Introduction: Indirect evidence suggests iGlarLixi is as efficacious as basal insulin (BI) + rapid acting insulin (RAI) for management of type 2 diabetes (T2D) . However, there are no direct comparisons of iGlarLixi (once-daily [QD]) vs. a BI+RAI regimen (multiple daily injections [MDI]) . SoliSimplify compared these treatments using real-world data from a US database. Methods: Electronic medical records were analyzed retrospectively using propensity score matching (PSM) to compare therapy advancement with iGlarLixi or BI+RAI in adults ≥18 years with T2D on BI and ≥1 HbA1c available value at baseline and 6-month follow-up. The primary objective was non-inferiority of iGlarLixi to BI+RAI in HbA1c change from baseline to 6 months (margin 0.3 %) . Results: PSM generated cohorts with balanced baseline characteristics (N=814 in each group; Table) . HbA1c reduction from baseline to 6 months with iGlarLixi was non-inferior to BI+RAI (p<0.025) . Weight gain was significantly lower with iGlarLixi than with BI+RAI (p<0.for the difference) . At 6 months, achievement of HbA1c <7 % without hypoglycemia and weight gain was similar between groups. Hypoglycemia was low in both groups, likely due to underreporting. Conclusions: In this real-world study, QD iGlarLixi was as effective as MDI BI+RAI in HbA1c reduction and had a favorable body weight benefit. Disclosure R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. A.Y.Cheng: Advisory Panel; Abbott, AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Dexcom, Inc., Eli Lilly and Company, HLS Theraoeutics, Insulet Corporation, Janssen Pharmaceuticals, Inc., Medtronic, Novo Nordisk, Sanofi, Board Member; Type 1 Diabetes Think Tank Network, Other Relationship; Diabetes Canada, Speaker's Bureau; Bausch Health, Canada, Merck & Co., Inc. G.R.Galstyan: n/a. K.Djaballah: Employee; Sanofi. X.Li: Employee; Eisai Co., Ltd., Sanofi. M.Coudert: Employee; Sanofi. J.Frias: Advisory Panel; Altimmune, Becton, Dickinson and Company, Eli Lilly and Company, Gilead Sciences, Inc., Intercept Pharmaceuticals, Inc., Merck & Co., Inc., Sanofi, Consultant; 89bio, Inc., Akero Therapeutics, Inc., Altimmune, Becton, Dickinson and Company, Carmot Therapeutics, Inc., Eli Lilly and Company, Novo Nordisk, Pfizer Inc., Sanofi, Research Support; Afimmune Limited, Akero Therapeutics, Inc., AstraZeneca, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb Company, Carmot Therapeutics, Inc., Eli Lilly and Company, Intercept Pharmaceuticals, Inc., Ionis Pharmaceuticals, Janssen Pharmaceuticals, Inc., Madrigal Pharmaceuticals, Inc., Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk, Pfizer Inc., Poxel SA, Sanofi, Speaker's Bureau; Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk, Sanofi. Funding Sanofi
We aimed to compare weekly rates of sensor detected hypoglycemia (SDH), person reported hypoglycemia (PRH) and psychological outcomes in people with type 1 (T1D) and insulin treated type 2 diabetes (T2D) using routine continuous glucose monitoring (CGM) or capillary blood glucose monitoring (BGM) in the prospective observational Hypo-METRICS study. Participants (T1D/CBG=67, T1D/CGM=210, T2D/CBG=192, T2D/CGM=133, 55% men, median (IQR) age 56 (45-66) years) completed person reported outcomes measures, wore a blinded study CGM and reported PRH in real time on the Hypo-METRICS app for 10 weeks. We used the Wilcoxon rank sum test. Median weekly PRH rates were higher in CGM vs BGM users in both T1D (4.5 (2.4-6.3) vs 2.6 (1-3.9) Z=-5.1, p<0.005) and T2D (1.7 (0.6-2.3) vs 1.0 (0.2-1.2), Z=-5.8 p<0.005). There were no differences in SDH rates at 70 or 54mg/dl for CGM or BGM users with T1D or T2D (Table 1). Diabetes distress (Problem Areas In Diabetes) was higher in CGM vs BGM users with T1D (25 (10-36) vs 19 (5-26), Z=-3.2, p=0.008), but not T2D. There were no significant differences between CGM and BGM users in Hypoglycaemia Fear Survey Behaviour or Worry subscales, depression (PHQ-9) or anxiety (GAD-7) in either group. Despite similar SDH rates, T1D CGM users have higher PRH and diabetes distress scores; this may reflect populations with greater access to CGM. Further research is needed to investigate these findings. Disclosure N.Zaremba: None. M.Evans: Advisory Panel; Zucara Therapeutics, Pila Pharma, Dexcom, Inc., Other Relationship; Novo Nordisk, AstraZeneca, Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company. E.Renard: Consultant; Abbott Diabetes, Dexcom, Inc., AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Roche Diabetes Care. S.R.Heller: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk, Medtronic. J.Speight: Research Support; Sanofi, Medtronic, Abbott Diabetes, Lilly, Novo Nordisk A/S, Speaker's Bureau; Sanofi. S.A.Amiel: Advisory Panel; Medtronic, Other Relationship; Sanofi, Novo Nordisk. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. P.Divilly: None. G.Martine-edith: Other Relationship; Novo Nordisk A/S. Z.Mahmoudi: Employee; Novo Nordisk. U.Soeholm: Employee; Novo Nordisk A/S. B.E.De galan: Research Support; Novo Nordisk. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi, Vertex Pharmaceuticals Incorporated. R.J.Mccrimmon: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk A/S. J.K.Mader: Advisory Panel; Novo Nordisk A/S, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Medtronic, Becton, Dickinson and Company, Pharmasense, embecta, Research Support; A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Dexcom, Inc., Profusa, Inc., Speaker's Bureau; Novo Nordisk A/S, A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Boehringer Ingelheim Inc., Becton, Dickinson and Company, Ypsomed AG, Viatris Inc., Servier Laboratories, Medtrust, Stock/Shareholder; Decide Clinical Software GmbH. Funding Innovative Medicines Initiative 2 Joint Undertaking (777460)
Aim: To examine how hypoglycemia while asleep impacts self-reported daily functioning among adults with type 1 diabetes (T1D) . Methods: On 70 consecutive mornings, 250 people with T1D wearing a continuous glucose monitor reported sleep quality, mood, and alertness via the Hypo-METRICS smartphone app. Each night was categorized based on presence (+) or absence (-) of person-reported hypoglycemia (PRH) and sensor-detected hypoglycemia (SDH) into one of four types (see Figure 1, Type A-D) . Multilevel regression assessed associations between hypoglycemia and daily functioning (unstandardized coefficients (β) on original 0-scale) , adjusted for baseline demographic, clinical and psychological factors. Results: In the first 54 adults (52% women, age[M±SD]: 45±15 years) , nighttime PRH (Type C & D, Figure 1) was associated with reduced subjective sleep quality (C: β=-0.67; D: β=-0.58) , mood (C: β=-0.43; D: β=-0.58) and alertness (C: β=-0.34, p=0.015; D: β=-0.46) (all p<0.0unless specified) compared to nights without hypoglycemia (Type A) . Nights with SDH only (Type B) showed no significant reductions in sleep, mood or alertness (p>0.05) . Conclusion: These novel data show the potentially pivotal role of the subjective experience of hypoglycemia for sleep quality, mood and alertness. Disclosure U.Soeholm: Research Support; Novo Nordisk A/S. E.Renard: Consultant; Abbott, AstraZeneca, Boehringer Ingelheim International GmbH, Dexcom, Inc., Insulet Corporation, LifeScan, Lilly, Novo Nordisk, Roche Diabetes Care, Sanofi, Tandem Diabetes Care, Inc. E.J.Abbink: None. P.M.Baumann: None. S.R.Heller: Advisory Panel; Eli Lilly and Company, Medtronic, Mylan N.V., Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk A/S. B.E.De galan: Research Support; Novo Nordisk. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi. M.Evans: Advisory Panel; Pila Pharma, Zucara Therapeutics, Other Relationship; Abbott Diabetes, Dexcom, Inc., Medtronic, Novo Nordisk, Research Support; AstraZeneca, Sanofi, Speaker's Bureau; Lilly Diabetes. D.Pollard: Other Relationship; Novo Nordisk. R.J.Mccrimmon: Advisory Panel; Novo Nordisk, Sanofi, Research Support; Diabetes UK, European Union, MedImmune. S.A.Amiel: Advisory Panel; Medtronic, Novo Nordisk, Other Relationship; Sanofi. M.M.Broadley: None. C.Hendrieckx: None. J.Speight: Advisory Panel; Insulet Corporation, Research Support; Novo Nordisk, Sanofi. P.Choudhary: Advisory Panel; Abbott Diabetes, Lilly Diabetes, Medtronic, Research Support; Novo Nordisk, Speaker's Bureau; Dexcom, Inc., Glooko, Inc., Insulet Corporation, Sanofi. F.Pouwer: Research Support; Eli Lilly and Company, Novo Nordisk, Sanofi. N.Zaremba: None. P.Divilly: None. G.Martine-edith: Other Relationship; Novo Nordisk. G.Nefs: None. Z.Mahmoudi: Employee; Novo Nordisk A/S. J.K.Mader: Advisory Panel; Abbott Diabetes, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Speaker's Bureau; Abbott Diabetes, Eli Lilly and Company, Medtronic, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Servier Laboratories, Stock/Shareholder; decide Clinical Software GmbH. M.Cigler: None. Funding This work was supported by the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement 777460
Current definitions of sensor detected hypoglycemia (SDH) give high levels of asymptomatic hypoglycemia on continuous glucose monitoring (CGM). We defined individually optimised thresholds and durations for sensor detected hypoglycemia (SDH) that better identify symptomatic hypoglycemia experienced by people with insulin treated diabetes. We analysed 10 weeks of blinded CGM (Libre 2) and FitBit data from 435 participants [217 type 1, 218 type 2]. They self reported symptomatic hypoglycemia on the Hypo-METRICS smartphone app. We used particle Markov chain Monte Carlo optimization to generate the threshold and duration of SDH that maximizes detection of symptomatic hypoglycemia for each individual (and by Fitbit sleep status). When using individual definitions of SDH, precision for detection of symptomatic hypoglycemia increased by 23% with 2% loss of sensitivity vs the consensus definition of Level 1 SDH (70mg/dl > 15 mins). Precision and sensitivity increased by 41% and 20% respectively vs level 2 SDH (54 mg/dl > 15 mins). Increased precision, with minimal change of sensitivity, were greatest during sleep, and irrespective of diabetes types and sleep status (Table). Optimizing SDH definitions at the individual level and by sleep status could minimize false alarms without increasing missed clinically important hypoglycemia episodes. Disclosure Z.Mahmoudi: Employee; Novo Nordisk. B.E.De galan: Research Support; Novo Nordisk. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi, Vertex Pharmaceuticals Incorporated. R.J.Mccrimmon: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk A/S. E.Renard: Consultant; Abbott Diabetes, Dexcom, Inc., AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Roche Diabetes Care. S.R.Heller: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk, Medtronic. M.Evans: Advisory Panel; Zucara Therapeutics, Pila Pharma, Dexcom, Inc., Other Relationship; Novo Nordisk, AstraZeneca, Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company. J.K.Mader: Advisory Panel; Novo Nordisk A/S, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Medtronic, Becton, Dickinson and Company, Pharmasense, embecta, Research Support; A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Dexcom, Inc., Profusa, Inc., Speaker's Bureau; Novo Nordisk A/S, A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Boehringer Ingelheim Inc., Becton, Dickinson and Company, Ypsomed AG, Viatris Inc., Servier Laboratories, Medtrust, Stock/Shareholder; Decide Clinical Software GmbH. S.A.Amiel: Advisory Panel; Medtronic, Other Relationship; Sanofi, Novo Nordisk. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. Hypo-resolve consortium: n/a. P.Divilly: None. G.Martine-edith: Other Relationship; Novo Nordisk A/S. D.Boiroux: Employee; Novo Nordisk A/S. N.Zaremba: None. U.Soeholm: Employee; Novo Nordisk A/S. M.Gomes: Employee; Novo Nordisk A/S. A.A.Vaag: None. J.Speight: Research Support; Sanofi, Medtronic, Abbott Diabetes, Lilly, Novo Nordisk A/S, Speaker's Bureau; Sanofi. Funding Innovative Medicines Initiative 2 Joint Undertaking (777460)
The multicentre prospective observational Hypo-METRICS study assessed rates of sensor detected hypoglycemia (SDH) and person reported hypoglycemia-PRH (symptoms resolved by carbohydrates or measured glucose <72 mg/dl), in people with type 1 (T1D) and insulin treated type 2 (T2D) diabetes. We report overall rates of hypoglycemia and the proportion and rates of undetected SDH. All 602 participants (277 T1D vs 325 T2D) had ≥1 PRH in the 3 months prior to the study. They wore a blinded continuous glucose monitor and recorded PRH on the Hypo-METRICS smartphone app for 10 weeks. SDH was defined by ATTD consensus. PRH without SDH ± 1 hour was consider undetected. The median (IQR) weekly rate of PRH was 3.4 (1.9-5.3) vs 0.8 (0.3-1.7) episodes/week in T1D vs T2D respectively (p<0.01), SDH <70mg/dl was 6.7 (3.9-10.8) vs 2.1 (0.9-4.3) episodes/week respectively (p<0.01) and SDH <54mg/dl was 1.3 (0.5-2.8) vs 0.3 (0-0.6) episodes/weeks respectively (p<0.01). The proportion of undetected episodes at SDH <70mg/dl was higher in T2D, 68 vs 78% (p<0.01) and at SDH <54mg/dl, 62 vs 82% (p<0.01). The weekly rates of undetected episodes were higher in T1D for SDH <70mg/dl (4.6 vs 1.8 episodes/week, p<0.01) and for SDH <54mg/dl (0.8 vs 0.2 episodes /week, p<0.01). Baseline characteristics are in table 1. Most sensor hypoglycemia goes undetected by people with diabetes. Further work will assess the impact of undetected episodes. Disclosure P.Divilly: None. S.R.Heller: Advisory Panel; Zealand Pharma A/S, Zucara Therapeutics, Other Relationship; Eli Lilly and Company, Research Support; Dexcom, Inc., Speaker's Bureau; Novo Nordisk, Medtronic. M.Evans: Advisory Panel; Zucara Therapeutics, Pila Pharma, Dexcom, Inc., Other Relationship; Novo Nordisk, AstraZeneca, Abbott Diabetes, Speaker's Bureau; Eli Lilly and Company. J.K.Mader: Advisory Panel; Novo Nordisk A/S, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Medtronic, Becton, Dickinson and Company, Pharmasense, embecta, Research Support; A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Dexcom, Inc., Profusa, Inc., Speaker's Bureau; Novo Nordisk A/S, A. Menarini Diagnostics, Abbott Diabetes, Roche Diabetes Care, Eli Lilly and Company, Sanofi, Boehringer Ingelheim Inc., Becton, Dickinson and Company, Ypsomed AG, Viatris Inc., Servier Laboratories, Medtrust, Stock/Shareholder; Decide Clinical Software GmbH. S.A.Amiel: Advisory Panel; Medtronic, Other Relationship; Sanofi, Novo Nordisk. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. Hypo-resolve consortium: n/a. G.Martine-edith: Other Relationship; Novo Nordisk A/S. Z.Mahmoudi: Employee; Novo Nordisk. N.Zaremba: None. U.Soeholm: Employee; Novo Nordisk A/S. B.E.De galan: Research Support; Novo Nordisk. U.Pedersen-bjergaard: Advisory Panel; Novo Nordisk A/S, Sanofi, Vertex Pharmaceuticals Incorporated. R.J.Mccrimmon: Advisory Panel; Sanofi, Speaker's Bureau; Novo Nordisk A/S. E.Renard: Consultant; Abbott Diabetes, Dexcom, Inc., AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company, Insulet Corporation, MannKind Corporation, Novo Nordisk, Sanofi, Roche Diabetes Care. Funding Innovative Medicines Initiative 2 Joint Undertaking (777460)
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