Insulin Pump Therapy Research Articles

Effects of initiating insulin pump therapy in the real world: A nationwide, register-based study of adults with type 1 diabetes

AimsWe aimed to estimate effects of insulin pump therapy (IPT) on HbA1c level, HbA1c variability, and risk of hospitalised diabetic ketoacidosis (DKA) and severe hypoglycaemia (SH), compared with multiple daily insulin injections (MDI). MethodsWe identified a cohort of all adults with type 1 diabetes in Denmark using national registry data and assigned each individual to either IPT (treatment) or MDI (control) from 2010 to 2020. We estimated average treatment effects on the treated (ATT) and treatment effects among population subgroups using treatment-staggered difference-in-differences. ResultsThe cohort consisted of 26,687 individuals with a collective 243,601 person-years of observation; 38,823 (16 %) were IPT person-years. We identified an ATT for HbA1c of −0.33 % (95 % CI −0.39 to −0.27; −3.6 mmol/mol [95 % CI −4.2 to −2.9]). ATTs were larger among women and individuals who were older, had highest baseline HbA1c, and used continuous glucose monitoring. ATT for HbA1c variability (−0.016 % [−0.028 to −0.0041); −0.17 mmol/mol [95 % CI −0.30 to −0.045]) corresponded to a 6.5 % decrease in the standard deviation of HbA1c. ATTs for DKA and SH corresponded to 0.52 additional and 0.11 fewer hospitalisations per 1,000 person-years, respectively. ConclusionsIPT significantly reduced HbA1c level and variability, compared with MDI. However, it also marginally increased the risk of hospitalised DKA.

Diabetes distress in adult patients with type 1 and type 2 diabetes.

Background: Diabetes is a chronic and demanding condition, exposing patients to complex physical and mental challenges, and making them particularly vulnerable to distress. Diabetes distress related to disease in diabetic patients is a term encompassing challenges associated with the psychosocial adaptation required of these individuals. Aim of the study: To assess distress in patients with diabetes mellitus. Material and methods: This study was conducted among 107 patients with type 1 and 2 diabetes mellitus reporting for follow-up at a diabetes clinic. The Diabetes Distress Scale (DDS) was used for data collection. Results: Moderate and severe diabetes distress was found in 36.4% and 15% of respondents in the study group, respectively. The total mean score for the DDS was 2.19. The largest percentages of respondents with high levels of distress were observed in patients with a financial situation rated lower than good (30.6%), those having less than secondary education (28.0%), and those under 30 years of age (27.8%). Patients with type 1 diabetes (26.9%), a disease duration > 30 years (30.8%), those using insulin pump therapy (30%) or CGM (Continuous Glucose Monitoring) and FGM (Flash Glucose Monitoring) systems (50%), and those showing ≥ 3 chronic diabetic complications (37.5%) experienced severe distress. Conclusions: Overall, diabetic patients showed a moderate level of distress. The greatest inconveniences caused by the disorder were associated with regimen-related distress and emotional burden. Rural patients with a lower level of education and a lower financial status showed higher levels of distress. Patients experiencing chronic complications from diabetes and those with higher levels of glycated hemoglobin also presented with more severe distress.

Abstract #1325274: Ramadan Fasting in Patients With Type 1 Diabetes Mellitus on Insulin Pump Followed Up in a Virtual Diabetes Clinic at King Abdulaziz Medical City, Jeddah

Ramadan is a lunar-based holy month in which Muslims are obligated to fast from before the dawn until sunset. The objective of this study is to assess the efficacy and safety of fasting Ramadan in patients with type 1 diabetes mellitus (T1DM) on insulin pump therapy followed up in a virtual insulin pump clinic.

Insulin Pump Therapy Efficacy and Key Factors Influencing Adherence in Pediatric Population-A Narrative Review.

Objective: we aimed to highlight the state of the art in terms of pediatric population adherence to insulin pumps. This study intends to underline the significance of identifying and minimizing, to the greatest extent feasible, the factors that adversely affect the juvenile population's adherence to insulin pump therapy. Materials and methods: articles from PubMed, Embase, and Science Direct databases were evaluated using the following search terms: adherence, pump insulin therapy, children, pediatric population, and type 1 diabetes, in combination with several synonyms such as compliance, treatment adherence, pump adherence, patient dropouts, and treatment refusal. Results: A better glycemic control is connected to a better adherence to diabetes management. We identify, enumerate, and discuss a number of variables which make it difficult to follow an insulin pump therapy regimen. Several key factors might improve adherence to insulin pump therapy: efficient communication between care provider and patients (including home-based video-visits), continuous diabetes education, family support and parental involvement, as well as informational, practical assistance, and emotional support from the society. Conclusions: every cause and obstacle that prevents young patients from adhering to insulin pumps optimally is an opportunity for intervention to improve glycemic control and, as a result, their quality of life.

Glucose profiles of older adults with type 1 diabetes using sensor-augmented pump therapy in Australia: pre-randomisation results from the ORACL study

Older adults with type 1 diabetes are recommended modified glucose targets. However, data on the effects of diabetes technology in older age are scarce. We assessed older adults established on sensor-augmented insulin pump therapy during clinical trial run-in and compared their continuous glucose monitoring (CGM) profiles with consensus recommendations. We aimed to provide insight into the applicability of currently recommended CGM-based targets while accounting for current Diabetes UK guidelines. In this analysis, adults aged 60 years or older with type 1 diabetes with a duration of at least 10 years and entering the Older Adult Closed Loop (ORACL) trial were studied. The trial was done at two tertiary hospitals in Australia. Individuals who were independent with diabetes self-management, as well as those receiving caregiver assistance for their diabetes management, were eligible for inclusion. Participants underwent baseline clinical assessment, which included medical history and examination, testing for frailty, functional ability, cognitive functioning, psychosocial wellbeing, and subjective sleep quality; fasting venous blood samples were collected for C-peptide, glucose, and glycated haemoglobin A1c measurement. Sensor-augmented pumps, carbohydrate-counting education, and diabetes education were provided to participants by diabetes nurse educators, dietitians, and endocrinologists experienced in type 1 diabetes clinical care. CGM data were subsequently collected for 2 weeks during sensor-augmented pump therapy. The ORACL trial is registered with the Australian New Zealand Clinical Trial Registry, ACTRN12619000515190. Our analysis included all 30 participants who completed the ORACL trial run-in-19 (63%) women and 11 (37%) men (mean age 67 years [SD 5], median diabetes duration 38 years [IQR 20-47], and insulin total daily dose 0·55 units [0·41-0·66] per kg bodyweight). Ten (33%) of 30 participants had impaired hypoglycaemia awareness and six (20%) were pre-frail; none were frail. The median CGM time in range 3·9-10·0 mmol/L was 71% (IQR 64-79). The time spent with glucose above 10·0 mmol/L was 27% (18-35) and above 13·9 mmol/L was 3·9% (2·4-10·2). The time with glucose below 3·9 mmol/L was 2·0% (1·2-3·1) and the time below 3·0 mmol/L was 0·2% (0·1-0·4). Only two (7%) of 30 participants met all CGM-based consensus recommendations modified for older adults. Time in hypoglycaemia was lower among the 16 participants with predictive low-glucose alerts enabled than among the 14 participants not using predictive low-glucose alerts (median difference -1·1 percentage points [95% CI -2·0 to -0·1]; p=0·038). This difference was even greater overnight (-2·3 percentage points [-3·2 to -1·0]; p=0·0018). One serious adverse event occurred (elective cardiac stent). Using sensor-augmented pumps after multidisciplinary education, this group of older adults without frailty achieved a time in range far exceeding minimum consensus recommendations. However, the current stringent hypoglycaemia recommendations for all older adults were not met. Predictive low alerts could reduce hypoglycaemia, particularly overnight. Investigation into the effectiveness of CGM-based targets that consider frailty, functional status, and diabetes therapies for older adults is warranted. JDRF and Diabetes Australia.

Influence of the personalities and adherence to therapy on the metabolic control type 1 diabetes in adolescents

Introduction. Diabetes mellitus type 1 (T1DM) in children and adolescents occupies a leading place in the structure of chronic diseases of childhood. Despite modern advances in the treatment and control of CT 1, adolescents have problems with glycemic control in comparison with other age groups.Aim. Is to estimate the correlation between the degree of compensation for diabetes in adolescents and the features of the personality profile, emotional and behavioural characteristics and environmental factors.Materials and methods. The study included 101 children aged 11 to 17 years, treated to pump insulin therapy or multiple injections of insulin. Adherence and compliance to therapy was assessed using the Medication Adherence Questionnaire (MAQ) and the Self Care Inventory-Revised Version (SCI-R). Emotional and behavioral problems were evaluated using the Youth self-report for ages 11-18. Characterization of personality profile was assessed using the The Sixteen Personality Factor Questionnaire». Results. Diabetes was compensated in 25% of children (HbA1c < 7,0%). A statistically significant relationship was established between the degree of patient compliance and the level of HbA1c. The predictive role of individual psychological characteristics on compliance has been determined. Factors such as realism and acceptance of moral norms have a positive impact on compliance.Conclusions. The therapy compliance indicator is the most significant indicator of better compensation for type 1 diabetes in adolescents. The personality traits of adolescents, such as acceptance of moral norms and realism — sensitivity have a predictive effect on the therapy compliance.

Insulin pumps in children - a systematic review.

Insulin pump therapy is a real breakthrough in managing diabetes Mellitus, particularly in children. It can deliver a tiny amount of insulin and decreases the need for frequent needle injections. It also helps to maintain adequate and optimal glycemic control to reduce the risk of metabolic derangements in different tissues. Children are suitable candidates for pump therapy as they need a more freestyle and proper metabolic control to ensure adequate growth and development. Therefore, children and their caregivers should have proper education and training and understand the proper use of insulin pumps to achieve successful pump therapy. The pump therapy continuously improves to enhance its performance and increase its simulation of the human pancreas. Nonetheless, there is yet a long way to reach the desired goal. To review discusses the history of pump development, its indications, types, proper use, special conditions that may enface the children and their families while using the pump, its general care, and its advantages and disadvantages. We conducted comprehensive literature searches of electronic databases until June 30, 2022, related to pump therapy in children and published in the English language. We included 118 articles concerned with insulin pumps, 61 were reviews, systemic reviews, and meta-analyses, 47 were primary research studies with strong design, and ten were guidelines. The insulin pump provides fewer needles and can provide very tiny insulin doses, a convenient and more flexible way to modify the needed insulin physiologically, like the human pancreas, and can offer adequate and optimal glycemic control to reduce the risk of metabolic derangements in different tissues.

Efficacy of insulin dosing algorithms for high-fat high-protein mixed meals to control postprandial glycemic excursions in people living with type 1 diabetes: A systematic review and meta-analysis.

Optimizing postprandial blood glucose (PPG) levels after mixed meals that contain high fat and protein remains a challenge in the treatment of type 1 diabetes. This study evaluated the efficacy of different algorithms used for dosing insulin based on counting units of high fat and high protein (HFHP) meals with the current conventional method of counting carbohydrates alone to control PPG excursions. The MEDLINE, EMBASE, and Cochrane electronic databases were searched, with the analysis restricted to randomized control trials (RCTs). The primary outcome was the PPG (mean and standard deviation) at 240 min. The pooled final estimate was the mean difference (MD) of the PPGs at 240 min using random effect models to account for heterogeneity. In total, 15 studies were identified and included in the systemic review, of which 12 were RCTs, and three studies were non-randomized trials. The pooled MD of the PPG at 240 min was in favor of additional insulin doses in HFHP meals compared to the carbohydrate counting alone. The statistically significant results favored the combined bolus (30:70) that split over 2h in insulin pump therapy with pooled MD of the PPG, 240 min of -24.65; 95% CI: -36.59, -8.41; and heterogeneity, 0%. Other statistically significant results favored the additional insulin added to insulin to carb ratio (ICR) of meal bolus (25-60% ICR) in multiple daily injections therapy with the pooled MD of PPG at 240 min, -21.71; 95% CI: -38.45, -4.73; and heterogeneity, 18%. Insulin treatment based on fat and protein content, in addition to carbohydrate counting, is more effective than the carbohydrate counting method alone; however, further research is warranted to determine the best equation for fat and protein counting, particularly in people with multiple daily injections.

Efficacy of Control-IQ Technology in a General Endocrine Clinic

ObjectiveRecent advances in technology have allowed for the expanded use of hybrid closed-loop insulin pump therapy and automated insulin delivery systems for the management of diabetes mellitus. We assessed the outcomes of introducing Tandem t:slim X2 with the Control-IQ technology in a general endocrine clinic. MethodsData from 66 adults with type 1 (n = 61) and type 2 (n = 5) diabetes mellitus were aggregated for analysis. Patients were either transitioned from traditional insulin pump therapy or multiple daily injection therapy to Tandem t:slim X2 with the Control-IQ technology from January 2020 to June 2021. The assessed clinical end points included changes in time below range, time above range, and time in target range. Changes in hemoglobin A1C before and after Control-IQ technology implementation were noted. The primary outcome was a change in time in target range with the Control-IQ technology. ResultsThere was a significant increase in time in target range when comparing pre- and post–Control-IQ technology (49.5% vs 63.3%, P < .0003) values. There was a reduction in time above range (46.8% vs 34.9%, P < .0013), a decrease in time below range (4.0% vs 1.7%, P = .017), and a decrease in hemoglobin A1C after transitioning to the Control-IQ technology (7.7% [61 mmol/mol] vs 7.1% [54 mmol/mol], P < .017). The patient dropout rate was low (7%). ConclusionThe Control-IQ technology system was effective in reducing hyperglycemia while increasing time in target range and decreasing hypoglycemia. This technology is a useful and effective addition to the growing number of automated insulin delivery systems. The clinical outcomes mirror the results found in the key adult pivotal trials.

Diabete hi-tech

Recently, technological innovations have radically changed diabetes care. Insulin pumps and continuous glucose monitoring systems have significantly improved diabetes outcomes in both children and adults with Type 1 diabetes. For this reason, the major international associations recommend the use of technology in the management of Type 1 diabetes. The limitations of glycemic self-monitoring have prompted research to develop alternative techniques, favouring the expansion of continuous blood glucose monitoring systems (CGMs). CGM measures interstitial glucose through tiny sensors inserted in the subcutaneous tissue. Sensors can provide information in real time on the current glucose level and its trend. These data can be uploaded to the cloud and checked any time by doctors, patients and their caregivers. CGM can be combined with multiple daily injections (MDI) therapy or continuous subcutaneous insulin infusion (CSII). With CSII, basal insulin is supplied in the form of a continuous infusion and pre-meal bolus doses are calculated based on the meals’ carbohydrate content. A variety of insulin pumps is available, some of which can communicate with specific CGM devices, helping the patient to make better decisions about insulin dosing. This approach is known as sensor-augmented insulin pump therapy and it is the gold standard for the treatment of Type 1 diabetes in children and young adults, as recommended by the Italian Association of Paediatric Endocrinology and Diabetology. In the most recent systems, basal insulin delivery can be automatically modified through algorithms, based on CGM results, target glucose and the amount of active insulin, even though the patients still have to set the pre-meal insulin bolus manually. This system is defined as a partially hybrid closed-loop system, also known as artificial pancreas. Compared to MDI, CSII is associated with better control of blood glucose - measured by haemoglobin A1c and glycemic variability -, reduction of daily insulin requirement and an improvement of the quality of life. Psychophysical disabilities, language barriers or socio-economic disadvantage should not be considered limitations of CSII treatment as long as the caregiver is able to manage the therapy. Nowadays, MDI is recommended as first line therapy exclusively for those patients who do not want to use insulin pumps due to physical discomfort. The aim of this article is to provide updated information on the management of paediatric diabetes with modern technological devices for glucose monitoring and insulin delivery.

RESALE OF REFURBISHED INSULIN PUMPS, IS IT POSSIBLE?

There is no doubt that CSII with Insulin pump Therapy has proved superior to MDI (multiple Dose Injection) therapy in Type1DM as well as Type2DM patients. Economics has been a very important issue while advocating the Pump to either patients, type 1 or type 2 Diabetes Mellitus patients. Out of 9 (Nine) patients using Insulin Pumps in our centre GANDHI CLINIC, PUNE, INDIA, there are 5(FIVE) Type 2 patients and 4(FOUR) Type 1DM patients. Two Pumps are deposited at my Clinic due to the sad demise of the Type2DM patients. The relatives of these patients do wish to sell these pumps with some depreciation price i.e. at lower price than the new one. One patient (type2DM) has stopped using the Insulin pump due to the adverse advice from another healthcare provider. This person with Diabetes also wants to sell the pump at some discounted price. As per my survey in the Metro city of Pune (INDIA) approximately 700 insulin pumps are sold, out of these at least 5-7% of total pumps are not being used anymore. The unused pumps are at least 50 in number in this city of PUNE. Total number of pumps used in INDIA is 70000-72000 pumps approx. The total unused pumps by the patients in INDIA could be about 3000 to 5000 pumps approximately. This revenue loss in this resource constrained country could be in millions of Dollars. This scenario may be same in many developing countries wherein the healthcare budgets are limited. In INDIA, Insulin Pump Therapy is not yet covered by Insurance policy of all the patients. Since the pumps are usually purchased by pocket expenses or with Loan or selling some assets like land or Gold, the relatives of the patients are not wrong in expecting some nancial recovery after losing the most important thing ie the PERSON. This is also to be considered if patient does not want to continue the use of pump due to any reason. We do see refurbished cars sold and there are eligible and deserving candidates available who cannot purchase a new model of the Car. I am sure INDIA is an important market of Diabetes Technology related Products like Insulin Pump and CGMs. This article is aimed at KOLs in Diabetology and Economists in the world for a basic policy change in favour of the patient care and economics.

Insulin edema after initiation of hybrid closed-loop insulin pump therapy with continuous glucose monitoring: a case report

BackgroundInsulin edema is a rare complication which can present after initiation or intensification of insulin therapy in people with diabetes. Initiation of closed-loop hybrid insulin pump therapy can result in rapid improvement in glycemic control for people with diabetes. We present a case in which transition to a closed-loop hybrid insulin pump system, followed by significant improvement in glycemic control, led to development of insulin edema in a person with type 1 diabetes.Case presentationWe present a 51-year-old woman with type 1 diabetes of 16 years duration, on insulin pump therapy for more than 10 years, who presented for follow-up 7 weeks after transitioning to a hybrid closed-loop insulin pump system with continuous glucose monitoring (CGM). She complained of weight gain and bilateral lower extremity edema which had started two weeks after the change in pump modality. Laboratory studies and echocardiogram did not reveal any etiology of the acute edema. HbA1c was 3.3% lower than the previous measurement 15 weeks earlier, and there was a significant increase in the daily total insulin dose. With exclusion of other causes of acute edema, the patient was diagnosed with insulin edema and started on hydrochlorothiazide. On follow up, her lower extremity edema significantly improved although her weight did not return to baseline.ConclusionTo our knowledge, this is the first case of insulin edema reported in a person with type 1 diabetes using CGM and a hybrid closed-loop insulin pump system. The increase in total daily insulin dose, rapid improvement of glycemic control, and lack of hypoglycemic episodes were important factors to consider in evaluation of this case. Use of hybrid closed-loop systems can help achieve rapid improvement in glycemic control in people with diabetes. This case suggests that consideration should be given to adjusting initial blood glucose targets when starting these remarkable new technologies in people with baseline poor glycemic control.

Facilitators and Barriers to Smart Insulin Pen Use: A Mixed-Method Study of Multidisciplinary Stakeholders From Diabetes Teams in the United States.

This study sought to identify barriers and facilitators to successful smart insulin pen (SIP) use and gauge prescribing practices and integration into clinical practice by assessing provider and care team perspectives at participating endocrinology clinics within the T1D Exchange Quality Improvement Collaborative. The identified provider-related, patient-related, and clinic- and operational-level barriers and facilitators varied based on clinic knowledge, capacity, and resources. High-impact barriers included insurance coverage and prescribing processes; high-impact facilitators included improved diabetes clinic visit quality and use of SIPs as an alternative to insulin pump therapy. Findings indicated the need for provider and care team education and training on proper SIP features, use, and prescribing.

Diabetestechnologie in der Schwangerschaft

The use of diabetes technology in pregnant women with type 1 diabetes, as well as in gestational diabetes and type 2 diabetes is becoming increasingly important. In the phase of increasing insulin resistance, especially in the second trimester, the focus is to adjust insulin therapy based on continuous glucose monitoring (CGM) targets. This requires proper bolus management and aggressive injection–eating intervals. In addition, it is essential that counseling have a strong focus on women’s eating behaviors, due to the high potential in terms of glycemic control. Sensor-augmented insulin pump therapy is used without trial data (low suspend, predictive low-glucose suspend, hybrid closed loop) and a few studies are expected to be undertaken in the near future, leaving observation as the only viable option for now. Artificial pancreas systems are the future, both in terms of control and well-being.

Technological Developments and Quality of Life in Type 1 Diabetes Mellitus Patients: A Review of the Modern Insulin Analogues, Continuous Glucose Monitoring and Insulin Pump Therapy.

Type 1 Diabetes Mellitus (T1DM) is a chronic autoimmune disease, which is characterized by an increased prevalence worldwide, which, in fact, tends to take extensive dimensions. The recent rapid development of science and technology has significantly contributed to the improvement of the management of type 1 diabetes mellitus, both in achieving the required euglycaemic regulation and reducing the psychological burden associated with the disease, consequently improving the quality of life of the patients with type 1 diabetes mellitus. A literature review from 2010, related to the contribution of the modern insulin analogues, continuous glucose monitoring and the insulin pump, was performed using Scopus, ScienceDirect and PubMed databases. Studies included in the review support a direct and indirect association of technological innovations with the quality of life. The use of type 1 diabetes mellitus technology was negatively associated with the frequency of the hypoglycaemias and the value of the glycosylated hemoglobin, while at the same time, the development and use of the related technology were highly associated with an improvement in the quality of life. Patients' quality of life is an indicator of the management of type 1 diabetes mellitus, and it is just as important as glycaemic regulation. Through this review, it was concluded that a better quality of life of T1DM patients was associated with the improvement of glycosylated hemoglobin and hypoglycemic episodes.

국내 인슐린 주입기기 요양비 지원 정책 현황 및 개선 방안

Intensive insulin therapy is the primary treatment option for patients with type 1 and uncontrolled type 2 diabetes. Insulin pump therapy and multiple daily insulin injections (MDI) are the principal methods of intensive insulin therapy. The clinical utility of an insulin pump is generally greater than an MDI regimen. An artificial pancreas, which is an insulin pump with an integrated continuous glucose monitor (CGM), has recently been introduced on the market with emerging clinical evidence. Although it may offer clinical benefits and reduce the self-management burden among patients with diabetes, its potential for inappropriate use and unaffordability are the major barriers to its universal utilization. Despite the medical assistance program offered by the Korean National Healthcare System, which provides coverage for consumables and devices for diabetes treatment, some patients cannot afford to use an advanced insulin delivery system (i.e., the artificial pancreas). Under the current reimbursement policy, the healthcare system considers an insulin pump and a CGM as separate items for regulatory and reimbursement purposes. In other words, the artificial pancreas is categorized as an insulin pump and reimbursed at the same amount as a traditional insulin pump. The fundamental operating function may be the same between the artificial pancreas and a traditional insulin pump; however, there should be a different reimbursement pathway to make a novel category for the artificial pancreas instead of categorizing it under insulin pumps and to differentiate pricing based on the comparative (cost-) effectiveness among insulin delivery devices. Other countries such as the United States, the United Kingdom, Germany, and France are moving toward rapid and universal adoption of the artificial pancreas supported by their clinical governance and regulatory affairs. In this review, we highlight the need to improve the accessibility and affordability of advanced diabetes technology by discussing the current issues in the reimbursement policy that limit the universal use of advanced insulin delivery devices in Korea.

Perioperative Identification and Management of Hyperglycemia in Orthopaedic Surgery.

The consequences of undermanaged perioperative hyperglycemia are notable and can have a serious impact on adverse postoperative outcomes, especially surgical site infections and periprosthetic joint infections (PJIs). Preoperative screening of hemoglobin A1c with a goal threshold of <7.45% is ideal. There are a variety of risk factors that contribute to hyperglycemia that should be considered in the perioperative period, including glucocorticoid use, nutritional factors, patient-specific factors, anesthesia, and surgery. There are expected trends in the rise, peak, and fall of postoperative blood glucose levels, and identifying and treating hyperglycemia as swiftly as possible are the fundamental aims of treatment and improved glucose control. Performing frequent postoperative blood glucose monitoring (in the post-anesthesia care unit, on the day of surgery at 1700 and 2100 hours, and in the morning of postoperative day 1) should be considered to allow for the early detection of alterations in glucose metabolism. In addition, instituting a postoperative dietary restriction of carbohydrates should be considered. The use of insulin as a hypoglycemic agent in orthopaedic patients is relatively safe and is an effective means of controlling fluctuating blood glucose levels. Insulin therapy should be administered to treat hyperglycemia at ≥140 mg/dL when fasting and ≥180 mg/dL postprandially. Insulin therapy should be ceased at blood glucose levels of <110 mg/dL; however, monitoring for glycemic dysregulation should be continued. In all cases of complex diabetes, consultation with diabetes specialty services should be considered. The emerging use of technology, including continuous subcutaneous insulin pump therapy and continuous glucose monitoring, is an exciting area of further research and development as such technology can more immediately detect and correct aberrations in blood glucose levels.

Internal model control based module for the elimination of meal and exercise announcements in hybrid artificial pancreas systems

Background and ObjectivesHybrid artificial pancreas systems outperform current insulin pump therapies in blood glucose regulation in type 1 diabetes. However, subjects still have to inform the system about meals intake and exercise to achieve reasonable control. These patient announcements may result in overburden and compromise controller performance if not provided timely and accurately. Here, a hybrid artificial pancreas is extended with an add-on module that releases subjects from meals and exercise announcements. MethodsThe add-on module consists of an internal-model controller that generates a “virtual” control action to compensate for disturbances. This “virtual” action is converted into insulin delivery, rescue carbohydrates suggestions, or insulin-on-board limitations, depending on a switching logic based on glucose measurements and predictions. The controller parameters are tuned by optimization and then related to standard parameters from the open-loop therapy. This module is implemented in a hybrid artificial pancreas system proposed by our research group for validation. This hybrid system extended with the add-on module is compared with the hybrid controller with carbohydrate counting errors (hybrid) and the hybrid controller with an alternative unannounced meal compensation module based on a meal detection algorithm (meal detector). The validation used the educational version of the UVa/Padova simulator to simulate the three controllers under two scenarios: one with only meals and another with meals and exercise. The exercise was modeled as a temporal increase of the insulin sensitivity resulting in the glucose drop usually related to an aerobic exercise. ResultsFor the scenario with only meals, the three controllers achieved similar time in range (proposed: 85.1 [77.9,88.1]%, hybrid: 84.0 [75.9,86.4]%, meal detector: 81.9 [79.3,83.8]%, median [interquartile range]) with low time in moderate hypoglycemia. Under the scenario with meals and exercise, the proposed module reduces 4.61% the time in hypoglycemia achieved with the other controllers, suggesting an acceptable amount of rescues (27.2 [23.7, 31.0] g). ConclusionsThe proposed add-on module achieved promising results: it outperformed the meal-detector-based controller, even achieving a postprandial performance as good as the hybrid controller (with carbohydrate counting errors). Also, the rescue suggestion feature of the module mitigated exercise-induced hypoglycemia with admissible rescue amounts.

A mixed-method study examining family physicians’ perceptions regarding insulin pump therapy

Background: Primary health care (PHC) physicians lack sufficient knowledge about insulin pump therapy. Objectives: to assess the level of knowledge and attitude of PHC physicians toward Insulin Pumps. Methods: A cross-sectional study was done on PHC physicians working in primary healthcare settings at the main University Hospital and at the medical services centers at King Abdulaziz University, Jeddah, Saudi Arabia. Data about participants’ demographics, experience, specialty, workplace, and current position were collected. Their knowledge and attitude toward insulin pump therapy were assessed through online Google Forms. A qualitative part of the study was done by interviewing six physicians to report their opinion about insulin pumps therapy. Results: There was a lack of understanding of the function of an insulin pump and the elimination of the usage of finger sticks, however most of them were aware of the different types of insulin dosages and the appropriate age group for insulin pump therapy. The majority of the participants had a favorable attitude toward insulin pump therapy, as evidenced by the qualitative and quantitative findings of the study. Physicians who were 30 to 49 years old, consultants, and those with 10 to 19 years of experience all scored much better on knowledge. Knowledge deficits, a hazy system, financial concerns, the lack of pumps, and the lack of a skilled physician were all barriers to initiating patients on insulin pump therapy. Conclusions: There is a need for training programmes to increase PHC understanding and attitudes about insulin pump therapy. Keywords: knowledge, attitude, insulin, pumps, PHC, Jeddah

Mitchell-Riley Syndrome: Improving Clinical Outcomes and Searching for Functional Impact of RFX-6 Mutations.

Aims/HypothesisCaused by biallelic mutations of the gene encoding the transcription factor RFX6, the rare Mitchell–Riley syndrome (MRS) comprises neonatal diabetes, pancreatic hypoplasia, gallbladder agenesis or hypoplasia, duodenal atresia, and severe chronic diarrhea. So far, sixteen cases have been reported, all with a poor prognosis. This study discusses the multidisciplinary intensive clinical management of 4 new cases of MRS that survived over the first 2 years of life. Moreover, it demonstrates how the mutations impair the RFX6 function.MethodsClinical records were analyzed and described in detail. The functional impact of two RFX6R181W and RFX6V506G variants was assessed by measuring their ability to transactivate insulin transcription and genes that encode the L-type calcium channels required for normal pancreatic beta-cell function.ResultsAll four patients were small for gestational age (SGA) and prenatally diagnosed with duodenal atresia. They presented with neonatal diabetes early in life and were treated with intravenous insulin therapy before switching to subcutaneous insulin pump therapy. All patients faced recurrent hypoglycemic episodes, exacerbated when parenteral nutrition (PN) was disconnected. A sensor-augmented insulin pump therapy with a predictive low-glucose suspension system was installed with good results. One patient had a homozygous c.1517T>G (p.Val506Gly) mutation, two patients had a homozygous p.Arg181Trp mutation, and one patient presented with new compound heterozygosity. The RFX6V506G and RFX6R181W mutations failed to transactivate the expression of insulin and genes that encode L-type calcium channel subunits required for normal pancreatic beta-cell function.Conclusions/InterpretationMultidisciplinary and intensive disease management improved the clinical outcomes in four patients with MRS, including adjustment of parenteral/oral nutrition progression and advanced diabetes technologies. A better understanding of RFX6 function, in both intestine and pancreas cells, may break ground in new therapies, particularly regarding the use of drugs that modulate the enteroendocrine system.