Insulin-treated Adults Research Articles

Tirzepatide Improved Health-Related Quality of Life Compared with Insulin Lispro in Basal Insulin-Treated Adults with Type 2 Diabetes and Inadequate Glycaemic Control: A Randomised Controlled Phase 3b Trial (SURPASS-6).

Patients with type 2 diabetes (T2D) who require intensification of basal insulin therapy need treatment options that can improve their health-related quality of life (HRQoL) and translate into better outcomes. These analyses compared patient-reported outcomes (PROs) in patients with T2D receiving tirzepatide or insulin lispro. The randomised, open-label, multinational, phase 3b SURPASS-6 trial (NCT04537923) was conducted at 135 medical research centres and hospitals in 15 countries and compared two recommended treatment intensification strategies in people with T2D and inadequate glycaemic control on basal insulin: addition of once-weekly tirzepatide versus addition of prandial insulin lispro. Randomisation was stratified by country, baseline glycated haemoglobin level and metformin use. PROs were measured using the Short Form-36 Health Survey version 2 (SF-36v2) acute form (secondary outcome), EQ-5D-5L, Ability to Perform Physical Activities of Daily Living (APPADL) questionnaire and Impact of Weight on Self-Perceptions (IW-SP) questionnaire (tertiary/exploratory outcomes). PROs were compared for the tirzepatide-pooled dose group (5, 10 and 15 mg) and each tirzepatide dose group versus insulin lispro at 52 weeks using the modified intention-to-treat efficacy analysis set. Between 19 October 2020 and 01 November 2022, 2267 people were assessed and 1428 participants with T2D were randomised. At 52weeks, participants in the tirzepatide-pooled group had statistically significant improved scores across all SF-36v2 domains and both component summary scores compared with insulin lispro-treated participants (p < 0.05), with the largest differences observed in the general health, vitality and mental health domains. Statistically significant improved APPADL and IW-SP total scores, as well as EQ visual analogue scale and EQ-5D-5L index scores (after adjustment for baseline scores), were observed in tirzepatide-pooled participants compared with insulin lispro-treated participants. In adult patients with T2D and inadequate glycaemic control with basal insulin, tirzepatide treatment was associated with greater improvements in HRQoL than prandial insulin therapy in addition to clinically significant improvements in glycaemic and body weight-related parameters.

Trends in clinical characteristics, medication use, and glycemic control in insulin-treated patients with type 1 and type 2 diabetes in Finland in 2012-2019: Nationwide real-world evidence study.

To describe the clinical characteristics and medication purchases of insulin-treated adults in Finland at index (January 1, 2012 or first insulin purchase) and December 31, 2019. Additionally, to describe basal insulin (BI) treatment patterns and associated changes in hemoglobin A1c (HbA1c) values. In this descriptive study using nationwide registries, we included adults with at least two reimbursed insulin purchases within 12 months of the first purchase between January 1, 2012 and December 31, 2019. We formed four study groups: type 1 diabetes (T1D) and type 2 diabetes (T2D)-diagnosed people who were further divided into prevalent or naïve users (start of insulin use before or after January 1, 2012). Insulin treatment patterns were estimated from medication purchase data and glycemic control from HbA1c results. Out of 145 020 people included, 34 359 had T1D and 110 661 T2D. By 2019, in parallel with the adaptation of new noninsulin medications, second-generation basal insulin (BI) analogues were adopted by 45.9% and 21.1% of prevalent T1D and T2D users. At index, HbA1c target (≤53 mmol/mol) was reached by 17% and 35% of T2D naïve and prevalent users, respectively, and by 17% of T1D prevalent users. At study end, the target was reached respectively by 41%, 34%, and 22% of insulin users. Insulin initiation improved and discontinuation worsened glycemic control in T2D, with lesser effects seen after treatment gaps or switches between BIs. Our study showed that glycemic control in insulin users has remained stable or improved between 2012 and 2019 despite aging population and in parallel with introduction of new treatment options, providing valuable insight into Finnish national diabetes care.

Use of continuous glucose monitoring in insulin-treated older adults with type 2 diabetes

BackgroundFew studies have reported the adherence to and efficacy of continuous glucose monitoring (CGM) for improving diabetes management in insulin-treated older adults with type 2 diabetes mellitus (T2DM).MethodsProspective observational cohort study using FreeStyle Libre Flash CGM in insulin-treated adults > 65 years with T2DM and HbA1c between 7% and 9%. The participants wore the CGM during the 6-weeks study period. The primary outcome was time in range (TIR) between 70 and 180 mg/dL. Secondary outcomes included time below range (TBR), glycemic variability (GV), adherence, and use of glucose data for self-insulin adjustment. Linear regressions with random effects verified the changes in TBR, TIR, time above range (TAR), GV, and GMI across the three visits using CGM (baseline, 4 weeks and 6 weeks), controlled for sex, age, educational level, and health system (private or public).ResultsA total of 66 participants completed the six weeks of CGM (age 72·8 ± 5·3 years; BMI 27·8 ± 3·6 kg/m2), HbA1c: 8·0 ± 0·6%, with an overall sensor utilization of 93·1 ± 6·0%. We observed a stability in TIR (baseline: 63.5 ± 18.9% vs. endpoint: 65.5 ± 18.8%; β = 1,0, p = 0.190). Despite the low TBR at the baseline, we observed statistically significant reduction over the study period (baseline: 5.8 ± 7.0% vs. endpoint: 3.8 ± 4.7%; (β=-1.00, p = 0.008). Glucose variability also reduced from the baseline (34.9 ± 7.2%) to the endpoint (33.0 ± 6.8%) (β=-0.99, p = < 0.001).ConclusionFreeStyle Libre Flash CGM is well accepted by older adults with T2DM and allows participants to make therapeutic decisions to reduce TBR and glycemic variability.

Digital technology and healthcare delivery in insulin-treated adults with diabetes: a proposal for analysis of self-monitoring blood glucose patterns using a dedicated platform.

A remote platform for diabetes care (Roche Diabetes® Care Platform, RDCP) has been developed that allows combined face-to-face consultations and remote patient monitoring (RPM). A dedicated flowchart is proposed as a clinical approach to help healthcare professionals in the appropriate interpretation of structured self-monitoring blood glucose data, as visualized on the RDCP during the visits, and in the optimal management of patients using the integrated RDCP-RPM tools. The platform organizes patterns in different blocks: (i) hypoglycemia; (ii) hyperglycemia; (iii) blood glucose variability; (iv) treatment adherence, which identifies a possible individual pattern according to glycemic control challenges, potential causal factors, and behavioral type patterns. The flowchart proposed for use of the RDCP-RPM is self-explanatory and entails 3 steps: (1) evaluation of quality and quantity of self-monitoring blood glucose data; (2) pattern analysis; (3) personalized suggestions and therapy changes. The main aim of the remote treatment flowchart proposed is to support healthcare professionals in the identification of hypoglycemic and hyperglycemic patterns using the RDCP regardless of the HbA1c value and ongoing treatment, which however, become crucial in combination with pattern analysis in the therapeutical choice.

Comparison of Glycemia Risk Index with Time in Range for Assessing Glycemic Quality.

Background: The glycemia risk index (GRI) is a novel composite continuous glucose monitoring (CGM) metric that gives greater weight to hypoglycemia than to hyperglycemia and to extreme hypo/hyperglycemia over less extreme hypo/hyperglycemia. This study aimed at validating the effectiveness of GRI and at comparing it with time in range (TIR) in assessing glycemic quality in clinical practice. Methods: A total of 524 ninety-day CGM tracings of 194 insulin-treated adults with diabetes were included in the analysis. GRI was assessed according to standard metrics in ambulatory glucose profiles. Both cross-sectional and longitudinal analyses were performed to compare the GRI and TIR. Results: The GRI was strongly correlated not only with TIR (r = -0.974), but also with the coefficient of variation (r = 0.683). To identify whether the GRI differed by hypoglycemia even with a similar TIR, CGM tracings were grouped according to TIR (50% to <60%, 60% to <70%, 70% to <80%, and ≥80%). In each TIR group, the GRI increased as time below range (TBR)<70 mg/dL increased (P < 0.001 for all TIR groups). In longitudinal analysis, as TBR<70 mg/dL improved, the GRI improved significantly (P = 0.003) whereas TIR did not (P = 0.704). Both GRI and TIR improved as time above range (TAR)>180 mg/dL improved (P < 0.001 for both). The longitudinal change was easily identifiable on a GRI grid. Conclusions: The GRI is a useful tool for assessing glycemic quality in clinical practice and reflects hypoglycemia better than does TIR.

381-P: Studying the Impact of Nasal Glucagon on Real-Life Experiences of Severe Hypoglycemia Treatment (SIMPLEST)

Background: Severe hypoglycemia (SH) is feared by people with diabetes (PwD) and those who care for them due to its impact on everyday life. Studies have shown that ready-to-use nasal glucagon (NG) is preferred over reconstitutable injectable glucagon; however, real-life experiences that PwD and health care providers (HCPs) have with NG are unknown. Objective and Methods: A cross-sectional, web-based study was conducted in the US and Germany among: i) insulin-treated adults who owned NG for at least 2 months to assess impact of NG on everyday life, and ii) HCPs who prescribed NG within 6 months of study initiation to assess HCPs’ experiences with NG in meeting their patients’ needs. Data were analysed descriptively, and US results are presented. Results: Of 292 PwD (mean age 42, 47% T1D, 86% high fear of hypoglycemia total screener score, 37% impaired hypoglycemia awareness), 68% had been treated with NG. Over 90% agreed that NG had positively impacted quality of life (QoL) items (Figure). Of 71 HCPs (endocrinologists 87%), 90% were satisfied with NG meeting patients’ needs. Over 80% of HCPs were satisfied with training time on NG and confident with patient and caregiver’s ability to apply the training for a SH event. Conclusion: The positive impact of NG on QoL, less fear of hypoglycemia, and high confidence in caregiver’s ability to use NG may help improve PwD’s everyday life related to hypoglycemia management. Disclosure B.Mitchell: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. A.Ponce-ibarra: Employee; Lilly Deutschland GmbH, Stock/Shareholder; Eli Lilly and Company. E.Moennig: Employee; Lilly Deutschland GmbH, Stock/Shareholder; Eli Lilly and Company. S.Odak: Other Relationship; Eli Lilly and Company. D.J.Mcsorley: Other Relationship; Eli Lilly and Company, Sage Pharmaceuticals, Novavax, Bristol-Myers Squibb Company, Seattle Genetics, Inc., Boston Scientific Corporation, Blood Centers of America, Inc. E.Spaepen: Consultant; Eli Lilly and Company. L.Jackson: Other Relationship; Eli Lilly and Company. L.Zografos: Other Relationship; Eli Lilly and Company. Y.Yan: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company

960-P: Hemodialysis-Related Glycemic Patterns among People with Insulin-Treated Type 2 (T2D) Diabetes—Role of Continuous Glucose Monitoring (CGM)

Background: Hemodialysis (HD) impacts glucose and insulin metabolism and increases hypoglycaemia rates. Glucose-containing dialysate decreases the risk, but studies using CGM metrics are lacking. Methods: Prospective observational study of insulin-treated adults with T2D, receiving hemodialysis (dialysate glucose 100mg/dl), at least thrice weekly. Subjects were instructed to wear a Dexcom G6-Pro for 10 days. We assessed CGM metrics (mean glucose, %TIR, %TAR, %TBR, and hypoglycemic and hyperglycemic rates) during three time periods: 20-hours before (PreHD), during (HD, ~4 hours), and 20-hours after (PostHD) hemodialysis sessions. Results: Among 56 subjects (mean age 57.3±9, HbA1c 7.2±1.4), mean glucose, %TAR, %TIR and rates of hypoglycaemia &amp;lt;70mg/dl were significantly better during HD. %TAR &amp;gt;180mg/dl and &amp;gt; 250mg/dl were significantly higher after HD, see Table 1. Other hypoglycaemia metrics were overall low, and not different in relation to HD timing. Conclusion: CGM patterns demonstrated improved glycemic control during dialysis, with tendency for higher glucose metrics before HD. Hypoglycaemia metrics were low, while severe hyperglycemia excursions are common across all HD-related periods. Future studies using newer CGM technology and providing longer duration of CGM monitoring are needed for subjects with T2D treated by HD. Disclosure R.J.Galindo: Consultant; Novo Nordisk, Eli Lilly and Company, Sanofi, Pfizer Inc., Bayer Inc., WW (Weight Watchers), Research Support; Novo Nordisk, Eli Lilly and Company, Dexcom, Inc. B.Moazzami: None. A.Y.G.Gerges: None. L.Peng: None. K.R.Tuttle: Consultant; Lilly, AstraZeneca, Gilead Sciences, Inc., Research Support; Bayer Inc., Boehringer Ingelheim (Canada) Ltd., Novo Nordisk, Goldfinch Bio, Inc., Traveere Pharmaceuticals. G.Umpierrez: Research Support; Abbott, Dexcom, Inc., Baxter.

704-P: Time in Range and Time Below Range in Insulin-Treated Older Adults with Type 2 Diabetes

Hypoglycemia is the key limiting step for optimizing glycemic control in older adults. Continuous glucose monitoring (CGM) technology has not been well-evaluated in insulin treated older patients with type 2 diabetes (T2D) . Methods: This prospective observational cohort study assessed of glycemic control using the FreeStyle Libre Flash CGM in insulin treated older adult patients with T2D. Subjects &amp;gt;65 years with T2DM on insulin therapy and HbA1c between 7% and 9%, with or without oral agents, were identified from a public hospital and a private diabetes clinic and invited by phone to participate (n= 462) . Patients treated with GLP1 agonists; eGFR &amp;lt;30 ml/min; Hb &amp;lt;11g/dL; ALT&amp;gt; 3x ULN; glucocorticoid use in the previous 3 months, and active malignancy were excluded. Participants worn the CGM continuously during a 6-weeks study period. They returned to clinic every 2 weeks for CGM data downloaded and new CGM placement, assessment of glycemic control and hypoglycemia. The investigators adjusted insulin treatment at each visit as needed. The first 2 weeks of CGM was considered baseline point and the last 2 weeks was the endpoint. The differences on time in range (TIR 70-180, mg/dl) and time below range (TBR, &amp;lt; 70 mg/dl) was tested using the Wilcoxon Signed-rank test with p &amp;lt;0.05. Results: A total of 125 patients were randomized and 49 patients completed the 6 weeks follow-up (women=53.9%; age=72.8 ± 5.0 years; BMI=28.3±3.6 Kg/m2; eGFR=62.4 ± 16.6; ml/min A1c=8.0 ± 0.57%; GMI=7.1 ± 0.8%. The patients had a median TIR of 65% (min= 7%, max= 94%) at the baseline and 68% (min= 4%; max= 97%) at the endpoint. The median TBR was 3% (min= 0%, max= 23%) at the baseline and 2% (min= 0%; max= 18%) at the end of study. The TBR was significantly reduced after 6 weeks of CGM (p&amp;lt;0.01) . Conclusions: An individualized approach may be possible using FreeStyle Libre Flash CGM to avoid overtreatment and undertreatment of older adults with T2D. CGM is a useful tool to reduce hypoglycemia in insulin older adults with T2D. Disclosure S.A.O.Leite: None. M.Silva: None. A.C.R.Lavalle: None. M.Bastos: None. M.C.Bertogy: None. S.C.Vieira: None. G.E.Umpierrez: Research Support; AstraZeneca, Dexcom, Inc., Novo Nordisk. Funding Abbott DiabetesCare (ADC-OUS-IIS-19-47)

697-P: Inpatient Glycemic Control and Glucose Variability by Continuous Glucose Monitoring in Older Adults with Type 2 Diabetes

Few studies have reported on differences in glycemic control and glucose variability by continuous glucose monitoring (CGM) in hospitalized insulin-treated older adults with type 2 diabetes (T2D) . Accordingly, we combined data from 3 inpatient randomized clinical trials using CGM in insulin-treated patients with T2D. Glycemic parameters were compared in 103 older adults (≥60 years) and 160 younger adults (&amp;lt;60 years) . Older adults, as compared to younger adults, had significantly lower HbA1c and blood glucose (BG) upon admission, and had lower overall mean daily CGM glucose values and higher percent time in range between 70-180 mg/dl during hospital stay. Glycemic variability (GV) did not differ between the two groups when assessed through direct univariate comparisons using coefficient of variation (CV) , mean amplitude of glucose excursion (MAGE) , and standard deviation (SD) ; however, a multivariate analysis adjusted for GFR, BMI, admission BG and HbA1c, indicated that older adults have higher GV during the hospital stay compared to younger adults. Conclusion: Our study indicates that older adults with T2D have better glycemic control on admission (BG and HbA1c) and had higher % time in range (70-180 mg/dl) , no difference in hypoglycemia, but greater GV during hospitalization compared to younger adults. Disclosure T.Idrees: None. F.J.Pasquel: Consultant; AI Health LLC, Boehringer Ingelheim International GmbH, Dexcom, Inc., Research Support; Dexcom, Inc., Insulet Corporation, Merck &amp; Co., Inc. L.Peng: None. G.E.Umpierrez: Research Support; AstraZeneca, Dexcom, Inc., Novo Nordisk. R.J.Galindo: Advisory Panel; Sanofi, WW International, Inc., Research Support; Dexcom, Inc., Eli Lilly and Company, Novo Nordisk. M.A.Urrutia: None. I.A.Castro-revoredo: None. E.Moreno: None. A.L.Migdal: None. G.Davis: Consultant; Medscape, Research Support; Insulet Corporation. P.Vellanki: n/a. M.Fayfman: None.

Previously unrecognized risk factors for severe hypoglycaemia requiring emergency medical care in insulin-treated type 2 diabetes: Results from a real-world nested case-control study.

AimSeveral risk factors for severe hypoglycaemia (SH) are associated with insulin‐treated diabetes. This study explored potential risk factors in adults with insulin‐treated type 2 diabetes mellitus (T2DM).Materials and MethodsIn this case‐control study, adults with T2DM initiating insulin were identified in the IQVIA PharMetrics® Plus database. The index date was the date of the first SH event (cases). Using incidence‐density sampling, controls were selected from those who had been exposed ‘at risk’ of SH for the same amount of time as each case. After exact‐matching on the well‐established factors, previously unreported risk factors were evaluated through conditional logistic regression.ResultsIn 3153 case‐control pairs, pregnancy [odds ratios (OR) = 3.20, p = .0003], alcohol abuse (OR = 2.43, p < .0001), short‐/rapid‐acting insulin (OR = 2.22/1.47, p < .0001), cancer (OR = 1.87, p < .0001), dementia/Alzheimer′s disease (OR = 1.73, p = .0175), peripheral vascular disease (OR = 1.59, p < .0001), antipsychotics (OR = 1.59; p = .0059), anxiolytics (OR = 1.51, p = .0012), paralysis/hemiplegia/paraplegia (OR = 1.51, p = .0416), hepatitis (OR = 1.50, p = .0303), congestive heart failure (OR = 1.47, p = .0002), adrenergic‐corticosteroid combinations (OR = 1.45, p = .0165), β‐adrenoceptor agonists (OR = 1.40, p = .0225), opioids (OR = 1.38, p < .0001), corticosteroids (OR = 1.35, p = .0159), cardiac arrhythmia (OR = 1.29. p = .0065), smoking (OR = 1.28, p = .005), Charlson Comorbidity Index score 2 (OR = 1.28, p = .0026), 3 (OR = 1.41, p = .0016) or ≥4 (OR = 1.57, p = .0002), liver/gallbladder/pancreatic disease (OR = 1.26, p = .0182) and hypertension (OR = 1.19, p = .0164) were independently associated with SH.ConclusionsAlthough all people with insulin‐treated diabetes are at risk of SH, these results have identified some previously unrecognized risk factors and sub‐groups of insulin‐treated adults with T2DM at greater risk. Scrutiny of current therapies and comorbidities are advised as well as additional glucose monitoring and education, when identifying and managing SH in vulnerable populations.

A Glycemia Risk Index (GRI) of Hypoglycemia and Hyperglycemia for Continuous Glucose Monitoring Validated by Clinician Ratings.

A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data. We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation. The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals. The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

The Impact of Hypoglycemia on Productivity Loss and Utility in Patients With Type 2 Diabetes Treated With Insulin in Real-world Canadian Practice: Protocol for a Prospective Study.

BackgroundType 2 diabetes mellitus (T2DM) imposes a substantial burden owing to its increasing prevalence and life-threatening complications. In patients who do not achieve glycemic targets with oral antidiabetic drugs, the initiation of insulin is recommended. However, a serious concern regarding insulin is drug-induced hypoglycemia. Hypoglycemia is known to affect quality of life and the use of health care resources. However, health economics and outcomes research (HEOR) data for economic modelling are limited, particularly regarding utility values and productivity losses.ObjectiveThis real-world prospective study aims to assess the impact of hypoglycemia on productivity and utility in insulin-treated adults with T2DM from Ontario and Quebec, Canada.MethodsThis noninterventional, multicenter, 3-month prospective study will recruit patients from 4 medical clinics and 2 endocrinology or diabetes clinics. Patients will be identified using appointment lists and enrolled through consecutive sampling during routinely scheduled consultations. To be eligible, patients must be aged ≥18 years, diagnosed with T2DM, and treated with insulin. Utility and productivity will be measured using the EQ-5D-5L questionnaire and Institute for Medical Technology Assessment Productivity Cost Questionnaire, respectively. Questionnaires will be completed 4, 8, and 12 weeks after recruitment. Generalized estimating equation models will be used to investigate productivity losses and utility decrements associated with incident hypoglycemic events while controlling for individual patient characteristics. A total of 500 patients will be enrolled to ensure the precision of HEOR estimates.ResultsThis study is designed to fill a gap in the Canadian evidence on the impact of hypoglycemia on HEOR outcomes. More specifically, it will generate productivity and utility inputs for the economic modeling of T2DM.ConclusionsInsulin therapy is expensive, and hypoglycemia is a significant component of economic evaluation. Robust HEOR data may help health technology assessment agencies in future reimbursement decision-making.International Registered Report Identifier (IRRID)PRR1-10.2196/35461

Clinical Utility of Switching to Insulin Degludec From Other Basal Insulins in Adult Patients With Type 1 or Type 2 Diabetes

ObjectivesThe effects of switching Canadians from other basal insulins to degludec (IDeg) in an outpatient setting are unknown. Our aim in this study was to evaluate the clinical effectiveness and safety of switching insulin-treated adults with either type 1 (T1DM) or type 2 (T2DM) diabetes mellitus to IDeg. MethodsThis was a retrospective observational cohort study of Albertans who were switched to IDeg between December 1, 2018, and December 1, 2019, and followed until March 1, 2020. We used administrative databases (provincial cohort) and electronic medical records (clinic cohort) to gather data and interrupted time series for the primary outcome analysis. ResultsWe analyzed a provincial cohort of 5,294 patients, 287 of whom were also included in the clinic cohort (T1DM, n=80; T2DM, n=207). After switching to IDeg, glycated hemoglobin (A1C) decreased by −0.3 (95% confidence interval [CI], −0.4% to −0.2%) and the reduction in A1C was maintained throughout the follow-up period. Rates of all-cause hospitalizations/emergency department visits per patient were not affected (hospitalizations pre-switch 0.07 [95% CI, 0.07 to 0.08], post-switch 0.08 [95% CI, 0.06 to 0.09], p=0.45; ED visits pre-switch 0.25 [95% CI, 0.23 to 0.27], post-switch 0.26 [95% CI, 0.23 to 0.29], p=0.27). In the clinic cohort, at switch, there was an average basal insulin dose reduction of 11.2% (T1DM), 12.3% (T2DM) and 16.3% (patients with insulin resistance). ConclusionsPatients with inadequate glycemic control or who find their basal insulin dosing inconvenient may benefit from switching to Ideg, with the potential for small improvementa in A1C at lower basal insulin doses.

Effect of insulin degludec versus insulin glargine U100 on time in range: SWITCH PRO, a crossover study of basal insulin-treated adults with type 2 diabetes and risk factors for hypoglycaemia.

AimsTo compare time in range (TIR) with use of insulin degludec U100 (degludec) versus insulin glargine U100 (glargine U100) in people with type 2 diabetes.Materials and MethodsWe conducted a randomized, crossover, multicentre trial comparing degludec and glargine U100 in basal insulin‐treated adults with type 2 diabetes and ≥1 hypoglycaemia risk factor. There were two treatment periods, each with 16‐week titration and 2‐week maintenance phases (with evaluation of glucose using blinded professional continuous glucose monitoring). The once‐weekly titration (target: 3.9–5.0 mmol/L) was based on pre‐breakfast self‐measured blood glucose. The primary endpoint was percentage of TIR (3.9─10.0 mmol/L). Secondary endpoints included overall and nocturnal percentage of time in tight glycaemic range (3.9–7.8 mmol/L), and mean glycated haemoglobin (HbA1c) and glucose levels.ResultsAt baseline, participants (n = 498) had a mean (SD) age of 62.8 (9.8) years, a diabetes duration of 15.1 (7.7) years and an HbA1c level of 59.6 (11.0) mmol/mol (7.6 [1.0]%). Noninferiority and superiority were confirmed for degludec versus glargine U100 for the primary endpoint, with a mean TIR of 72.1% for degludec versus 70.7% for glargine U100 (estimated treatment difference [ETD] 1.43% [95% confidence interval (CI): 0.12, 2.74; P = 0.03] or 20.6 min/d). Overall time in tight glycaemic range favoured degludec versus glargine U100 (ETD 1.5% [95% CI: 0.15, 2.89] or 21.9 min/d). Degludec also reduced nocturnal time below range (TBR; <3.9 mmol/L) compared with glargine U100 (ETD −0.88% [95% CI: −1.34, −0.42] or 12.7 min/night; post hoc) and significantly fewer nocturnal hypoglycaemic episodes of <3.0 mmol/L were observed.ConclusionsDegludec, compared with glargine U100, provided more TIR and time in tight glycaemic range, and reduced nocturnal TBR in insulin‐treated people with type 2 diabetes.

1039-P: Potential Risk Factors for Severe Hypoglycemia in Insulin-Treated Adults with Type 2 Diabetes (T2DM)

Background: In insulin-treated patients (pts) with T2DM, untreated severe hypoglycemia (SH) can be life-threatening. We used a healthcare claims database (db) to identify less established SH risk factors in this group. Methods: Adults with T2DM and ≥1 insulin claim (2012-2018) were identified in IQVIA’s PharMetrics® Plus db. Cases with SH were matched to controls using incidence density sampling and exact matched on well‑known factors (age, sulfonylurea pharmacy claim, prior SH, renal disease). A conditional logistic regression model tested associations between potential risk factors and SH occurrence. Results: In 3153 cases/3153 matched controls, mean ± SD age was 56.2 ± 10.9 years. Identified risk factors included pregnancy (odds ratio for exposure ≤1 mo before SH = 3.2, 95% CI 1.7-6.0) and pharmacy claims: short-acting insulin (2.2, 1.6-3.1), rapid-acting insulin (1.5, 1.3-1.7), anxiolytics (1.5, 1.2-1.9), antipsychotics (1.6, 1.1-2.2), corticosteroids (1.4, 1.1-1.7), opioids (1.4, 1.2-1.6), β-adrenergic agonists (1.4, 1.1-1.9). Higher comorbidity score, alcohol abuse and certain comorbidities also raised SH risk (Fig 1). Conclusion: Acknowledging limitations of claims db analyses, our study identified certain comorbidities and medications (primarily within 1 mo of SH) as additional risk factors for SH. Such data may help facilitate interventions for pts with T2DM at increased SH risk. Disclosure J. Settles: Employee; Self; Eli Lilly and Company. C. J. Child: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. M. Gorritz: Consultant; Self; Amgen Inc., Eli Lilly and Company, Novartis Pharmaceuticals Corporation, Otsuka America Pharmaceutical, Inc., Takeda Pharmaceutical Co. J. K. Multani: Other Relationship; Self; Eli Lilly and Company. C. Mcguiness: Research Support; Self; AbbVie Inc., Allergan plc, Amgen Inc., Astellas Pharma Inc., Eli Lilly and Company, GlaxoSmithKline plc., Novartis Pharmaceuticals Corporation, Regeneron Pharmaceuticals Inc., Sanofi, Takeda Pharmaceutical Co. R. Wade: Research Support; Self; Eli Lilly and Company. H. Kan: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Bristol-Myers Squibb Company, GlaxoSmithKline plc. Funding Eli Lilly and Company

714-P: How Often Do Patients on Insulin Therapy Measure Postprandial Glycemia and Modify Insulin Doses Accordingly? From an Online Survey in Spain

Introduction: Controlling postprandial glycemia (PPG) is critical to achieve glycemic targets and has been associated with poor cardiovascular outcomes. However, few patients measure PPG and even less make changes on treatment based on these data. Objectives: To evaluate how often patients on insulin therapy analyze PPG and modify insulin doses based on these data. As secondary objectives, we evaluate how patients discussed PPG during the visits and the predictive factors for PPG measurement. Material and Methods: This was an anonymous on-line cross-sectional observational study of an unselected sample of diabetes patients on insulin. Data were extracted from a questionnaire available in two internet sources: Canal Diabetes and the Spanish Diabetes Foundation. The study was approved by the Ethics Committee of the Fundación Jiménez Díaz Hospital in Madrid. Results: Data presented as means ± (SD) or frequencies (%). Among the predictive factors for PPG measurement and based treatment changes were diabetes type, follow-up setting (Specialized vs. Primary Care), insulin injection number and CGM use. Conclusions: In this unselected on-line sample of insulin-treated adults, 50.7% measured their PPG, despite this was recommended by HCP and most (95%) considered PPG measurement as relevant. Therefore, improvement in diabetes education on PPG and its treatment is key to improve overall glycemic control. Disclosure C. Tejera: None. E. Lecumberri: None. A. Muñoz-Garach: Speaker's Bureau; Self; Lilly Diabetes, Novo Nordisk A/S, Sanofi-Aventis. F. Ampudia Blasco: None. F. Ampudia Blasco: None.

Glycemic impact of intensified self monitoring of blood glucose in insulin treated subjects with type 2 diabetes mellitus

Objective:The aim of this study was to evaluate if intensified self-monitoring of blood glucose (SMBG) improves glycemic control in insulin-treated subjects with type 2 diabetes mellitus (T2DM). Methods:Ninety-six adults with stable but poorly controlled [glycated hemoglobin (HbA1c) level &gt;7.5%] T2DM receiving twice-daily biphasic insulin were randomly assigned to either of the two groups: intensive monitors (IM) that performed SMBG at least twice daily or conventional monitors (CM) that performed SMBG at their discretionary frequency for 12 weeks. Demographic, clinical, and glycemic indices, including fasting blood glucose (FBG), postprandial glucose (PPG), and HbA1c, were compared at baseline and week 12. Results:A total of 71 subjects (25 IM and 46 CM) completed the study. Both groups had similar HbA1c at baseline. From baseline to week 12, the IM group had higher mean daily test strip usage (P &lt;0.001), engaged in more frequent insulin dose adjustments (P &lt;0.001), and attained greater daily insulin dosage (P = 0.002). All glycemic indices including FBG, PPG, and HbA1c improved significantly from baseline to week 12 in the IM but not in the CM group. HbA1c level declined by −1.2 ±0.4% in the IM group (P = 0.002). There was no difference in the frequency of hypoglycemia in both groups. The monthly cost of intensified SMBG was nearly four times that of conventional monitoring (P &lt;0.001). Conclusion:Both short- and long-term glycemic control significantly improved by intensified SMBG in stable but poorly controlled insulin-treated adults with T2DM. Intensified SMBG enabled better self-titration of insulin and probably other self-care practices. This benefit, however, occurred at the expense of costs that may be difficult to sustain in resource-poor countries.

Hypoglycaemia among Insulin-Treated Patients with Diabetes: Southeast Asia Cohort of IO HAT Study.

ObjectiveTo provide real-world data on hypoglycaemia incidence in patients with type 1 (T1D) or type 2 diabetes (T2D) from the Southeast Asian cohort of the International Operations Hypoglycaemia Assessment Tool (IO HAT) study.MethodologyIO HAT was a non-interventional, multicentre, 6-month retrospective and 4-week prospective study of hypoglycaemic events among insulin-treated adults with T1D or T2D, including four countries in Southeast Asia (Singapore, Philippines, Indonesia, and Bangladesh). Data were collected using a two-part self-assessment questionnaire (SAQ1 for retrospective and SAQ2 for prospective). The primary endpoint was the percentage of patients experiencing at least one hypoglycaemic event during the 4-week prospective observational period (ClinicalTrials.gov Identifier: NCT02306681).ResultsA total of 2594 patients completed SAQ1. Nearly all patients reported experiencing any hypoglycaemic event in the 4-week prospective period (T1D, 100%; T2D, 97.3%), with all patients reporting higher rates in the prospective versus retrospective period. Severe hypoglycaemia was also reported higher prospectively (57.2% and 76.9%) than retrospectively (33.9% and 12.2%) in both T1D and T2D, respectively. Nocturnal hypoglycaemia was reported higher retrospectively than prospectively.ConclusionIncidence of any and severe hypoglycaemia in the Southeast Asian cohort of IO HAT was higher prospectively versus retrospectively, suggesting hypoglycaemia has previously been under-reported in this region.

Glycemic impact of intensified self monitoring of blood glucose in insulin treated subjects with type 2 diabetes mellitus

Objective: The aim of this study was to evaluate if intensified self-monitoring of blood glucose (SMBG) improves glycemic control in insulin-treated subjects with type 2 diabetes mellitus (T2DM). Methods: Ninety-six adults with stable but poorly controlled [glycated hemoglobin (HbA1c) level >7.5%] T2DM receiving twice-daily biphasic insulin were randomly assigned to either of the two groups: intensive monitors (IM) that performed SMBG at least twice daily or conventional monitors (CM) that performed SMBG at their discretionary frequency for 12 weeks. Demographic, clinical, and glycemic indices, including fasting blood glucose (FBG), postprandial glucose (PPG), and HbA1c, were compared at baseline and week 12. Results: A total of 71 subjects (25 IM and 46 CM) completed the study. Both groups had similar HbA1c at baseline. From baseline to week 12, the IM group had higher mean daily test strip usage ( P P P = 0.002). All glycemic indices including FBG, PPG, and HbA1c improved significantly from baseline to week 12 in the IM but not in the CM group. HbA1c level declined by −1.2±0.4% in the IM group ( P = 0.002). There was no difference in the frequency of hypoglycemia in both groups. The monthly cost of intensified SMBG was nearly four times that of conventional monitoring ( P Conclusion: Both short- and long-term glycemic control significantly improved by intensified SMBG in stable but poorly controlled insulin-treated adults with T2DM. Intensified SMBG enabled better self-titration of insulin and probably other self-care practices. This benefit, however, occurred at the expense of costs that may be difficult to sustain in resource-poor countries.

The economic impact of insulin-related hypoglycemia in Denmark: an analysis using the Local Impact of Hypoglycemia Tool

Aims: To estimate the direct cost of hypoglycemia in insulin-treated adults with type 1 diabetes (T1DM) and type 2 diabetes (T2DM) in Denmark.Materials and methods: The Local Impact of Hypoglycemia Tool (LIHT) was used to estimate the costs associated with insulin-related hypoglycemia. Average utilization of healthcare resources, including the costs of pre-hospitalization, hospital admission, healthcare professional contact and follow-up, glucose/glucagon, and extra SMBG tests to monitor blood glucose following an episode, was used to calculate an average cost per severe and per non-severe hypoglycemic episode. The cost per episode was then applied to the rates of severe and non-severe hypoglycemia in people with T1DM and T2DM in Denmark.Results: The direct cost of insulin-related hypoglycemia in Denmark is DKK 96.2 million per year, which equates to EUR 12.9 million. For people with T1DM prone to severe hypoglycemia (defined as having ≥2 severe episodes in the past year), the cost per person per year increases by DKK 4,155 compared with the T1DM population average, and for people with T2DM prone to non-severe hypoglycemia (defined as having ≥1 non-severe episode in the last 4 weeks), the cost increases by DKK 647 per person per year compared with the T2DM population average.Conclusions: The LIHT highlights the substantial economic burden of insulin-related hypoglycemia in Denmark, and provides a means to estimate the savings that could be made by lowering hypoglycemia rates. For example, the costs associated with using a new insulin or introducing a patient education program could be offset with the cost saving from reducing hypoglycemia.