bluuebunny/crossref_metadata_2025_split huggingface dataset:
380-P: Towards Prevention of Nonsevere Hypoglycemia in Type 1 Diabetes with Oral Glucose at a Higher Blood Glucose Threshold—The REVERSIBLE Trial
Authors: CHENG RAN , TALEB NADINE , WU ZEKAI , MESSIER VIRGINIE , RABASA-LHORET RÉMI 
Published: June 2023

Background: Current guidelines recommend initiating the treatment of non-severe (NS) hypoglycemia with 15g of carbohydrates (CHO) at 15 minutes intervals when blood glucose (BG) reaches &lt;72 mg/dl. Despite this recommendation, NS hypoglycemia management remains challenging for people living with type 1 diabetes (pwT1D) and more optimal treatment strategies are required. We aim to assess the efficacy of 15g of CHO at higher treatment thresholds.
Methods: The REVERSIBLE Trial is an open-label, randomized, three interventions x three periods cross-over study. Following inpatient insulin-induced decrease in BG, 16g of oral carbohydrates is administered at a plasma glucose threshold of &lt;72 mg/dl, ≤81 mg/dl or ≤90 mg/dl. The primary outcome is the time (in minutes) spent in hypoglycemia (&lt;72 mg/dl) after the initial correction.
Results: Participants (n=29) characteristics are 52% male, 46.8±16.3 years old, BMI of 26.4±3.9 kg/m2, diabetes duration of 26.2±15.9 years, A1c of 53.4±15.5 mmol/mol and 62% insulin pump users. When comparing &lt;72 mg/dl (control) to ≤81 mg/dl and ≤90 mg/dl treatment thresholds, 100% vs. 86% (p=0.1201) vs. 34% (p&lt;0.0001) of participants had hypoglycemia. These hypoglycemic events lasted 26.0±12.6 vs. 17.9±14.7 (p=0.026) vs. 7.1±11.8 (p=0.002) minutes, with a blood glucose nadir of 56.5±9.9 vs. 63.5±7.9 (p=0.008) vs. 73.4±9.7 mg/dl (p=0.002) respectively. In the control group, 69% of participants required more than one treatment to reach or maintain normoglycemia (≥ 72 mg/dl) compared to 52% in the ≤81 mg/dl group and 31% in the ≤90 mg/dl group with no significant rebound hyperglycemia (&gt;180mg/dl) within the first hour.
Conclusion: Compared with &lt;72 mg/dl, consuming 16g of oral carbohydrates at ≤81 mg/dl and ≤90 mg/dl shortened the time spent in hypoglycemia, lessened the glucose nadir and reduced the need for repetitive treatments. For some NS episodes, pwT1D could benefit from CHO intake at a higher BG threshold.

Disclosure
R.Cheng: None. N.Taleb: Consultant; Viatris Inc. Z.Wu: Other Relationship; Eli Lilly and Company. V.Messier: None. R.Rabasa-lhoret: Consultant; Dexcom, Inc., Abbott, Janssen Pharmaceuticals, Inc., Novo Nordisk Canada Inc., Sanofi, Lilly, Tandem Diabetes Care, Inc., Insulet Corporation.

Funding
JDRF (4-SRA-2018-651-Q-R); Canadian Institutes of Health Research (JT1-157204)
381-P: Studying the Impact of Nasal Glucagon on Real-Life Experiences of Severe Hypoglycemia Treatment (SIMPLEST)
Authors: MITCHELL BETH , PONCE-IBARRA ALFONSO , MOENNIG ELISABETH , ODAK SHARDUL , MCSORLEY DAVID J. , SPAEPEN ERIK , JACKSON LAURIN , ZOGRAFOS LAURIE , YAN YU 
Published: June 2023

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
390-P: Improving Quality of Life and Self-Efficacy through a Hypoglycemia Management Program—The HARPdoc Randomised Controlled Trial
Authors: AMIEL STEPHANIE A. , TOSCHI ELENA , HELLER SIMON R. , STADLER MARIETTA A. , CHOUDHARY PRATIK , DE ZOYSA NICOLE 
Published: June 2023

Background: A significant minority (15-18%) of adults with type 1 diabetes (T1D) continue to experience problematic hypoglycemia despite access to structured education in flexible insulin therapy and advanced technologies. Many have impaired awareness of hypoglycemia, now recognised to be associated with significant mental health burden. The HARPdoc trial (Hypoglycemia Awareness Restoration Program for people with problematic hypoglycemia Despite Optimised Care) showed that a group programme focused on cognitions and motivation improved scores for diabetes distress, anxiety and depression compared to BGAT (blood glucose awareness training, which addresses education and behaviours), with similarly reduced rates of severe hypoglycaemia.
Methods: This exploratory study addresses the further impact of these programmes on quality of life and mental health. Quality of life was measured at baseline with EQ-5D-5L and it and service use (Adult Service Utilisation Schedule) were measured at 12 and 24 months after randomised participation to either HARPdoc or BGAT.
Results: Mean EQ-5D scores rose by 14%, +0.1 HRQoL utility score (HUS), over 24 months in HARPdoc and fell by 1%, -0.007 HUS in BGAT. Use of mental health services after HARPdoc or BGAT was 26 vs 56 contacts with a psychiatrist, psychologist or counsellor in months 0-12 and 1 vs 17 contacts in months 13 - 24 respectively.
Conclusions: We conclude that HARPdoc reduces previously treatment-resistant severe hypoglycaemia in adults with type 1 diabetes but also enhances quality of life, whilst reducing use of mental health services. We hypothesise that the psychosocial aspects of HARPdoc increase self-efficacy and coping skills, thereby reducing disease burden and the need to access general and mental healthcare provision.

Disclosure
S.A.Amiel: Advisory Panel; Medtronic, Other Relationship; Sanofi, Novo Nordisk. E.Toschi: Advisory Panel; Eli Lilly and Company. 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.A.Stadler: None. P.Choudhary: Advisory Panel; Medtronic, Novo Nordisk, Dexcom, Inc., MannKind Corporation, Insulet Corporation, Research Support; Abbott Diabetes, Speaker's Bureau; Sanofi, Lilly. N.De zoysa: None.

Funding
JDRF (4-SRA-2017-266-M-N); National Institute of Health Research UK
398-P: Renal Proximal Tubular Metallothionein 3 Contributes to Diabetic Kidney Lesion
Authors: TAKIYAMA YURI , TAKIYAMA TAKAO , BESSHO RYOICHI , KITSUNAI HIROYA , TAKIYAMA YUMI 
Published: June 2023

Metallothionein (MT) is a cysteine-rich protein with an antioxidant. MT3, one isoform of the four MTs, is upregulated in the renal proximal tubular cells in type 2 diabetic subjects. To investigate the role of human MT3, we used the mouse sglt2 promoter for targeting human MT3 gene to renal proximal tubular cells in transgenic mice (MT3TG). MT3TG showed nodular glomerulosclerosis without hyperglycemia. Electron microscopy presented thickened glomerular basement membranes, numerous endoplasmic reticulum in proximal tubules and cytoplasmic swelling of the endothelium of peritubular capillaries accompanied with abnormal capillary formation around the glomerulus, suggesting proximal tubular MT3 induces retrogradely glomerular hypertension. Affymetrix Human Gene 1.0 ST arrays identified 43 upregulated and 81 downregulated genes between control and MT3-knockdown human renal proximal tubular epithelial cells (HRPTECs, Lonza) under hypoxia, an early event in diabetic kidney. Among them, ceruloplasmin (CP) and cytochrome b reductase 1 (CYBRD), the crucial players in the cooper and iron metabolism, were downregulated. In fact, MT3TG presented cytoplasmic co-expression of MT3, CP and CYBRD1 in renal proximal tubules. Hypoxia induced a remarkable increase in MT3 in HRPTECs, and the HIF-1alpha siRNAs abolished that. Despite of no antioxidant response element in the human MT3 promoter, Nrf2 siRNA significantly decreased hypoxia-induced MT3 expression. Moreover, MT3 and Nrf2 siRNAs inhibited hypoxia-induced CP and CYBRD1, but not HIF-1 alpha siRNA. Together with the inhibitory effects of mitochondrial inhibitors, NOX4 inhibitors and antioxidant NAC on hypoxia-induced MT3 expression, hypoxia-induced oxidative stress might be involved in the inductions of CP and CYBRD1. Of note, empagliflozin decreased hypoxia-induced MT3, CP and CYBRD1. Our study suggests that MT3 might contributes to diabetic kidney lesion via CP and CYBRD1against hypoxia-induced oxidative stress.

Disclosure
Y.Takiyama: None. T.Takiyama: None. R.Bessho: None. H.Kitsunai: None. Y.Takiyama: Research Support; Boehringer Ingelheim Japan, Inc., Taisho Pharmaceutical Holdings Co., Ltd., Ono Pharmaceutical Co., Ltd., Abbott Japan Co., Ltd., Roche Diabetes Care, MSD Life Science Foundation, Japan Society for the Promotion of Science, Teijin Pharma Limited, Kyowa Kirin Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., Eli Lilly Japan K.K.
4-OR: Impaired Awareness of Hypoglycemia (IAH) in Older Adults with Type 1 Diabetes in the WISDM Study
Authors: BILAL ANIKA , YI FANCHAO , WHITAKER KERI J. , PRATLEY RICHARD E. , CASU ANNA 
Published: June 2023

Background: The prevalence of IAH in type 1 diabetes (T1D) varies from 20 - 37%. Risk factors for IAH include advanced age, longer diabetes duration, recurrent hypoglycemic events, and high glucose variability. Little is known about IAH in older adults with T1D.
Methods: Participants with T1D and ≥60 years of age enrolled in the WISDM study were defined as having IAH if their Clarke score was ≥ 4 or normal awareness (NAH) if &lt;4. We compared continuous glucose monitoring (CGM) metrics in those with IAH and NAH at baseline and in those in whom IAH did or did not improve over 26 weeks of observation.
Results: Of the 199 participants (mean age 68 years, 52% females, 96% White), 61 (30.6%) had IAH. Daytime hypoglycemia was more common in those with compared to those without IAH at baseline (Table). After 26 weeks, daytime hypoglycemia and glycemic variability were significantly less in those in whom IAH improved (n=18) compared to those in whom it did not (n=40).
Conclusion: Results of this analysis in older adults with T1D confirm that diabetes duration, c-peptide and %CV are associated with IAH. Among those with IAH, daytime hypoglycemia was significantly more common, while improvements in IAH over 26 weeks were associated with significantly lower rates of daytime hypoglycemia at follow up.

Disclosure
A.Bilal: None. F.Yi: None. K.J.Whitaker: None. R.E.Pratley: Other Relationship; Bayer Inc., Corcept Therapeutics, Dexcom, Inc., Gasherbrum Bio, Inc., Hanmi Pharm. Co., Ltd., Hengrui (USA) Ltd., Merck Sharp & Dohme Corp., Novo Nordisk, Pfizer Inc., Rivus Pharmaceuticals Inc., Sanofi, Scohia Pharma Inc., Sun Pharmaceutical Industries Ltd. A.Casu: None.
40-LB: The Association between Changes in Physical Activity Before and After Thyroidectomy and Incident Type 2 Diabetes in Patients with Thyroid Cancer
Authors: PARK JIYUN , PARK HYUNJU , KIM SOO-KYUNG , CHO YONG-WOOK , HAN KYUNGDO , KIM KYUNG-SOO 
Published: June 2023

Background: Thyroid cancer patients who underwent thyroid-stimulating hormone suppression therapy after thyroidectomy is increased a risk for type 2 diabetes mellitus (T2DM). However, whether the changes in physical activity (PA) before and after thyroidectomy in patients with thyroid cancer are associated with T2DM has not been evaluated yet. We investigated the association between changes in PA before and after thyroidectomy and incident T2DM in patients with thyroid cancer.
Methods: An observational cohort study of 69,526 thyroid cancer patients who underwent thyroidectomy between 2010 and 2016 was performed using the Korean National Health Information Database. PA was defined as mid-term or vigorous exercise at least 1 day in a week. PA changes over time were divided into four groups: persistent non-exercisers (n = 18,441), new exercisers (n = 14,599), exercise dropouts (n = 11,023), and exercise maintainers (n = 25,463).
Results: During mean 4.5 years of follow-up, the incidences per 1,000 person years of T2DM were lower in patients who performed PA before or after thyroidectomy than persistent non-exercisers (10.77 in persistent non-exerciser group, 8.28 in new exerciser group, 8.59 in exercise dropout group, and 7.61 in exercise maintainer group). Compared with the persistent non-exerciser group, the exercise dropout group (adjusted hazard ratio [aHR] 0.81, 95% confidence interval [CI], 0.72-0.91), new exerciser group (aHR 0.87, 95% CI 0.78-0.97), and the exercise maintainer group (aHR 0.84, 95% CI 0.76-0.93) had lower risks of incident T2DM. When we stratified patients according to energy expenditure, PA with &lt; 1,500 metabolic equivalent of task (MET)-min/week in exercise maintainers was associated with lower risk of incident T2DM than non-exercisers, but PA with ≥ 1,500 MET-min/week was not.
Conclusion: In patients with thyroid cancer, PA before or after thyroidectomy was associated with lower risk of incident T2DM.

Disclosure
J. Park: None. H. Park: None. S. Kim: None. Y. Cho: None. K. Han: None. K. Kim: None.
403-P: Profiling of Circulating MicroRNAs (miRNAs) Associated with Progression to End Stage Kidney Disease (ESKD) in Diabetes—Preanalytical and Analytical Considerations
Authors: SATAKE EIICHIRO , MD DOM ZAIPUL , KOBAYASHI HIROKI , RICCA JOSEPH , O'NEIL KRISTINA , KROLEWSKI BOZENA , PEZZOLESI MARCUS G. , KROLEWSKI ANDRZEJ 
Published: June 2023

Background: miRNAs are short non-coding RNA molecules involved in gene regulation. Previously, we identified 17 plasma miRNAs (8 risk and 9 protective miRNAs) associated with progression to ESKD in diabetes (JASN 2021). Factors that influence the measurement of miRNA concentrations, and thus could impact replication of these findings, including extraction method, miRNA profiling method, and the miRNA source biofluid, have not been investigated.
Methods: Plasma and serum were obtained from patients who participated in the Joslin Kidney Study. Extraction-free plasma and serum miRNA profiles were obtained using the HTG EdgeSeq platform. RNA was also extracted from plasma and used to measure miRNAs by RNA sequencing (RNASeq) and quantitative RT-PCR (qRT-PCR).
Results: Out of 2,083 miRNAs on the EdgeSeq platform, almost all of them (96%) were detected in plasma without RNA extraction, while only 45% of these miRNAs were detected in RNA extracted from the same plasma specimens. The content of miRNAs detected in extracted RNA was significantly enriched for GC sequences in comparison with miRNAs that were lost during RNA extraction. In the specimens with RNA extracted, significantly lower number of miRNAs were detected by RNASeq or qRT-PCR (31% and 26%, respectively) in comparison with the EdgeSeq platform. Regarding the 17 miRNAs associated with ESKD, many of them had different concentrations in serum samples than in plasma and had lower concentration or were not detected in plasma samples with profiled following RNA extraction.
Conclusion: This study demonstrates very strong effects of pre-analytical and analytical factors on concentration of circulating miRNAs. To replicate our findings for 17 circulating miRNAs, it is critical that plasma specimens be used and that miRNAs be measured using the EdgeSeq platform or other platforms that do not require prior extraction of RNA.

Disclosure
E.Satake: None. Z.Md dom: None. H.Kobayashi: Research Support; Bayer Inc. J.Ricca: None. K.O'neil: None. B.Krolewski: None. M.G.Pezzolesi: Research Support; Renalytix. A.Krolewski: None.

Funding
National Institutes of Health (DK131061-01)
415-P: Reduction in the Risk of Peripheral Neuropathy and Preservation of Kidney Function with Metformin, Linagliptin, or Their Fixed-Dose Combination, Compared with Placebo in Prediabetes—A Randomized Controlled Trial
Authors: GABRIEL RAFAEL , TUOMILEHTO JAAKKO 
Published: June 2023

Objective: To compare the effect of glucose-lowering drugs plus lifestyle modification with lifestyle alone on peripheral nerve and kidney function in people with prediabetes.
Methods: Multicenter, randomized, placebo-controlled trial in 658 individuals aged 45-74 years with prediabetes (IFG or IGT), were randomized to either metformin monotherapy, linagliptin monotherapy, fixed-dose combination of linagliptin/metformin or masked placebo. Main outcomes: 1-year reduction in the risk of small fiber peripheral neuropathy (SFPN) estimated by foot electrochemical skin conductance &lt;70 µSiemens, measured with the SUDOSCAN® and estimated glomerular filtration rate (eGFR).
Results: The percentage of people at high-risk of SFPN increased by 29.6% in the placebo group, while the increase was significantly lower in the three active-drug groups:1.8% in the metformin group, 4.3% in the linagliptin group, and 3.9% in the combination linagliptin/metformin group (p&lt;0.001 for all three comparisons). eGFR remained significantly higher with the fixed-dose combination linagliptin/metformin (3.3 mL/min; 95% CI: 0.38; 6.22, p = 0.03) than with placebo. FPG was significantly lower with metformin monotherapy (-0.3 mmol/L: 95%CI: -0.48; 0.12, p=0.0009), and with the fixed-dose combination metformin/linagliptin (-0,2 mmol/L; 95% CI: -0.37; -0.03, p = 0.0219) than with placebo. Reduction in body weight was significantly greater (-2.0 kg/year, 95% CI:-5.65; -1.65, p=0.0006) with metformin monotherapy, and with the combination metformin/linagliptin (-1.9 kg/year; 95% CI: -3.02; -0.97, p=0.0002) than with placebo.
Conclusion: In people with prediabetes, 1-year treatment with metformin and linagliptin, combined or in monotherapy, was associated with a lower risk of SFPN, and with a better preservation of kidney function than with placebo.

Disclosure
R.Gabriel: None. J.Tuomilehto: Stock/Shareholder; Orion pharma.

Funding
European Commission (FP7EC-GA 279074); Boehringer Ingelheim Germany (1218.166); Merck Healthcare KGaA (EMR200084_621); Instituto de Salud Carlos III (PI11/01653)
44-LB: The Effect of Substituting Water for Diet Beverages on CGM Metrics in People with Type 2 Diabetes (T2D)—The Study of Drinks with Artificial Sweeteners (SODAS)
Authors: ODEGAARD ANDREW , BANTLE ANNE , SEAQUIST ELIZABETH R. , REIKES ANDREW , PEREIRA MARK A. 
Published: June 2023

Objectives: Diet beverages (DB) are the largest contributor to artificial sweetener intake in the U.S. diet. People with T2D are the highest consumers of DB, tending to consume them in place of added sugar, especially sugar-sweetened beverages. However, there is little evidence on the health impact of habitual DB consumption by people with T2D. To inform this topic we conducted a randomized trial.
Methods: The SODAS study is a two-arm parallel trial with a run-in period of 2 weeks and 24 week intervention that randomized 181 adults with T2D (HbA1c 6.5 - ≤ 8.5%), age 35+ years, who were usual consumers of commercial DB to receive and consume either: 1) A commercial DB of choice (24 oz. daily); or 2) Unflavored sparkling or flat bottled water of choice (H2O) (24 oz. daily). Outcomes include measures of clinical diabetes control and mechanisms that may alter clinical risk. Here we report preliminary secondary outcome results from continuous glucose monitor (CGM) metrics. Participants wore a blinded, Abbott Freestyle Libre CGM for 3, 2-week periods (run-in, week 12, week 24). We conducted an intent to treat analysis to assess the between-arm difference in change of CGM metric from baseline-week 12- week 24 via linear mixed regression models.
Results: 179 participants will have complete data when study finishes collection in late March 2023, and 166 had provided complete data at the time of analysis. Participants were a mean age of 58 years, and 55% were men. Time in range (TIR, % of readings 70-180 mg/dL) decreased in both arms and at week 24 the mean TIR for DB was 71.3 (SE 2.8) v. 64.3 (SE 2.8) for H2O, difference of means 7.0 (95% CI -0.7, 14.8), P=0.08). Glycemic variability (%CV) was 27.0 (SE 0.8) for DB at week 24 v. 28.7 (SE 0.8) for H2O, difference in means 1.6 (95% CI -3.8, 0.5), P=0.13.
Conclusions: Preliminarily, in people with T2D who habitually consumed DB, there were no significant differences in CGM metrics when substituting H20 intake for DB.

Disclosure
A. Odegaard: None. A. Bantle: None. E. R. Seaquist: Consultant; Zucara Therapeutics. A. Reikes: Other Relationship; GlaxoSmithKline plc. M. A. Pereira: None.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (R01DK117028)
440-P: Complications of Diabetes after 15 Years—Comparing Telemedicine with Conventional Care
Authors: KESAVADEV JOTHYDEV , SHANKAR ARUN , JOTHYDEV KRISHNADEV , JOSHI SHASHANK R. , KRISHNAN GOPIKA , SANAL GEETHU , BASANTH ANJANA , CHANDRAN GOPIKA B. , JOTHYDEV SUNITHA 
Published: June 2023

Diabetes Tele-Management System (DTMS®), a telemedicine (TM)-based intervention and follow-up program for diabetes management comprising of a multidisciplinary team performs drug titration, provides dietary advice & educates the patients and their caregivers periodically with the help of customized software and user interface. The study was done to examine the long-term effect of TM consultation along with face-to-face consultation (F-F) in metabolic control & prevention of complications. A total of 495 T2D (62.91 ± 11.64 years (Y); 62.2% males, duration of diabetes: 8.41 ± 2.78 Y), were de-identified. The treatment group [TG- 63.41±11.73 Y; 62.92% males; 8.04±1.82 Y of T2D] included T2D with ≥1F-F and ≥5 TM consultations per year. The propensity score-matched control group [CG-62.17±11.50 Y; 58.69% males; 7.98±2.96 Y of T2D] included T2D who were not on regular follow-up with compromised F-F and TM visits. Data of 15±5 years were collected from DTMS and statistically analyzed. Significant improvement (p &lt; 0.001) in clinical parameters including HbA1c, FBS, lipid profile, BP & weight from baseline to 10 Y of follow up was observed in TG. 9.8% in TG and 82.1% in CG had diabetic complications (Table 1). This 15 year long real-world experience reveals a robust difference between the 2 arms providing compelling evidence to fund TM consultations.

Disclosure
J.Kesavadev: None. A.Shankar: None. K.Jothydev: None. S.R.Joshi: Advisory Panel; Biocon, Zydus Cadila, Torrent Pharmaceuticals Ltd, Franco India, Consultant; Glenmark Pharmaceuticals, Twin Health, Speaker's Bureau; Abbott Nutrition, Sanofi, Abbott, Novo Nordisk, Lupin Pharmaceuticals, Inc. G.Krishnan: None. G.Sanal: None. A.Basanth: None. G.B.Chandran: None. S.Jothydev: None.