Conventional Insulin Research Articles

Uso de Simulador de Baixo Custo na Autoaplicação de Insulina: Estudo Quase-experimental

Objetivo: Avaliar o efeito de uma intervenção educativa com uso de simulador de baixo custo na prática de autoaplicação de insulina entre indivíduos com DM2. Método: Estudo quase-experimental (before and after), com 136 indivíduos que convivem com Diabetes Mellitus tipo II e fazem uso de insulina convencional. O estudo será divido em duas etapas, a primeira etapa será a pré-intervenção e intervenção e a segunda etapa, pós-intervenção. Os dados serão analisados pelo teste estatístico Qui-quadrado e por medidas de tendência central, considerando nível de confiança de 95%. Resultados esperados: A intervenção educativa com uso de simulador de baixo custo voltada aos indivíduos que fazem uso de insulina poderá favorecer o desenvolvimento de habilidades para uma autoaplicação correta e segura de insulina, tal como a remissão de sinais e sintomas cutâneos nos locais de injeção.

The Use of Technology in Managing Diabetes in Youth Part 2-Insulin Pump Technologies: Information and Tips for the School Nurse.

Insulin pump technologies are commonly used by youth with type 1 diabetes (T1D) for intensive insulin therapy, the gold standard for T1D care. Insulin pump technologies are advancing rapidly, with new insulin pumps becoming available every year offering improvements in glycemic control. School nurses must understand the basics of insulin pump therapy and distinguish between advanced pump technologies to best support their students with T1D. This is the second article in a three-part series on the use of technology in managing diabetes in youth. The first article described continuous glucose monitoring (CGM) devices and provided tips for the school nurses in incorporating CGM into the student's individualized healthcare plan. The purpose of this article is to summarize insulin pump technologies, from conventional insulin pump therapy to advanced automated insulin delivery systems and to describe keys to success with insulin pump technologies. Part 3 will focus on special considerations and problem solving related to technology use in the school setting.

Insulin delivery with a needle-free insulin injector versus a conventional insulin pen in Chinese patients with type 2 diabetes mellitus: A 16-week, multicenter, randomized clinical trial (the FREE study)

BackgroundInsulin therapy is poorly accepted by patients with type 2 diabetes mellitus (T2DM). A needle-free insulin injector has been developed for patients who fear injections or are reluctant to initiate insulin therapy when it is clearly indicated. The objective of this trial was to evaluate the glucose-lowering effect, tolerability, patient satisfaction and compliance with insulin treatment via a needle-free insulin injector (NFII) compared with insulin treatment via a conventional insulin pen (CIP) in patients with T2DM. MethodsA total of 427 patients with T2DM were enrolled in a prospective, multicenter, randomized, open-label study, and were randomly assigned 1:1 to receive 16 weeks’ treatment with basal insulin or premixed insulin administered either by a NFII or CIP. Trial registrationClinicalTrials.gov (NCT03243903). FindingsIn the 412 patients who completed the study, the adjusted mean reduction of HbA1c from baseline at week 16 in the NFII group was 0.55% (95% CI −0.71, −0.39), which was non-inferior and statistically superior to the HbA1c reduction in the CIP group (0.26%, 95% CI −0.42, −0.11). Patients in the NFII group showed significantly higher treatment satisfaction scores than those in the CIP group (mean scores, 8.17 ± 1.78 vs. 7.21 ± 2.22, respectively; p<0.0001). The occurrence of hypoglycemia was similar in the two groups, and the NFII group showed reduced incidences of skin scratches, indurations and lower VAS pain scores. InterpretationInsulin therapy through needle-free injector showed a non-inferior glycemic-lowering effect and a significantly enhanced level of patient satisfaction with insulin treatment compared with conventional insulin therapy through needle injections. In addition, the needle-free injector also had a better safety profile. FundingThis study were funded by Beijing QS Medical Technology Co., Ltd, as well as The Major Chronic Non-communicable Disease Prevention and Control Research.

Insulin Pump Therapy for Patients With Type 2 Diabetes Mellitus: Evidence, Current Barriers, and New Technologies.

An increasing number of patients with type 2 diabetes mellitus (T2DM) use insulin pumps. The first insulin pumps especially designed for patients with T2DM have recently become available. However, national guidelines do not primarily recommend the use of continuous subcutaneous insulin infusion (CSII) for this patient group. The effectiveness of CSII in T2DM has not yet been convincingly demonstrated, despite some positive evidence. An overview and an assessment of various studies to date will be given. T2DM is a heterogeneous disease with a substantial phenotypic variability; therefore, it is difficult to provide general conclusions about the effectiveness of CSII in T2DM therapy. The pump types, characteristics, and associated barriers may play a relevant role for therapy outcome. Most advanced functions like various bolus dosages offered by conventional insulin pumps are not needed for T2DM treatment and complicate the device handling for this subject group. Additionally, new technologies like increased connectivity, advanced software features, and interoperability are currently becoming available representing further barriers. The implementation of this technological progress might be a benefit for pumps for T2DM as well. However, these have not been sufficiently examined either and increased security challenges due to integrated peripheral components should not be neglected in terms of a sound cybersecurity. Pump features and handling for patients with T2DM should be as easy as possible, indicating a need for insulin pumps specially designed for patients with T2DM. However, it has to be investigated if pumps designed for T2DM are more effective than other intensified insulin regimens.

Comparison of glucose variability in patients with type 2 diabetes administrated glargine with needle-free jet injector and conventional insulin pen

ABSTRACT Background The effects of insulin delivered by needle-free jet injector on glycemic variations (GV) in patients with type 2 diabetes (T2D) which remains largely unknown. Research design and methods We aimed to compare the glucose variability in Chinese T2D patients administrated glargine 100 U/mL (Gla-100) with a needle-free jet injector and conventional insulin pen. This was a self-comparative, observational study of 26 patients who were subjected to a flash glucose monitoring system (FGM) for 14 consecutive days. During the study period, all subjects received Gla-100 daily before breakfast using a conventional insulin pen, with the exception of day 3 and day 7, when insulin was delivered by needle-free jet injection. We analyzed FGM data of day 3, day 5, day 7, and day 9 at the endpoint. Results There were no differences in the glycemic variability between the jet injector group and the conventional pen group. However, patients with needle-free jet injection had a lower 24 hr mean glucose (MG) and lower incremental area under the curve (AUC) of 1 hr, 12 hr, and 24 hr, compared to the conventional pen group (p = 0.001). Conclusions Gla-100 delivered by needle-free jet injection potentially lowered MG in patients with T2D in the Chinese population.

Insulin Delivery with a Needle-Free Insulin Injector Versus a Conventional Insulin Pen in Chinese Patients with Type 2 Diabetes Mellitus: A 16-Week, Multicenter, Randomized Clinical Trial (the FREE Study)

Background: Insulin therapy is poorly accepted by patients with type 2 diabetes mellitus (T2DM). A needle-free insulin injector has been developed for patients who fear injections or are reluctant to initiate insulin therapy when it is clearly indicated. Objective To evaluate the glucose-lowering effect, tolerability, patient satisfaction and compliance with insulin treatment via a needle-free insulin injector (NFII) compared with insulin treatment via a conventional insulin pen (CIP) in patients with T2DM. Methods: A total of 427 patients with T2DM were enrolled in a prospective, multicenter, randomized, open-label study, and were randomly assigned 1:1 to receive 16 weeks’ treatment with basal insulin or premixed insulin administered either by a NFII or CIP. Findings: In the 412 patients who completed the study, the adjusted mean reduction of HbA1c from baseline at week 16 in the NFII group was 0.55% (95% CI -0.71, -0.39), which was non-inferior and statistically superior to the HbA1c reduction in the CIP group (0.26%, 95% CI -0.42, -0.11). Patients in the NFII group showed significantly higher treatment satisfaction scores than those in the CIP group (mean scores, 8.17 ± 1.78 vs 7.21 ± 2.22, respectively; p<0.0001). The occurrence of hypoglycemia was similar in the two groups, and the NFII group showed reduced incidences of skin scratches, indurations and lower VAS pain scores. Interpretation: Insulin therapy through needle-free injector showed a greater glycemic-lowering effect and a significantly enhanced level of patient satisfaction with insulin treatment compared with conventional insulin therapy through needle injections. In addition, the needle-free injector also had a better safety profile. Trial registration: ClinicalTrials.gov (NCT03243903) Funding Statement: Beijing QS Medical Technology Co., Ltd, China. This work was also supported by Grants 2016YFC1305600, 2016YFC1305603 from the Major Chronic Non-communicable Disease Prevention and Control Research. Declaration of Interests: Linong Ji receives consulting fees from Beijing QS Medical Technology Co. He also reports grants and personal fees from Novo Nordisk, Merck, Bristol-Myers Squibb, Novartis, Sanofi, MSD, AstraZeneca, and Roche, and personal fees from Eli Lilly, Takeda, Bayer, and Boehinger Ingelheim, outside the submitted work. The other authors have nothing to disclose. Ethics Approval Statement: Before the study was commenced, approval was received from the Ethics Committee of Peking University People’s Hospital, and the study was conducted in accordance with the moral, ethical, and scientific principles of the declaration of Helsinki and the provisions of good clinical practice (GCP) in China. Written informed consent was obtained from all participants.

A case study of eight type 2 diabetic stage 4 chronic kidney disease patients showing lower glycemic variability with faster-acting insulin aspart as compared to insulin aspart

Background. Peaks and nadirs of blood glucose level varying daily in a person is referred to as glycemic variability (GV). GV associated with diabetics has been recently linked to cardiovascular disorders (CVD) or even chronic kidney disease (CKD) progression. Faster-acting insulin aspart is the latest ultra-rapid acting bolus insulin which has shown much lesser intra- and inter-patient variability as compared to conventional bolus insulin. Material and methods. However, inadequate data exist regarding GV in patients with advanced stages of CKD. Hence, with this objective, the present case study was undertaken with eight patients divided into two equal groups, wherein faster-acting insulin aspart and insulin aspart were used as the boluses, respectively. Continuous glucose monitoring data of the patients were taken for the initial four days to calculate mean amplitude of glycemic excursion (MAGE) of the total four days for each individual (mmol/L) to see the difference in GV. A value of > 3.607 mmol/L (65 mg/dL) was considered to be statistically significant. Results. In this case study of eight stage 4 CKD type 2 diabetic patients, statistically significant lower GV was observed in the faster-acting insulin aspart arm when compared with the insulin aspart arm. The pvalue was 0.0004 in unpaired t-test and < 0.05 for U in Mann-Whitney U test after ruling out the baseline confounding factors. Conclusions. This study confirms the stable pharmacokinetic and dynamic properties of faster-acting insulin aspart and subsequent studies with larger numer of patients are required for a conclusive outcome.

Intercellular adhesive molecule-1 (ICAM-1) in proliferative diabetic retinopathy

Purpose: To determine the level of intercellular adhesion molecule-1 (ICAM-1) in vitreous fluid of patients with proliferative diabetic retinopathy (PDR) and its affecting factors including HbA1c level, duration of diabetes mellitus (DM) and insulin usage.&#x0D; Methods: A cross-sectional study was conducted in Cipto Mangunkusumo National General Central Hospital, Jakarta, Indonesia from June 2015 to August 2016. Thirty-three consecutive vitreous samples harvested from PDR patients underwent vitrectomy. The level of vitreous ICAM-1 was determined by enzyme-linked immunosorbent assay.&#x0D; Results: Based on the glycemic status, vitreous ICAM-1 level in the uncontrolled glycemic group (21.61 ng/ml) was lower than controlled glycemic group (24.20 ng/ml). Patients with DM for more than 10 years had higher level of vitreous ICAM-1 (26.30 ng/ml). Vitreous ICAM-1 level in DM patients with insulin was higher than those without insulin (27.07 ng/ml vs. 24.17 ng/ml). There was no statistically significant difference between vitreous ICAM-1 levels among all groups (p &gt; 0.05).&#x0D; Conclusion: The concentration of vitreous ICAM-1 may not be influenced by glucose control and conventional insulin therapy.

Indian reality of managing type 2 diabetes: an expert review of global and national guidelines for optimum insulin use

Several guidelines provide recommendations on insulin therapy in people with type 2 diabetes mellitus (T2DM). Major global guidelines have been adapted in multiple countries, and local consensus recommendations have been published giving guidance on insulin therapy considering local realities. This expert review focuses on the recommendations from global and Indian guidelines on insulin therapy in people with T2DM. It emphasizes on a patient-centric approach, including the glycemic parameters, psychosocial aspects, phase of life, and the Indian realities of T2DM management in guiding optimum insulin therapy for initiation and intensification. Therapeutic inertia towards timely insulin initiation needs to be bridged. Owing to the high carbohydrate diet and high postprandial glucose (PPG) excursions, insulin co-formulation and premix insulins offering total glycemic control can be preferred for a timely insulin initiation in Indians with T2DM that is uncontrolled despite multiple oral antidiabetic drugs. They also provide simplicity and convenience for insulin initiation and intensification. Among basal insulins, insulin degludec and glargine U300 are found to be safer, and offer more dosing flexibility than the first-generation basal insulin analogs. Faster-acting insulin aspart has been shown to provide better PPG control and dosing flexibility compared to a rapid-acting insulin analog with a lower risk of hypoglycemia. Thus, based on available evidences, a preferred use of insulin analog over conventional human insulins is suggested, keeping cost considerations in mind. The review also discusses optimum use of concomitant medications with insulin therapy for T2DM management.

The Efficacy of Intensive versus Conventional Insulin Therapy in Reducing Mortality and Morbidity in Medical and Surgical Critically Ill Patients: A Randomized Controlled Study.

Context:Stress hyperglycemia in critically ill patients has been a matter of debate for years without any conclusive answer till date regarding glucose management and treatment thresholds.Aims:We planned a study with an aim to compare the efficacy of intensive versus conventional insulin therapy in reducing the mortality and morbidity in critically ill patients. The primary objective was to compare mortality between the two groups. The secondary objective was to find out if intensive insulin therapy is better than conventional insulin therapy in terms of various outcomes such as infections and need for inotropes and transfusion requirements.Settings and Design:It was a prospective randomized controlled study. The study population included 100 patients who received mechanical ventilation and admitted to the intensive care department of a tertiary care institute.Subjects and Methods:Patients were randomly assigned to two groups: intensive insulin therapy (IIT) and conventional insulin therapy (CIT) to receive either intensive or conventional insulin therapy. Insulin infusion was started only when blood glucose levels exceeded 200 mg%. Blood glucose levels were maintained between 80 and 110 mg% in the IIG and between 180 and 200 mg% in the CIG.Statistical Analysis Used:The data collected were analyzed separately for both the groups using Student's t-test and Chi-square test.Results:The two groups were comparable in terms of baseline demographic data including age, sex, preadmission diabetic status, and HbA1c at the time of admission. The two groups were not comparable in terms of Acute Physiology and Chronic Health Evaluation-II scores, and the difference between them was statistically significant with higher scores in the conventional group. The primary outcome, that is, mortality, was higher in the CIG with 29 patients (58%) versus 3 (6%) in the IIG (P = 0.02). The secondary outcomes were the measures of morbidity including infections, need for inotropic support, and need for blood transfusions, and these were significantly higher in the conventional group (P < 0.05).Conclusions:We conclude that tight glycemic control significantly lowers mortality and morbidity in critically ill patients, both surgical and medical. These benefits appear with the maintenance of tight blood glucose control of 80–110 mg.dL − 1 and not due to administration of insulin.

What Do You Need to Know About Traditional Insulin Formulations?

Although insulin analogues show noninferiority to conventional insulins in regard to glycemic control and hemoglobin A1c reductions, they are significantly more expensive, and health care providers need to better understand how to transition some patients back to more affordable options.

Electronic cigarettes and insulin resistance in animals and humans: Results of a controlled animal study and the National Health and Nutrition Examination Survey (NHANES 2013-2016).

BackgroundThe popularity of electronic cigarettes (E-cigarettes) has risen considerably. Several studies have suggested that nicotine may affect insulin resistance, however, the impact of E-cigarette exposure on insulin resistance, an early measure of cardiometabolic risk, is not known.Methods and resultsUsing experimental animals and human data obtained from 3,989 participants of the United States National Health and Nutrition Examination Survey (NHANES), respectively, we assessed the association between E-cigarette and conventional cigarette exposures and insulin resistance, as modelled using the homeostatic model assessment of insulin resistance (HOMA-IR) and glucose tolerance tests (GTT). C57BL6/J mice (on standard chow diet) exposed to E-cigarette aerosol or mainstream cigarette smoke (MCS) for 12 weeks showed HOMA-IR and GTT levels comparable with filtered air-exposed controls. In the NHANES cohort, there was no significant association between defined tobacco product use categories (non-users; sole E-cigarette users; cigarette smokers and dual users) and insulin resistance. Compared with non-users of e-cigarettes/conventional cigarettes, sole E-cigarette users showed no significant difference in HOMA-IR or GTT levels following adjustment for age, sex, race, physical activity, alcohol use and BMI.ConclusionE-cigarettes do not appear to be linked with insulin resistance. Our findings may inform future studies assessing potential cardiometabolic harms associated with E-cigarette use.

Switch-over Study with Fast-acting Insulin Aspart Showing Lower Glycemic Variability in Type 2 Diabetics with Stage 4 Chronic Kidney Disease: A Case Series.

BackgroundDespite conventional insulin treatment being considered an effective approach for glycemic regulation during renal dysfunction, there is still a major clinical need for better insulin therapy to stabilize fluctuations in glucose levels.AimThe aim of this study was to assess the impact of mealtime fast-acting insulin aspart therapy on glycemic variability as compared to regular human insulin therapy in advanced chronic kidney disease (CKD) patients with type 2 diabetes (T2D).MethodsData from eight patients were retrospectively collected after analyzing 57 patients' data between July 2019 and October 2019. All T2D patients with stage 4 CKD were switched to mealtime fast-acting insulin aspart on account of recurrent hypoglycemic events. The continuous glucose monitoring data of the first four days were analyzed to calculate the mean amplitude of glucose excursions (MAGE) as well as five other glycemic variability indices, namely, standard deviation, mean, continuous overall net glycemic action, average daily risk range, and J index.ResultsThe primary endpoint of 24-h MAGE significantly decreased from 7.01 ± 2.59 to 4.19 ± 1.06 mg/dL (p = 0.012) when short-acting regular human insulin (RHI) therapy was replaced with mealtime fast-acting insulin aspart therapy. However, no significant change was observed in 24-h mean glucose levels and other indices of glucose variability. Significant reduction in 24-h and night-time hypoglycemic events was reported in patients after therapy switch during the four-day follow-up period.ConclusionsThe present study demonstrated an improvement in glycemic variability with the administration of fast-acting insulin aspart as compared to RHI, suggesting that modern bolus insulin replacement might prove to be a useful therapeutic strategy in type 2 diabetes patients with advanced CKD. Further clinical studies will be required to confirm the benefits of this therapeutic approach.Relevance for patientsThe safety and effectiveness of fast-acting insulin aspart in CKD patients have not yet been established. The clinical effectiveness and better safety profile of newer mealtime insulin therapy may prompt a reconsideration of its use in patients with an advanced stage of renal dysfunction, leading to better adherence and improved quality of life.

Feasibility Studies on Nafion Membrane Actuated Micropump Integrated With Hollow Microneedles for Insulin Delivery Device

A paradigm shift in conventional insulin delivery techniques is required to provide diabetic patients with painless, precise, safe and accurate insulin delivery solutions. Large size insulin molecules can be pushed through human skin layers by a micropump through hollow microneedles which provide a painless interphase to human skin. Ionic polymer metal composite membranes offer great advantages in micropump actuation due to their large deflections at relatively low actuation voltages. This makes them suitable to be implemented in insulin delivery devices. This article presents a novel integrated design of an insulin delivery device (IDD) consisting of a hollow microneedle array, drug reservoir and Nafion membrane actuation based micropump. To test the feasibility of the gold coated Nafion 115 membrane, it is utilized in the conventional circular as well as modified geometry having greater degree of freedom of movement by introducing cuts in membrane in a micropump structure and then implemented in the proposed IDD structure. The IDD achieves a DI water flowrate of 47.2 μ L/min and Insulin flowrate of 44.8 μ L/min for membrane with modified geometry which is higher as compared to the conventional membrane design. The device can achieve tunable insulin flowrate in the range of 20-45 μ L/min by varying the frequency (0.1-0.5Hz) and voltage (3-6V) paving way for its commercialization for painless insulin delivery.

Role of ultrafast-acting insulin analogues in the management of diabetes.

To control both fasting and prandial plasma glucose levels in people with diabetes, insulin therapy must mimic "normal" physiological insulin secretion as much as possible. This is achieved with a long-acting insulin injected once or twice daily and a bolus of insulin injected before every meal. Prandial (bolus) insulin can either be regular human insulin (RHI) or a rapid-acting insulin analogue (RAIA). Although the efficacy of RHI has been established over approximately 35 years of clinical use, RAIAs offer several clinical advantages over RHI, namely that they have been engineered with a reduced tendency to aggregate as hexamers, which allows for rapid dissociation and absorption after a subcutaneous injection. Conventional RAIAs include insulin lispro, insulin aspart, and insulin glulisine. The more recently developed fast-acting insulin aspart (faster aspart) is an ultrafast-acting mealtime insulin that contains the conventional insulin aspart in a new formulation with the excipients niacinamide and L-arginine to achieve faster insulin absorption than RHI and the conventional insulin aspart formulation. This article reviews the clinical evidence supporting the use of RAIAs as part of a basal-bolus regimen in patients with diabetes, with a focus on new formulations whose pharmacological profiles more closely mimic the endogenous prandial insulin secretion pattern that is seen in individuals without diabetes. This review also provides a clinical perspective to help guide health care professionals in the use of RAIAs.

Glycemic control amongst diabetic subjects on insulin therapy: Still off target!

Introduction: Prevalence of diabetes is increasing worldwide. Good glycemic control is essential for prevention of complications of diabetes. Despite of availability of multiple medications, it is difficult to achieve good glycemic control. Insulin therapy is considered to be the best option available for attaining glycemic control. But, whether insulin therapy has achieved it is an important question to be addressed. Objective: To assess the glycemic control in subjects with diabetes on insulin therapy. Materials and Methods: A cross-sectional study was done at Karnataka Institute of Endocrinology and research, Bangalore, in 448 diabetic patients who were on insulin therapy as a part of their diabetic therapy. Data collected was analyzed using SPSS 22 version software. Results: Majority of the subjects were men (61.38%) and in the age group of &gt; 60 years (44.9%). Many of the subjects on insulin therapy had duration of diabetes &gt; 5 years, with 36.4% having duration of 10-20 years, while another 36% had duration of 5 -10 years. Premixed insulin (81.47%) was the most commonly used insulin regimen. 82.6% of the subjects were on conventional insulin and only 13.2% were on insulin analogues. Insulin syringe was the most commonly used delivery device, with 64.7% of subjects using it, while insulin pen was used by 33.5% subjects. Despite of insulin therapy, the glycemic control was poor and 81.4% had HbA1c &gt;8%. Only 5.7% of the subjects had HbA1c &lt;7%. 94.9% of the subjects reported that they were regular with their insulin therapy. Only 20.1% adjusted the insulin dose by self. Conclusions: The present study has found that despite being on insulin therapy, large percentage of subjects was unable to achieve good glycemic control.

Postprandial Glucose Control in Type 1 Diabetes: Importance of the Gastric Emptying Rate.

The achievement of optimal post-prandial (PP) glucose control in patients with type 1 diabetes (T1DM) remains a great challenge. This review summarizes the main factors contributing to PP glucose response and discusses the likely reasons why PP glucose control is rarely achieved in T1DM patients. The macronutrient composition of the meal, the rate of gastric emptying and premeal insulin administration are key factors affecting the PP glucose response in T1DM. Although the use of continuous insulin infusion systems has improved PP glucose control compared to conventional insulin therapy, there is still need for further ameliorations. T1DM patients frequently present a delayed gastric emptying (GE) that produces a lower but more prolonged PP hyperglycemia. In addition, delayed GE is associated with a longer time to reach the glycemic peak, with a consequent mismatch between PP glucose elevation and the timing of premeal insulin action. On this basis, including GE time and meal composition in the algorithms for insulin bolus calculation of the insulin delivery systems could be an important step forward for optimization of PP glucose control in T1DM.

725-P: Reducing Hypoglycemic Risk during Postprandial Exercise with Closed-Loop Insulin Delivery in Adults with Type 1 Diabetes: Announced and Unannounced Exercise

Background: Exercise-induced hypoglycemia is a major barrier for physical activity practice. Compared to conventional insulin therapy, closed-loop (CL) insulin delivery reduces hypoglycemic risk during post-absorptive exercise but has not been studied during postprandial exercise. Methods: Randomized crossover trial comparing 3 strategies for a postprandial (PP) exercise (90 min after breakfast) at 60% of VO2peak for 60min: 1) Unannounced exercise (Unann); 2) Announced exercise with reduced insulin bolus (Ann+RB): increased glucose target combined with a 33% meal bolus reduction); 3) Announced exercise with full bolus (Ann+FB): increased glucose target combined with usual meal bolus in 37 adults with type 1 diabetes. Results: Median percentage time spent in hypoglycemia (&amp;lt;70 mg/dl) was reduced with Ann+RB compared to Unann (Primary outcome; 0[0-0]% vs. 0[0-26]%; p&amp;lt;0.05). The drop in plasma glucose during exercise was smaller with Ann+RB (-5.5 ± 50.5 than with Ann+FB (-46.8 ± 52.2) and Unann (-43.2 ± 48.6) strategies (p &amp;lt;0.05). Accordingly, hypoglycemic events were reduced with Ann+RB (n=2) compared to Ann+FB (n=3) and Unann (n=9). However, Ann+BR strategy was associated with increased time in hyperglycemia (&amp;gt; 250mg/dl). Conclusion: Announcement of postprandial exercise to the closed-loop algorithm combined with meal bolus reduction reduced hypoglycemic risk, yet at the expense of mild increase in hyperglycemia. Disclosure S. Tagougui: None. N. Taleb: None. C. Suppere: None. I. Boukabous: None. V. Messier: Other Relationship; Self; Eli Lilly and Company. R. Rabasa-Lhoret: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Merck &amp; Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Novo Nordisk A/S.

1077-P: Treatment of Post-pancreatectomy Diabetes in Individuals with Congenital Hyperinsulinism Using a Bihormonal Bionic Pancreas

Congenital Hyperinsulinism (HI) is a disorder of beta-cell function that results in severe hypoglycemia. Near-total pancreatectomy (Ppx) is necessary for intractable hypoglycemia in the most severe cases, which results in diabetes later in life. The evolution of diabetes after Ppx is characterized by marked hypo- and hyper-glycemia due to residual dysregulated insulin secretion and glucagon deficiency. We aim to evaluate the safety and efficacy of a bihormonal bionic pancreas (BHBP) in individuals with HI and post-Ppx diabetes. Autonomously adaptive dosing algorithms in the BHBP use data from an integrated continuous glucose monitor (CGM) to control subcutaneous delivery of insulin and glucagon. Our hypothesis is that the BHBP will result in improved glycemic control compared to conventional insulin pump (CIP) therapy. This is an open-label, random-order, crossover, pilot study. Subjects with HI and post-Ppx diabetes are randomly assigned to BHBP therapy or CIP therapy during a 4-day inpatient stay, followed by the opposite intervention at least 1 week later. The BHBP was initialized with only the subject’s body weight. The coprimary outcomes are mean glucose and time with CGM glucose &amp;lt; 60 mg/dL analyzed over days 2-4. Seven subjects age 7-25 years (4 F) with mean A1C of 7.5% (SD 0.57) have completed the study to date. Mean CGM glucose was 148 mg/dL (SD 14) during the BHBP period vs. 156 mg/dL (SD 28) during the CIP period. All subjects had mean glucose during their BHBP period at or below 169 mg/dL (corresponding to A1C of 7.5%), whereas only 57% of subjects met this goal during their CIP period. Mean time with CGM glucose &amp;lt; 60 mg/dL was 0.07% (SD 0.60%) during the BHBP period vs. 1.71% (SD 3.48) during the CIP period. The BHBP was well tolerated. Relative to CIP therapy, the BHBP was able to produce, with greater ease of use, comparable, if not superior, results in terms of mean glucose and reduced frequency of hypoglycemia in individuals with HI and post-Ppx diabetes. Disclosure A. Rayannavar: None. L.M. Mitteer: None. K. Lord: None. C.P. Hawkes: None. C.A. Balliro: None. F. El-Khatib: Employee; Self; Beta Bionics. Stock/Shareholder; Self; Beta Bionics. E. Damiano: Advisory Panel; Self; Novo Nordisk A/S. Board Member; Self; Beta Bionics. Employee; Self; Beta Bionics. Stock/Shareholder; Self; Beta Bionics. Stock/Shareholder; Spouse/Partner; Beta Bionics. Other Relationship; Self; Ascensia Diabetes Care, Senseonics. S.J. Russell: Advisory Panel; Self; Companion Medical, Unomedical a/s. Consultant; Self; Flexion Therapeutics. Research Support; Self; Beta Bionics, MITRE Corporation, Novo Nordisk A/S, Zealand Pharma A/S. Other Relationship; Self; ADOCIA, Ascensia Diabetes Care, Ascensia Diabetes Care, Lilly Diabetes, Roche Diabetes Care, Senseonics. D. De Leon: Consultant; Self; Crinetics, Novartis Pharmaceuticals Corporation, ProSciento, Soleno Therapeutics, Zealand Pharma A/S. Employee; Spouse/Partner; Merck &amp; Co., Inc. Research Support; Self; Crinetics, Dexcom, Inc., Zealand Pharma A/S. Stock/Shareholder; Self; Merck &amp; Co., Inc. Funding Zealand Pharma A/S; Dexcom, Inc.; University of Pennsylvania; Children's Hospital of Philadelphia Women's Committee; National Institutes of Health (T32DK06368-14 to A.R.); Pediatric Endocrine Society

1080-P: A Prospective, Multicenter, Randomized, Open-Label, Parallel-Group Clinical Trial Comparing Patient Satisfaction and Compliance with a Needle-Free Insulin Injector vs. Conventional Insulin Pen Injections in Chinese Patients with Type 2 Diabetes Mellitus

Background: The proportion of patients with type 2 diabetes (T2DM) using insulin is still very low and often is initiated relatively late. The needle-free insulin injector is designed for diabetic patients who fear injections or are reluctant to initiate insulin therapy when it is clearly indicated. Objective: To evaluate patient satisfaction and compliance with a needle-free insulin injector versus conventional insulin pen injections in patients with T2DM treated for 16 weeks. Methods: A total of 427 patients with T2DM were enrolled in a multicenter, prospective, randomized, open-label study, and were randomized 1:1 to receive basal insulin or premixed insulin via a needle-free injector or via conventional insulin pen injections. Patients’ quality-of-life (determined by the SF-36 questionnaire), the insulin dose administered, compliance with insulin therapy (as evaluated by missing injections), and patients’ satisfaction with their injection device (scored on a scale of 0 to 10) were evaluated. Results: In the 412 patients who completed the study, mean SF-36 questionnaire scores were increased significantly in both the needle-free injector and conventional insulin pen groups (123.21 ± 16.64 vs. 122.11 ± 16.82, respectively), with no significant difference between the 2 groups. There was also no significant difference between the groups in compliance. However, subjects in the needle-free injector group showed significantly higher treatment satisfaction scores than those in the conventional insulin pen group after 16 weeks of treatment (mean scores, 8.17 ± 1.78 vs. 7.21 ± 2.22, respectively; P &amp;lt; 0.0001). Conclusions: The needle-free injector improved the quality-of-life of T2DM patients and significantly enhanced their satisfaction with insulin treatment compared with conventional insulin pen injections. Disclosure Y. Wang: None. L. Ji: Advisory Panel; Self; AstraZeneca. Consultant; Self; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck KGaA, Merck Sharp &amp; Dohme Corp., Novartis AG, Novo Nordisk A/S, Roche Pharma, Sanofi, Takeda Pharmaceutical Company Limited. Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Eli Lilly and Company, Merck Sharp &amp; Dohme Corp., Novartis AG, Roche Pharma, Sanofi. L. Guo: None. X. Ran: None. L. Chen: Research Support; Self; Becton, Dickinson and Company. Z. Ma: None. Z. Sun: None. Z. Shan: None. X. Xu: None. G. Wang: None.