Multiple Daily Insulin Injections Research Articles

Characteristics of Children with Newly Diagnosed Type 1 Diabetes Mellitus in Brunei Darussalam.

This study aims to characterize the presentation, biochemical status of children with T1DM at diagnosis, the type of subcutaneous insulin regimens initiated, and to determine the incidence of T1DM in Bruneian children aged 18 years and younger. A retrospective electronic and paper medical chart review was performed on patients aged 18 years and younger diagnosed with T1DM from 2013 to 2018 in Brunei Darussalam. A total of 31 children with a mean age of 10.2 ± 3.6 years old were diagnosed with T1DM, of which 66.7% presented with diabetic ketoacidosis (DKA), a majority in severe DKA with an intercurrent illness (p = 0.021). The mean HbA1c was 13.6 ± 2.7% with a mean serum glucose of 37.0 ± 14.9 mmol/L at diagnosis. In the majority of the children (67.7%), multiple daily injections of subcutaneous insulin were initiated. The incidence of T1DM in children aged 18 years and younger was 4.9 per 100,000 for the year 2018. The majority of the patients in this study presented with severe DKA with an intercurrent illness. This highlights the importance of childhood T1DM awareness among the public and healthcare providers. The incidence of childhood T1DM in Brunei Darussalam is similar to other countries in the Asian region, being relatively low, compared to the rest of the world.

Fasting and postprandial plasma glucose contributions to hemoglobin A1c and time in range in people with diabetes on multiple daily injection insulin therapy: Results from the PRONTO-T1D and PRONTO-T2D clinical trials

AimsTo investigate contributions of changes in fasting plasma glucose (FPG) and postprandial glucose (PPG) to changes in hemoglobin A1c (HbA1c) and time-in-range (TIR, 70–180 mg/dL) in people with type 1 diabetes (T1D) and type 2 diabetes (T2D) treated with multiple daily injections (MDI) of insulin lispro (rapid/ultra-rapid formulations). MethodsMultivariate regression models were used to quantify the contributions of FPG and PPG reductions to change in HbA1c and TIR using data from the PRONTO-T1D (N = 1222) and PRONTO-T2D (N = 673) clinical trials. TIR was derived from 10-point self-monitored blood glucose (SMBG) profiles overall, as well as from continuous glucose monitoring (CGM) in the PRONTO-T1D CGM substudy (n = 269/1222). ResultsA 1 mmol/L FPG reduction corresponded with a 0.09–0.12 % (95 % confidence interval [CI] 0.06–0.15 %) HbA1c reduction in PRONTO-T1D and 0.17–0.26 % (95 % CI 0.13–0.30 %) in PRONTO-T2D (both p < 0.0001). A 1 mmol/L PPG reduction corresponded with a 0.05–0.09 % (95 % CI 0.01–0.12 %) HbA1c reduction in PRONTO-T1D (p < 0.001) and 0.10–0.15 % (95 % CI 0.05–0.19 %) in PRONTO-T2D (p < 0.0001). Reductions in FPG and PPG were significantly associated with increased TIR whether derived from SMBG (7.87–12.95 % [95 % CI 6.81–14.23 %]; all p < 0.0001) or CGM (3.35–4.18 % [95 % CI 2.11–5.39 %]; all p < 0.05). ConclusionsFPG and PPG significantly impact HbA1c and TIR. Balanced management of both FPG and PPG is important to achieve glycemic goals for people with diabetes on MDI insulin therapy. Clinical trials registrationPRONTO-T1D ClinicalTrials.gov identifier: NCT03214367; PRONTO-T2D ClinicalTrials.gov Identifier: NCT03214380

Insulin pump treatment vs. multiple daily insulin injections in patients with poorly controlled type 2 diabetes mellitus: a comparison of cardiovascular effects

Abstract Background Both hyper- and hypo-glycaemia, as well as large glycaemic variability (GV) are associated with increased cardiovascular events in patients with type 2 diabetes mellitus (T2DM); possible contributing mechanisms of the increased cardiovascular risk include endothelial dysfunction and cardiac sympatho-vagal imbalance. Recent studies suggest that continuous subcutaneous insulin infusion (CSII) improves glycaemic control compared to multiple daily insulin injections (MDI). Purpose In this study, we assessed whether CSII may improve cardiac autonomic and vascular dilation function compared to MDI. Methods We enrolled in a small randomized pilot study consecutive T2DM patients without cardiovascular disease with poor glycaemic control, despite optimized MDI therapy. Patients were randomized to CSII (Group 1) or to continue MDI (Group 2); insulin dose was adjusted to achieve optimal glycaemic target ranges. Patients were studied at baseline and after 6 months by: 1) assessment of flow-mediated dilation (FMD) and nitrate-mediated dilation (NMD) of the brachial artery; 2) heart rate variability (HRV) by 24-hour ECG Holter monitoring; 3) a 7-day continuous glucose monitoring (CGM) was performed at baseline and follow-up in 8 and 7 patients of Group 1 and 2, respectively. Results Overall, 21 patients were enrolled, 12 randomized to CSII and 9 to MDI. Daily insulin dose, glycated hemoglobin levels and CGM parameters did not differ significantly between the 2 groups, both at baseline and at follow-up. Both FMD (6.7±2.5 vs 4.6±2.0 %, p=0.51) and NMD (8.9±3.1 vs 7.0±3.0 %, p=0.18), as well as HRV parameters, showed no significant differences between the 2 groups at 6-month follow-up. No relation between GV and both peripheral dilator function and cardiac autonomic function was also detected. Conclusions In this small, randomized pilot study we show that, in T2DM patients, CSII achieves similar medium-term glycaemic control compared to MDI, without any significant adverse effect on the cardiovascular system.

Functional insulin aspart/insulin degludec-based microneedles for promoting postprandial glycemic control.

Insulin aspart (IAsp) and insulin degludec (IDeg), as the third generation of insulin, have a faster onset time or a more durable action period, which may simulate the secretion of insulin under physiological conditions. Microneedles (MNs) are transdermal delivery devices that may allow diabetic patients to easily deploy transdermal insulin therapy while considerably reducing injection pain. In this study, we investigated the combination of dissolving MNs with IAsp or IDeg therapy as an alternative to daily multiple insulin injections, aiming to improve glycemic control and patient compliance. Mechanical properties of the MNs, structural stability of insulin encapsulated in the MNs, and transdermal application characteristics were studied to assess the practicality of insulin-loaded MNs for diabetes therapy. In vivo experiments conducted on diabetic rats demonstrated that the IAsp- and IDeg-loaded MNs have comparable blood glucose control abilities to that of subcutaneous injections. In addition, the therapeutic properties of insulin-loaded MNs under diverse dietary conditions and application strategies were further investigated to provide new information to support future clinical trials. Taken together, the proposed MNs have the potential to improve balances between glycemic control, hypoglycemia risk, and convenience, providing patients with simpler regimens. STATEMENT OF SIGNIFICANCE: 1. The fabricated functional insulin-loaded dissolving microneedles closely matched the glucose rise that occurs in response to meals, demonstrating promising alternatives for multiple daily insulin injections. 2. The hypoglycemic properties of insulin microneedles were investigated under diverse dietary conditions and application strategies, yielding new information to support future clinical trials. 3. Molecular dynamics simulations were utilized to study the interactions between the insulin and microneedle matrix materials, providing a strategy for theoretically understanding drug stability as well as the release mechanism of drug-loaded microneedles.

Prolonged Honeymoon Period in Type I Diabetes (T1D) Patients on Low-Carbohydrate Diet (LCD)

The presented case is a 68-year-old female with Type 1 diabetes (T1D). She was admitted for an emergency case with acute distress in January 2018 and was diagnosed with T1D with a blood glucose (BG) level of 459 mg/dL, HbA1c of 13.7%, glutamic acid decarboxylase autoantibody (GADA) level &gt;2000 U/mL (&lt;5 U/mL), and C-reactive protein (CRP) level of 1.10 ng/mL. She received Multiple Daily Injections (MDI) of insulin for 3 months, and then her HbA1c decreased to 7.3%. After that, she has been on a super-low carbohydrate diet (LCD) and received only Lantus XR and ipragliflozin. Serum CRP showed 0.2 ng/mL, suggesting a prolonged honeymoon period for years through continuous LCD.

Effect of Postmeal Fast-Acting Insulin Aspart Injection on the Frequency of Hypoglycemia among Pre-School Children with Type 1 Diabetes: An Open-Label, Cross-Over, Randomized Control Trial.

To study the effect of postmeal Fast-acting insulin Aspart (Fiasp®) on the frequency of hypoglycemia compared to premeal injection among preschool children with type 1 diabetes. A single-center trial was conducted among 65 pre-school children (6 mo to 6 y) with Type 1 diabetes for at least 6 mo, on multiple daily insulin injections. Children were randomized to receive their meal bolus postmeal or premeal for the first 3 mo, followed by cross-over at 3 mo. The two groups were compared at the end of 6 mo for the change in frequency of hypoglycemia and hyperglycemia, HbA1c, glycemic variability, and parental satisfaction. Ten children (5 in each group) underwent pharmacokinetic studies. The trial was approved by Institutional Ethics Committee and registered with the Controlled Trial Registry of India vide no CTRI/2020/10/028750. Fifty-four children completed the study, with 27 children in each group. There were no significant differences in the frequency of clinical (p = 0.921), severe (p = 0.167) or serious (p = 0.753) hypoglycemia in the two groups. There were no differences in secondary outcome parameters and pharmacokinetics. The premeal or postmeal injection ofFiasp® does not affect the frequency of hypoglycemia or other glycemic control parameters among pre-school children with Type 1 diabetes. The trial is registered with the Controlled Trial Registry of India vide no CTRI/2020/10/028750.

A European Cost-Utility Analysis of the MiniMed™ 780G Advanced Hybrid Closed-Loop System Versus Intermittently Scanned Continuous Glucose Monitoring with Multiple Daily Insulin Injections in People Living with Type 1 Diabetes.

Background: Advanced hybrid closed-loop (AHCL) automated insulin delivery systems are the most effective therapy in terms of assisting people with type 1 diabetes (T1D) to achieve glycemic targets; however, the cost can represent a barrier to uptake. In this study, a cost-utility analysis of the MiniMed™ 780G AHCL system (MM780G) versus intermittently scanned continuous glucose monitoring (is-CGM) plus multiple daily insulin injections (MDI) in people with T1D not achieving glycemic goals was performed across six European countries. Methods: Clinical input data were sourced from the ADAPT trial. Assuming a baseline HbA1c of 9.04%, HbA1c reductions of 1.54% for AHCL and 0.2% for is-CGM+MDI were modeled. The analyses were performed from a payer perspective over a time horizon of 40 years and an annual discount rate of 3% was applied. Results: Across all countries, the use of AHCL was projected to result in an incremental gain in quality-adjusted life expectancy of >2 quality-adjusted life years (QALYs) versus is-CGM+MDI. Lifetime direct costs were higher with AHCL resulting in incremental cost-utility ratios for AHCL versus is-CGM+MDI ranging from EUR 11,765 per QALY gained in Austria to EUR 43,963 per QALY gained in Italy. Conclusions: For people with T1D managed with is-CGM+MDI not achieving glycemic targets, initiation of the MM780G system was projected to improve long-term clinical outcomes; however, due to differences in health care costs between countries, the health economic outcomes differed. In all included countries, AHCL is likely to be cost-effective relative to is-CGM+MDI for people not achieving glycemic goals with is-CGM+MDI. The ADAPT trial is registered with ClinicalTrials.gov, NCT04235504.

THU364 A Rare Case Of Concurrent Diabetic Ketoacidosis And Grave’s Thyrotoxicosis

Abstract Disclosure: A.D. Teixeira: None. E. Ukponmwan: None. P. Kachhadia: None. S. Aldasouqi: None. A. Abu Limon: None. Introduction: Type 1 Diabetes Mellitus (T1DM) is marked by deranged glycemic control due to the autoimmune destruction of insulin producing β cells in the pancreas. It affects 1.5 million adults in the United States. Approximately one-third of these patients may develop autoimmune polyglandular syndrome (APS). Autoimmune Thyroid Disease (AITD) is the most commonly associated autoimmune disease, with Hashimoto’s Thyroiditis more commonly observed than Graves Disease (GD). Patients with AITD and T1DM meet criteria for APS type 3A. Here, we present a case of a patient hospitalized for T1DM with diabetic ketoacidosis (DKA) who was also found to have concurrent GD. Case Presentation: Our patient was a 50 year old male who presented to the hospital with complaints of nausea and vomiting for a two day duration. He had symptoms of unintentional weight loss, polyuria and polydipsia for about two months prior to presentation. He was found to have blood sugar level of 438 mg/dL, with pH of 7.05 (7.35-7.45), anion gap of 30, bicarbonate level of 7.0 mmol/L (20-30 mmol/L), Beta-hydroxybutyrate level of 82mg/dL (n&amp;lt;4.10 mg/dL). Hemoglobin A1C was 15.1% . EKG revealed atrial fibrillation with RVR, and therefore thyroid function tests (TFTs) were ordered and showed a thyroid stimulating hormone (TSH) level of 0.01uIU/mL (0.35-4 uIU/mL), free thyroxine (FT4) of 1.29 ng/dL (0.61-1.37 ng/dL) and free triiodothyronine (FT3) levels of 4.4 pg/mL (2.8-4.4 pg/mL). Endocrinology evaluation of the patient’s Thyroid US showed some mild vascularity. Cardiac evaluation of patient’s atrial fibrillation did not reveal any other causes of arrythmia. Further labs showed TSI of 2.6 (n&amp;lt;1.3 TSI index) with normal TRAb and TPO levels. T1DM antibody testing revealed GAD-65 antibody (Ab) level of 51.3 nmol/L (n &amp;lt;0.02 nmol/L), Zinc Transporter 8 Ab level of &amp;gt;500 U/mL (n&amp;lt;15 U/mL). He was started on methimazole with good tolerance and was discharged upon resolution of his DKA with multiple daily injections of insulin. Discussion: AITD is the most prevalent autoimmune disease associated with T1DM, with GD being a less common association compared to Hashimoto’s thyroiditis. Many patients diagnosed with T1DM may develop other autoimmune conditions. On rare occasions these diseases can present concurrently, as it did with our patient. Recognition and awareness of APS types helps physicians recognize and screen for other autoimmune conditions that have previously been seen together. Literature search shows very few cases with both diseases presenting at the same time on hospitalization. However, with the recent COVID-19 pandemic, 5 cases were reported of simultaneous disease following vaccination. Our patient had no known exposure to COVID-19 virus or vaccine when he developed symptoms. Presentation: Thursday, June 15, 2023

THU310 A Presentation Of Diabetic Ketoacidosis In Gestational Diabetes

Abstract Disclosure: C. Yim: None. S.L. Liu: None. T. Spaic: None. Diabetic ketoacidosis (DKA) is a diabetic emergency characterized by wide anion gap acidosis, presence of ketones (in serum and/or urine) and, frequently, uncontrolled hyperglycemia. In pregnancy, DKA more commonly occurs in women with pre-existing diabetes, usually type 1 diabetes, and is exceptionally rare in women with gestational diabetes mellitus (GDM). We report a case of a 37-year-old woman in her second pregnancy who presented to hospital with DKA at 29+3 weeks gestation shortly after diagnosis of GDM 4 days earlier. In her first pregnancy, she was diagnosed with GDM at 28 weeks, required treatment with metformin at 35 weeks, which she stopped postpartum. She conceived her second pregnancy 3 months postpartum so was not screened for diabetes postpartum. In her second pregnancy, there was no evidence of diabetes on early antenatal labwork at 7 weeks: Hemoglobin A1c (HbA1c) 5.6%, random glucose 3.6 mmol/L. Early GDM screening at 21+1 weeks with 75 gram oral glucose tolerance test (OGTT) was normal: fasting glucose 4.4 mmol/L 1-hour glucose 9.0 mmol/L, 2-hour glucose 6.5 mmol/L. She presented to hospital at 29+3 weeks gestation with a 2-day history of polyuria, polydipsia, dizziness, and decreased oral intake without nausea or vomiting. Four days prior to presentation, she was diagnosed with GDM on a 75g OGTT (fasting glucose 6.2 mmol/L, 1-hour glucose 15.1 mmol/L, 2-hour glucose 11.9mmol/L). Admission labwork showed serum glucose 34.8 mmol/L, anion gap 18, pH 7.29, bicarbonate 17 and beta-hydroxybutyrate 2.97. She was treated with IV fluids and insulin and initiated on multiple daily injections of insulin. Other than pregnancy, no clear precipitating factor was found. HbA1C was 6.4%, serum insulin and C-peptide levels were inappropriately low at 22 pmol/L and 296 pmol/L respectively. Her anti-glutamic acid decarboxylase and anti-islet cell antibodies were negative. Lipase was mildly elevated at 226U/L but improved to 144U/L with treatment. Abdominal ultrasound did not demonstrate any findings suggestive of acute pancreatitis. Her 24-hour urinary free cortisol was 366 nmol and 442 nmol, both within normal trimester-specific range. Her salivary cortisol was in the normal range (10.5nmol and 10.9nmol). Following discharge, she remained significantly insulin resistant with suboptimal glycemic control (total daily insulin requirements ∼3.5 units/kg/day, HbA1C 7.9% at 35+6 weeks). Due to increased insulin resistance in pregnancy, DKA can progress more rapidly compared to nonpregnancy. Given increased rates of perinatal morbidity and mortality associated with DKA, treatment and monitoring should be promptly initiated. A high index of suspicion is especially important given that DKA is a rare presentation in GDM. Other precipitating factors of newly decompensated diabetes should also be ruled out. Presentation: Thursday, June 15, 2023

Carbohydrate Counting vs. Fixed Meal Plan in Indian Children with Type 1 Diabetes Mellitus: A Randomized Controlled Trial.

To study the impact of carbohydrate counting vs. fixed-meal plan on glycemic control, quality of life (QoL) and diabetes-related emotional distress in children with Type 1 diabetes mellitus (T1DM). Children aged 6-18 y with T1DM of duration >1 y were eligible for the study if they were on multiple daily injections of insulin and regularly monitoring blood glucose. Those with celiac disease, hypothyroidism, any underlying chronic renal/liver/systemic disease or HbA1c >13% were excluded. Both groups received education on diabetes management and healthy diet. In the intervention arm, parents were taught to quantify carbohydrate content and modify insulin doses according to insulin-carbohydrate ratio. The control arm had dietary prescription according to recommended dietary allowance and food exchange list. Standard validated questionnaires were used to assess the QoL and emotional distress related to diabetes. One hundred twenty five patients (61 intervention, 64 controls) were enrolled and 91.8% and 84.3%, respectively, completed 6-mo follow-up. There was a reduction in HbA1c in both the groups, but was not statistically significant within or between groups {Intervention: 8.9 (1.4) to 8.6 (1.5) vs. control: 9.1 (1.6) to 8.8 (1.9), [95% CI 8.3-9.3 vs. 8.3-9.0, intention to treat (ITT), p= 0.63]}. There was a significant reduction in diabetes distress in the intervention group; DAWN Problem Areas in Diabetes Questionnaire (PAID) score with a median (interquartile range) of 21 (11-33) vs. control: 27 (20-40), (p=0.04). Patients in the carbohydrate-counting group demonstrated lower diabetes distress scores and less emotional burnout compared to fixed-meal plan over a 6 mo period though overall glycemic control was comparable between groups.

The use of multiple daily injections versus insulin pump therapy for HgbA1c reduction in patients with insulin-dependent type 2 diabetes.

More than 35 million Americans live with type 2 diabetes (T2D), resulting in the need for newer strategies and technologies to manage the disease. Insulin pump therapy (IPT) has historically been reserved for type 1 diabetes, although emerging data demonstrates improved glucose outcomes for patients with T2D using IPT. To measure the change in HgbA1c in patients with T2D after changing therapy from multiple daily injections (MDI) to continuous subcutaneous insulin infusion through IPT. A retrospective comparison study was conducted by reviewing the electronic medical record of patients with T2D, older than 18 years, who had been on multiple daily insulin injections for at least 1 year, followed by IPT for at least 1 year. One hundred seventy-one patients met the inclusion criteria. There was a statistically significant reduction in mean HgbA1c from 9.6% to 7.6%. Insulin pump therapy may result in lower HgbA1c levels for T2D not at goal on MDI. Patients on multiple daily insulin injections who are not at goal should be considered for IPT.

Nocturnal Glucose Patterns with and without Hypoglycemia in People with Type 1 Diabetes Managed with Multiple Daily Insulin Injections.

Nocturnal hypoglycemia (NH) is a potentially dangerous and underestimated complication of insulin therapy. In this study, we aimed to determine which patterns of nocturnal glucose profiles are associated with NH in patients with type 1 diabetes (T1D) managed with multiple daily insulin injections. A dataset of continuous glucose monitoring (CGM) recordings obtained from 395 adult subjects with T1D was used for modeling. The clustering of CGM data was performed using a hierarchical clustering algorithm. Ten clusters without hypoglycemia and six clusters with NH episode(s) were identified. The differences among the clusters included initial and final glucose levels, glucose change during the night, and the presence of uptrends or downtrends. Post-midnight hyperglycemia was revealed in 5 out of 10 clusters without NH; in patterns with downtrends, initially elevated glucose prevented NH episodes. In clusters with initially near-normal glucose levels and downtrends, most episodes of NH were observed from midnight to 4 a.m.; if glucose was initially elevated, the episodes occurred at 2-4 a.m. or 4-6 a.m., depending on the time of the start of the downtrend. The results demonstrate the diversity of nocturnal glucose profiles in patients with T1D, which highlights the need for a differentiated approach to therapy adjustment.

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.

An educational programme and patient‐reported outcomes using flash glucose monitoring and automated bolus calculation in type 1 diabetes

AbstractIntroduction: Our primary aim was to describe the educational programme and user's guide for decision support for persons with type 1 diabetes who commence carbohydrate counting with automated bolus calculator (ABC) and flash (intermittently scanned) glucose monitoring (isCGM). The programme was developed for the ABC Flash trial, conducted in The Capital Region of Denmark in 2018–2020. We also aimed to evaluate the impact of the programme and the combined interventions on patient‐reported outcome parameters.Methods: The programme and user's guide are described in detail. In total, 35 adults with type 1 diabetes and sub‐optimal HbA1c treated with multiple daily insulin injections completed the 26‐week educational programme on initiating ABC and isCGM. Patient‐reported outcomes were self‐evaluated before and after (Audit of Diabetes Dependent Quality of Life questionnaire, Diabetes Treatment Satisfaction Questionnaire, Problem Areas in Diabetes and Diabetes Empowerment Scale). Changes over time in the different sub‐areas of diabetes‐related burden on quality of life, treatment satisfaction, diabetes‐related distress and psychosocial self‐efficacy were analysed.Results: During participation in the educational programme on initiating ABC and isCGM, diabetes‐related burden on work and sex life and several treatment satisfaction and psychosocial self‐efficacy sub‐areas improved.Conclusion: Implementation of the educational programme and initiating combined intervention with carbohydrate counting with ABC and isCGM improve treatment satisfaction and different psychosocial areas among persons with type 1 diabetes. Copyright © 2023 John Wiley &amp; Sons.

Continuous Subcutaneous Infusion Versus Multiple Daily Injections of Insulin for Pregestational Diabetes in Pregnancy: A Systematic Review and Meta-Analysis.

The use of continuous subcutaneous insulin infusion (CSII) therapy in pregnancies affected by pregestational diabetes mellitus (DM) has generated mixed outcome data worthy of further investigation. This systematic review and meta-analysis aims to evaluate clinical outcomes associated with CSII versus multiple daily injections (MDIs) in pregnant persons with pregestational DM. A predefined, systematic, librarian-assisted search of MEDLINE (PubMed), Embase, Cochrane Library, Scopus, ClinicalTrials.gov, and World Health Organization International Clinical Trial Registry Platform (published from 2010 to 2022) yielded 3003 studies describing pregnancy outcomes associated with CSII and/or MDI for pregestational DM. The primary exposure was mode of insulin administration, with cesarean delivery and neonatal hypoglycemia as the primary maternal and neonatal outcomes, respectively. Secondary outcomes included hypertensive disorders of pregnancy, first and third-trimester glycemic control, large-for-gestational age (LGA) neonate, preterm birth, neonatal intensive care unit admission, need for respiratory support, hyperbilirubinemia, 5-minute Apgar <7, shoulder dystocia, and perinatal mortality. We calculated pooled odds ratios (OR) with 95% confidence intervals (CI) using random-effects models. Among 39 eligible studies, 39% of the 5518 pregnancies included were exposed to CSII. Odds of cesarean delivery were higher with CSII (20 studies: 63% vs 56%, odds ratio [OR] 1.3 [95% confidence interval (CI) 1.2-1.5]), but we did not identify a difference in the odds of neonatal hypoglycemia (23 studies: 31% vs 34%, OR 1.1 [95% CI 0.9-1.5]). Among secondary outcomes, only the odds of LGA (20 studies: 47% vs 38%, OR 1.4 [95% CI 1.2-1.6]) were higher in individuals using CSII versus MDI. Use of CSII (vs MDI) for pregestational DM in pregnancy is associated with higher odds of cesarean delivery and delivery of an LGA neonate. Further evaluation of how CSII use may influence neonatal size and delivery route is warranted.

Dual hormone fully closed loop in type 1 diabetes: a randomised trial in the Netherlands – study protocol

IntroductionThe management of type 1 diabetes (T1DM) has undergone significant advancements with the availability of novel technologies, notably continuous and flash glucose monitoring (CGM and FGM, respectively) and hybrid closed...

Switching to a Minimed 780G closed-loop hybrid system: Real-life experience in a center of Latin America

IntroductionInsulin pumps serve as alternative insulin delivery methods with physiological similarity to the normal pancreas. The MiniMed 780G device is an advanced closed-loop hybrid system. Recent real-life studies have allowed reaching a higher percentage of time in range (TIR) (70 to 180 mg/dL). Being an emerging technology, it is of the utmost value to report on the early experience of use of this device. MethodsThis was an observational, descriptive, cross-sectional study that included patients older than 18 years with types 1 diabetes mellitus and other types switched to a Medtronic 780G insulin pump. Baseline clinical and glycemic control variables and those after 4 weeks of using the SmartGuard mode were evaluated. ResultsThirty-nine patients (mean age, 33 years) were analyzed, 95 % of whom had type 1 diabetes with an average disease duration of 17 years. The values for time below range (TBR) <54 mg/dL, TBR <70 mg/dL, TIR, time above range (TAR) >180 mg/dL, and TAR >250 mg/dL were 0 %, 3 %, 72 %, 21 %, and 3 %, respectively, at baseline and 1 %, 2 %, 79 %, 14 %, and 2 %, respectively, after the intervention. The changes in TIR varied based on prior therapy: multiple daily injections of insulin, 13 % improvement; MiniMed Paradigm Veo/MiniMed 640G, 6 % improvement; and MiniMed 670G, −4 % improvement. ConclusionIn conclusion, the application of a hybrid closed-loop system allowed for better glycemic control based on international standards. The average percentage improvement in TIR was lower than that in other studies and was dependent on the previous method of insulin administration, achieving lower performance with the migration from recent technologies such as the Minimed 670G.

Treatment Satisfaction and Well-Being With CGM in People With T1D: An Analysis Based on the GOLD Randomized Trial.

The GOLD trial demonstrated that continuous glucose monitoring (CGM) in people with type 1 diabetes (T1D) managed with multiple daily insulin injections (MDI) improved not only glucose control but also overall well-being and treatment satisfaction. This analysis investigated which factors contributed to improved well-being and treatment satisfaction with CGM. The GOLD trial was a randomized crossover trial comparing CGM versus self-monitored blood glucose (SMBG) over 16 months. Endpoints included well-being measured by the World Health Organization-Five Well-Being Index (WHO-5) and treatment satisfaction by the Diabetes Treatment Satisfaction Questionnaire (DTSQ) as well as glucose metrics. Multivariable R2-decomposition was used to understand which variables contributed most to treatment satisfaction. A total of 139 participants were included. Multivariable analyses revealed that increased convenience and flexibility contributed to 60% (95% confidence interval [CI] = 50%-69%) of the improvement in treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire change version [DTSQc]) observed with CGM, whereas perceived effects on hypoglycemia and hyperglycemia only contributed to 6% (95% CI = 2%-11%) of improvements. Significant improvements in well-being (WHO-5) by CGM were observed for the following: feeling cheerful (P = .025), calm and relaxed (P = .024), being active (P = .046), and waking up fresh and rested (P = .044). HbA1c reductions and increased time in range (TIR) were associated with increased treatment satisfaction, whereas glycemic variability was not. HbA1c reduction showed also an association with increased well-being and increased TIR with less diabetes-related distress. While CGM improves glucose control in people with T1D on MDI, increased convenience and flexibility through CGM is of even greater importance for treatment satisfaction and patient well-being. These CGM-mediated effects should be taken into account when considering CGM initiation.

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.

Development and Validation of Binary Classifiers to Predict Nocturnal Hypoglycemia in Adults With Type 1 Diabetes.

One of the biggest challenges for people with type 1 diabetes (T1D) using multiple daily injections (MDIs) is nocturnal hypoglycemia (NH). Recurrent NH can lead to serious complications; hence, prevention is of high importance. In this work, we develop and externally validate, device-agnostic Machine Learning (ML) models to provide bedtime decision support to people with T1D and minimize the risk of NH. We present the design and development of binary classifiers to predict NH (blood glucose levels occurring below 70 mg/dL). Using data collected from a 6-month study of 37 adult participants with T1D under free-living conditions, we extract daytime features from continuous glucose monitor (CGM) sensors, administered insulin, meal, and physical activity information. We use these features to train and test the performance of two ML algorithms: Random Forests (RF) and Support Vector Machines (SVMs). We further evaluate our model in an external population of 20 adults with T1D using MDI insulin therapy and wearing CGM and flash glucose monitoring sensors for two periods of eight weeks each. At population-level, SVM outperforms RF algorithm with a receiver operating characteristic-area under curve (ROC-AUC) of 79.36% (95% CI: 76.86%, 81.86%). The proposed SVM model generalizes well in an unseen population (ROC-AUC = 77.06%), as well as between the two different glucose sensors (ROC-AUC = 77.74%). Our model shows state-of-the-art performance, generalizability, and robustness in sensor devices from different manufacturers. We believe it is a potential viable approach to inform people with T1D about their risk of NH before it occurs.