bluuebunny/crossref_metadata_2025 huggingface dataset:
609-P: Effects of Oligomalt (OM), a New Slowly Digestible Carbohydrate (SDC), on Postprandial (PP) Glucose, Insulin, and GLP-1 Trajectories Compared with Maltodextrin (MD) in People with Obesity (PwO) or Type 2 Diabetes (T2D)—A Double-Blind RCT
Authors: ERIK JOHANSEN ODD , NEUTEL JOEL M. , GUPTA SANJAY , MARIANI BARBARA , UFHEIL GERHARD , PERRIN EMILIE , OCAMPO NAOMI , VON EYNATTEN MAXIMILIAN
Published: June 2024

Introduction & Objective: to assess glucometabolic effects of OM, a novel fully digestible SDC.

Methods: In a cross-over RCT, we tested 33g and 50g of OM/MD in PwO (n=26, mean age 44 yrs, BMI 29.9 kg/m2, HbA1c 5.3%), and 50g in people with T2D (n=22, age 61 yrs, BMI 31.8 kg/m2, HbA1c 7.4%). OM/MD was dissolved in water (300mL) and consumed fasted. The primary exploratory endpoint was the incremental area under the curve (iAUC) for glucose, assessed by frequent blood sampling over 3h. Insulin and GLP-1 were also assessed. Analysis was performed by a mixed model (LS mean [95% CI]).

Results: OM elicited a significantly lower PP glucose response vs MD, for both doses in PwO (Fig) (e.g., 0-60 min 33g: ΔGlu iAUC -38% [-12.95 (-19.50, -6.41) mg/dLxh, p=0.0002]; 50g: -28% [-10.07 (-16.52, -3.61), p=0.0027]), as well as for PP insulin response (-60% to -38% across dose, and time periods, Fig [all p <0.05]). The 0-90 min PP GLP-1 response with OM relative to MD was smaller (50g: -24.2% [p=0.0425]; 33g: -22.7% [p=0.1883]), whereas 90-180 min larger (Fig; 50g: +408.6% [p<0.0001]; 33g: +308.0% [p=0.0036]. Patterns were similar in people with T2D.

Conclusion: The results underscore a slow hydrolysis of OM, and support it`s glucometabolic advantages over MD, hence representing a healthier carbohydrate.

Disclosure

O. Johansen: Employee; Nestlé Health Science. J.M. Neutel: None. S. Gupta: None. B. Mariani: None. G. Ufheil: Employee; Nestlé Health Science. E. Perrin: Other Relationship; Nestlé Health Science. N. Ocampo: None. M. von Eynatten: Employee; Nestlé Health Science.
61-OR: Effectiveness of Telemedicine plus Conventional Care vs. Conventional Care Alone in Reducing Complications of Diabetes—A Pilot Study
Authors: KESAVADEV JOTHYDEV , SHANKAR ARUN , SANAL GEETHU , JOTHYDEV KRISHNADEV , BASANTH ANJANA , RAJ K SOURAV , JOTHYDEV SUNITHA
Published: June 2024

Telehealth interventions are increasingly recognized as effective strategies for improving health and ensuring better patient outcomes. This study focuses on Diabetes Tele-Management System (DTMS®), a comprehensive telemedicine program established in Kerala, India in 1997. In this cross-sectional study, T2D for >10yrs were divided into 2groups. One group received Conventional Care (CC): minimum of three physical visits per year. Another group received Telemedicine as an add-on to Conventional Care (TCC): same physical visits plus at least two telemedicine consultations per month. TCC group (n=59; age: 59.86±10.91yrs; 52.5% females; duration: 14.78±3.69yrs) exhibited a 48.4% lower proportion of complications than the CC group (n=65; age: 56.18±10.5yrs; 55.4% females; duration: 11.19±4.57yrs) (p < 0.05). All the subjects were literate with nearly 50 % being graduates. Neuropathy was the most common complication observed, followed by CAD. (Figure) This study over 8-10yrs of follow-up demonstrates that integrating telemedicine with conventional care significantly reduces micro and macrovascular complications in T2D by 48.4 % compared to conventional care. This model may be recommended as a standard of care in diabetes based on evolving evidence as a highly cost-effective strategy.

Disclosure

J. Kesavadev: None. A. Shankar: None. G. Sanal: None. K. Jothydev: None. A. Basanth: None. S. Raj K: None. S. Jothydev: None.
612-P: Impact of Continuous Glucose Monitoring (CGM) vs. Blood Glucose Monitoring (BGM) on Dietary Adherence and Weight during a Medically Supervised Ketogenic Diet Program (MSKDP) in People with Type 2 Diabetes (T2D)
Authors: WILLIS HOLLY J. , MCKENZIE AMY L. , ROBERTS CAROLINE G.P. , ASCHE STEPHEN E. , KRIZKA SHANNON , ADAMS REBECCA N. , VOLK BRITTANIE M. , ZOLLER ALISON R. , ATHINARAYANAN SHAMINIE J. , BERGENSTAL RICHARD M.
Published: June 2024

Introduction: Lifestyle-based interventions that promote nutritional ketosis can be effective for T2D management. This three-month trial compared use of CGM or BGM to support a MSKDP delivered via continuous remote care.

Methods: In this randomized trial, CGM (N=81) or BGM (N=82) data were used by participants and the care team to support dietary adherence and medication management decisions. Differences in 90-day mean blood beta-hydroxybutyrate (BHB) levels and in changes in dietary intake and weight from baseline to three months (Base to M3) were assessed. This is a secondary and exploratory outcome analysis.

Results: Participants in CGM and BGM arms were not different at baseline (Mean + SD): 53 + 10 years old; 10 + 8 years with T2D; HbA1c 8.1% + 1.2%; taking 2.2 + 1.0 diabetes medications. The 90-day mean BHB levels were 0.54 mmol/L for CGM and 0.48 mmol/L for BGM; p=0.24. Energy and carbohydrate intake decreased significantly (Base to M3), with no differences between arms. Weight change did not differ between arms. See Table 1. Mean 90-day BHB levels were negatively correlated with carbohydrate intake (r= -0.26; p=0.02) and weight change (r= -0.28; p=0.01) at M3.

Conclusion: The MSKDP led to large decreases in energy and carbohydrate intake, and both CGM and BGM led to similar BHB levels and weight change.

Disclosure

H.J. Willis: Research Support; Abbott. Other Relationship; Abbott. Research Support; Academy of Nutrition and Dietetics, Dexcom, Inc. A.L. McKenzie: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. Employee; Abbott. C.G.P. Roberts: Other Relationship; Virta Health Corp. S.E. Asche: Stock/Shareholder; Gilead Sciences, Inc., AbbVie Inc., GlaxoSmithKline plc. S. Krizka: None. R.N. Adams: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. B.M. Volk: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. A.R. Zoller: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. S.J. Athinarayanan: Employee; Virta Health Corp. R.M. Bergenstal: Other Relationship; Abbott. Research Support; Arkray Marketing. Consultant; Ascensia Diabetes Care, Bigfoot Biomedical, Inc., CeQur. Other Relationship; Dexcom, Inc., Eli Lilly and Company. Consultant; embecta, Hygieia. Research Support; Insulet Corporation. Consultant; MannKind Corporation. Other Relationship; Medtronic, Novo Nordisk. Consultant; Onduo LLC, Roche Diabetes Care. Other Relationship; Sanofi. Research Support; Tandem Diabetes Care, Inc. Other Relationship; UnitedHealth Group. Consultant; Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S.

Funding

Abbott Diabetes Care
617-P: Impact of Culturally Sensitive, Mobile Health Based Nutrition Platform in Metabolic Health of African Americans in Southeast Virginia
Authors: CASELLINI CAROLINA M. , PARSON HENRI , PETTAWAY JORDAN L. , AUSTIN-STEPHENS ANN-MARIE B. , STEPHENS ED , BARTHOLMAE MARILYN M. , INGRAM AMBER M. , SEARS TANEISHA , HAQUE FERAS , EKDAHL LUKE , AYESHA FNU , SIRAJ ELIAS S.
Published: June 2024

Mobile health (mHealth) lifestyle interventions for obesity have gained popularity. However, acceptance and efficacy of these in minority populations is less known. The aim of this study was to assess efficacy of a 12-week culturally sensitive mHealth dietary intervention on weight in African Americans (AA) Randomized 12-week pilot study of 43 overweight or obese AA. Subjects were randomized to mHealth intervention (INT) or Standard of Care (SOC). INT included virtual session with dietitian, customized meal plans based on personal preferences, and educational videos. SOC included CDC-guidelines on weight loss. Mixed Methods Repeated Measures analysis was used Baseline characteristics were similar between the groups (age 60 years, weight 204 lbs, 84% females, 67% hypertension, 56% dyslipidemia and 25% diabetes). Mean weight loss was 4.4 lbs for INT & 3.2 lbs for SOC. Weight significantly improved in both groups over time (p=0.0002) but there was no significant difference between the groups. 74% of INT and 68% of SOC lost weight (Figure 1) This study shows potential benefit of tailoring mHealth interventions in a minority population. Results should be interpreted within the context of small sample size and short duration. Qualitative feedback from participants led to improvements in INT and a larger and longer 48-weeks study is underway to better assess the efficacy of INT

Disclosure

C.M. Casellini: None. H. Parson: None. J.L. Pettaway: None. A.B. Austin-Stephens: None. E. Stephens: None. M.M. Bartholmae: None. A.M. Ingram: None. T. Sears: None. F. Haque: None. L. Ekdahl: None. F. Ayesha: None. E.S. Siraj: Consultant; Novo Nordisk. Research Support; Novo Nordisk. Consultant; Boehringer-Ingelheim, Eli Lilly and Company.

Funding

Hampton Roads Biomedical Research Consortium (HRBRC)
624-P: Cardiometabolic Improvements Increase with Weight Loss among People with Type 2 Diabetes in a Carbohydrate-Restricted Nutrition Therapy
Authors: ADAMS REBECCA N. , ATHINARAYANAN SHAMINIE J. , ROBERTS CAROLINE G.P. , VOLK BRITTANIE M. , ZOLLER ALISON R. , MCKENZIE AMY L.
Published: June 2024

Background: Recent therapeutic advancements yield cardiovascular benefit with weight loss (WL) significantly greater than the 5% target, but carbohydrate restriction has been associated with improved cardiometabolic markers independent of WL. We explored differences in cardiometabolic outcomes by percent WL in the context of carbohydrate-restricted nutrition therapy (CRNT) delivered via a continuous remote care model at Virta Health.

Method: Percent WL at 1 year was computed among patients with T2D, and they were categorized into 5 WL groups: <5%, 5-9%, 10-14%, 15-19%, & 20+%. We randomly selected 250 patients within each WL group and conducted 8 linear mixed effects models (intent-to-treat analyses) to assess cardiometabolic changes within and between groups (N=1250; 49% female; enrollment mean age=55, BMI=36, HbA1c=7.6%).

Results: All markers improved across WL groups except total cholesterol (TC) and LDL-C. The change in all markers except TC differed by WL group, such that HbA1c, HDL-C, TG, and liver markers improved more with greater WL and LDL-C increased within normal range in the 2 highest WL groups only. TC was unchanged.

Conclusion: Overall, cardiometabolic benefits increased with WL in T2D, but even patients with <5% WL had some clinically significant improvements (e.g., HbA1c -0.7%) in the context of CRNT.

Disclosure

R.N. Adams: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. S.J. Athinarayanan: Employee; Virta Health Corp. C.G.P. Roberts: Other Relationship; Virta Health Corp. B.M. Volk: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. A.R. Zoller: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. A.L. McKenzie: Employee; Virta Health Corp. Stock/Shareholder; Virta Health Corp. Employee; Abbott.
629-P: Serum Creatinine–to–Cystatin C Ratio Is Related to Handgrip Strength as Well as Muscle and Fat Mass in People with Type 2 Diabetes Independently of Glycemic Control and Daily Protein Intake
Authors: MORIYA TATSUMI , SUZUKI AKIHIKO , HITOMI MAMIKO , MATSUBARA MADOKA , MIYATSUKA TAKESHI
Published: June 2024

Sarcopenia is one of the serious diabetic complications and it is related to poorer glycemic control and other diabetic chronic complications. Therefore, it is necessary to diagnose sarcopenia as early as possible in people living with diabetes. Serum creatinine to cystatin C ratio (Scr/Scys) and difference between eGFRcr and eGFRcys (diff. eGFR) were proposed as markers for sarcopenia in person with diabetes. We aimed to examine whether or not Scr/Scys or diff. eGFR predicted muscle and body fat mass in 50 persons with type 2 diabetes (32 male, 63±11 years old, BMI 26.5±5.0 kg/m2, HbA1c 7.7±1.4 %, eGFRcr 57±21 ml/min/1.73 m2, eGFRcys 61±26 ml/min/1.73 m2). 1) HbA1c was correlated with muscle mass (R=0.31, p=0.033), but not handgrip strength.2) Muscle mass was correlated with handgrip strength (r=0.58, p<0.001), but not with body fat mass.3) Both eGFRcr and eGFRcys themselves were not related to muscle and body fat mass, and handgrip strength.4) Scr/Scys was associated with handgrip strength (r=0.62, p<0.001) and muscle and fat mass (r=0.43, p=0.002; r=-0.38, p=0.007, respectively).5) The diff.eGFR was associated with handgrip strength (r=-0.39, p=0.007), but not with muscle and fat mass.6) Daily protein intake evaluated in 24 hr urine collection was related to muscle mass (r=0.47, p=0.019), whereas protein intake at breakfast was not.7) Multivariate analysis showed that Scr/Scys related to muscle mass (p=0.012) independently of both HbA1c (p=0.954) and daily protein intake (p=0.129).

Conclusions: The Scr/Scys could be a reliable marker to reflect handgrip strength as well as muscle and body fat mass. The muscle mass might be maintained in person with enough daily protein intake. These results suggested beneficial findings to diagnose sarcopenia as early as possible in people with type 2 diabetes.

Disclosure

T. Moriya: None. A. Suzuki: None. M. Hitomi: None. M. Matsubara: None. T. Miyatsuka: None.
641-P: Body Image and Insulin Restriction among Adolescents with Type 1 Diabetes
Authors: SANNEGOWDA RACHNA , CAMPBELL MARYJANE , GURNURKAR SHILPA , PIERCE JESSICA S. , WASSERMAN RACHEL M.
Published: June 2024

Introduction: Adolescents with type 1 diabetes (T1D) are at increased risk for disordered eating compared to peers without T1D. We examined whether a single item assessing preference for thinness vs. glycemic control was associated with T1D health outcomes (HbA1c and DKA) among adolescents with T1D.

Methods: 224 adolescents (M age=16.9±1.1, 49% female, M HbA1c=8.5%±1.3) were recruited through the T1D Exchange to complete an online survey, including one item from the Diabetes Eating Problems Survey-R, “I would rather be thin than have good control of my diabetes”, which included a 6-point Likert scale (never to always), and one item from the Diabetes-Specific Risk-Taking Inventory, “Taken less insulin than you knew you needed”, which included a 6-point Likert scale (never to daily). Adolescents also reported whether they experienced DKA in the past year. We obtained HbA1c values from the T1D Exchange Registry database.

Results: Greater priority for thinness was correlated with higher HbA1c (r=0.17, p=0.01). Adolescents who experienced DKA in the past year also reported higher priority for thinness over glycemic levels (M=1.80, SD=1.86) than those who had not experienced DKA (M=0.88, SD=1.35; t(164)=2.43, p < 0.05). Adolescents who reported experiencing DKA in the last year did not differ in how frequently they restricted insulin (M=2.33, SD=1.59) compared to adolescents who had not experienced DKA (M=2.37, SD=1.51; t(163)=0.12, p > .05).

Conclusions: Prioritizing thinness over glycemic health may increase risk for higher HbA1c and DKA; and may be more closely associated with DKA events than restricting insulin. This finding aligns with existing evidence that body image concerns are predictive of diabetes outcomes, and recommendations in ADA guidelines to screen for body image concerns. This single item (prioritizing thinness) may be a useful question for such screening. Future research should examine how body image concerns are linked with disordered eating behaviors and T1D outcomes.

Disclosure

R. Sannegowda: None. M. Campbell: None. S. Gurnurkar: None. J.S. Pierce: None. R.M. Wasserman: None.

Funding

Helmsley Charitable Trust, Type 1 Diabetes Exchange Pilot Award
642-P: Reasons behind Fasting Ramadan against Medical Advice for Individuals under 18 Years with Uncontrolled Type 1 Diabetes—A Tertiary Center Experience
Authors: RAHME ZAHRA , MESBAH NAGLAA , TAHA NEHAD , ALROUDHAN DHERAR
Published: June 2024

Introduction: Although sick and pre-pubertal children are exempted from fasting, many patients with T1D choose to fast.

Objectives: To explore feelings & perceptions towards Fasting Ramadan of children &adolescents with uncontrolled type 1 diabetes (T1D) who insisted on fasting Ramadan against medical advice.

Methods: Before Ramadan, children and adolescents under 18 years with uncontrolled T1D received advice by their healthcare providers to not fast Ramadan to avoid the severity of acute complications. Shortly after the end of the month of Ramadan, the patients who fast against medical advice were invited to attend a focus group to discuss emotions towards fasting Ramadan. Data from the focus group was analyzed using thematic analysis.

Results: Forty-four patients with T1D duration 5.25 ± 4.32 y (age 12.7 ± 3.78 y); HbA1c 7.96% ± 1.34% (before Ramadan) participated in prior Ramadan education. 34% fasted against medical advice; 70.2% intend to fast again in the following years. The 4 main themes emerged from the focus group: 1- Proud to meet a religious obligation of Islam, 2-feeling happy sharing their fasting experience with the community and avoiding social stigma, 3-feeling "normal" as all their peers, 4- readiness to follow strict instructions to control diabetes to be able to fast again.

Conclusion: Although of the current Fasting Ramadan guidelines clearly highlight the risk of fasting Ramadan for T1D, especially in uncontrolled patients, still, many T1D individuals insist on fasting due to social stigma and misconceptions of religious rules, regardless of the risk they may face. Therefore, we need to develop a new protocol and guidelines to closely follow up with those individuals during fasting days. Adding to that the importance of Muslim Clerics' role in clarifying the opinion of religion in fasting Ramadan for people with chronic diseases to help them in improving acceptance and adherence to medical advice regarding fasting.

Disclosure

Z. Rahme: None. N. Mesbah: None. N. Taha: None. D. Alroudhan: None.
652-P: Impact of a Six-Month Digital Health Coaching Program on Individuals with Type 2 Diabetes Mellitus Experiencing Food Insecurity in Rural Areas
Authors: MOORE JASMINE , RUTLAND SARAH , MURPHY JANE , TARASOVICH MERCEDES
Published: June 2024

Individuals with type 2 diabetes mellitus (T2DM) experiencing food insecurity often have worse health outcomes than those not experiencing food insecurity. These poor outcomes are often exacerbated among individuals who live in rural areas. Current studies have evaluated the impact of digital health coaching (DHC) and food delivery programs as separate interventions. This study was conducted to assess the impact of a combined health coaching and food delivery intervention on individuals with T2DM who live in rural areas. In this retrospective analysis, individuals were referred by a national insurance payor and screened for food insecurity by a social worker, provider, or payor record. Participants were considered to live in a rural area if they lived outside of a US Census Bureau Urbanized Area (an urban area of 50,000 or more people). Patient reported outcome measures were collected at baseline and 6 months after starting the program. Paired t-tests were used to determine significant differences. At 6 months, 1093 participants were enrolled in the DHC and food delivery program. Of those enrolled, 31% lived in a rural area. Rural participants had significant improvements in HbA1c (7.49 to 6.93, P<0.0295), diabetes distress (2.71 to 2.01, P<0.0001), and food insecurity (2.46 to 1.20, P<0.0024). There were also significant improvements in the PROMIS mental health score (43.04 to 46.30, P=0.0024) and PROMIS physical health score (40.07 to 43.61, P=0.0007). While previous studies have focused on the impact of health coaching or food delivery, few assessed the impact of a combined intervention, and most studies had a small percentage of rural participants. Participants who completed the 6-month intervention had significant improvements among food insecurity and diabetes related quality of life metrics. A combined intervention may lead to improved mental and physical health outcomes among rural populations with T2DM and food insecurity.

Disclosure

J. Moore: None. S. Rutland: Employee; Quest Diagnostics. J. Murphy: Employee; Quest Diagnostics. M. Tarasovich: Employee; Quest Diagnostics.
658-P: Diabetes Distress and Hearing Impairment—Differential Racial/Ethnic Associations in Adults with Diabetes
Authors: JACOBS MOLLY M. , ELLIS CHARLES , EVANS ELIZABETH
Published: June 2024

Introduction: Substantial literature has documented the association between diabetes and hearing impairment, however, the relationship between diabetes distress and hearing impairment is poorly understood.

Methods: The 2021 National Health Interview Survey (NHIS) included diabetes distress, hearing impairment, and demographic/household characteristics. Multilevel, binary dependent variable regressions evaluated these association between diabetes distress and hearing impairment controlling for age, income, residence, marital status, rurality, educational attainment, insurance, and household composition. Interaction terms tested for sex, race, income, and residential differences in these associations. Finally, the association between hearing aid use and distress was tested.

Results: Over 25% of adults with diabetes in the sample reported hearing difficulty and 30% reported diabetes distress. Results indicated that diabetes distress was significantly more likely among female (OR=1.44, CI=1.20, 1.74), low income earning (OR=1.97, CI=1.47, 2.55), Black (OR=1.46, CI=1.12, 1.93) and Hispanic (OR=1.47, CI=1.07, 2.04) individuals with diabetes compared to their counterparts. Diabetic individuals with hearing impairment (OR=1.48, CI=1.18, 1.85) were comparatively more likely to report distress particularly among females (OR=1.31, CI=1.68) and Hispanic (OR=1.63, CI=1.08, 3.15) respondents. However, when diabetics with hearing impairment used a hearing aid, they were nearly 20% less likely (OR=0.83, CI=0.57, 0.99) to report diabetes related distress than those without assistive devices.

Conclusion: Diabetes distress was significantly more likely among individuals with hearing impairment, particularly hearing-impaired female, and Hispanic respondents. Hearing aid usage decreased the likelihood of distress suggesting that potential communication difficulties could potentially explain the observed differences in distress.

Disclosure

M.M. Jacobs: None. C. Ellis: None. E. Evans: None.
67-PUB: Ambulatory Blood Pressure Monitoring among Type 2 Diabetes Mellitus Patients in India—A Prospective Observational Study
Authors: PATNI BIJAY , SAXENA ASHISH K. , KUMAR SINGH NAGENDRA , SINGH AKASHKUMAR N. , VERMA NARSINGH , MAHESHWARI ANUJ
Published: June 2024

T2DM increases the risk of HTN, with 35-75% of diabetes-related complications linked to HTN. Traditional HTN measurement methods, including single-office BP measurements, may be fallacious and miss out on masked HTN and desynchrony in nocturnal BP. This multicentric, cross-sectional study aimed to assess different BP parameters in Indian patients with T2DM. A total of 229 T2DM patients (mean age [range]: 56.8 [17-88] years and 139 were men) with normal clinical BP (<140/90 mmHg) who visited the investigating doctors for routine clinical management of T2DM over 6 months were included and further referred for ABPM. The 24-hour (h) ABPM device was connected to the patient at the clinic during a routine visit and was collected the following day. The ABPM report was sent to the treating doctor, and the collected data was analyzed using an Excel spreadsheet. HTN defined by either elevated 24-h mean or daytime or nighttime BP was detected in 138 (60.27%) patients who were normotensives during the office visit. The majority of these were either female patients (n=45), and/or who were aged >60 years. Among 229 patients, the observed nocturnal BP patterns exhibited as follows: normal dippers (10-20%) were seen in 66 patients (28.8%), excess dippers (>20%) in 4 patients (1.74%), non-dippers (<10%) in 112 patients (48.9%), static BP (no BP fluctuations) in 4 patients (1.74%), and BP risers at night in 43 patients (18.77%). Only 66 patients (28.8%) had normal dipping circadian BP patterns. HCPs often label patients as normotensive based on a single clinic-based reading, but this can be misleading. A significant number of T2DM patients labeled normotensives may be hypertensives or have nocturnal BP desynchrony, negatively impacting their prognosis. Physicians should therefore check the BP of their T2DM patients in each visit and on suspicion of HTN mediated organ damage; subject the patient to 24-h ABPM study to detect such cases which are missed out by taking office BP.

Disclosure

B. Patni: None. A.K. Saxena: None. N. Singh: None. A.N. Singh: None. N. Verma: None. A. Maheshwari: None.
70-OR: PROTECT Per-Protocol Analysis—Preserving ß-Cell Function in Children and Adolescents with Newly Diagnosed Stage 3 Type 1 Diabetes (T1D)
Authors: HEROLD KEVAN C. , DAYAN COLIN , CHATENOUD LUCIENNE , GITELMAN STEPHEN E. , SUMNIK ZDENEK , SIMMONS KIMBER M. , SZYPOWSKA AGNIESZKA , KNECHT LAURA , NIEMOELLER ELISABETH , TIAN WEI , RAMOS ELEANOR L.
Published: June 2024

Background & Aims: Teplizumab is an anti-CD3 mAb approved for delaying onset of Stage 3 T1D in people ≥8 years old with Stage 2 T1D. In the PROTECT study intent-to-treat (ITT) population, teplizumab demonstrated significantly greater β‑cell function preservation vs placebo (PBO; least-squares mean difference of C-peptide ln(AUC+1) change from baseline to Week 78 between teplizumab and PBO was 0.13 pmol/mL; p<0.001). In the ITT population, insulin dose was lower with teplizumab vs PBO from Week 12. Here we explore reduction in insulin dose and sustained glycemic control in the per-protocol (PP) population.

Methods: The Phase 3 PROTECT study (NCT03875729) of 8-17-year-olds with Stage 3 T1D, diagnosed ≤6 weeks, randomized participants 2:1 to two 12-day courses of teplizumab or PBO. The PP population excluded those who received incorrect treatment, took prohibited medications, became pregnant, or had <80% treatment compliance.

Results: In the PP analysis, teplizumab showed consistent results in reduced insulin dose, and greater % time in range (TIR) vs the PBO group (Table); HbA1c levels were not significantly different between groups.

Conclusions: Participants treated with teplizumab showed greater β-cell function preservation and clinically relevant metabolic outcomes including lower insulin doses and greater TIR vs PBO.

Disclosure

K.C. Herold: Consultant; Sanofi. C. Dayan: Consultant; Provention Bio, Inc., Sanofi. Other Relationship; Dompé. Advisory Panel; Avotres Inc., Amgen Inc. L. Chatenoud: Consultant; Provention Bio, Inc., Sanofi. S.E. Gitelman: Advisory Panel; Abata Therapeutics, Avotres Inc., Genentech, Inc., GentiBio, SAB Biotherapeutics, Inc., Sanofi. Z. Sumnik: None. K.M. Simmons: Advisory Panel; Provention Bio, Inc. Consultant; Provention Bio, Inc. Research Support; Provention Bio, Inc., Novartis AG. Consultant; Medtronic. A. Szypowska: Speaker's Bureau; Abbott. Advisory Panel; Dexcom, Inc., Medtronic. Speaker's Bureau; Sanofi, Novo Nordisk. Advisory Panel; SYNOPIS Pharma, Proglikemia. Research Support; Provention Bio, Inc. L. Knecht: Employee; Sanofi, Provention Bio, Inc. E. Niemoeller: Employee; Sanofi-Aventis Deutschland GmbH. Stock/Shareholder; Sanofi. W. Tian: Employee; Sanofi. E.L. Ramos: None.

Funding

Provention Bio, a Sanofi company
706-P: Incidence of Those Who Delay in Seeking Treatment in Treatment-Naive Type 2 Diabetes Mellitus Patients—A Clinic-Based Cross-Sectional Descriptive Study in India
Authors: PATIL SHUBHASHREE M. , SABOO BHARAT , PATIL AASHNA , AHMED JAMIL AHMED ANSARI AYAZ , GANGURDE APARNA C. , SANGHAVI PRITI , SINGH MRINALINI , BAGRI SEEMA A. , DBRITTO SYBAL N. , SURYA SHAIKH RUKIYA M. , SHAH TANUJA N. , KOLHE CHARUSHEELA N. , BAMBHANIA HARDIK T. , GAJARE ROHINI S. , JASHNANI SEEMA M. , SHAH KINNARY R. , SHAH PRANJALI K. , KHOT SANJYOTI S.
Published: June 2024

Objective: This clinic-based cross-sectional descriptive study aimed to assess the incidence of delayed treatment-seeking behavior among treatment-naive patients with Type 2 Diabetes Mellitus (T2DM) in India.

Methods: This multi-centric, prospective cross sectional real world study was conducted across 20 sites in Mumbai, a metro in western India. Drug naive T2DM Patients who come to study sites for routine consultation were enrolled into the study post taking a study participation consent. Data from 7th September ‘23 to 31st December ‘23 analyzed.

Results: In this study involving 269 enrolled patients (average age 46.3 years, 58% male), the mean HbA1c was 9.5%. Notably, 30% reported delaying treatment by over 3 months after diagnosis. The distribution of the time of diagnosis was as follows: within a month - 41%, 1-2 months - 29%, 3-6 months - 12%, and >6 months - 19%. The mean delay period was 2.2 months. Among patients who delayed treatment, 57% have tried alternative treatments and 43% had relied on lifestyle/diet changes only. Among the alternative treatments tried, 70% had tried Ayurveda, 18% had used homemade remedies, and 12% had tried Homeopathy.

Conclusion: The study highlights a substantial delay in seeking treatment among newly diagnosed T2DM patients in a Metro in India where access to specialists is good. These delays lead to poorer initial glycemic control. This study emphasizes the importance of enhanced population education to start early intervention in the management of T2DM to prevent complications and improve long-term outcomes.

Disclosure

S.M. Patil: None. B. Saboo: None. A. Patil: None. A. Ansari: None. A.C. Gangurde: None. P. Sanghavi: None. M. Singh: None. S.A. Bagri: None. S.N. Dbritto: None. R.M. Surya Shaikh: None. T.N. Shah: None. C.N. Kolhe: None. H.T. Bambhania: None. R.S. Gajare: None. S.M. Jashnani: None. K.R. Shah: None. P.K. Shah: None. S.S. Khot: None.
708-P: Association of Hypoglycemia Problem-Solving Abilities with Severe Hypoglycemia in Adults with Type 1 Diabetes—A Poisson Regression Analysis
Authors: SAKANE SEIKO , SAKANE NAOKI
Published: June 2024

Background: Severe hypoglycemia (SH) poses a significant challenge in the management of type 1 diabetes (T1D); however, the factors that offer protection other than diabetes technologies are under-studied. The primary objective of this study was to examine the association between hypoglycemia problem-solving (HPS) abilities and severe hypoglycemic events in adults with T1D using Poisson regression analysis.

Methods: In this cross-sectional study, 287 adults with T1D (mean age: 50.3 ± 14.5 years, male: 36.2%, diabetes duration: 17.5 ± 11.2 years, mean HbA1c: 7.7 ± 0.9%) were included and categorized into two groups: non-SH (n = 262) and SH (n = 25). Data on diabetic complications, the hypoglycemia problem-solving scale (HPSS), and treatment details were collected. Impaired awareness of hypoglycemia (IAH) was evaluated using Gold's method. Univariate and multivariable Poisson regression models were used for the analysis, and the findings were presented as incidence rate ratios (IRRs) at 95% confidence intervals (CIs).

Results: The incidence of SH was 16.7 (95% CI: 7.5-26.0) per 100 person-years. Univariate Poisson regression analysis associated IAH, diabetic peripheral neuropathy (DPN), problem-solving perception score of HPSS (HPSS1), real-time continuous glucose monitoring use, continuous subcutaneous insulin infusion usage with SH, whereas multivariate Poisson regression analysis significantly associated the HPSS 1 score (IRR: 0.51, 95% CI: 0.34, 0.76; P = 0.001) and DPN (IRR: 4.65, 95% CI: 1.96-11.04; P < 0.001) with SH.

Conclusion: We identified HPS abilities, in addition to DPN, were associated with SH in adults with T1D.

Disclosure

S. Sakane: None. N. Sakane: None.
719-P: Metabolomic Characteristics Associated with Changes in Fasting Blood Glucose in a 12-Month Lifestyle Intervention Trial
Authors: LEWIS KIMBERLY A. , STROEBEL BENJAMIN M. , ZHANG LI , KANAYA ALKA M. , FLOWERS ELENA
Published: June 2024

Introduction & Objective: Lifestyle interventions are effective type 2 diabetes (T2D) prevention strategies, yet little is known about metabolic pathways associated with intervention response in at-risk individuals. The study's purpose was to characterize the baseline metabolome in adults at risk for T2D who responded to a 12-month lifestyle intervention randomized controlled trial with significantly reduced fasting blood glucose (FBG).

Methods: This study analyzed de novo untargeted primary metabolome data from 113 plasma samples stored in a biorepository. The parent study recruited participants from San Diego and San Francisco communities between 2009-2012. Data were acquired via the West Coast Metabolomics Core Laboratory using validated liquid chromatography mass spectrometry methods and 15-25 internal standards. Metabolites were quantified by peak heights. Relative concentrations were compared between lifestyle intervention responders and non-responders using independent t-tests and then adjusted for multiple comparisons.

Results: Six metabolites were significantly different (unadj p<0.05) between the group of responders and non-responders (pelargonic acid, oleic acid, lysine, hypoxanthine, heptanoic acid, 3-hydroxybutyric acid).

Conclusions: At-risk adults in our sample who responded to a lifestyle intervention with significantly decreased FBG exhibited baseline differences in primary metabolism compared with those that did not respond. Findings align with our previously work in this sample characterizing the gene targets and microRNAs, which implicated novel pathways of neurodegenerative and protein misfolding disorders, as well as immune function and inflammation pathways known to be associated with T2D. Findings may help to refine target biological pathways for prevention therapies or define a subtype of participants who are best suited for lifestyle interventions to manage T2D risk.

Disclosure

K.A. Lewis: None. B.M. Stroebel: None. L. Zhang: None. A.M. Kanaya: None. E. Flowers: None.

Funding

Larry L. Hillblom Foundation (2022-D-011-FEL)
733-P: Efficacy and Safety of HS-20094 in Patients with Type 2 Diabetes—A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial
Authors: LIU LIN , SHI XIAOXIA , HE FEI , CHENG ZHIFENG , SONG WEIHONG , WANG ZHONGJING , CUI YIMIN , ZHANG JUNQING
Published: June 2024

Introduction and Objective: HS-20094 is a novel dual GIP and GLP-1 receptor agonist. A 4-week POC study was conducted to assess the preliminary efficacy and safety of HS-20094 in patients with type 2 diabetes (T2DM).

Methods: This was a randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov number, NCT06118008). Patients with T2DM poorly controlled with diet and exercise alone or with stable metformin (HbA1c ≥7.0 to ≤10.0%) were randomly (4:1:1) assigned within each cohort to receive HS-20094 (5mg, 10mg or 15mg), semaglutide (1.0mg), or placebo subcutaneously once-weekly. The primary outcome was the change in HbA1c from baseline to week 4. Efficacy results between groups were compared using analysis of covariance (ANCOVA) with baseline value as a covariate and status of metformin use as a fixed effect.

Results: Totally, 54 subjects received at least one dose of HS-20094, semaglutide or placebo. Least square mean (LSM) change in HbA1c was -0.63%, -0.75%, -0.84%, and -0.59% in HS-20094 of 5mg, 10mg, 15mg and semaglutide, respectively (all p<0.01 vs placebo). LSM change in fasting blood glucose in corresponding cohort was -2.87, -2.25, -2.79, and -1.92mmol/L, respectively (all p<0.01 vs placebo). LSM percent change in body weight was -1.27%, -2.51%, -4.41%, and -1.35%, respectively (p = 0.192, p= 0.016, p<0.001, and p = 0.179 vs placebo). The occurrence of adverse events (AEs) was not dose-dependent in HS-20094. The most common AE included decreased appetite, abdominal distension and vomiting. No severe hypoglycemia was reported.

Conclusion: In patients with T2DM, HS-20094 was generally safe and showed meaningful HbA1c, fasting blood glucose and body weight reductions.

Disclosure

L. Liu: None. X. Shi: None. F. He: None. Z. Cheng: None. W. Song: None. Z. Wang: None. Y. Cui: None. J. Zhang: None.
737-P: Acute Healthcare Utilization, Mortality, and Cardiovascular Events following GLP-1-RA Initiation by Patients with Advanced Chronic Kidney Disease—A Real-World Comparative Study
Authors: ZHANG SHUYAO , SIDRA FNU , ALVAREZ CARLOS A. , KINAAN MUSTAFA , LINGVAY ILDIKO , MANSI ISHAK
Published: June 2024

Introduction & Objective: Treatment with glucagon-like peptide-1 receptor agonists (GLP1-RA) in patients with type 2 diabetes and chronic kidney disease (CKD) may attenuate the progression of renal disease and cardiovascular events but their real-world impact on healthcare utilization and mortality in this population are not well-defined. This study aims to compare outcomes following initiation of GLP1-RA vs Dipeptidyl peptidase-4 inhibitors (DPP4i), as active comparators, in patients with diabetes and advanced CKD.

Methods: Retrospective cohort study using data from Veterans Health Administration during fiscal years 2006 to 2021. Inclusion criteria included U.S. veterans aged 35 years or older with advanced CKD who filled either GLP1-RA or DPP4i prescriptions. The primary outcome was acute healthcare utilization. Secondary outcomes were all-cause mortality and acute cardiovascular events (not including death).

Results: The eligible cohort included 26,997 GLP1-RA users and 37,708 DPP4 users. After propensity score matching (16,076 pairs) and 2.2 years mean follow-up duration, use of GLP1-RA was associated with lower annual rate of acute healthcare utilization (coefficient of regression β = -0.15, 95% CI -0.25 to -0.05, p=0.004) and lower all-cause mortality as compared to the DPP4i group (OR 0.84, 95% CI 0.79 to 0.89, p<0.01) with time-to- death analysis showing a HR of 0.86 (95%CI: 0.82-0.90, p <0.001). There was no significant difference in cardiovascular events between groups (OR 0.98, 95% CI 0.92 to 1.06, p=0.66). Conclusions: Use of GLP1-RA in patients with advanced CKD was associated with lower annual rate of acute healthcare utilization and decreased all-cause mortality. There was no significant difference in cardiovascular events between the matched groups.

Disclosure

S. Zhang: Stock/Shareholder; Eli Lilly and Company, Novo Nordisk, Amgen Inc. F. Sidra: None. C.A. Alvarez: Research Support; Boehringer-Ingelheim, Bristol-Myers Squibb Company, Merck & Co., Inc. M. Kinaan: None. I. Lingvay: Consultant; Altimmune, Astra Zeneca, Bayer, Biomea, Boehringer-Ingelheim, Carmot, Cytoki Pharma, Eli Lilly, Intercept, Janssen/J&J, Mannkind, Mediflix, Merck, Metsera, Novo Nordisk, Pharmaventures, Pfizer, Sanofi. Research Support; NovoNordisk, Sanofi, Mylan, Boehringer-Ingelheim. Consultant; TERNS Pharma, The Comm Group, Valeritas, WebMD, and Zealand Pharma. I. Mansi: None.
745-P: Effects of Liraglutide on GLP-1, GIP, and Glucagon Concentrations in Persons with Type 2 Diabetes with Multiple Daily Insulin Injections during a 24-Week Period
Authors: KOCI MARSEL , HIRSCH IRL B. , SEYED AHMADI SHILAN , LIND MARCUS
Published: June 2024

Introduction and Objective: Although there is extensive knowledge of metabolic and cardiovascular effects of GLP-1 analogues, placebo-controlled trials are sparse examining how endogenous incretins are affected during therapy. The aim of this study was to evaluate the concentrations of GLP-1, GIP and glucagon in liraglutide treated persons with type 2 diabetes (T2D) and associations with changes in glycemic control.

Methods: The current analysis included 106 patients with available biobank samples of the 124 persons with T2D who took part in the double-blind placebo-controlled MDI liraglutide trial. Differences in GLP-1, GIP and glucagon between treatment groups were evaluated using analysis of covariance, adjusting for baseline values. Linear regression was used to evaluate baseline concentrations of GLP-1, GIP, and glucagon as possible predictors for a greater or smaller treatment effect of liraglutide on HbA1c.

Results: At 12 weeks GLP-1 was 25% lower (95% CI 9-37%, p=0.003) and GIP 39% higher (95% CI 8-79%, p=0.012) in the liraglutide group compared to the placebo group. At 24 weeks differences were sustained. Glucagon was lower in the liraglutide group at 12 weeks (p=0.052) but reached similar levels as the placebo group after 24 weeks (p=0.98). In the liraglutide group mean Hba1c decreased from 9.0% to 7.4%. Each 30% decrease in glucagon concentration at baseline was associated with 0.3% greater reduction in HbA1c at 24 weeks of treatment with liraglutide compared to placebo (95% CI 0.1-0.5%, p=0.001).

Conclusion: An essential mechanism of metabolic effects of GLP-1 analogues is potentially mediated via increased GIP levels in persons with T2D. According to our findings serum glucagon levels may be an important biomarker for GLP-1 analogue responders.

Disclosure

M. Koci: None. I.B. Hirsch: Advisory Panel; Abbott. Research Support; Dexcom, Inc. Advisory Panel; Roche Diabetes Care. Research Support; MannKind Corporation, Tandem Diabetes Care, Inc. Advisory Panel; embecta. Research Support; Tandem Diabetes Care, Inc. Advisory Panel; Vertex Pharmaceuticals Incorporated. S. Seyed Ahmadi: None. M. Lind: Consultant; AstraZeneca, Boehringer-Ingelheim, Eli Lilly and Company. Research Support; Eli Lilly and Company. Consultant; Novo Nordisk. Research Support; Novo Nordisk. Consultant; Nordic InfuCare.
755-P: GLP-1RA Therapy Recovers Vascular Regenerative Cell Content in High Cardiovascular–Risk Individuals with Type 2 Diabetes
Authors: KRISHNARAJ AISHWARYA , PARK BRADY , BAKBAK EHAB , VERMA RAJ , QUAN ADRIAN , TEOH HWEE , HESS DAVID A. , VERMA SUBODH
Published: June 2024

Objective: GLP-1RAs are recommended as first-line therapy for cardiorenal risk reduction in people with T2D. We have shown that SGLT2 inhibitor therapy increased circulating vascular regenerative (VR) cell content in individuals with T2D. The ORIGINS-RCE trial recently reported that VR cell content was decreased in South Asian (SA) individuals compared to people of White European (WE) origin. This sub-analysis sought to determine the impact of GLP-1RA and SGLT2 inhibitor therapy on VR cell content in SA vs. WE individuals with T2D.

Methods: ORIGINS-RCE enrolled 120 individuals of SA or WE ethnicity with T2D and/or CVD. Within this cohort, 88 had T2D amongst whom 22 were on a GLP-1RA, 39 on an SGLT2 inhibitor, and 27 on neither. Multi-parametric flow cytometry was used to enumerate pro-vascular vs. pro-inflammatory progenitor cell subsets.

Results: The absolute count of VR cells (ALDHhiSSClowCD133+ cells/106 MNC) in the GLP-1RA group (310 ±56) was similar to that in the SGLT2 inhibitor group (244 ± 23; P=0.32), but greater than that in the neither therapy group (216 ± 33; P=0.027). The GLP-1RA group also had greater endothelial progenitor cell content (ALDHhiSSClowCD34+CD45-CD133+; 11 ± 3) compared to the neither therapy group (7 ± 2; P=0.011). The pro-inflammatory burden of ALDHhiSSChi precursor cells in the GLP-1RA group (41845 ± 12616) was lower than that of the neither therapy (53900 ± 7249; P=0.015). While there was no difference in ALDHhiSSClowCD133+ content between WE and SA individuals within the GLP-1RA and neither therapy groups, there were less of these cells among the SA (vs. WE) individuals in the SGLT2 inhibitor group (202 ±28 vs. 318 ± 31; P=0.010), suggesting a lack of a protective response of SGLT2 inhibitor therapy in SA people.

Conclusion: In individuals with T2D, VR progenitor cell content varied according to medication use and ethnic origin. These data uncovered conserved cardioprotective benefits of GLP-1RA therapy in high-risk SA individuals.

Disclosure

A. Krishnaraj: None. B. Park: None. E. Bakbak: None. R. Verma: None. A. Quan: None. H. Teoh: Other Relationship; Canadian Medical and Surgical Knowledge Translation Research Group. D.A. Hess: None. S. Verma: Other Relationship; Amarin Corporation, Amgen Inc., AstraZeneca, Bayer Inc., Boehringer-Ingelheim, Canadian Medical and Surgical Knowledge Translation Research Group, Eli Lilly and Company, HLS Therapeutics Inc., Janssen Pharmaceuticals, Inc., Novartis AG, Novo Nordisk, Pfizer Inc., PhaseBio Pharmaceuticals, Inc., S&L Solutions Event Management, Sanofi.

Funding

CIHR (#369189 and #186065); Heart and Stroke Foundation (#G-23-0035127)
765-P: Efficacy and Safety of Switching to iGlarLixi from Premixed Insulin (PI) in South Korean People Living with Type 2 Diabetes (T2D)—Subanalyses of Soli-SWITCH Study
Authors: LIM SOO , HALUZIK MARTIN , YUN JAE-SEUNG , LEE JIHYUN , KIM SANGYONG , ALVAREZ AGUSTINA , LAUAND FELIPE , REN YAN , JIB YOO SOON
Published: June 2024

Introduction & Objective: iGlarLixi is a once-daily injectable fixed-ratio combination of insulin glargine 100 U/mL + lixisenatide and may be a simplified treatment option vs PI. This sub-analysis of the Soli-SWITCH study (EudraCT number 2021-003711-25) assessed the efficacy and safety of switching to iGlarLixi in people with T2D from South Korea currently receiving once- or twice-daily PI.

Methods: In this phase 4, 24-week, single-arm study, participants switched from PI to iGlarLixi at baseline. Key inclusion criteria: participants aged ≥18 years diagnosed with T2D ≥6 months before the screening visit; had received PI for ≥3 months and <10 years ± oral antidiabetic drugs, with stable doses for 3 months. Participants who experienced severe hypoglycemia within <6 months prior to screening were excluded. The primary endpoint was change in HbA1c from baseline to Week 24. Secondary endpoints included the proportion of participants achieving HbA1c <7% at Week 24 and safety.

Results: From 162 participants, 62 (38.3%) evaluable participants were from South Korea and received iGlarLixi. At baseline, mean HbA1c was 8.6%, standard deviation (SD) ± 0.7%. By Week 12, mean HbA1c had decreased by 1.4% (SD ± 0.8; 95% confidence interval [CI]: -1.5, -1.2). At Week 24, mean HbA1c was reduced from baseline by 1.3% (SD ± 1.0; 95% CI: -1.6, -1.1); similarly, in the total population, mean HbA1c reduced from baseline to Week 24 by 1.2% (SD ± 0.9%; 95% CI: -1.4, -1.1). In the overall population, confirmed symptomatic hypoglycemia occurred in 38.3% of total participants (ADA level 1: 35.8%; ADA level 2: 15.4%; ADA level 3: 0.0%). No new safety signals were observed.

Conclusion: In this sub-analysis of Soli-SWITCH, iGlarLixi demonstrated improved glycemic outcomes in South Korean participants living with T2D switching from PI, and may represent a simplified and efficacious treatment option vs PI in people of Asian ethnicity.

Disclosure

S. Lim: None. M. Haluzik: Advisory Panel; Sanofi, Novo Nordisk, Eli Lilly and Company, AstraZeneca, Bayer Inc., Johnson & Johnson Medical Devices Companies. Consultant; Merck & Co., Inc., Sanofi, Novo Nordisk, Eli Lilly and Company, AstraZeneca, Bayer Inc., Boehringer-Ingelheim, Johnson & Johnson Medical Devices Companies, Novatin. Research Support; Sanofi. Speaker's Bureau; Sanofi, Novo Nordisk. J. Yun: None. J. Lee: None. S. Kim: Research Support; Sanofi, Novo Nordisk, Boryung, Hanmi Pharm. Co., Ltd., Handok, Deawoong. Speaker's Bureau; Boryung, Hanmi Pharm. Co., Ltd., Handok, Sanofi, Novo Nordisk. A. Alvarez: Employee; Sanofi. Stock/Shareholder; Sanofi. F. Lauand: Employee; Sanofi. Stock/Shareholder; Sanofi. Y. Ren: Consultant; Sanofi. Employee; Aixial. S. Yoo: None.

Funding

Sanofi