bluuebunny/crossref_metadata_2025_split huggingface dataset:
113-OR: The OPTIFAST (OP) Total and Partial Meal Replacement Program Improves Cardiometabolic Risk in Adults With Obesity—Secondary and Exploratory Analysis of the OPTIWIN Study
Authors: ARD JAMY D. , NEELAND IAN , ROTHBERG AMY E. , CHILTON ROBERT , DE LUIS DANIEL , HAWKINSON ANDREA H. , COHEN SARAH S. , ERIK JOHANSEN ODD 
Published: June 2023

The effects of weight loss on atherosclerotic cardiovascular disease (ASCVD) risk factors using a partial or total meal replacement program (MRP) are not fully understood. We performed secondary and exploratory analyses of changes in blood pressure (BP), lipids, and global ASCVD risk in a randomized, controlled MRP trial using OP (n=135) compared with a low-calorie food-based (FB) dietary plan (n=138) that resulted in significant weight loss at week (W) 26 (reduction phase) and W52 (maintenance). Baseline characteristics were well balanced (mean [standard deviation] age OP/FB 47 [11]/47 [11] years, BMI 38.4 [5.5]/39.2 [6.2] kg/m2, females 86/79%, 10-year ASCVD risk &lt;5% 87/74%, dysglycemia 52/50%). Changes in risk factors were estimated by a linear mixed model. At W26, systolic/diastolic BP were significantly reduced with OP vs FB (table), and a greater proportion achieved ≤ 130/80 mmHg (66.7% vs 53.6%, OR 2.11 [95% CI 1.10, 4.03], p=0.024). All lipid parameters significantly improved, as did the global ASCVD risk. A similar, but slightly attenuated pattern was observed at W52. In subgroup analysis by age (&lt;40, 40-59, ≥ 60 years), SBP (&lt;/≥ 130 mmHg) and sex, greater treatment effects were generally seen with higher SBP and age, and in men. In people with obesity at low ASCVD risk, OP significantly improved CV risk factors and global ASCVD risk.

Disclosure
J.D.Ard: Advisory Panel; Novo Nordisk, Consultant; Eli Lilly and Company, Intuitive Surgical, Regeneron, Other Relationship; Optum Labs, Weight Watchers International, Research Support; Nestlé Health Science, Boehringer Ingelheim Inc., Epitomee, KVK Tech. I.Neeland: Consultant; Nestlé Health Science, Speaker's Bureau; Boehringer Ingelheim and Eli Lilly Alliance, Bayer Inc. A.E.Rothberg: None. R.Chilton: None. D.De luis: None. A.H.Hawkinson: Employee; Nestlé Health Science. S.S.Cohen: Consultant; Nestlé Health Science. O.Johansen: Employee; Nestlé Health Science.

Funding
Nestlé Health Science
1136-P: Type A Insulin Resistance Masquerading as Type 1 Diabetes Mellitus
Authors: LOS EVAN A. , WIRTHWEIN KACI 
Published: June 2023

More than 150 mutations in the INSR gene encoding the insulin receptor have been identified causing a spectrum of insulin resistance syndromes from mild (type A insulin resistance) to more severe (Rabson-Mendenhall syndrome, Donahue syndrome). Type A insulin resistance typically presents in childhood or early adulthood. We describe a 19-year-old male with type A insulin resistance due to heterozygous INSR gene mutation, c.3470A&gt;G (His1157Arg). This mutation has previously been identified in female patients with hyperglycemia, insulin resistance. The patient presented at age 14 with polyuria, polydipsia, hyperglycemia (glucose 200s) without acidosis, and normal BMI (50th%) and was presumed to have type 1 diabetes. He was treated with insulin though required escalating doses to 2-2.5 units/kg/day and was started on metformin to improve insulin sensitivity which had a minor effect on total daily insulin requirements. HbA1c was typically 7-9% for several years with this treatment plan and BMI remained near 50th%. The patient was subsequently lost to follow-up and after self-discontinuing insulin for approximately 1 year, re-presented with hyperglycemia, the absence of ketonuria or acidosis, elevated insulin level (92.2 μIU/ml), negative islet cell antibodies, HbA1c 10.9%. Notably, he did not have acanthosis nigricans. Subsequent genetic testing revealed a mutation in the INSR gene consistent with type A insulin resistance. This case highlights the importance of considering monogenic forms of diabetes and insulin resistance syndromes in lean patients who require higher-than-expected insulin doses with presumed type 1 diabetes.

Disclosure
E.A.Los: Other Relationship; Medtronic. K.Wirthwein: None.
1138-P: INNOVATIONS—Improving Care of Patients with Type 1 Diabetes Mellitus through Utilization of Telemedicine and Outreach—Twelve-Month Outcomes
Authors: RASBACH LISA E. , PURRINGTON VIRGINIA C. , ADKINS DEANNA , BENJAMIN ROBERT 
Published: June 2023

Despite advances in diabetes treatment options, many youth fail to meet glucose targets and remain at risk of developing complications. Additional diabetes support in the form of telehealth may help youth meet diabetes related goals. Eligible youth had insulin dependent diabetes, Medicaid insurance, were ages 8-18, and willing to use a continuous glucose monitor (CGM). The quality improvement project provided weekly check-ins with a diabetes educator and monthly video visits with a nurse practitioner. Participants also received visit reminder calls. We measured A1c at quarterly clinic visits and tracked ED/hospitalization rates. 12-month data presented. Youth (N=26, 65% female, 88% NHB), aged 8-18 yr, diabetes duration 6.3±4.3 years, 23% were on insulin pumps. There was a significant difference between baseline A1c (mean 12.3%) at 6 months (mean A1c 11.2%) (p=0.02) and at 9 months (mean A1c 11.2%) (p=0.02). There was no significant difference in hospitalization rates during the 12-month intervention. There was no difference in visit adherence at 3, 6, 9, or 12 months during the intervention compared to those times prior. Participants were wearing CGM significantly more 3 months into the intervention compared to 3 months prior (p=0.008). Although not statistically significant, more participants were using CGM consistently at 6, 9 and 12-month time points compared to prior. 27% of participants started insulin pumps during the intervention. An intensive telehealth intervention provided interim improvement in glycemic control. Although not statistically significant, more participants used CGM consistently during the intervention, which could have clinical significance over time. Efforts to improve the durability of technology use and glycemic control warrant exploration.

Disclosure
L.E.Rasbach: None. V.C.Purrington: None. D.Adkins: None. R.Benjamin: None.

Funding
Innovation Health Grant (2933476)
1142-P: Use of a Relational Agent Smart Phone App Aims to Improve Time in Range (TIR) for Youth with Type 1 Diabetes (T1D)
Authors: MACCOLL SOPHIE , SPARTZ BRITANEY , DEWIT EMILY L. , LOCKEE BRENT , WILLIAMS DAVID D. , BARNES MITCHELL S. , CLEMENTS MARK A. 
Published: June 2023

Background: Youth with T1D struggle to achieve blood glucose (BG) TIR targets. However, their inclination for technology makes a glucose self-management app an ideal intervention. We aimed to improve TIR using a relational agent smart phone app. The Happy Bob (HB) app uses Dexcom Continuous Glucose Monitor (CGM) data with personified nudges to gamify engagement for users in BG monitoring.
Method: We collaborated with HB developers to customize an app for youth ≥12 years old with T1D, who use Dexcom and a smartphone. We analyzed participants’ CGM data 28-days pre- and post-enrollment and required at least 7-days of wear time in both 28-day periods.
Results: For a cohort of N=31, average %TIR was (Mean±SD) 54.35±23.61 vs 56.32±22.54 pre- to post-intervention (p=0.3560), with % low and very low showing modest changes (Table 1). We further divided the cohort into 2 groups: those with a change in TIR &lt;5.0% (n=22) vs those with a change ≥5.0% (n=9). Notably, the ≥5.0% group had lower %TIR values pre-intervention compared to the &lt;5.0% group (33.56±11.63 to 62.86±22.00; p=0.0008) and showed an average increase in TIR of 15.1%.
Summary: In this pilot cohort, TIR values did not improve from pre- to post-intervention Future work should examine whether HB has a positive impact when bundled with additional interventions like remote patient monitoring.

Disclosure
S.Maccoll: None. B.Spartz: None. E.L.Dewit: None. B.Lockee: None. D.D.Williams: None. M.S.Barnes: None. M.A.Clements: Consultant; Glooko, Inc., Research Support; Dexcom, Inc., Abbott Diabetes.

Funding
The Leona M. and Harry B. Helmsley Charitable Trust
115-LB: Human Feasibility of a Semiconductor-Based Continuous Glucose Monitoring System
Authors: MUJEEB-U-RAHMAN MUHAMMAD , HONARVAR NAZARI MEISAM , SENCAN MEHMET , NADIR ABDULLAH , HEITHAUS JOHN H. , MARCUS ALAN O. 
Published: June 2023

CGMs have advanced significantly in recent years. However, accuracy, response speed, size, and cost improvements are still required for better adoption and outcomes. We combine semiconductor and nano technologies to create an extremely miniaturized (5x smaller than a rice grain) electrochemical sensing platform, IMSense. It is user-insertable under the skin using a custom injector and is also user-removable. It has a multi-sensor array and sends multiplexed data to an external transmitter which processes and relays it to a reader via BLE. It also has a reference sensor to monitor the system status. We previously validated the system in the lab and in animals. Recently, a study in a cohort of 10 persons (with and without diabetes) was approved. In the study, fingerprick readings from each subject were taken every 15 minutes for one day (6 hours) using a Contour SMBG meter (reference) and compared against readings from IMSense, Dexcom, and Abbott CGMs. The results show that the IMSense tracks the reference precisely. A response curve in a person with diabetes and the Clarke error grid for the study are shown (the correlation coefficient between IMS and reference is 93%). The three glucose sensors and the reference sensor on an IMSense device are used to formulate an accurate combined signal. These results demonstrate the human feasibility of monitoring glucose using an integrated sensor array on a single semiconductor device.

Disclosure
M. Mujeeb-u-rahman: None. M. Honarvar nazari: None. M. Sencan: None. A. Nadir: None. J. H. Heithaus: None. A. O. Marcus: Other Relationship; Integrtated Medical Sensors.

Funding
National Institutes of Health (DK111001)
1150-P: Improving Early Diagnosis of Presymptomatic Stage 2 Type 1 Diabetes with a Sample-Sparing Assay
Authors: TSAI JASON 
Published: June 2023

Teplizumab was approved by the FDA in Nov 2022 as the first therapeutic to delay progression of type 1 diabetes from pre-symptomatic stage 2 to clinical onset stage 3. Nevertheless, individuals with stage 2 type 1 diabetes do not exist in hospital systems, and more than 85% of them do not have family history. Large scale population testing remains the only effective way of identifying eligible patients for disease interventional drugs. Thus, accurate, accessible and low cost tests are urgently needed to implement such screening programs. To that end, we have conducted a pilot retrospective screening efficacy study with blinded serum specimens from the Diabetes Prevention Trial of Type 1 Diabetes (DPT-1) study from the NIDDK central repository. A total of 97 serum specimen from subjects that either developed T1D within 5 years (i.e. 50 progressors) or had at least 5 years of follow-up (i.e. 47 progressors) were included in the study. A subject was considered high-risk for T1D progression if positive for two or more islet autoantibodies, and vice versa. Under this scheme, the multiplex ADAP assay achieved PPV and NPV of 49% and 92% for 5 years progression risks. The matching radiobinding assay (RBA) had PPV and NPV of 50% and 77% in this cohort. The improved NPV stemmed from 12 progressors tested positive for multiple islet autoantibodies by multiplex ADAP but not by RBA. Notably, 6 out of these 12 subjects tested positive for multiple islet autoantibodies by RBA in subsequent sampling events with a median delay of 2.8 years compared to multiplex ADAP.
In summary, the multiplex ADAP assay could be an ideal tool for large scale identification of individuals with stage 2 type 1 diabetes due to its sample-sparing nature (i.e. 4µL serum input), non-radioactiveness, compatibility with widely-available real-time qPCR instruments and favorable risk prediction capability.

Disclosure
J. Tsai: Stock/Shareholder; Enable Biosciences.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (R44DK124009-01)
1162-P: Promoting Career Development of Physicians Engaged in Type 1 Diabetes (T1D) Research—The New DiabDocs Multicenter National K12 Program
Authors: DASANI KOMAL D. , BISHOP FRANZISKA K. , GOLDEN SHERITA , LAFFEL LORI M. , MIRMIRA RAGHAVENDRA G. , STECK ANDREA , TAMBORLANE WILLIAM V. , WILLI STEVEN M. , MAAHS DAVID M. , DIMEGLIO LINDA 
Published: June 2023

Background: Given low rates of physicians entering diabetes research, NIH recently funded a multi-center National K12 “DiabDocs” Program to train and support physician-scientists for productive academic careers in T1D. Specific aims for the program include: 1) Expand the geographical access to diabetes K12 programs in the US, 2) Create a diverse nationwide cohort of promising physician-scientists through shared programmatic training experiences, 3) Develop a national mentor community, 4) Ensure consistency and effectiveness of mentoring, including focused attention on diversity, equity and inclusion.
Methods: DiabDocs program administration is comprised of 2 Program Directors, an Executive Leadership Committee, a National Advisory Committee and Scientific Review Committee. Recruitment for the first cohort of program Scholars began in August 2022. Candidates self-nominated with a Letter of Intent (LOI). Eligible Scholars were then invited to submit a full application and attend a program retreat. Of the 12 LOIs received from 12 different institutions, 10 candidates were invited to submit a full application and attend the program retreat. At the retreat, 19 reviewers from 16 different institutions participated in diversity training, conducted interviews, and gathered as a study section to discuss applications.
Results: Ultimately 4 scholars were selected: 2 with pediatric endocrinology and 2 with adult endocrinology backgrounds. Three scholars are women, and 1 scholar self-identifies as from a group underrepresented in medicine (25%). The next application cycle is planned for Jan-March 2023.
Conclusions: The DiabDocs program will address the critical shortage of trained physician-scientists focused on T1D. We anticipate that the planned program training combined with existing research infrastructures will engage a talented and diverse pool of scholars and accelerate their career trajectories.

Disclosure
K.D.Dasani: None. L.Dimeglio: Advisory Panel; Merck & Co., Inc., Consultant; Abata Therapeutics, Vertex Pharmaceuticals Incorporated. F.K.Bishop: None. S.Golden: Advisory Panel; Abbott Diabetes, Medtronic. L.M.Laffel: Advisory Panel; Medtronic, Lilly Diabetes, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Roche Diagnostics, Provention Bio, Inc., Consultant; Dexcom, Inc., Janssen Pharmaceuticals, Inc., Medscape. R.G.Mirmira: None. A.Steck: None. W.V.Tamborlane: None. S.M.Willi: Advisory Panel; Boehringer Ingelheim International GmbH, Medtronic. D.M.Maahs: Advisory Panel; Medtronic, LifeScan Diabetes Institute, MannKind Corporation, Consultant; Abbott, Research Support; Dexcom, Inc.

Funding
National Institute of Diabetes and Digestive and Kidney Diseases (K12DK133995)
1166-P: Identifying Knowledge Strengths and Deficits of Young Adults with Type 1 Diabetes (T1D)
Authors: KUBOTA-MISHRA ELIZABETH A. , MIRANDA NELLY , HILLIARD MARISA E. , MCKAY SIRIPOOM 
Published: June 2023

Among challenges that young adults with T1D face in their care are expectations for independence with healthcare system navigation and diabetes knowledge competency. This is a particular concern given increased hemoglobin A1c (HbA1c) and complications among young adults. A 50-item diabetes-specific knowledge assessment (KA) was developed and utilized in a young adult diabetes program to identify the areas of strength and deficits to guide education and care. To identify the competency of diabetes knowledge, KA items were categorized to describe strengths, deficits, and variable responses. A retrospective chart review was performed in patients with T1D transferring from Texas Children's Hospital to a single adult endocrinology program. Inclusion criteria included T1D for &gt;1 year and completion of KA by diabetes educator or provider. Each KA item was scored on a 1-4 scale (4 = high). Scores were grouped into 3 categories: strengths as &gt;80% of the young adults scoring ≥3, deficits as &gt;50% score &lt;3, and Variable (V) not meeting criteria for strength nor deficit. Over 4.5 years, 142 patients had KAs (M age 20.5 ± 1.4 yrs, HbA1c = 8.8 ± 1.9%, T1D duration = 10.4 ± 4.7 yrs, 54% pump, 52% CGM). KA strengths (18) included questions addressing insurance card, safe sex practices, teaching treatment of mild hypoglycemia, and insulin pump management. KA deficits (11) included diabetes specific knowledge, alcohol use, tobacco, pregnancy, and acute and chronic complications of diabetes. Variable questions (21) included diabetes pathophysiology, identifying an adult PCP and hospital, and counting carbohydrates. Complications of diabetes, the effect of alcohol on blood glucose, glucagon administration, and pregnancy and diabetes should be re-educated upon transfer to adult healthcare. Questions related to insurance cards, safe sex, and insulin pump management may not need to be immediately prioritized at transfer. Further research with this KA will validate it for implementation in clinics and research.

Disclosure
E.A.Kubota-mishra: None. N.Miranda: None. M.E.Hilliard: None. S.Mckay: None.
1168-P: Time-Limited Eating in Youth with Newly Diagnosed Type 1 Diabetes—Feasibility and Impact on Beta-Cell Function
Authors: BERMAN CASEY , VIDMAR ALAINA , FLORES GARCIA JAQUELIN J. , RAYMOND JENNIFER 
Published: June 2023

Introduction: Time limited eating (TLE) improves β-cell function, increases insulin sensitivity, lowers fasting glucose, and increases time in range in adults with T2D. Objectives: This study aims to evaluate TLE in pediatric new-onset T1D, at which time residual β-cell function may be preserved.
Aim 1) Evaluate feasibility, acceptability, and safety of TLE. Aim 2) Test impact of TLE on β-cell function and insulin sensitivity. Aim 3) Assess effectiveness of TLE on glycemic control.
Methods: A randomized controlled trial of youth aged 12-25 years diagnosed with T1D within 12 months; randomization to intervention (8-hour feed/16-hour fast) or control group (≥12-hour feed) for an 8-week period. Feasibility is evaluated using questionnaires and adherence. Safety is indicated by hypoglycemia frequency. β-cell function is evaluated by mixed meal tolerance test (MMTT) with area under C-peptide curve (AUC). Glycemic control is evaluated by time in range (TIR 70-180 mg/dL) on CGM and HbA1c.
Results: Six youths have entered, three have completed (2 intervention, 1 control). Participants in intervention group adhered to TLE ~94% of time. Both reported TLE felt safe, noted improved stability of glucose, chose to continue TLE after study ended, and would recommend to others with T1D. No increased hypoglycemia frequency noted on CGM. Participant 2 (intervention) had increase in AUC from baseline (87.45 to 152.4) and decrease in HbA1c (-1.3 percentage points), although participant 1 (intervention) had decrease in AUC and no change in HbA1c. Participant 3 (control) had increase in AUC and decrease in HbA1c, both changes less than participant 2. No improvement in TIR on CGM was demonstrated in either group.
Conclusion: This is the only known study evaluating TLE in youth with T1D and has the potential to advance management of T1D by introducing meal-timing early in diagnosis. Thus far the intervention appears feasible and safe, however more data is needed. Recruitment continues to be underway.

Disclosure
C.Berman: None. A.Vidmar: Advisory Panel; Rhythm Pharmaceuticals, Inc., Research Support; Dexcom, Inc. J.J.Flores garcia: None. J.Raymond: None.
1171-P: The Challenges of Implementing a Clinic-Based Peer Support Program for Young People with T1D—The DiaBuddies Study
Authors: COMMISSARIAT PERSIS , OWENS HALEY L. , VOLKENING LISA K. , LAFFEL LORI M. 
Published: June 2023

Aim: Many adolescents and young adults (AYAs) with T1D express a desire to meet others with T1D. We designed a pilot peer support program (DiaBuddies) and assessed feasibility of the match process and program implementation.
Methods: Eligible participants (13-25 years old) were recruited and enrolled virtually. After informed consent, participants completed questions about preferred match type (peer vs mentor vs mentee), personal interests, and reasons for entry. Study staff “matched” AYAs 1:1 based on shared interests and mutual preferences on match type. Matches were introduced by email and encouraged to interact using any modality (e.g., text, video, in-person) and frequency they preferred. Study staff did not monitor interactions.
Results: Eighteen AYAs (94% female, 89% non-Hispanic white, age 18.9±6.0, T1D duration 8.5±3.3 years) were enrolled from April-December 2022. Median time between first contact and consent was 14 days (range 4-63). The majority (83%) preferred a same-age peer match. Reasons for participation included: not knowing many people with T1D, wanting to discuss T1D with people who shared their experiences, and feeling eager to give advice and support. Six pairs (n=12) have been matched; median time between consent and match was 40 days (range 25-133). Unmatched participants (n=6) have been waiting a median of 131 days (range 21-196) for a suitable match. During the study, 2 participants expressed disappointment that their match was not responsive to messages, and 5 participants expressed excitement about knowing someone new with T1D.
Conclusion: The DiaBuddies pilot study presented challenges with virtual recruitment and matching AYAs on shared interests. Open-ended questions limited opportunity to match objectively, affecting participant wait time and possibly decreasing enthusiasm. Future programs should incorporate lessons learned by modifying the match process to better facilitate AYAs’ desired type and frequency of peer support.

Disclosure
P.Commissariat: None. H.L.Owens: None. L.K.Volkening: None. L.M.Laffel: Advisory Panel; Medtronic, Lilly Diabetes, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Roche Diagnostics, Provention Bio, Inc., Consultant; Dexcom, Inc., Janssen Pharmaceuticals, Inc., Medscape.

Funding
JDRF; National Institutes of Health (P30DK036836)