and comparing the effects of regular insulin and fast-acting insulin on glycemic outcomes following those meals. Methods. This single-center, randomized, cross-over trial included 43 children and adolescents with T1DM randomly assigned to receive three interventional insulin doses for lunch meals over 3 consecutive days; Intervention A (100% insulin-to-carbohydrate ratio (ICR) dose given as premeal insulin lispro with an additional insulin sensitivity factor-calculated correction dose after 3 hr), Intervention B (130% ICR dose split into 60% premeal insulin lispro and 40% postmeal insulin lispro after 30 min), and Intervention C (130% ICR dose split into 60% premeal insulin lispro and 40% postmeal regular insulin after 30 min). The test meal consisted of two slices of pizza (weight: 150 g, carbohydrates: 40 g, fat: 15 g, protein: 20 g, and calories: 380 kcal). Postprandial blood glucose levels were monitored for 6 hr. Results. There were no significant differences in postprandial blood glucose excursions following the three interventions. However, Intervention C had a significantly lower late (3–6 hr) blood glucose area under the curve ( p = 0.01 ). Postprandial hypoglycemia developed in 12 participants (27.9%) following Interventions A and B and in 17 participants (39.5%) following Intervention C ( p = 0.32 ). Conclusions. Using regular insulin as a postmeal portion of increased and split insulin doses provided better late postprandial glycemic outcomes following mixed fat and protein meals. However, the amount of additional insulin used needs optimization to reduce the frequency of postprandial hypoglycemia. This trial is registered with NCT04783376.

Newly diagnosed type 1 diabetes mellitus in a human immunodeficiency virus-infected patient with antiretroviral therapy-induced immune reconstitution inflammatory syndrome: a case report

BackgroundDiabetes that develops in human immunodeficiency virus (HIV)-infected patients who receive antiretroviral therapy (ART) is usually type 2 diabetes mellitus (T2DM); however, autoimmune diabetes, such as type 1 diabetes mellitus (T1DM) can also develop in this population. After treatment with ART, patients might experience clinical deterioration following an increase in the CD4 cell count, which is termed immune reconstitution inflammatory syndrome (IRIS). Here, we describe an HIV-infected patient on ART who developed T1DMat due to IRIS, highlighting the clinical complexity in diagnosis and treatment.Case presentationA 36-year-old man infected with HIV had a nadir CD4 cell count of 15.53/μL before medication, which increased to 429.09/μL after 9 months of regular ART. The fasting serum glucose at 9 months was between 96 mg/dL and 117 mg/dL. After 11 months of ART, the patient was admitted to hospital for diabetic ketoacidosis (DKA) and Graves’ disease (GD). Noninsulin antidiabetics (NIADs) were prescribed following the resolution of DKA. However, poor glycemic control was noted despite well-titrated NIADs. Further investigation demonstrated poor pancreatic beta cell function and elevated anti-glutamic acid decarboxylase (anti-GAD) and anti-tyrosine phosphatase-like insulinoma antigen 2 (anti-IA2) titers. According to the results, he was diagnosed with T1DM and received multiple daily injections(MDI) of insulin. The regimen of MDI was insulin degludec as basal insulin and insulin aspart as prandial insulin. After MDI therapy, his glycemic control was improved.ConclusionIn this case, T1DM was ascribed to IRIS. Although this phenomenon has been demonstrated in previous case reports, further study is necessary to realize the mechanism of this association. Therefore, we emphasize that when HIV-infected patients on ART experience an unstable blood glucose level and abnormal thyroid function, physicians should consider T1DM and GD associated with ART-induced IRIS to reduce the subsequent complications and more serious endocrine dysfunction.

Visually controlled pulsatile release of insulin from chitosan poly-acrylic acid nanobubbles triggered by focused ultrasound

Insulin therapy is the most effective way to control the blood glucose value of diabetic patients. The most effective administration route for insulin is subcutaneous injection because bioavailability for non-injection administration is low and unstable. However, patients often need a multiple daily insulin injection regimen to control basal and postprandial blood glucose, which causes various complications. Controlled pulsatile drug release technology using ultrasound as an external stimulus source is a very promising method to avoid multiple injections of insulin. However, most of the drug-loaded microbubbles used for ultrasound-mediated treatment have a short half-life, which limits their use in controlled pulsatile drug release. More importantly, how to control insulin release is still a challenge. In this paper, chitosan poly-acrylic acid nanobubbles as drug carriers of insulin were prepared to achieve a visually controlled pulsatile release of insulin triggered by focused ultrasound. The experimental results in vivo demonstrated that nanobubbles were stable enough to achieve long-term visualization for 7 days after intramuscular injection in rats. Under the guidance of ultrasound imaging, it is visible to find the position and observe the gray values change of nanobubbles. Thus, when triggered by focused ultrasound, the amount of insulin could be accurately pulsatile released from nanobubbles. In vivo experiments in rats showed that the visually controlled pulsatile release of insulin could be achieved for a long time, up to 3 consecutive days. The blood glucose level could be repeatedly reduced by focused ultrasound irradiation with just one injection. Our research provided a promising way for visually controlled pulsatile release of insulin, which would significantly reduce the injection frequency of insulin.

Fast-Acting Insulin Aspart in Patients with Type1 Diabetes in Real-World Clinical Practice: A Noninterventional, Retrospective Chart and Database Study.

This study utilized continuous glucose monitoring data to analyze the effects of switching to treatment with fast-acting insulin aspart (faster aspart) in adults with type1 diabetes (T1D) in clinical practice. A noninterventional database review was conducted in Sweden among adults with T1D using multiple daily injection (MDI) regimens who had switched to treatment with faster aspart as part of basal-bolus treatment. Glycemic data were retrospectively collected during the 26weeks before switching (baseline) and up to 32weeks after switching (follow-up) to assess changes in time in glycemic range (TIR; 70-180mg/dL), mean sensor glucose, glycated hemoglobin (HbA1c) levels, coefficient of variation, time in hyperglycemia (level1, > 180 to ≤ 250mg/dL; level2, > 250mg/dL), and time in hypoglycemia (level1, ≥ 54 to < 70mg/dL; level2, < 54mg/dL) (ClinicalTrials.gov Identifier NCT03895515). Overall, 178 participants were included in the study cohort. The analysis population included 82 individuals (mean age 48.5years) with adequate glucose sensor data. From baseline to follow-up, statistically significant improvements were reported for TIR (mean increase 3.3%-points [approximately 48min/day]; p = 0.006) with clinically relevant improvement (≥ 5%) in 43% of participants. Statistically significant improvements from baseline were observed for mean sensor glucose levels, HbA1c levels, and time in hyperglycemia (levels1 and 2), with no statistically significant changes in time spent in hypoglycemia. Switching to faster aspart was associated with improvements in glycemic control without increasing hypoglycemia in adults with T1D using MDI in this real-world setting.

Close intervention sessions complement intensive insulin therapy in paediatric diabetes: a longitudinal study

ObjectiveTo examine the impact of multidisciplinary team input and intensive insulin therapy on glycaemic control in children and adolescents with diabetes over a 13-year period.DesignTwo statistical approaches were used to...

Increased Time in Range with Ultra Rapid Lispro Treatment in Participants with Type 2 Diabetes: PRONTO-Time in Range.

To evaluate time in range metrics and HbA1c in people with type 2 diabetes (T2D) treated with ultra rapid lispro (URLi) using continuous glucose monitoring (CGM) for the first time in this population. This was a Phase 3b, 12-week, single-treatment study in adults with T2D on basal-bolus multiple daily injection (MDI) therapy using basal insulin glargine U-100 along with a rapid-acting insulin analog. Following a 4-week baseline period, 176 participants were newly treated with prandial URLi. Participants used unblinded CGM (Freestyle Libre). Primary endpoint was time in range (TIR) (70-180mg/dl) during the daytime period at Week 12 compared to baseline with gated secondary endpoints of HbA1c change from baseline and 24-h TIR (70-180mg/dl). Improved glycemic control was observed at Week 12 versus baseline including mean daytime TIR (change from baseline [Δ] 3.8%; P = 0.007), HbA1c (Δ - 0.44%; P < 0.001), and 24-h TIR (Δ 3.3%; P = 0.016) with no significant difference in time below range (TBR). After 12weeks, there was a statistically significant decrease in postprandial glucose incremental area under curve, overall, across all meals, within 1h (P = 0.005) or 2h (P < 0.001) after the start of a meal. Basal, bolus, and total insulin dose were intensified with increased bolus/total dose ratio at Week 12 (50.7%) versus baseline (44.5%; P < 0.001). There were no severe hypoglycemia events during the treatment period. In people with T2D, URLi in an MDI regimen was efficacious with improved glycemic control including TIR, HbA1c, and postprandial glucose without increased hypoglycemia/TBR. CLINICALTRIAL REGISTRATION NUMBER: NCT04605991.

Time-Action Profile of Technosphere Insulin in Children with Type1 Diabetes.

Technosphere insulin (TI) is aninhaled dry powder ultra-rapid-acting insulin. This report describes the results of the first study of TI in children with type1 diabetes (T1D). Pharmacokinetics (PK) of TI and the effect of TI on circulating glucose concentrations were evaluated in a single-arm study that enrolled children ages 8-17years with T1D for more than 1year, on a stable multiple daily insulin injection (MDI) regimen, and meeting pre-defined pulmonary function testing criteria (at least 70% predicted). To assess PK, subjects received an individualized single preprandial dose of TI (4-12U, in 4-U increments) via oral inhalation, basedon their usual meal-time subcutaneously injected rapid-acting insulin dose and meal content. Serum insulin and blood glucose were measured at -30 to 250min relative to dosing. Twenty-seven children with T1D participated in this single-dose PK study. Mean subject age was 13.3years (59% female; 81.5% White). Meanserum insulin Cmax (maximum concentration) was 77.3, 119.15, and 207.7µU/mL for doses of 4, 8, and 12U, respectively. Tmax occurred at 10.5, 13.9, and 14.6min post-dose for 4, 8, and 12U.Glucose lowering 30-60min post-dose was consistent with the PK profile. Serum insulin rapidly increased post-dose and returned to baseline by 120min. The data suggests the PK of TI in youth with T1D ages 8-17years was similar to that seen in previous adult studies. ClinicalTrials.gov identifier, NCT02527265.

Nighttime hypoglycemia in Japanese children with type 1 diabetes mellitus treated with multiple daily injection insulin therapy.

Prevention of hypoglycemia is an important strategy for glycemic management in patients with type 1 diabetes mellitus (T1D). Hypoglycemia is difficult to recognize at night while sleeping, particularly when using multiple daily injection (MDI) insulin therapy rather than sensor-augmented insulin-pump therapy. Therefore, it is possible that patients with T1D are at higher risk of nocturnal hypoglycemia when insulin is administered using an MDI regimen. We investigated nocturnal hypoglycemia in 50 pediatric patients with T1D on MDI insulin therapy using data from an intermittently scanned continuous glucose monitoring (isCGM) system. Hypoglycemia was observed on 446 of the 1,270 nights studied. Most of the hypoglycemic episodes were severe (blood glucose <54 mg/dL). On nights when hypoglycemia occurred, the blood glucose concentrations measured using finger-stick blood glucose monitoring (FSGM) before sleep and the next morning were lower than nights when hypoglycemia did not occur. However, few values were below the normal blood glucose range, suggesting that FSGM alone may be insufficient to detect nocturnal hypoglycemia. Approximately 7% of time was spent below the normal glucose range during the 10 hours from 21:00 to 7:00 the next morning. This result suggests that the patients on MDI insulin therapy could end up spending more time in hypoglycemia than is recommended by the American Diabetes Association (time below range <4.0% of time per day). Monitoring glucose levels overnight using an isCGM sensor may improve glycemic management via automatic detection of blood glucose peaks and troughs.

Dual-basal-insulin regimen for the management of dawn phenomenon in children with type 1 diabetes: a retrospective cohort study.

Handling of the dawn phenomenon (DP) with multiple daily insulin injection (MDII) regimen is a real challenge. We aimed to demonstrate the effectiveness of a dual-basal-insulin (a long-acting glargine and an intermediate-acting neutral protamine Hagedorn (NPH)) regimen for the management of DP in children with type 1 diabetes mellitus (T1DM). The primary efficacy outcome was to overcome morning hyperglycemia without causing hypoglycemia during the non-DP period of the night. Retrospective cohort study. Charts of 28 children with T1DM (12 female; 42.8%, mean age 13.7 ± 2.1 years) treated with MDII were retrospectively reviewed. The median duration of diabetes was 4.5 years (range 2-13.5 years). DP was diagnosed using a threshold difference of 20 mg/dL (0.1 mmol/L) between fasting capillary blood glucose at 3 a.m. and prebreakfast. NPH was administered at midnight in addition to daily bedtime (08.00-09.00 p.m.) glargine (dual-basal-insulin regimen). Midnight, 03:00 a.m., prebreakfast and postprandial capillary blood glucose readings, insulin-carbohydrate ratios, and basal-bolus insulin doses were recorded the day before the dual-basal-insulin regimen was started and the day after the titration of the insulin doses was complete. Body mass index standard deviation scores (BMI SDS) at the onset-3rd-12th month of treatment were noted. Before using dual basal insulin, prebreakfast capillary blood glucose levels were greater than those at midnight and at 03:00 a.m. (F = 64.985, p < 0.01). After titration of the dual-basal-insulin doses, there were significant improvements such that there were no statistically significant differences in the capillary blood glucose measurements at the three crucial time points (midnight, 03.00 a.m., and prebreakfast; F = 1.827, p = 0.172). No instances of hypoglycemia were reported, and the total daily insulin per kilogram of body weight did not change. The BMI SDS remained steady over the course of the 1-year follow-up. In this retrospective cohort study, the dual-basal-insulin regimen, using a long-acting glargine and an intermediate-acting NPH, was effective in overcoming early morning hyperglycemia due to insulin resistance in the DP. However, the effectiveness of the dual-basal-insulin regimen needs to be verified by prospective controlled studies using continuous glucose monitoring metrics or frequent blood glucose monitoring.

ISPAD Clinical Practice Consensus Guidelines 2022: Ramadan and other religious fasting by young people with diabetes.

ISPAD Clinical Practice Consensus Guidelines 2022: Ramadan and other religious fasting by young people with diabetes.

217-OR: A Randomized Controlled Trial Comparing the Safety and Efficacy of IDegLira vs. Basal Bolus in Patients with Poorly Controlled Type 2 Diabetes and Very High HbA1c (&amp;gt;9%–15%) : IDegLira HIGH Trial

IDegLira-HIGH trial was a non-inferiority, prospective, randomized clinical trial, comparing the efficacy and safety of insulin degludec/liraglutide combination (IDegLira) and a regimen of multiple daily injections (MDI) with basal-bolus insulin (BB) in adults (&amp;gt;18-80 years of age) , with type 2 diabetes (T2D) , and very high HbA1c (&amp;gt;9%-15%) , previously treated with basal insulin or multiple oral agents. Primary endpoint was change in HbA1c from baseline to week 26. Secondary endpoints included incidence of hypoglycemia, changes on weight and glycemic variability (% coefficient of variation [%CV]) . Treatment with IDegLira and BB insulin resulted in similar improvement in glycemic control: 7.7±1.7% and 7.7±1.5%, (p=0.76) , with a reduction from baseline of -3.2±2.3% and -3.0±1.8%, (p=0.39) at 26-weeks. IDegLira resulted in lower rates of hypoglycemia &amp;lt;70 mg/dl (22% vs. 36%, p=0.05) , similar glycemic variability (CGM %CV 30.4±9.1% vs. 33.2±7.3%, p=0.08) , and greater weight loss (-3.7±4.1 kg vs. +8.4±5.4 kg, p&amp;lt;0.01) compared to BB. IDegLira was associated with higher rates of nausea (Table 1) . Conclusions: In patients with T2D and very high HbA1c (≥9%-15%) , a regimen of daily IDegLira injection is non-inferior to MDI with BB insulin on HbA1c reduction and was associated with weight loss and less hypoglycemia. Disclosure R.J.Galindo: Advisory Panel; Sanofi, WW International, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk. G.E.Umpierrez: Research Support; AstraZeneca, Dexcom, Inc., Novo Nordisk. B.Moazzami: None. M.F.Scioscia: None. P.Vellanki: n/a. G.M.Davis: Consultant; Medscape, Research Support; Insulet Corporation. F.J.Pasquel: Consultant; AI Health LLC, Boehringer Ingelheim International GmbH, Dexcom, Inc., Research Support; Dexcom, Inc., Insulet Corporation, Merck &amp; Co., Inc. M.Fayfman: None. A.L.Migdal: None. J.Saling: None. Funding Investigator-initiated study to Emory University (PI. Dr. Rodolfo J. Galindo) from Novo Nordisk.

Adherence to Mediterranean Diet Is Associated With Better Glycemic Control in Children With Type 1 Diabetes: A Cross-Sectional Study.

Type 1 diabetes (T1D) is a chronic condition, with increased morbidity and mortality, due to a higher rate of cardiovascular disease among other factors. Cardiovascular risk increases with the worse glycemic profile. Nutrition has a deep impact on diabetes control. Adherence to the Mediterranean diet (MD) has been shown to decrease cardiovascular risk in children and adults with obesity and adults with type 2 diabetes, but its impact on T1D children has been scarcely analyzed. We hypothesized that the degree of adherence to MD could relate to the increased time in range in children with T1D.Patients and MethodsCross-sectional analysis involving two university hospitals. We measured the adherence to MD with the Mediterranean Diet Quality Index for children and teenagers (KIDMED) questionnaire, which is a validated tool for this purpose. A score of <5 indicates poor adherence to MD, while a good adherence is indicated by a score of >7. Demographic and clinical data were registered on the same day that the questionnaire was taken, with informed consent. Additionally, the patients' ambulatory glucose profiles (AGPs), were registered from the participants' glucose monitors (continuous or flash devices), and daily insulin needs were recorded from patients' insulin pumps (n=28). Other cardiovascular risk factors such as lipid profile, vitamin D levels, and other biochemical parameters were registered from a blood test, performed 2 weeks before recruitment, as part of the patients' annual screening.ResultsNinety-seven patients (44 girls), with an average age of 11.4 years (± 3.01), were included. Seventy-one of them were on multiple daily injection regimens, and all had either continuous or flash glucose monitoring. Fifty-three had HbA1c levels of <7.5%, while only 21 had a time in range (TIR) of >70%. Contingency analysis showed that the odds of having HbA1c <7.5% increase in children with KIDMED score of >7 (O.R. 2.38; ICR 1.05–5.41; p = 0.036). Moreover, the KIDMED score and the HbA1c levels were negatively correlated (R: −0.245; p-value: 0.001), while the KIDMED score and TIR showed a positive correlation (R: 0.200; p-value: 0.009).ConclusionsOur data suggest that adherence to MD may contribute to better glycemic control in children. This should be taken into account at the time of nutritional education on T1D patients and their families.

Vascular and Myocardial Function in Young People with Type 1 Diabetes Mellitus: Insulin Pump Therapy Versus Multiple Daily Injections Insulin Regimen.

Multiple daily injections (MDI) and continuous subcutaneous insulin infusion (CSII) are two modalities of treating type 1 diabetes mellitus (T1DM). The benefits of CSII on long-term metabolic control and outcomes compared to those of MDI are still debated. We investigated both vascular function and myocardial performance in T1DM adolescents on MDI or CSII treatment. One hundred twenty-three T1DM subjects (mean age 14.16±2.55 years), 63 on MDI regimen, 60 on CSII, and 57 controls were enrolled. Anthropometric and biochemical characteristics were evaluated. Ultrasound assessments of carotid intima-media thickness (cIMT), flow-mediated dilatation of brachial artery, anteroposterior diameter of the infrarenal abdominal aorta (APAO), and transthoracic echocardiography were performed. T1DM subjects on the CSII regimen showed better glycemic control than those on MDI, expressed as glycated haemoglobin (HbA1c). c-IMT and APAO were higher in MDI than CSII patients (0.61±0.11 mm vs. 0.56±0.07 mm, p=0.04; 13.61±3.29 mm vs. 11.65±1.84 mm, p=0.01, respectively). Left and right Tei index and left E/e' ratio were higher in MDI than CSII subjects (0.82±0.40 vs. 0.52±0.19, p=0.002; 0.86±0.41 vs. 0.64±0.1, p=0.02; 5.89±2.0 vs. 4.73±1.59, p=0.02, respectively). Multiple regression analyses showed that glucose level, HbA1c and diabetes onset were significantly related to vascular and echocardiographic parameters in MDI and CSII patients. CSII regimen in T1DM adolescents improves glycemic control and seems to ameliorate endothelial function and global myocardial performance as compared to MDI therapy.

Videocapillaroscopy, Insulin-Induced Skin Lipohypertrophy, and Bruising: A Preliminary Approach

Background: Lipohypertrophy (LH) is a frequent cutaneous complication in people with insulin-treated type-2 DM (IT-T2DM). Its pathogenesis is not fully known, however. Retinal and kidney microangiopathy (MIA) is also frequent in such patients, especially in case of poor metabolic control. Aim: To assess whether specific nailfold video-capillaroscopy (NVC) patterns could be identified in MIA-affected IT-T2DM patients, thus eventually helping explain LH pathogenesis. Methods: 50 IT-T2DM patients with LH and 50 without LH undergoing NVC were enrolled. All followed a multiple daily injection regimen and had established retinal and renal microangiopathic complications. Results: While confirming expected MIA-related skin changes in both groups, our data failed to detect any specific NVC pattern in LH-affected patients yet showed the most severe NVC changes to be significantly associated with HbA1c values over 9%. Conclusion: Severe NVC-assessed MIA lesions reflect longstanding poor metabolic control in IT-T2DM rather than contributing to LH pathogenesis.