Insulin Management Research Articles

Patient Reported Outcomes (PRO) in a Study of Human Regular U-500 Insulin (U-500R) Delivered by Continuous Subcutaneous Insulin Infusion (CSII) or Multiple Daily Injections (MDI) in Patients with T2D

Persons with T2D treated with U-500R have shown improved glycemic control. This prospective analysis evaluated the impact on PRO of U-500R delivered by CSII (using an investigational Omnipod U-500TM Insulin Management System) or MDI (using a U-100 syringe). In this 26-week (week), open-label, parallel trial, 420 patients treated with >200 units/day of insulin for T2D were randomized to CSII (n=209) or MDI (n=211) treatment groups. The Treatment-Related Impact Measure for Diabetes (TRIM-D) and Diabetes Device (TRIM-DD) questionnaires were assessed at baseline, week 14, and week 26. Results are shown in Table 1. TRIM-D scores (overall score and all 5 domain scores) and TRIM-DD overall score in both groups improved significantly from baseline to week 26 (p<0.05). At week 26, change in baseline score for the CSII group was significantly higher than the MDI group in all TRIM-D measures (p<0.05). At week 26, there were no significant differences in the change from baseline score between the CSII and MDI groups in TRIM-DD overall or its domains. In summary, the U-500R CSII device scored significantly better than MDI in the perceived impact on diabetes treatment (TRIM-D) but not for diabetes device (TRIM-DD). PROs for diabetes treatment improved significantly from baseline to week 26 in patients treated with U-500R by either CSII or MDI. Disclosure X. Peng: Employee; Self; Eli Lilly and Company. J. Chen: None. L. Fan: Employee; Self; Eli Lilly and Company. L. Ilag: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. T.T. Ly: Employee; Self; Insulet Corporation. J. Johnson: Employee; Self; Eli Lilly and Company.

Pharmacokinetics and Pharmacodynamics of Human Regular U-500 Insulin (U-500R) Administered via Continuous Subcutaneous Insulin Infusion (CSII) vs. Subcutaneous Injection (SCI) in Adults with Type 2 Diabetes and High Insulin Requirements

There have been no euglycemic clamp studies on U-500R in obese patients with type 2 diabetes mellitus (T2DM) and high insulin requirements. This open-label, randomized, 2-way crossover, euglycemic clamp study (NCT02588950) evaluated PK/PD of U-500R administered by CSII (using an investigational Omnipod® U-500 Insulin Management System) compared to SCI (using a U-100 syringe), in adults with T2DM requiring >150 U/day of insulin. Subjects (N=11, mean BMI: 39.6 kg/m2, mean A1C: 10.2%) each received a 100 U dose via CSII [primed with a 12-hour (hour) U-500R basal infusion] and a single SCI, both followed by a 24 hour clamp. Serum insulin concentrations were corrected for endogenous insulin using C-peptide for both administration methods. Basal infusion values in CSII were adjusted with baseline and model corrections. Following SCI, using model corrected method, time of maximum observed drug concentration (tmax) was about 1.5 hour longer compared to CSII [LSmean ratio (90% CI): 1.46 (1.08, 1.97)]. There was no statistically significant difference between CSII and SCI in median tmax, areas under the curve [AUC(0-24), AUC(0-tlast)], and maximum concentration. There was no statistically significant difference between CSII and SCI in median time to maximum glucose infusion rate (GIR) [CSII: 7.2 hour; SCI: 8 hour], median time of 50% of maximum GIR before Rmax (tRmax50) [CSII: 2.85 hour; SCI: 3.59 hour], and median time to last GIR [CSII: 18.9 hour; SCI: 14.6 hour]. No severe hypoglycemia was reported. U-500R was well tolerated whether given by syringe or CSII. The PK/PD profiles and time action parameters were similar with both methods of administration. Disclosure X. Ma: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. R.P. Prescilla: None. S. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. H. Linnebjerg: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. L. Morrow: Stock/Shareholder; Self; ProSciento. Employee; Spouse/Partner; Eli Lilly and Company. J.A. Jackson: Other Relationship; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. J. Johnson: Employee; Self; Eli Lilly and Company. D. Leishman: Employee; Self; Eli Lilly and Company.

Reduced Rate of Acute Complications with Tubeless Insulin Pump Use—Data from 2,640 Patients in the German/Austrian DPV Registry

Little is known about the rates of acute complications when switching from MDI or traditional insulin pumps to tubeless insulin pump therapy. The German/Austrian Diabetes patients follow-up-registry (DPV) includes 2691 patients with type 1 (n=2640), type 2 (n=17) and LADA/other (n=34) diabetes types treated for 1.3±1.3 years with a tubeless insulin pump (Omnipod® Insulin Management System, Insulet Corp, Billerica, MA) since 2013. Patients with type 1 diabetes had a mean age of 12.3 year [IQR 9.6-15.0], diabetes duration 2.5 year [0.7-5.9], HbA1c 7.7% [6.8-8.3]. The prior treatment modality was 59.3% MDI, 37.5% other pump and 2.4% tubeless pump as initial therapy (0.3% unknown). Discontinuation of tubeless pump treatment in patients with type 1 diabetes was 7.3% and occurred after 0.7±0.9 mo. Despite the typical age-dependent increase in HbA1c in this primarily adolescent population, the rate of severe hypoglycemia (Level 3), hypoglycemic coma and DKA decreased between 29% to 76% with Omnipod System use compared to the year prior to treatment switch in the total cohort and type 1 patients with 3 year follow-up (n=835) (Table). In conclusion, analysis of the DPV registry shows that use of the Omnipod System has high treatment retention rates in type 1 diabetes and is associated with low rates of severe hypoglycemia and DKA in this age-group prone to acute complications.Three Year Outcomes with Omnipod System UseVariable (mean)Total CohortPatients with 3 yr Follow-upPost-OmnipodPost-OmnipodPre-Omnipod (prior year)1 yr (n=2167)2 yr (n=1351)3 yr (n=848)Pre-Omnipod (prior year)1 yr (n=835)2 yr (n=835)3 yr (n=835)Age, yr13.914.714.414.611.512.413.514.4BMI-SDS0.440.540.560.600.430.500.550.61Insulin dose, U/kg/d0.820.760.790.820.790.770.790.83HbA1c, %7.697.597.857.947.557.497.817.97Severe hypoglycemia (Level 3) patients affected per year, %5.25.54.33.75.77.24.73.6Severe hypoglycemia (coma) patients affected per year, %1.51.41.00.51.71.81.40.4DKA patients affected per year, %5.83.33.02.16.63.63.02.2 Disclosure T. Biester: Speaker's Bureau; Self; Medtronic, Ypsomed AG. T. Danne: Speaker's Bureau; Self; A. Menarini Diagnostics. Advisory Panel; Self; Abbott, AstraZeneca, Bayer AG, Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Dexcom, Inc.. Research Support; Self; Eli Lilly and Company. Stock/Shareholder; Self; DreaMed Diabetes, Ltd.. Research Support; Self; Insulet Corporation. Speaker's Bureau; Self; Menarini Group. E. Bollow: None. A. Schwandt: None. B. Heidtmann: None. B. Rami-Merhar: Speaker's Bureau; Self; A. Menarini Diagnostics, Eli Lilly and Company, Medtronic MiniMed, Inc., Roche Diabetes Care Health and Digital Solutions. T. Haak: Speaker's Bureau; Self; Abbott. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions, Sanofi, Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company, AstraZeneca. R.W. Holl: None.

Implementation of a Perioperative Insulin Protocol in an Advanced Practice Provider (APP)–Led Limb Salvage Hospitalist Team

We implemented a standardized perioperative insulin management protocol (PIP) for patients with hyperglycemia and acute diabetic foot problems. Our multidisciplinary quality improvement (QI) project retrospectively compared outcomes in the APP-led hospitalist team (TU) using the PIP vs. other hospitalist teams (OT) managing similar patients. We chose glargine U100 as the basal insulin to simplify preoperative dose adjustments. There were no statistical differences in either arm with respect to mean age (53-57 years), female distribution (26-27%), mean weight (85-94 kg) and race/ethnicity (Hispanic 52-62%, Black 34-21% and non-Hispanic white 11-17%). Patients in TU (n=44) and OT (n=42) were started on basal/bolus insulin 80 v 74% of the time, respectively. Initial basal insulin doses (units) were similar (24 ± 12 v 26 ± 24), while initial prandial insulin amounts were higher in TU than OT (21 ± 10 v 13 ± 12; p<0.01), respectively. Use of insulin types were consistent with PIP protocol and hospital formulary guidelines, with TU using glargine and aspart in 89% and 82% of patients, while OT used NPH and Regular in 69% and 76% of patients, respectively. Mean admission A1C (9.1±2.3 v 9.2±2.2 %) and capillary blood glucose (CBG in mg/dl) (239±117 v 257±123) were similar for TU and OT. Mean CBG during hospitalization was lower for TU (163 ± 31 v 187 ± 44; p<0.01). Pre-op (145 ± 49 v 153 ± 50; p=0.48) and immediately post-op (153 ± 74 v 162 ± 81; p=0.59) CBGs were similar for TU and OT, respectively. Hypoglycemia (CBG<70) occurred in 32% of TU and 19% of OT (p=0.18) with only one CBG<50 recorded in each arm. There were no differences in ER visits or readmissions within 30 days of discharge; there was a trend for shorter hospital LOS in TU (14±8 v 18±9 days; p=0.08). A standardized PIP improved perioperative glycemic control without increasing hypoglycemia risk. Wider implementation of this protocol through incorporation into electronic order sets will be the next step in our QI initiative. Disclosure K. Odedosu: None. K.K. OConnell: None. M.C. Jordan: Employee; Spouse/Partner; Accenture. U. Gunasekaran: None. P.E. Fox: None. J.N. McNulty: None. S. Harder: None. L. Meneghini: Advisory Panel; Self; Novo Nordisk Inc., Sanofi US. Consultant; Self; Sanofi US, Novo Nordisk Inc.. Advisory Panel; Self; Intarcia Therapeutics, Inc.. Other Relationship; Self; American Diabetes Association.

Human Regular U-500 Insulin via Continuous Subcutaneous Insulin Infusion vs. Multiple Daily Injections in Adults with T2D—The VIVID Study, Primary Population

VIVID is the first prospective, randomized controlled trial to assess efficacy and safety of U-500R (Humulin® R U-500) administered by CSII (using an investigational Omnipod U-500™ Insulin Management System) vs. MDI (TID). This 26-week, open-label, multicenter, parallel study (NCT02561078) enrolled adults with T2D on 201-600 units of insulin/day with or without other antihyperglycemic agents. We report data for the primary population (N=340), excluding participants on concomitant GLP-1 RAs or SGLT2 inhibitors. Data for the all-randomized population are reported separately. Baseline characteristics were similar between arms. CSII showed noninferior A1C reduction vs. MDI (primary objective) and superior FPG reduction at 26 weeks with adjustment for multiplicity. CSII showed significantly greater A1C reduction at a lower total daily dose with no multiplicity adjustment. Clinically important hypoglycemia rates (<54 mg/dL) and weight gain were similar; severe and nocturnal (≤70 mg/dL) hypoglycemia rates were statistically higher for CSII vs. MDI (Table). In this population, U-500R via CSII had greater efficacy at a lower dose vs. MDI with higher hypoglycemia rates for some categories. CSII with U-500R may be a viable option for T2D patients on high-dose insulin. Individualized dose titration will be important to safely achieve A1C targets. Disclosure G. Grunberger: Research Support; Self; Medtronic MiniMed, Inc., Novo Nordisk Inc.. Speaker's Bureau; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi, Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Janssen Pharmaceuticals, Inc.. A. Bhargava: None. T.T. Ly: Employee; Self; Insulet Corporation. H. Zisser: Employee; Self; Verily Life Sciences LLC.. Stock/Shareholder; Self; Verily Life Sciences LLC. L. Ilag: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. J.K. Malone: Employee; Self; Eli Lilly and Company. S. Zhang: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. J. Johnson: Employee; Self; Eli Lilly and Company.

Long-Term Use of Omnipod® Insulin Management System Associated with Lower A1c in Adults with Established Diabetes and A1c =8%

Tubeless patch pumps may offer unique benefits enhancing long-term glycemic benefits seen in adults with diabetes starting continuous subcutaneous insulin infusion (CSII) therapy. We retrospectively evaluated adults with diabetes >6 months to assess changes in A1c and weight 1 year after initiating the Omnipod® Insulin Management System (Insulet Corp., Billerica, MA). Changes were assessed by baseline A1c category (<7.0%, 7.0-7.9%, 8.0-8.9%, and ≥9.0%) and then stratified by prior insulin regimen (MDI 65%, CSII 35%). At Omnipod initiation, 195 patients (39% male, 97% T1D) had (mean±SD) age 42±14 years and diabetes duration 21±14 years. Baseline A1c and weight were 7.9±1.3% and 175±36 lbs with no significant differences according to prior regimen. After 1 year, patients had 0.2% A1c reduction (p<.05) and non-significant weight change (+0.8 lb). Significant A1c reductions were noted in adults with baseline A1c ≥8% (A1c 8.0-8.9%: -0.3% (p<.05) and A1c ≥9.0%: -1.1% (p<.005). Modest to no increase in A1c was found in patients with baseline A1c <8% (A1c <7.0%: +0.2% (p<.05) and A1c 7.0-7.9% (p=NS). Weight did not change across all A1c categories. The Table shows changes in A1c by insulin regimen before Omnipod initiation. In adults with diabetes and A1c ≥8%, Omnipod initiation was associated with significantly lower A1c, most notably in those transitioning from MDI.Change in A1c 1 Year after Omnipod Initiation by Baseline A1c and Insulin RegimenBaseline A1c (%)n (MDI/CSII)MDI, Baseline A1c (%)MDI, ∆A1c (%)CSII, Baseline A1c (%)CSII, ∆A1c (%)<7.023/146.4±0.40.4†6.3±0.6-0.047.0-7.949/307.5±0.30.17.4±0.30.3*8.0-8.929/108.4±0.3-0.3*8.6±0.3-0.2≥9.025/1510.0±1.3-1.5†9.6±0.6-0.4†p<.005, *p<.05 Disclosure L.J. Tinsley: None. L.M. Laffel: Consultant; Self; Eli Lilly and Company, Novo Nordisk Inc., Sanofi US, MannKind Corporation, Roche Diagnostics Corporation, Dexcom, Inc., Insulet Corporation, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Johnson & Johnson Diabetes Institute, LLC.. Z. Guo: None. N. Naik: None. J.E. Layne: Employee; Self; Insulet Corporation. T.T. Ly: Employee; Self; Insulet Corporation. S.N. Mehta: None.

Glycemic Management in the Bariatric Surgery Population: A Review of the Literature

Obesity is a worldwide epidemic often complicated by multiple comorbidities, including type 2 diabetes mellitus (T2DM). Bariatric surgery is an increasingly common and effective weight-loss strategy for obese patients that may result in resolution of metabolic-related disease states, such as T2DM. Although bariatric surgery has many positive outcomes for patients, dietary and pathophysiologic changes can create difficult-to-control blood glucose, especially in the immediate perioperative setting. Depending on oral antidiabetic agent and insulin needs preoperatively, many patients require cessation of oral agents and reduction or cessation of insulin. Unfortunately, despite available perioperative bariatric surgery guidelines, no specific recommendations for perioperative oral antidiabetic agent or insulin management exist. The purpose of this article is to review the current body of evidence for blood glucose management in the setting of bariatric surgery. An English-language PubMed and MEDLINE search was conducted from 1964 through March 2018 using the following search terms alone and in various combinations: bariatric surgery, gastric banding, laparoscopic sleeve gastrectomy (LSG), Roux-en-Y gastric bypass (RYGB), glucose management, insulin, and oral antidiabetic agent. Five articles were identified evaluating insulin management in the perioperative bariatric surgery setting, which were separated into two categories: immediate perioperative insulin management and long-term postoperative insulin management. Overall, various blood glucose management insulin protocols were evaluated. All studies included some type of insulin reduction in the perioperative setting. No studies identified specifically evaluated down-titration or discontinuation of oral antidiabetic agents. Given the lack of specific guideline recommendations, limitations of standardized insulin protocols, and inconsistency of outcomes studied, perioperative insulin at reduced doses compared to previous maintenance doses coupled with frequent blood glucose monitoring is reasonable. An opportunity exists for successful protocols to be addressed in future, larger studies.

Perceptions of insulin use in type 2 diabetes in primary care: a thematic synthesis

BackgroundIncreasing numbers of patients with type 2 diabetes mellitus are progressing to insulin therapy, and despite its potency many such individuals still have suboptimal glycaemic control. Insulin initiation and intensification is now often conducted by Practice Nurses and General Practitioners in many parts of the UK. Therefore, gaining insight into perspectives of patients and primary care clinicians is important in determining self-management and engagement with insulin. A thematic synthesis of studies was conducted exploring the views and experiences of people with type 2 diabetes and of healthcare professionals on insulin use and management in the context of primary care.MethodsProtocol based systematic searches of electronic databases (CINAHL, Cochrane Library, EMBASE, MEDLINE, PsycINFO, and Web of Science) were performed on 1 October 2014 and updated on 31 March 2015, to identify studies that identified the views and experiences of adults with type 2 diabetes or primary care clinicians on the use of insulin in the management of type 2 diabetes. Studies meeting the review inclusion criteria were critically appraised using the CASP qualitative research checklist or Barley’s checklist for survey designs. A thematic synthesis was then conducted of the collected studies.ResultsThirty-four studies were selected. Of these, 12 used qualitative interviews (nine with patients and three with healthcare professionals) and 22 were survey based (14 with patients, three with healthcare professionals, and five with both). Twelve key themes were identified and formed three domains, patient perceptions, healthcare professional perceptions, and health professional-patient relationships. The patient-centred themes were: insulin-related beliefs, social influences, psychological factors, hypoglycaemia, and therapy barriers. The clinician-related themes were: insulin skills of general practitioners, healthcare integration, healthcare professional-perceived barriers, hypoglycaemia, and explanations for adherence. Healthcare professional-patient relationship themes were drawn from the perspectives of patients and from clinicians.ConclusionsThis review reveals multiple barriers to optimal insulin use in primary care at both the patient and healthcare professional levels. These barriers indicate the need for multimodal interventions to: improve the knowledge and competencies of primary care professionals in insulin use; provide more effective patient education and self-management support; and introduce integrated insulin support systems.

Assessment of Mitigation Methods to Reduce the Risk of Hypoglycemia for Announced Exercise in a Uni-hormonal Artificial Pancreas.

Moderate physical activity improves overall health conditions in subjects with type 1 diabetes. However, insulin management during and after exercise is challenging due to the effects of exercise on glycemic control. Artificial pancreas (AP) systems aim to automatically control blood glucose levels, but exercise-induced hypoglycemia is a major challenge for these systems, especially in uni-hormonal configurations. The aim of this work was to evaluate the ability of several feed-forward (FF) actions to prevent exercise-induced hypoglycemia in a closed-loop setting. A closed-loop control algorithm combined with FF actions aimed at eliminating exercise-induced hypoglycemia was evaluated in silico using the UVa/Padova type 1 diabetes simulator. The simulator was modified with an exercise model fitted to clinical data. The FF actions were evaluated in two scenarios: (1) exercise sessions during postprandial period and (2) exercise sessions during fasting period. The mitigation methods proposed in this work were able to minimize the occurrence of hypoglycemic events related with exercise in both scenarios. The time spent in hypoglycemic range in the 2-h period after exercise decreased from 33.3% to 0.0% (P < 0.01) and from 41.3% to 0.0% (P < 0.01) in both scenarios tested. Besides that, the occurrence of hypoglycemic events after exercise sessions was also reduced. The combination of the FF actions presented in this article within an AP system showed to be an effective strategy to mitigate the risk of hypoglycemia in front of aerobic exercise.

Abstract #310 Clinically Significant Hypoglycemia: Impact of the Guideline-Based Hypoglycemia Alert Level on Insulin Management in the Hospital

Abstract #310 Clinically Significant Hypoglycemia: Impact of the Guideline-Based Hypoglycemia Alert Level on Insulin Management in the Hospital

Type 1 Diabetes in Children and Adolescents.

Type 1 Diabetes in Children and Adolescents.

Advancing Patient Safety and Access to Concentrated Insulin (U-500 Regular Insulin) in the Veterans Health Administration: A Clinician Education Program in the Primary Care Setting.

IN BRIEF The national epidemic of diabetes and the exposure of Vietnam veterans to Agent Orange has led to insulin resistance requiring concentrated insulin (U-500 regular [U-500R] insulin) for glycemic control. Initiation of U-500R insulin is limited to endocrinology expertise housed at “hub” Veterans Health Administration locations hours away from smaller “spoke” facilities. To overcome potential health care disparities and improve patient safety, a program was developed ensuring that all clinicians could co-manage U-500R insulin. This program evaluation was undertaken to improve patient safety and access to U-500R insulin by improving spoke clinicians’ knowledge of safe delivery and management of U-500R insulin.

Impact of a Novel Insulin Management Service on Non-insulin Pharmaceutical Expenses.

BackgroundStudies have shown that improvements in glycemic control are associated with avoidance or delayed onset of diabetes complications, improvements in health-related quality of life, and reductions in diabetes-related health care costs. Clinical practice guidelines recommend maintaining a hemoglobin A1c (HbA1c) level less than 7%, but among type 2 diabetes patients using insulin, two-thirds have HbA1c above 7% and one-third have HbA1c above 9%.ObjectivesThis study examined the use of insulin management services to enable patients to optimize insulin dosing to achieve HbA1c targets and subsequently reduce health care costs. Cost savings may be achieved through reduced complications and hospitalizations, as well as reduced outpatient, physician, and clinic costs. This study quantified the reduction in pharmaceutical expenses related to the use of an enhanced insulin management service to improve glycemic control.MethodsTwo hundred seventeen insulin-reliant patients were enrolled in the d-Nav® Insulin Guidance Service through a participating insurance group. A prospective cost analysis was conducted using data from enrolled patients who completed the first 90 days of follow up.ResultsOf the 192 patients who completed the 90-day study period, 54 (28.13%) were prescribed one or more expensive medications at baseline, but 45 (83.33%) of those patients were eligible for medication discontinuation after 90 days. At baseline, the annual cost of expensive medications per patient was $7564 (CI: $5191–$9938) and $1483 (CI: −$1463–$4429) at 90 days (p<0.001). Direct savings from medication elimination was estimated to be $145 per patient per month (PPPM) or $1736 per patient per year (PPPY) for all patients and $514 PPPM/$6172 PPPY for the target group. Patients that completed the 90-day period significantly reduced HbA1c levels from 9.37% (CI:7.72%–11.03%) at baseline to 7.71% (CI: 6.70%–8.73%) (p<0.001). A total of 170 (88.54%) patients had improved HbA1c at 90 days.ConclusionsUse of the insulin guidance service achieved improved glycemic control by optimizing insulin dosing, which enabled most patients using the service to reduce or eliminate the use of expensive diabetes medications. Further study is needed to assess the impact of optimized insulin dosing on other diabetes-related health care costs in a usual practice setting.

Impact of a Novel Insulin Management Service on Non-insulin Pharmaceutical Expenses

Background: Studies have shown that improvements in glycemic control are associated with avoidance or delayed onset of diabetes complications, improvements in health-related quality of life, and reductions in diabetes-related health care costs. Clinical practice guidelines recommend maintaining a hemoglobin A1c (HbA1c) level less than 7%, but among type 2 diabetes patients using insulin, two-thirds have HbA1c above 7% and one-third have HbA1c above 9%. Objectives: This study examined the use of insulin management services to enable patients to optimize insulin dosing to achieve HbA1c targets and subsequently reduce health care costs. Cost savings may be achieved through reduced complications and hospitalizations, as well as reduced outpatient, physician, and clinic costs. This study quantified the reduction in pharmaceutical expenses related to the use of an enhanced insulin management service to improve glycemic control. Methods: Two hundred seventeen insulin-reliant patients were enrolled in the d-Nav® Insulin Guidance Service through a participating insurance group. A prospective cost analysis was conducted using data from enrolled patients who completed the first 90 days of follow up. Results: Of the 192 patients who completed the 90-day study period, 54 (28.13%) were prescribed one or more expensive medications at baseline, but 45 (83.33%) of those patients were eligible for medication discontinuation after 90 days. At baseline, the annual cost of expensive medications per patient was $7564 (CI: $5191-$9938) and $1483 (CI: -$1463-$4429) at 90 days (p&lt;0.001). Direct savings from medication elimination was estimated to be $145 per patient per month (PPPM) or $1736 per patient per year (PPPY) for all patients and $514 PPPM/$6172 PPPY for the target group. Patients that completed the 90-day period significantly reduced HbA1c levels from 9.37% (CI:7.72%-11.03%) at baseline to 7.71% (CI: 6.70%-8.73%) (p&lt;0.001). A total of 170 (88.54%) patients had improved HbA1c at 90 days. Conclusions: Use of the insulin guidance service achieved improved glycemic control by optimizing insulin dosing, which enabled most patients using the service to reduce or eliminate the use of expensive diabetes medications. Further study is needed to assess the impact of optimized insulin dosing on other diabetes related health care costs in a usual practice setting.

AADE Practice Paper in Brief: Diabetes Educators Play a Critical Role in Successful Insulin Management

AADE Practice Paper in Brief: Diabetes Educators Play a Critical Role in Successful Insulin Management

New Medications for the Treatment of Diabetes.

New Medications for the Treatment of Diabetes.

Disordered eating and insulin restriction in type 1 diabetes: A systematic review and testable model

ABSTRACTAim: To provide an overview of the existing literature pertaining to insulin restriction as a disordered eating behaviour in individuals with type 1 diabetes and present a novel maintenance model: The Transdiagnostic Model of Disordered Eating in Type 1 Diabetes.Method: A systematic review was conducted of the current literature relevant to insulin restriction and/or omission in the context of disordered eating in type 1 diabetes. A new maintenance model was then developed by incorporating diabetes-specific factors into existing eating disorder models.Results: Type 1 diabetes may complicate the development and maintenance of disordered eating behaviour. Diabetes-specific circumstances, including disease diagnosis, insulin management, insulin restriction, and diabetes-related complications, contribute to the maintenance of disordered eating cognitions and behaviours.Discussion: The proposed model offers a comprehensive representation of insulin restriction as a disordered eating behaviour in type 1 diabetes. Future research should test the model to further understand the mechanisms underlying disordered eating in type 1 diabetes and inform treatments for this at-risk population.

A new integrated care pathway for ambulance attended severe hypoglycaemia in the East of England: The Eastern Academic Health Science Network (EAHSN) model.

We developed a new clinical integrated pathway linking a regional Ambulance Trust with a severe hypoglycaemia (SH) prevention team. We present clinical data from the first 2000 emergency calls taken through this new clinical pathway in the East of England. SH patients attended by Ambulance crew receive written information on SH avoidance, and are contacted for further education through a new regional SH prevention team. All patients are contacted unless they actively decline. Median age (IQR) was 67 (50-80) years, 23.6% of calls were for patients over 80years old, and patients more than 90years old were more common than 20-25year olds in this population. Most calls were for patients (84.9%) who were insulin treated, even those over 80years (75%). One - third of patients attended after a call were unconscious on attendance. 5.6% of patients in this call population had 3 or more ambulance call outs, and they generated 17.6% of all calls. In total, 728 episodes (36.4%) were repeat calls. Insulin related events were clinically more severe than oral hypoglycaemic related events. Patients conveyed to hospitals (13.8%) were significantly older, with poorer recovery in biochemical hypoglycaemia after ambulance crew attendance. Only 19 (1%) opted out of further contact. Patients were contacted by the SH prevention team after a median 3 (0-6) days. The most common patient self - reported cause for their SH episode was related to perceived errors in insulin management (31.4%). This new clinical service is simple, acceptable to patients, and a translatable model for prevention of recurrent SH in this largely elderly insulin treated SH population.

Comparative assessment of the efficacy and safety of acarbose and metformin combined with premixed insulin in patients with type 2 diabetes mellitus.

This study, a subgroup analysis of the data from the Organization Program of DiabEtes INsulIN ManaGement study, aimed to compare the efficacy and safety profiles of acarbose and metformin used in combination with premixed insulin.This analysis included 80 and 192 patients taking only 1 oral antidiabetic drug, classified into acarbose (treated with acarbose + insulin) and metformin groups (treated with metformin + insulin), respectively. The efficacy and safety data were analyzed for within- and between-group differences. The clinical trial registry number was NCT01338376.The percentage of patients who achieved target hemoglobin A1c (HbA1c) <7% in the acarbose and metformin groups were 38.75% and 30.73%, respectively, after a 16-week treatment. The average HbA1c levels in the acarbose and metformin groups were comparable at baseline and decreased significantly in both groups at the end of the study. All 7 blood glucose decreased significantly in both groups at endpoint compared with that at baseline. Insulin consumption was higher in the metformin group in terms of total daily amount and units/kg body weight. Incidences of hypoglycemia were similar in both groups. Body weight changed significantly in both groups from baseline to endpoint, but with no significant difference between the groups. Mean scores of Morisky Medication Adherence Scale improved in both groups at endpoint.Combination of insulin with acarbose or metformin could improve glycemic control in patients with type 2 diabetes mellitus. Acarbose and metformin were found to be comparable in terms of efficacy, weight gain, and incidence of hypoglycemia.

Home-based insulin management in Dagaheley refugee camp, Kenya

This abstract corresponds with the following slides: https://f1000research.com/slides/6-689, presented at Medecins Sans Frontieres UK Scientific Days: Innovation 2017. To watch the presentation click here: https://f1000research.com/videos/6-807. This abstract is part of an F1000Research gateway that includes posters, slides and videos from the MSF Scientific Day: Innovation 2017. To see more please visit: https://f1000research.com/gateways/MSF/innovation.