Insulin Management Research Articles

1061-P: Effect of the Omnipod® Insulin Management System on Glycemic Control in Adults with Type 1 Diabetes Previously Treated with MDI or CSII

This multi-site, retrospective study evaluated the effect of treatment with a tubeless insulin pump (Omnipod Insulin Management System, Insulet Corp., Acton, MA) on glycemic control in adults with type 1 diabetes (n=166) compared to prior treatment with multiple daily injections (MDI) (63%) or continuous subcutaneous insulin infusion (CSII) (37%). The primary outcome was change in A1C from baseline to 12 months post-Omnipodinitiation. Secondary outcomes included change in A1C at 3- and 6-months, and change in A1C stratified by baseline A1C and prior treatment with MDI or other CSII. Baseline characteristics were mean±SD: age 44±14 y, diabetes duration 24±14 y, 57% female, A1C 8.1±1.5%. The decrease in A1C at 12 months post-Omnipod therapy was -0.2±1.2% (8.1±1.5% vs. 7.9±1.3%; p=0.01) compared to prior treatment. A decrease in A1C was observed at 3- and 6-mo: -0.3±1.2% (n=95; p=0.005) and -0.3±1.1% (n=87; p=0.04), respectively. The within group reduction in A1C at 12 months for prior MDI use was -0.35% (8.1±1.5% vs. 7.8±1.2%; p=0.008) vs. -0.03% (8.0±1.4% vs. 8.0±1.5%; p=0.761) for CSII. The proportion of patients grouped by A1C category is shown in the Figure. In conclusion, long-term use of the Omnipod System was associated with significant improvement in A1C in adults with type 1 diabetes, most notably in those with A1C ≥9.0% and those previously treated with MDI. Disclosure S.N. Mehta: None. D.F. Kruger: Advisory Panel; Self; Abbott, Boehringer Ingelheim Pharmaceuticals, Inc., Insulet Corporation. Consultant; Self; CeQur Corporation, Hygieia. Speaker's Bureau; Self; AstraZeneca, Dexcom, Inc., Eli Lilly and Company. Stock/Shareholder; Self; Dexcom, Inc. Other Relationship; Self; Novo Nordisk Inc. B.W. Bode: Consultant; Self; ADOCIA, Lexicon Pharmaceuticals, Inc., Novo Nordisk Inc. Research Support; Self; Becton, Dickinson and Company, Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Eyenuk Inc., Insulet Corporation, National Institutes of Health, Novo Nordisk Inc., Sanofi Research & Development, Senseonics, Xeris Pharmaceuticals, Inc. Speaker's Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi US, Senseonics. Stock/Shareholder; Self; AgaMatrix, Glytec, LLC. J.E. Layne: Employee; Self; Insulet Corporation. B. Dumais: None. J.R. Gallagher: None. T.T. Ly: Employee; Self; Insulet Corporation. Funding Insulet Corporation

1042-P: Real-World Treatment Patterns and Glycemic Profiles of 1,217 Adults with Type 2 Diabetes Using the Omnipod® Insulin Management System with Cloud-Based Data Management

Continuous subcutaneous insulin infusion may help optimize therapy in patients with type 2 diabetes, however, there is little real-world data on pump use in this population. This observational study characterized treatment patterns and glycemic profiles of a large cohort of adults with type 2 diabetes using a tubeless insulin pump (Omnipod® Insulin Management System, Acton, MA) with integrated blood glucose (BG) meter (Abbott Diabetes Care Inc., Alameda, CA) and data management system (Glooko, Mountain View, CA). From January 2015 through September 2018, usage data from the pump system were uploaded to the data management system and matched via device serial number to a second database of self-reported demographic data and de-identified. BG and insulin data from ≥3 mo of system use per patient were analyzed. Glycemic outcomes included mean glucose, estimated A1C and percent time in range 70-180, <70 and > 180 mg/dL. Patients (n=1,217) were age (mean±SD) 56.8±10.8y, 50% female and 58% used a tubeless insulin pump for ≥1 y. Glycemic profile included BG 174±39 mg/dL, estimated A1C 7.7%, time in range 70-180, <70 and >180 mg/dL: 57.8%±20.1, 3.2%±3.9, 39.0%±20.6, respectively. The total daily insulin was 58.3±26.5 U/d delivered as 60% basal/40% bolus with an average of 3.4±1.7 bolus deliveries per day and mean bolus amount of 7.0±3.9 U. CGM was used by 5.5% of the cohort for >50% of overall time of system use. These real-world data characterizing a large cohort of adults with type 2 diabetes provide insight to self-management patterns and glycemic profiles indicating that use of tubeless insulin pump was associated with glycemic control that exceeds U.S. National Healthcare Effectiveness Data and Information Set (HEDIS) standards for adequate diabetes control. Disclosure J.E. Layne: Employee; Self; Insulet Corporation. J. Jantz: Employee; Self; Insulet Corporation. Employee; Spouse/Partner; Insulet Corporation. J. He: Employee; Self; Insulet Corporation. Y. Zheng: Employee; Self; Insulet Corporation. Stock/Shareholder; Self; Insulet Corporation. E. Benjamin: Employee; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation. Funding Insulet Corporation

Audit of diabetic ketoacidosis management at a tertiary hospital in Johannesburg, South Africa.

Continuous intravenous infusion (CII) of insulin is the preferred method of treating diabetic ketoacidosis (DKA) worldwide, especially in patients with severe DKA. There is limited evidence evaluating low-dose bolus intravenous (IV) insulin management of DKA out of the intensive care unit (ICU). To conduct an audit of patients admitted with DKA, who were managed with bolus IV insulin at the medical acute-care unit (MACU), Chris Hani Baragwanath Academic Hospital (CHBAH), Johannesburg, South Africa, over a 4-month period to evaluate whether this is an effective treatment modality, as well as assess patient, disease and management characteristics related to the admissions. A prospective cross-sectional cohort study was done, interviewing 69 DKA patients from 1 September to 31 December 2017, and collecting relevant biochemical results from their hospital records. The current management protocol at CHBAH was observed, i.e. insulin therapy administered hourly as 10 IU IV insulin. The time to resolution of DKA, complications and deaths were recorded. Our cohort was predominantly male (60.56%), with an average age of 36 years. All patients were successfully treated with bolus IV insulin, with an average time to resolution of 21 hours. DKA was categorised as mild (19.72%), moderate (50.7%) and severe (29.58). Most patients presented with raised inflammatory markers (64.79%) and some degree of renal impairment (>60%). Complications occurred in 9 patients (12.68%); 7 of these were related to factors precipitating the DKA admission. No deaths occurred. The only factor predicting a longer time to resolution was severity, with an odds ratio of 4.89 (confidence interval 1.04 -22.84; p=0.044). Outcomes are favourable, with bolus IV insulin being used as the treatment modality in patients with mild, moderate and severe DKA at CHBAH. Further studies are needed to corroborate these results in other centres.

SGLT Inhibitors for Type 1 Diabetes: Proceed With Extreme Caution.

Intensive insulin management is currently the only option for effective treatment of type 1 diabetes. Recent data from the T1D Exchange (T1DX) registry (1), which comprises leading U.S. diabetes treatment centers, show that despite the widespread availability of insulin analogs and increasing use of insulin pumps and continuous glucose monitoring systems, only about 20% of adult patients achieve the A1C target of <7% (53 mmol/mol) recommended by the American Diabetes Association (2). It is reasonable to assume that glycemic control of patients receiving care outside of major centers might be even worse. The T1DX registry has also shown that nearly 5% of adult participants experienced one or more episodes of diabetic ketoacidosis (DKA) within the past 12 months (3), and the Centers for Disease Control and Prevention recently reported a 6.3% annual increase in hospitalization rates for DKA from 2009 to 2014, with highest rates in persons aged <45 years (4). Moreover, the majority of patients are either overweight or obese, potentially increasing their risk of cardiovascular disease (1). There is clearly an unmet need for noninsulin adjunctive therapies that improve glycemic control without increasing the risk of hypoglycemia or contributing to weight gain, and it is noteworthy that among nearly 50,000 pediatric and adult participants in the T1DX registry in the U.S. and the Prospective Diabetes Follow-up (DPV) registry in Germany and Austria, two large consortia of diabetes centers, adjuvant medications are being used off-label by 5.4% of participants in T1DX and 1.6% in DPV (5). Sodium–glucose cotransporter 2 (SGLT2) inhibitors block the SGLT2 transporter in the proximal renal tubule resulting in glucosuria and natriuresis and are approved and indicated for type 2 diabetes. Dual SGLT1+2 inhibitors have the additional effect of inhibiting SGLT1 in the gastrointestinal tract, thereby delaying intestinal absorption of glucose and galactose. Owing to …

Management of hyperglycaemia in persons with non-insulin-dependent type 2 diabetes mellitus who are started on systemic glucocorticoid therapy: a systematic review

ObjectivesWhat is the most effective pharmacological intervention for glycaemic control in known type 2 diabetes mellitus (DM) without prior insulin treatment and newly started on systemic glucocorticoid therapy?DesignWe conducted a...

INVESTIGATING THE PERFORMANCE OF ELECTROMAGNETIC PUMP FABRICATED USING TOOL BASED MICROMACHINING SETUP FOR MICRODELIVERY OF FLUID

Micropumps play an important role in the delivery of insulin, hormonal and pain management for biomedical application. The main reason for the micropump is to pump a small amount of fluid to the target area and also control the pumping fluid. Electromagnetically operated pump fabricated using tool-based micromachining setup for the micro-delivery of the fluid. The electromagnetic pump was supplied with an input voltage of 6V-12V and at different frequencies starting from 1Hz to 5Hz with the increment of 1Hz. The maximum head developed is at a frequency of 3Hz which the optimum frequency for this configuration of an electromagnetic pump is. The maximum head obtained at this optimal frequency is 25mm. Finally, in order to measure the flow rate of the electromagnetic pump the pump was actuated at 3Hz frequency alone by varying the head of the micropump from 4 to 20mm.

SUN-153 Patterns and Predictors of Peri-Operative Glycemic Control in Ambulatory Surgery: An Academic Single Center Experience

Introduction: Peri-operative glucose control improves patient outcomes. Most of the evidence for this stems from cardiac surgery where insulin management protocols are well developed. Guidelines for peri-operative insulin management in the ambulatory setting are fraught with significant variation in recommendations. Our study analyzes patterns of peri-operative insulin adjustment at our institution and attempts to identify predictors of hypo- and hyperglycemia. Methods: We identified patients with any form of diabetes on basal insulin, who underwent elective non-cardiac surgery over a 5 months period at our institution. Data regarding demographics, baseline diabetes control, peri-operative insulin changes, fingerstick glucose values on day of surgery and complications were abstracted through a chart review supplemented by a patient phone call. Primary outcome was glycemic control on day of surgery and secondary outcomes was self-reported complications postoperatively. Results:A total of 100 patients were included. Fasting hyperglycemia (Fingerstick glucose >140mg/dL) was noted in 42% of patients on day of surgery. Younger age (p=0.04) and longer duration of surgery (p=0.01) were found to predispose patients to hyperglycemia. Glycemic outcomes were also studied based on timing of basal dose, total daily insulin dose and pre-operative dose adjustment. The majority of patients who took an evening dose made no adjustments (73%) while those with morning dose typically held their dose on the day of surgery (77%). We found no statistically significant difference in risk of hypoglycemia or hyperglycemia attributable to pre-operative insulin adjustment. Severe fasting hyperglycemia (Fingerstick glucose >250mg/dL) was noted in 10% of patients, of which 50% required inpatient admission for glycemic management. The majority of the patients who had severe hyperglycemia had a hemoglobin A1c of more than 8.4%. Fasting hypoglycemia (Fingerstick glucose <70 mg/dL ) was noted in three patients in setting of no dose change and prolonged fasting. Discussion: Although multiple guidelines exist for pre-operative insulin adjustment, there is no unified clinical practice. Our study identified factors such as young age and long duration of surgery that should be considered when developing a peri-operative insulin plan as they could lead to hyperglycemia. Also, patients with hemoglobin A1c >8.4% could benefit from stricter control to minimize risk of severe hyperglycemia. Coordinated team efforts between endocrinology and anesthesiology during pre-surgical evaluations can benefit patients.

SUN-276 Acute Pancreatitis and Diabetic Ketoacidosis in an 8-Year-Old Following Induction Therapy for Pre-B Acute Lymphocytic Leukemia

Introduction Peg-Asparaginase and Dexamethasone are both used in the induction therapy for pre-B Acute Lymphocytic Leukemia (ALL) and have overlapping adverse effects. Peg-Asparaginase is an enzyme that causes depletion of asparagine which is an essential amino acid for leukemia cells. Dexamethasone is a long-acting glucocorticoid with a 30-fold increase in anti-inflammatory activity relative to Hydrocortisone. Hyperglycemia and acute pancreatitis are both adverse reactions of Peg-asparaginase and glucocorticoids. Clinical case An 8-year-old male with obesity presented with acute pancreatitis and diabetic ketoacidosis (DKA) following induction therapy for pre-B ALL. The patient was euglycemic at the time of diagnosis. On day 1 induction chemotherapy was administered which included IV vincristine, IT cytarabine and PO dexamethasone (4 mg BID daily). On day 2, patient developed hyperglycemia (167 mg/dL). On day 4 he received IV Peg-Asparaginase (3,800 IU). On day 8 patient returned with back pain, fatigue, polydipsia, polyuria, and Kussmaul breathing. Labs revealed hyperglycemia (1,118 mg/dL), metabolic acidosis with an elevated anion gap (pH 7.14, pCO2 < 17 mmHg, HCO3 4.6 mmol/L, anion gap 36), elevated lipase (2,256 IU/L), mild transaminitis, and elevated creatinine and BUN. Pancreatic ultrasound was consistent with pancreatitis. The patient was admitted to the pediatric ICU for insulin drip and management of pancreatitis. On day 10 he was transitioned to SQ glargine insulin. Chemotherapy was restarted with dexamethasone and vincristine. Patient had persistent hyperglycemia requiring lispro insulin to cover meals and to correct hyperglycemia. His glucose normalized on this treatment and insulin was tapered down to be discontinued 9 days after initially started. His HbA1c was 7.5% (normal <5.6%) and he had negative T1DM-related antibodies. A CT of the abdomen showed pancreatic inflammation but no fluid collection or necrosis. At the time of discharge, patient was euglycemic. In the following months, in the absence of glucocorticoids and asparaginase, the patient had multiple admissions for recurrent pancreatitis with development of a pseudocyst. No further episodes of hyperglycemia were documented. Conclusion DKA can develop as side effect of treatment with Peg-Asparaginase and glucocorticoids. Patients treated with these medications need to be closely monitored to identify and treat hyperglycemia and pancreatitis as early as it develops.

SUN-LB033 New Onset Diabetes in a Post-Renal Transplant Pediatric Patient with a Mutation of the Hepatocyte Nuclear Factor-1β Gene

Background: Maturity onset diabetes of the young (MODY) 5 is a rare type of dominantly inherited diabetes mellitus (DM). It is caused by mutations of the hepatocyte nuclear factor-1beta (HNF-1 beta) gene. Most are missense mutations that produce truncated proteins resulting in a variable clinical spectrum that may include kidney, genital and pancreatic abnormalities. We describe a case of a young patient diagnosed with DM after renal transplant; also, his diagnosis disclosed extensive family history of DM. Case: Six-year-old African-American patient with history of end stage renal disease due to bilateral cystic dysplasia presented with significant hyperglycemia three days after renal transplant. Polycystic kidney disease observed in prenatal ultrasound led to genetic testing. He was found to have a 1.0-1.8Mb deletion on chromosome microarray at 17q12 that included TCF2/HNF1B genes. His HbA1C was 5.8% at time of endocrine evaluation. He received one time high dose steroids in operating room and was started on tacrolimus after transplant. Pancreatic ultrasound showed normal pancreatic head, body not visualized. He was sent home with intensive insulin management on day 20 after renal transplant. Patient’s family history revealed mother with diagnosis of type 2 diabetes mellitus (T2DM) at age 19, maternal grandmother and great-grandmother diagnosed at early age with T2DM as well. Discussion: HNF-1 beta gene encodes a transcription factor that regulates nephron and embryonic pancreas development. MODY 5 is clinically heterogeneous disorder and the degree of insulin deficiency is variable, some family members who carry the gene remain free of diabetes into later adult life. The mean age of diagnosis of DM is 26 years with a range of 10–61 years. Our patient is only six years old and he may have presented earlier due post-transplant status, high dose steroids and tacrolimus use, all factors known to be triggers for hyperglycemia but the persistence of insulin requirement and levels of HbA1C being on pre-diabetes range at time of evaluation might be a sign of early deterioration of pancreatic function. Diagnosis of MODY5 has important implications for treatment, prognosis, and genetic counseling. Diabetes in these patients requires early use of insulin. Patient’s family members were advised to undergo genetic testing and screening for renal abnormalities and DM. Further studies on the correlation of phenotypes and genotypes will help delineate the clinical course of MODY 5. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. s presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.

Digital health technology and mobile devices for the management of diabetes mellitus: state of the art.

Diabetes mellitus is a disease that can be difficult to manage and requires high levels of health literacy and numeracy, self-monitoring and frequent contact with clinicians. If not optimally controlled, diabetes can lead to kidney failure, blindness and cardiovascular complications, which, in turn, contribute to increasing healthcare costs. Although not yet widely used, mobile health (mHealth) tools have enhanced diabetes management and prevention and are likely to play an increasing role with the growth of smartphone ownership and medical device innovations. Recent mHealth interventions targeting type 1 and type 2 diabetes are diverse in their goals and components, and include insulin management applications, wearable blood glucose meters, automated text messages, health diaries and virtual health coaching. In this paper, we review the modalities and components of various impactful interventions for insulin management, diabetes education, self-management and prevention. More work is needed to investigate how individual demographic, socioeconomic, behavioural and clinical characteristics contribute to patient engagement and the efficacy of mHealth tools for diabetes.

Comparison of Metformin with Insulin in the Management of Gestational Diabetes

Objective: Purpose of this study is to determine the efficacy of metformin as opposed to insulin in management of gestational diabetes mellitus. Methodology: The study took place in department of Gynecology and Obstetrics, Nishtar Hospital,Multan from May 2017 to March 2019. Study design is experimental prospective comparative study. Ethical approval was obtained from Hospital Ethics Committee. Sample was calculated using non probability consecutive sampling technique. Total 770 Patients were randomly divided into two equal groups, group M (metformin) and Group I (insulin). Glycemic control, mode of delivery and associated medical complication were recognized as possible maternal outcomes while congenital anomalies (if any), macrosomia, hypoglycemia, hyperbilirubinemia were the neonatal outcomes assessed by clinical and laboratory investigations. These outcomes were subjected to statistical analysis by using computer software SPSS version 23. Percentages were calculated for dichotomous variables and range, mean and standard deviation was calculated for continuous data. Chi square and t-test were applied to compare the two groups. P value less than 0.05 was considered as significant. Results: Overall 100% (n=770) female patients were included, in this study; divided into two equal groups 50% (n=385) in each i.e. metformin (Group M) and insulin (Group I). Significant difference was found between age (p=0.000), gravidity (p=0.012), gestational age (p=0.000), BMI in early pregnancy (p=0.000), FBS at entry (p=0.000), FBS after treatment (p=0.000), HBA1c at entry (p=0.000), HBA1c after treatment (p=0.000), in groups. Association was found between Preeclampsia (p=0.000), Pre-term birth (p=0.000), Neonatal birth weight>4 (p=0.002), neonatal hypoglycemia (p=0.000), in groups. Conclusion: This study concludes that metformin is as much effective as insulin in management of gestational diabetes mellitus. Metformin when used securely can prove effective as it does not cause any congenital anomalies or maternal or neonatal complications. But insulin still remains the gold standard for treatment of gestational diabetes mellitus. Keywords: Diabetes Mellitus, Gestational Diabetes, Metformin, Insulin, Pregnancy DOI : 10.7176/JMPB/54-11 Publication date : April 30 th 2019

Access to insulin: applying the concept of security of supply to medicines.

Security of supply of medicines is fundamental to ensure health for all. Furthermore, improving access to medicines is included in sustainable development goal 3. However, the concept of security of supply has mostly been applied to food, water and energy. Diversity of supply, vulnerability to disruption, expenditure, infrastructure, stability of exporting countries, ownership of production, price stability, access and equity, affordability, intellectual property, safety and reliability of supply, and countries’ capacity to adapt to market changes are all elements of security of supply. Based on these elements, we assessed security of supply for insulin, since access to insulin is a global problem. We found that three multinational companies, in Denmark, France and Germany, control 99% of the value of the global insulin market. Prices and affordability of insulin and access to it vary considerably between countries. Some countries are vulnerable to insulin shortage because they import insulin from only one source. Many countries spend large amounts of money on insulin and costs are increasing. Some countries lack an adequate infrastructure for procurement, supply chain management and distribution of insulin. Applying the security of supply concept to insulin showed that diversification of suppliers needs to be fostered. Global health actors should adopt a security of supply approach to identify medicines that are susceptible to supply issues and address this concern by strategic promotion of local production, strengthening regulatory harmonization, and adding local products to the World Health Organization’s programme on prequalification of medicines.

Insulclock: A Novel Insulin Delivery Optimization and Tracking System.

Achieving and maintaining controlled glycemic levels are challenging in people with insulin-treated diabetes mellitus, suboptimal insulin injections being the main obstacle to treatment success. This research article presents the main functionalities and performance tests on Insulclock®, an electronic device plugged into insulin pens and connected with a smartphone app to improve insulin management. Insulclock tracks the date, time of day, dose, type of insulin, temperature, and duration of insulin injections. Information is stored in the device memory and is available for analysis by patients and health care providers. Insulclock device also has a reminder system with visual and acoustic alerts to reduce insulin omissions and mistiming. The main performance tests reveal that Insulclock can detect seven types of insulin pens with a 97% correct classification rate. Among 556 injections, most of the doses were accurately detected (deviation = 0), with relative errors ranging from 3% to 7% across different dosages. The duration of injections recorded by this device strongly correlated with that detected by an external chronometer (R2 = 0.99, root-mean-square deviation [RMSD] = 0.39). Moreover, the precision of the temperature sensor was evidenced by high correlation of temperatures detected by Insulclock and by an external thermometer (Pearson's R2 = 0.90, RMSD = 0.45). Insulclock is a novel device capable of tracking dosing, timing, and missing insulin injections. The promising capabilities it offers for diabetes mellitus self-management may help health care providers, researchers, and insulin users avoid frequent errors in insulin administration.

Technology to overcome clinical inertia in insulin therapy

The evidence that lowering of blood glucose concentrations in diabetes can reduce risk of complications is well established; however, many people with type 2 diabetes do not reach recommended glycaemic targets. 1 Selvin E Parrinello CM Daya N Bergenstal RM Trends in insulin use and diabetes control in the U.S.: 1988–1994 and 1999–2012. Diabetes Care. 2016; 39: e33-e35 Crossref PubMed Scopus (72) Google Scholar Type 2 diabetes is typically a progressive disease with stepwise increases in blood glucose-lowering therapy needed to achieve and maintain glucose targets. Data from many health-care systems show that delays occur in intensifying therapies in those who do not to reach glycaemic targets. 2 Khunti K Millar-Jones D Clinical inertia to insulin initiation and intensification in the UK: a focused literature review. Prim Care Diabetes. 2017; 11: 3-12 Summary Full Text Full Text PDF PubMed Scopus (132) Google Scholar , 3 Harris S Yale JF Dempsey E Gerstein H Can family physicians help patients initiate basal insulin therapy successfully?: randomized trial of patient-titrated insulin glargine compared with standard oral therapy: lessons for family practice from the Canadian INSIGHT trial. Can Fam Physician. 2008; 54: 550-558 PubMed Google Scholar As a consequence, many people with diabetes spend years with poor glycaemic control. Automated insulin dosing guidance to optimise insulin management in patients with type 2 diabetes: a multicentre, randomised controlled trialThe combination of automated insulin titration guidance with support from health-care professionals offers superior glycaemic control compared with support from health-care professionals alone. Such a solution facilitated safe and effective insulin titration in a large group of patients with type 2 diabetes, and now needs to be evaluated across large health-care systems to confirm these findings and study cost-effectiveness. Full-Text PDF

Automated insulin dosing guidance to optimise insulin management in patients with type 2 diabetes: a multicentre, randomised controlled trial

Insulin therapy is most effective if dosage titrations are done regularly and frequently, which is seldom practical for most clinicians, resulting in an insulin titration gap. The d-Nav Insulin Guidance System (Hygieia, Livonia, MI, USA) is a handheld device that is used to measure glucose, determine glucose patterns, and automatically determine the appropriate next insulin dose. We aimed to determine whether the combination of the d-Nav device and health-care professional support is superior to health-care professional support alone. In this multicentre, randomised, controlled study, we recruited patients from three diabetes centres in the USA (in Detroit MI; Minneapolis, MN; and Des Moines IA). Patients were eligible if they were aged 21-70 years, diagnosed with type 2 diabetes with a glycated haemoglobin (HbA1c) concentration of 7·5% or higher (≥58 mmol/mol) and 11% or lower (≤97 mmol/mol), and had been using the same insulin regimen for the previous 3 months. Exclusion criteria included body-mass index of 45 kg/m2 or higher; severe cardiac, hepatic, or renal impairment; and more than two severe hypoglycaemic events in the past year. Eligible participants were randomly assigned (1:1), with randomisation blocked within each site, to either d-Nav and health-care professional support (intervention group) or health-care professional support alone (control group). Both groups were contacted seven times (three face-to-face and four phone visits) during 6 months of follow-up. The primary objective was to compare average change in HbA1c from baseline to 6 months. Safety was assessed by the frequency of hypoglycaemic events. The primary objective and safety were assessed in the intention-to-treat population. We used Student's t test to assess the primary outcome for statistical significance. This study was registered with ClinicalTrials.gov, number NCT02424500. Between Feb 2, 2015, and March 17, 2017, 236 patients were screened for eligibility, of whom 181 (77%) were enrolled and randomly assigned to the intervention (n=93) and control (n=88) groups. At baseline, mean HbA1c was 8·7% (SD 0·8; 72 mmol/mol [SD 8·8]) in the intervention group and 8·5% (SD 0·8; 69 mmol/mol [SD 8·8]) in the control group. The mean decrease in HbA1c from baseline to 6 months was 1·0% (SD 1·0; 11 mmol/mol [SD 11]) in the intervention group, and 0·3% (SD 0·9; 3·3 mmol/mol [9·9]) in the control group (p<0·0001). The frequency of hypoglycaemic events per month was similar between the groups (0·29 events per month [SD 0·48] in the intervention group vs 0·29 [SD 1·12] in the control group; p=0·96). The combination of automated insulin titration guidance with support from health-care professionals offers superior glycaemic control compared with support from health-care professionals alone. Such a solution facilitated safe and effective insulin titration in a large group of patients with type 2 diabetes, and now needs to be evaluated across large health-care systems to confirm these findings and study cost-effectiveness. US National Institutes of Health, National Institute of Digestive and Kidney Diseases.

Long-acting insulin management for blood glucose prediction models

Long-acting insulin management for blood glucose prediction models

Relationship between depression, sleep quality, and hypoglycemia among persons with type 2 diabetes

ObjectiveWe analyzed two cohorts of people with type 2 diabetes to evaluate the relationships between depression, sleep quality, and history of hypoglycemia. Research design and methodsTwo adult cohorts from Chicago (n = 193) and Bangkok, Thailand (n = 282) with type 2 diabetes completed questionnaires to assess sleep quality, depressive symptoms, and hypoglycemia frequency. Proportional odds logistic regression models for each cohort adjusted for duration of therapy, insulin and sulfonylurea management, and other factors. ResultsThose with hypoglycemia in both cohorts had a longer duration of diabetes, greater use of insulin, and worse sleep quality. The Chicago cohort used less sulfonylureas but had higher depressive symptom scores. The Thailand cohort had greater sulfonylurea use. In the final Thailand regression model, depressive symptoms were independently associated with hypoglycemia frequency. In both final Chicago and Thailand models, sleep quality was not associated with hypoglycemia frequency. ConclusionsIn the Thailand cohort, depressive symptoms were associated with hypoglycemia frequency.

A comparative study between topical insulin versus normal saline dressings in wound healing in diabetic foot ulcers

Introduction: Diabetic foot ulcer (DFU) is the most costly and devastating complication of diabetes mellitus, which affect 15% of diabetic patients during their lifetime. The purpose of this prospective study was to investigate the efficacy and safety of topical insulin in management of patients with diabetic foot ulcers. Materials and methodology: 74 patients were included in the study. 37 in the group A i.e. topical insulin dressing group & 37 in the group B i.e. normal saline dressing group. Initial wound debridement followed by wound measurements were done on day 1, 7 & 15. Reduction in wound area at end of day15 was compared. Results: There was statistically significant reduction in the area of ulcer at end of day 15 (p value

Exercise-induced hypoglycemia in type 1 diabetes: in-silico comparison between announced and unannounced strategies in closed-loop control

Abstract It is recommended that those with Type 1 Diabetes Mellitus participate in physical activity However, insulin management during and after exercise remains challenging for both patients and physicians. The artificial pancreas is a closed-loop system which aims to control blood glucose levels automatically however, with physical activity the system is unable achieve optimal glycemic control. In this work, two different strategies of announced and unannounced exercise are combined with a closed-loop algorithm to mitigate the risk of exercise-induced hypoglycemia caused by aerobic activity. In the announced strategy, patients must inform the system that they are planning to exercise, this allows the modification of various controller parameters and the suggestion of a controller calculated amount of carbohydrates before the onset of exercise. The unannounced strategy removes the need of exercise announcement and utilizes an algorithm to detect exercise and trigger a carbohydrate suggestion and changes to the controller parameters. Both strategies are evaluated in-silico using the UVa/Padova simulator, in a realistic scenario considering sessions of aerobic exercise with 60% of VO2max for a duration of 50 minutes. Results show that both strategies are able to reduce the occurrence of hypoglycemia events, with the unannounced strategy achieving better outcomes.

Insulin Requirements and Management in Trans-Catheter vs. Surgical Aortic Valve Replacement

Objective: Trans-catheter Aortic Valve Replacement/Aortic Valve Implantation (TAVR) are increasingly performed today. We compared insulin requirements between TAVR and Surgical Aortic Valve Replacement (SAVR) patients with and without diabetes mellitus (DM) to determine optimal glucose management strategies during the perioperative period (POP). Methods: Charts of consecutive patients undergoing aortic procedures were retrospectively reviewed for glucose ranges, insulin requirements and routes of insulin administration (subcutaneous vs. intravenous) for patients with and without DM to maintain BG < 180 mg/dl and compared between the surgical and trans-catheter groups. Results: Patients with SAVRs without DM and A1C < 6.5%, needed low dose insulin infusions and could be transitioned to subcutaneous insulin by 1.5 postoperative days. Patients with SAVR and DM had higher insulin requirements and were transitioned by 2.5 postoperative days. Patients with TAVR with no known DM did not need an insulin infusion in the perioperative period. Patients with TAVR with DM and an HbA1C < 6.5% did not require insulin infusions during the procedure but only postoperatively for short periods. Patients with DM and A1C ≥ 6.5%, required higher doses of insulin infusion and transitioned to subcutaneous insulin by postoperative day 1. Conclusions: TAVR patients have different insulin requirements compared to SAVRs (p < 0.05). This information helps build a glucose management algorithm for a procedure which is increasingly performed.