bluuebunny/crossref_metadata_2025 huggingface dataset:
1040-P: Ultra-Rapid Lispro (URLi) Accelerates Insulin Lispro Absorption and Insulin Action vs. Humalog (Lispro) Consistently across Study Populations: A Meta-analysis of Pharmacokinetic and Glucodynamic Data
Authors: LEOHR JENNIFER , DELLVA MARY A. , CARTER KALLIN , LABELL ELIZABETH S. , LINNEBJERG HELLE
Published: June 2020

URLi is a novel insulin lispro formulation developed to more closely match physiological insulin secretion and improve postprandial glucose control. This meta-analysis compared and assessed the consistency of the pharmacokinetics and glucodynamics between URLi and Humalog® in healthy subjects and patients with T1D or T2D. The analysis included 4 randomized, double-blind, crossover, single dose studies [healthy subjects (n=74), patients with T1D (n=80), and T2D (n=38)], evaluating subcutaneous doses of 7, 15, or 30 U of URLi and Humalog®. An 8 to10-h euglycemic clamp was conducted to assess pharmacodynamics. Meta-analysis showed a ∼5 min faster (95% CI:-5.38, -4.12 min) onset of appearance with URLi vs. Humalog. The early insulin exposure was ∼8 times greater (95% CI:6.63, 8.51) in first 15 min and 3 times greater (95% CI:2.74, 3.22) in the first 30 min after URLi vs. Humalog. URLi reduced the late insulin exposure after 3 hours by 43% (ratio 0.57; 95% CI:0.53, 0.60) and the duration of exposure by 68 min (95% CI:-76.86, -59.53 min) vs. Humalog. URLi had a faster onset of action occurring 10 min earlier (95% CI:-12.01, -8.64 min), and early action was increased 3-fold in the first 30 min (95% CI:2.72, 3.50 min) with URLi vs. Humalog. Late insulin action (glucose infused 4 h to end of the clamp) was reduced by 35% (ratio 0.65; 95% CI:0.61, 0.70) and duration of action was 44 min shorter with URLi (95% CI:-58.60, -29.02 min). Total exposure and glucose infused during the clamp was similar between URLi vs. Humalog across the dose range and in each study population. Across the studied dose range and study populations, URLi consistently had faster absorption, reduced late exposure, and an overall shorter exposure duration compared to Humalog. URLi demonstrated an earlier insulin action while reducing the late insulin action compared to Humalog across the studied dose range and study populations.

Disclosure

J. Leohr: None. M.A. Dellva: Employee; Self; Eli Lilly and Company. K. Carter: None. E.S. LaBell: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company, Johnson & Johnson, Novartis AG. H. Linnebjerg: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company.

Funding

Eli Lilly and Company
1044-P: The Impact of Basal Insulin Type, Prandial Dosing Plan, and Baseline Postprandial Glucose (PPG) on Glycemic Control after Treatment with Ultra-Rapid Lispro (URLi) or Humalog in Type 1 Diabetes: Planned Subgroup Analyses from PRONTO-T1D
Authors: BUE-VALLESKEY JULIANA M. , CHO JANG IK , HARDY THOMAS
Published: June 2020

URLi is a novel prandial insulin lispro formulation developed to more closely match physiological insulin secretion and improve PPG control. In PRONTO-T1D, a phase 3, 26-week, treat-to-target study comparing URLi to Humalog in patients with T1D on a multiple daily injection regimen with insulin glargine or degludec, mealtime URLi was non-inferior to mealtime Humalog for change from baseline HbA1c and superior for PPG control, with a similar safety profile to Humalog. Randomization to treatment was stratified by basal insulin type, baseline HbA1c and prandial insulin dosing plan (carb counting, yes/no). The impact of these subgroups and baseline 2-hour PPG on the efficacy and safety of URLi was assessed from the double-blind treatment groups: mealtime URLi (n=451) and mealtime Humalog (n=442). No significant treatment-subgroup interactions were noted (all p>0.1) but occasional treatment differences were seen within each subgroup (p<0.05) (Table 1.). Numerically, results suggest that basal insulin type, starting PPG, and starting HbA1c, but not prandial dosing plan, may influence the magnitude of the HbA1c improvement and/or hypoglycemia risk reduction among patients treated with URLi.

Disclosure

J.M. Bue-Valleskey: Employee; Self; Eli Lilly and Company. J. Cho: None. T. Hardy: Other Relationship; Self; Eli Lilly and Company.

Funding

Eli Lilly and Company
1049-P: Preexisting Chronic Kidney Disease Stage 3 Does Not Reduce Glycemic Efficacy of Metformin in U.S. Veterans with Type 2 Diabetes
Authors: GOSMANOVA ELVIRA , GEMOETS DARREN E. , KAMINSKY LAURENCE S. , KOVESDY CSABA P. , GOSMANOV AIDAR R.
Published: June 2020

Background: Metformin (MET) is approved for treatment of type 2 diabetes (T2D) in patients with chronic kidney disease stage 3 (CKD3); however, data on its glycemic efficacy in CKD3 is lacking.

Methods: This was a retrospective study including 85,997 U.S. veterans with T2D and estimated glomerular filtration rate (eGFR)≥30 ml/min/1.73m2 treated with MET monotherapy with adequate adherence (defined by proportion of days covered ≥80%) between 01/2010 and 08/2018. CKD3 was defined as eGFR 30-59 ml/min/1.73m2. Twelve-month time-averaged A1c changes from baseline were compared in patients without and with CKD3 using univariate and multivariate linear regression analyses adjusted for case-mix.

Results: The mean±SD age for the total cohort was 60.8±9.9 yrs, 95.2% were males, 76.3 and 13.0% were Whites and Blacks, respectively. Average daily mean±SD MET dose was 1341±202 mg. Pre-existing CKD3 was present in 7,566 (9.7%) of individuals. Baseline characteristics by CKD3 status are shown in Table 1. In unadjusted analysis, mean A1c reduction was 0.59±1.0 vs. 0.52±0.9 % in patients without and with CKD3 (p<0.001). The difference in A1C between two groups was lost after adjustments for baseline characteristics and MET dose (p=0.058).

Conclusions: In this large retrospective study, presence of preexisting CKD stage 3 did not affect glycemic efficacy of metformin monotherapy in T2D patients.

Disclosure

E. Gosmanova: None. D.E. Gemoets: None. L.S. Kaminsky: None. C.P. Kovesdy: Consultant; Self; Amgen, AstraZeneca, Bayer AG, Cara Therapeutics, Reata, Takeda Pharmaceutical Company Limited, Tricida. A.R. Gosmanov: None.
1053-P: Dasiglucagon Hypopal Autoinjector as a Fast and Effective Treatment for Severe Hypoglycemia: Results of a Phase 3 Trial
Authors: BAILEY TIMOTHY S. , WILLARD JULIE , KLAFF LESLIE J. , LIST LENA S. , MELGAARD ANITA E. , TEHRANCHI RAMIN
Published: June 2020

Severe hypoglycemia is a major concern for patients with diabetes on insulin therapy. Rescue requires caregivers to provide effective treatment, including glucagon injections. Dasiglucagon is a stable glucagon analog in development to be administered with the HypoPal® auto-injector for treatment of severe hypoglycemia. This phase 3 trial, ZP4207-17145, assessed the clinical efficacy and safety of 0.6 mg dasiglucagon subcutaneous (SC) administered via the HypoPal® auto-injector compared with placebo. In total, 45 eligible patients with T1D were randomized (3:1) to dasiglucagon or placebo and dosed following induced hypoglycemia. The primary endpoint was time to plasma glucose (PG) recovery, defined as first PG increase ≥20 mg/dL after treatment initiation without rescue glucose. Dasiglucagon injection provided a fast and effective increase in PG. The median time (95% CI) to recovery based on sampling time was 10 (8.0, 12.0) min for dasiglucagon and 35 (20.0, -) min for placebo (p<0.0001). The median (95% CI) estimated true time to recovery (interpolated between sampling times) was 9.3 (7.8, 10.3) min for dasiglucagon and 25.8 (19.2, 34.8) min for placebo. Nausea and vomiting are well-known side effects of glucagon and were reported in 61.8% and 29.8% of patients receiving dasiglucagon, respectively. Nausea was reported in 10% of patients receiving placebo. No safety concerns were raised for dasiglucagon.

In conclusion, dasiglucagon 0.6mg SC administered via the HypoPal® auto-injector provided fast and effective recovery from hypoglycemia. The results are consistent with previously reported results from a pivotal phase 3 trial testing dasiglucagon administered via a pre-filled syringe, NCT03378635, where a median time to recovery of 10 min was also observed.

Disclosure

T.S. Bailey: Consultant; Self; Abbott, LifeScan, Inc., Novo Nordisk A/S, Sanofi US. Research Support; Self; Abbott, Ascensia Diabetes Care, Capillary Biomedical, Inc., Dance Biopharm Holdings, Inc., Dexcom, Inc., Diasome Pharmaceuticals, Inc., Eli Lilly and Company, Kowa Pharmaceuticals America, Inc., Lexicon Pharmaceuticals, Inc., Medtronic, Medtrum, Novo Nordisk A/S, REMD Biotherapeutics, Sanofi-Aventis, Senseonics, Viacyte, Inc., vTv Therapeutics, Zealand Pharma A/S. Speaker’s Bureau; Self; Medtronic, Sanofi US. J. Willard: None. L.J. Klaff: Research Support; Self; Abbott, Ascensia Diabetes Care, Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, REMD Biotherapeutics, Roche Diabetes Care, Sanofi-Aventis, Xeris Pharmaceuticals, Inc., Zealand Pharma A/S. L.S. List: Employee; Spouse/Partner; Novo Nordisk A/S. Employee; Self; Zealand Pharma A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S, Zealand Pharma A/S. A.E. Melgaard: Employee; Self; Zealand Pharma A/S. R. Tehranchi: Employee; Self; Zealand Pharma A/S.
1070-P: Bromocriptine-QR (BQR) Ameliorates a Pro-oxidative Stress/Proinflammatory (POS/PI) Monocyte Phenotype in Poorly Controlled T2DM Subjects
Authors: EZROKHI MICHAEL , CINCOTTA ANTHONY , CERSOSIMO EUGENIO , ADAMS JOHN M. , ALATRACH MARIAM , AGYIN CHRISTINA , TRIPLITT CURTIS L. , COMINOS NICHOLAS , DEFRONZO RALPH A.
Published: June 2020

Background: Elevated sympathetic tone stimulates a POS/PI leucocyte phenotype that promotes cardiovascular disease (CVD) and augments postprandial hyperglycemia in T2D. BQR, a sympatholytic dopamine agonist for treatment of T2DM, improves postprandial dysglycemia and reduces CVD events.

Aim: To examine the effect of BQR on POS/PI phenotype of blood monocytes in T2DM.

Study Design: 15 T2DM subjects treated with a GLP-1 RA received BQR (3.2 mg/day) for 16 weeks. Endothelial function was measured by post-occlusion hyperemia. Blood monocytes were isolated and expression (PCR) of the following genes was quantitated: (i) master antioxidant gene regulators that increase in response to systemic oxidative stress (OS) (oxidation resistance gene 1 [OXR1] and nuclear factor erythroid 2 like 2 [NRF2]); (ii) genes known to induce a proinflammatory profile in T2DM (toll like receptor 2 [TLR2], nuclear factor kappa B p65 [NFkBp65], and L-selectin, a surface adhesion protein that stimulates transendothelial migration and PI biochemistry); (iii) glucocorticoid receptor [GCR] that produces a PI environment.

Results: BQR significantly improved HbA1c (-0.6%; baseline HbA1c=8.3%), postprandial hyperglycemia (by 22%) and endothelial dysfunction (by 36%). BQR reduced OS response gene transcript levels of OXR1 and NRF2 by 30% (P<0.03) and of PI genes TLR2, NFkBp65, GCR, and L-selectin by 40, 33, 26, and 32% respectively (P<0.05). Plasma levels of OS markers (TBARS and nitrotyrosine) and PI cytokines (MCP1 and IL-18) also were significantly reduced (p<0.01-0.05) by BQR.

Conclusion: BQR reduces postprandial dysglycemia, improves endothelial function, and improves multiple aspects of the POS/PI state in T2DM, providing a potential mechanism for BQR’s cardiovascular protective effect.

Disclosure

M. Ezrokhi: Employee; Self; VeroScience LLC. A. Cincotta: Employee; Self; VeroScience LLC. E. Cersosimo: None. J.M. Adams: None. M. Alatrach: None. C. Agyin: None. C.L. Triplitt: Speaker’s Bureau; Self; AstraZeneca, Janssen Pharmaceuticals, Inc., Lilly Diabetes, Xeris Pharmaceuticals, Inc. N. Cominos: Employee; Self; VeroScience LLC. R.A. DeFronzo: None.
1076-P: A 12-Week Treatment with Ciclosporin A Improves Insulin Secretion in Patients with Adult-Onset Autoimmune Diabetes: An Open-Label, Single-Arm, Pilot Study
Authors: ZHANG LEI , MENG WEI , CHEN SHUFANG , YANG YUXIU , WANG JUN , DONG YANHU
Published: June 2020

Objectives: Adult-onset autoimmune diabetes, defined as having latent autoimmune diabetes in adults (LADA), is characterized by a less intensive autoimmune process, in which a lymphocytic infiltration of the exocrine pancreas is involved. immunosuppressive agents may have potential therapeutic benefit. This is a pilot study examining the therapeutic effects of ciclosporin A on insulin secretion in patients with LADA.

Methods: The study was an open label, single arm, pilot trial. A total of 18 patients (12 men and 6 women with mean age of 40.6 yrs old) diagnosed with LADA were prospectively evaluated. All patients underwent insulin treatment at least for 3 months without any oral anti-hyperglycemic agent. All patients were prescribed ciclosporin A (50mg/day) for 12 weeks. Serum C-peptide concentrations were measured at baseline and 3 months after ciclosporin A intervention. We also evaluated total bilirubin (TBIL), direct bilirubin (DBIL), alanine aminotransferase (ALT), aspartate aminotransferase (AST), and creatinine (Cre) before and after ciclosporin A treatment. The primary outcome of the study was the change in serum C-peptide concentrations.

Results: A total of 17 patients completed the study. One patient was withdrawn at day 32 due to discontinuation of medication. Serum fasting C-peptide concentrations significantly increased from 0.12 ng/ml up to 0.32 ng/ml (P<0.001). After 12-week ciclosporin A intervention, there was no significant difference on TBIL (14.65 vs. 12.83umol/L, P>0.05), DBIL (4.70 vs. 4.65 umol/L, P>0.05), AST (17.41 vs. 17.82 U/L, p>0.05), ALT (18.19 vs. 18.08 U/L, p>0.05), or Cre (67.40 vs. 67.53 umol/L, P>0.05) compared with the corresponding baseline levels.

Conclusions: This pilot study demonstrates the potential therapeutic effects of oral administration of ciclosporin A for patients with LADA. Larger, controlled studies are needed to verify the findings.

Disclosure

L. Zhang: None. W. Meng: None. S. Chen: None. Y. Yang: None. J. Wang: None. Y. Dong: None.
108-OR: Application of a European Genetic Risk Score for Type 1 Diabetes in a Han-Chinese Population
Authors: WAN RAYMOND , SHARP SETH A. , TAM CLAUDIA H.T. , WEEDON MICHAEL N. , CHAN JULIANA C. , HAGOPIAN WILLIAM , ORAM RICHARD A. , MA RONALD C.
Published: June 2020

Increasing childhood obesity and young-onset diabetes have made clinically distinguishing between type 1 diabetes (T1D) and type 2 diabetes (T2D) more difficult. A Genetic risk score (GRS) for T1D was developed in European populations, with good discrimination of diabetes type. Here, we aim to evaluate T1D-GRS in a Han-Chinese cohort. We utilized whole genome genotyping data for 533 nondiabetic controls, 182 patients with T1D, and 6,209 patients with T2D. We computed the T1D-GRS for each subject using 30 T1D associated SNPs. The mean ages of the controls, T1D, and T2D subjects were 47±11, 32±15, and 57±13 years, respectively. Violin plots of the GRS for the 3 groups are shown in the Figure, along with p-values. The mean GRS across the controls, T1D, and T2D were 0.242, 0.256, and 0.242, respectively. The area under the curve (AUC) for GRS in T1D vs. T2D was 0.677 (95% CI: 0.635-0.718), and 0.678 (95% CI: 0.631-0.725) for T1D patients vs. controls. We conclude that T1D-GRS detects significant differences in T1D genetic risk between T1D and non-T1D in a Han-Chinese population, with subjects with T1D having a higher score. Further refinement incorporating single nucleotide polymorphisms (SNPs) specific for a Han-Chinese population is currently underway, and is expected to further improve classification of T1D in Han-Chinese.

Disclosure

R. Wan: None. S.A. Sharp: None. C.H.T. Tam: None. M.N. Weedon: None. J.C. Chan: None. W. Hagopian: Consultant; Self; Novo Nordisk Inc. R.A. Oram: None. R.C. Ma: Advisory Panel; Self; AstraZeneca. Stock/Shareholder; Self; GemVCare. Other Relationship; Self; AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Merck & Co., Inc., Novo Nordisk A/S, Pfizer Inc., Sanofi-Aventis, Tricida Inc.

Funding

Research Grants Council (T12-402/13N); Research Impact Fund (CUR4012-18)
1083-P: Bromocriptine-QR (BQR) Reduces Hypertriglyceridemia (HTG) in Hypertensive Type 2 Diabetes (T2D) Subjects
Authors: CHAMARTHI BINDU , EZROKHI MICHAEL , CINCOTTA ANTHONY H.
Published: June 2020

Chronically elevated sympathetic nervous system (SNS) activity increases hepatic triglyceride (TG) synthesis and secretion and adipose free fatty acid mobilization leading to further hepatic TG synthesis and HTG. HTG often occurs in the presence of hypertension and this can be a biomarker of chronically elevated SNS activity. BQR, a dopamine agonist, is the only sympatholytic antidiabetes agent approved for T2D. Preclinical studies have repeatedly demonstrated that circadian-timed bromocriptine therapy ameliorates HTG. This study evaluated if circadian-timed BQR (1.6-4.8 mg/day) reduces HTG in a population of hypertensive HTG T2D subjects. Hypertensive HTG T2D subjects from the Cycloset Safety Trial (HbA1c ≥ 7.0) treated at baseline with diet +/- any one or two antidiabetes agents of sulfonylurea, metformin, thiazolidinedione or insulin (N = 378) and randomized to BQR or placebo for 24 weeks were analyzed for between group difference in change from baseline fasting plasma TG level. After 24 weeks of therapy, BQR significantly reduced fasting TG levels by between 34 to 219 mg/dl (13 to 36%) and HbA1c from -0.4 to -1.2 as the baseline fasting TG level rose from ≥ 150 to ≥ 400 mg/dl (Figure). These TG effects were even more pronounced in such subjects with elevated resting heart rate. Circadian-timed BQR reduces hypertriglyceridemia in T2D and this effect increases with increasing fasting TG level.

Disclosure

B. Chamarthi: Employee; Self; VeroScience LLC. M. Ezrokhi: Employee; Self; VeroScience LLC. A.H. Cincotta: Employee; Self; VeroScience LLC.
1091-P: PK/PD of Glucagon and the Novel Glucagon Analog Dasiglucagon in Aqueous or Nonaqueous Formulations following SC Administration in Rats
Authors: WENANDER CAROLA , VALEUR ANDERS H. , ELANDER MIKAEL
Published: June 2020

Endogenous peptide hormones, such as glucagon used for treatment of severe hypoglycemia events in patients with diabetes, are commonly unstable in aqueous solution making development of ready-to-use injection solutions a challenge. Analogs of endogenous peptide hormones can be designed to increase the stability of the molecules. Another approach to enable easy administration of unstable peptides is to formulate them in non-aqueous formulations, such as DMSO (dimethyl sulfoxide).

The current study was conducted to compare the PK/PD of glucagon following SC administration in rats when formulated in DMSO or an aqueous formulation (Phosphate buffered solution (PBS)). The PD data were compared to data generated for the stable glucagon analog dasiglucagon in rats.

Four to six male Sprague-Dawley rats received 3 nmol/kg of glucagon in DMSO or in a PBS formulation or dasiglucagon at 2 nmol/kg in a PBS formulation. Blood samples for bioanalysis (glucagon groups only) and blood glucose measurement were taken at pre-dose (0) and 15, 30, 45, 60, 75, 90, 105 and 120 min post dose.

Glucagon in PBS demonstrated a faster absorption, a higher Cmax (98.3 versus 39.9 pmol/L) and faster Tmax (15 versus 45 minutes) compared to glucagon in DMSO. The increase in blood glucose was similar for glucagon and dasiglucagon in PBS and faster compared to glucagon in DMSO.

Disclosure

C. Wenander: Employee; Self; Zealand Pharma A/S. A.H. Valeur: Employee; Self; Zealand Pharma A/S. M. Elander: Employee; Self; Zealand Pharma A/S.
1111-P: Real-World Evidence of SGLT2 Inhibitor (SGLT2i) Use among Adults in the T1D Exchange Registry (T1DX)
Authors: HUGHES MICHAEL S. , BAILEY RYAN , CALHOUN PETER , LYONS SARAH , DESALVO DANIEL , SHAH VIRAL N.
Published: June 2020

Little is known about SGLT2i use in T1D outside a clinical trial setting. This cross-sectional analyses compares characteristics among T1DX registry participants using SGLT2i off-label compared with those not using SGLT2i and assess glycemic outcomes pre-post SGLT2i initiation. The analysis cohort included 204 SGLT2i users and 7124 non-users (n=7,328) in the T1DX registry aged ≥18 yrs with T1D for ≥1 yr. Demographic and clinical characteristics were compared between SGLT2i users and non-users. To assess the effect of SGLT2i use on glycemic outcomes, A1c pre and post-SGLTi initiation was compared. Of 7,328 participants analyzed, 2.8% reported using SGLT2i. Use of canagliflozin, dapagliflozin, and empagliflozin was reported by 50%, 27%, and 27% of SLGT2i users. SGLT2i use was associated with older age, longer T1D duration, higher BMI, and higher socioeconomic status. Glycemic outcomes for the cross-sectional comparison are shown in the Table. There was little difference in mean A1c pre- and post-SGLT2i initiation (8.1±1.0% vs. 8.0±1.1%, P=0.25), but % with A1c <7% nearly doubled (10% vs. 18%, P=0.02). Less than 3% of adults in the T1DX reported SGLT2i use and glycemic benefits were unclear. SGLT2i users reported similar incidence of DKA to non-users, but higher SH rates. While observational data must be interpreted with caution, these findings suggest a need for prospective evaluation of SGLT2i use in T1D.

Disclosure

M.S. Hughes: None. R. Bailey: None. P. Calhoun: Stock/Shareholder; Self; Dexcom, Inc. S. Lyons: Other Relationship; Self; Springer Publishing Company. D. DeSalvo: Consultant; Self; Dexcom, Inc., Insulet Corporation. V.N. Shah: Research Support; Self; Dexcom, Inc., JDRF, Mylan, Novo Nordisk A/S, Sanofi, vTv Therapeutics. Other Relationship; Self; Dexcom, Inc., Sanofi US.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust (G-2016PG-T1D053)
1126-P: Randomized Controlled Trial of Ipragliflozin or Sitagliptin Combined with Metformin in Type 2 Diabetes: NISM Study
Authors: KITAZAWA MASARU , KATAGIRI TAKASHI , SUZUKI HIROMI , MATSUNAGA SATOSHI , YAMADA MAYUKO H. , IKARASHI TOMOO , YAMAMOTO MASAHIKO , FURUKAWA KAZUO , IWANAGA MIDORI , HATTA MARIKO , FUJIHARA KAZUYA , YAMADA TAKAHO , TANAKA SHIRO , SONE HIROHITO
Published: June 2020

DPP-4i do not increase weight and SGLT2i are expected to reduce weight; thus, are widely used in daily practice. SGLT2i are recommended as second-line drugs after metformin (Met) in those at high risk of atherosclerotic cardiovascular disease (ASCVD), but suitable second-line drugs for the majority of patients not at high risk are not yet determined. Furthermore, reports of appropriate second-line drugs in East Asians who have a lower risk of ASCVD than Europeans are scarce. We compared the effects of ipraglifrozin (Ipra) and sitagliptin (Sita) after Japanese patients with type 2 diabetes had been taking Met and were without prior ASCVD in a 52-week randomized open-label trial (jRCTs031180205). The primary endpoint (PE) was a HbA1c reduction of ≥0.5% with no weight gain at 52 weeks. Among 111 patients (mean age 59.2 y, mean BMI 26.6 kg/m2, and male 61.3%), 54 and 57 patients received Ipra and Sita, respectively. After 52 weeks, achievement of the PE was statistically the same (37.0% and 40.3%, p=0.72), as was the HbA1c reduction ≥0.5% (38.9% and 54.4%, p=0.13). Lack of weight gain was higher for Ipra than Sita (94.4% and 54.4%, p<0.01). BMI, C-peptide and HDL-C improved with Ipra vs. Sita (p<0.05). Withdrawal for any adverse event occurred in 8 with Ipra and 4 with Sita (14.8% and 7.0%, p=0.23).Although glycemic control did not differ between Ipra and Sita, some ASCVD risk factors improved with Ipra.

Disclosure

M. Kitazawa: None. T. Katagiri: None. H. Suzuki: None. S. Matsunaga: None. M.H. Yamada: None. T. Ikarashi: None. M. Yamamoto: None. K. Furukawa: None. M. Iwanaga: None. M. Hatta: None. K. Fujihara: None. T. Yamada: None. S. Tanaka: None. H. Sone: Research Support; Self; Kyowa Hakko Kirin Co., Ltd., Novartis AG, Ono Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co.

Funding

Astellas Pharma Inc.
1139-P: Remogliflozin (SGLT2 Inhibitor) Significantly Reduces Albuminuria and Delays the Progression of Nephropathy in Type 2 Diabetes Mellitus Patients
Authors: GUPTA VISHAL K.
Published: June 2020

Remogliflozin is a novel SGLT2 inhibitor approved and available in India for the treatment of type 2 diabetes mellitus patients. This study was designed to determine the effect of Remogliflozin on diabetic nephropathy patients compared with placebo on the reduction of the albuminuria. We conducted a 24 week, double-blind, randomized, parallel-group study with 94 type 2 diabetics subjects with diabetic nephropathy (micro albuminuria range from 30 to 300) and HbA1c of 7.5 - 9.3%. Subjects were randomized to Remogliflozin (100 mg bid) and placebo with 1000 mg metformin OD. The primary end point was change in HbA1C from baseline, with secondary end points including change in fasting plasma glucose (FPG), body weight, and change in albuminuria. Safety and tolerability were also characterized. Result: As shown in Table in image.

Conclusion: Result of our study revealed that Remogliflozin significantly reduced albuminuria (p value <0.001) in type 2 diabetes mellitus patients with delay in progression of diabetic nephropathy as compared to placebo.

Disclosure

V.K. Gupta: None.
116-OR: Comparison of Pancreas vs. Islet Transplantation Outcomes from a Large Single Center
Authors: MARFIL-GARZA BRAULIO A. , LAM ANNA , BIGAM DAVID , SENIOR PETER , SHAPIRO A.M. JAMES
Published: June 2020

Background: Pancreas and islet transplantation can achieve optimal glycemic control in patients type 1 diabetes (T1DM) and persistent problematic hypoglycemia. We describe our experience with these two therapies over a 20-yr period.

Methods: Patients with T1DM undergoing pancreas (PT) or islet (IT) allotransplantation from January 1st 1999 to May 1st 2019 were included. Univariate analyses were done using X2 tests and Student’s t tests for categorical and continuous variables, respectively.

Results: We include 413 patients with a mean duration of T1DM of 30.6 yr (SD 10.8), 272 (65.9%) underwent IT and 141 (34.1%) PT. Mean follow-up was 7.4 yr (SD 5.2). More female patients (55.9% vs. 34.0%, p<0.001), and an older age at transplant were observed in the IT group (48.4 yr vs. 41.0 yr, p<0.001) compared to PT. Baseline mean glycated hemoglobin (HbA1c) was 8.4% (SD 1.2) which decreased to 6.6 (SD 0.8) and 5.6 (SD 0.7) in the IT and PT groups over the following 3 months after transplant, respectively. HbA1c remained lower as compared to baseline values up to 15 yr after transplant in both groups (7.3 [SD 1.4) in IT and 6.1 [SD 0.8) in PT, p=0.01 for both). Insulin independence rates were lower in the IT group vs. the PT group (77.2% vs. 95.0%, p<0.001), as well as the percentage of follow-up time off-insulin (46.6% [SD 31.2] vs. 92.3% [SD 18.5], p<0.001). However, the mean number of hospital admissions was lower in IT patients (1.2 [SD 0.7] vs. 1.7 [SD 1.2], p=0.009), similarly to 1-yr mortality rates (0.0% vs. 3.6%, p=0.002); mortality rates were equivalent thereafter.

Discussion: PT provides better glycemic control than IT. However, caveats including higher early mortality rates and greater long-term morbidity should be thoroughly discussed with patients. This study provides robust information to guide evidence-informed practice and establish more realistic expectations for both physicians and patients involved the care of IT and PT patients.

Disclosure

B.A. Marfil-Garza: None. A. Lam: None. D. Bigam: None. P. Senior: Research Support; Self; Allergan, Novo Nordisk. A. Shapiro: Consultant; Self; Viacyte, Inc.
117-OR: Islet Cell Transplantation for Type 1 Diabetes: The UIC Experience, 2004-2020
Authors: DANIELSON KIRSTIE K. , MONSON REBECCA S. , LI YI , OBERHOLZER JOSE
Published: June 2020

Allogeneic islet cell transplantation (ICT) can be an effective therapy for many patients with brittle type 1 diabetes, as it may reestablish hypoglycemic awareness and better attain optimal glycemic control. The ICT program at the University of Illinois at Chicago (UIC) began in 2004 and we herein present the summary of all patients’ outcomes to date. The 43 patients receiving ICT at UIC include 10 patients in the phase1/2 trial, 20 patients in the phase 3 trial, 10 patients in the Clinical Islet Transplant Consortium trials (CIT-02, n=2; CIT-06, n=4; CIT-07, n=4), and 3 University of Chicago patients transplanted with islets manufactured at UIC. Overall, the sample had a mean baseline age of 46.7 years, BMI 23.4, HbA1c 7.4%, and insulin dose 0.48 units/kg/day, and 74.4% were female, and 95.3% Non-Hispanic white. Single ICTs were performed in n=18, two ICTs in n=18, and three ICTs in n=7. Thirty seven completed 1-year follow-up after last ICT. The following results at 1-year post-last ICT are presented respectively for the phase 1/2 trial (21 ICTs), phase 3 trial (35 ICTs), and supplemental group (CIT and University of Chicago; 19 ICTs). The primary outcome of attaining both an HbA1c ≤6.5%, and no severe hypoglycemic episodes (SHEs) between 1-month and 1-year post-last ICT, was achieved in: 90%, 50%, and 54%. Insulin independence was attained in: 80%, 60%, and 54%. Graft failure occurred in: 0%, 25%, and 39%. In the two UIC trials combined, HbA1c decreased from 7.4% at baseline to 6.0%; and SHEs decreased from 1.0/month at baseline to 0.1/month. At 5-years post-last ICT in the two UIC trials, 11 of 15 (73.3%) still met the criteria for a successful primary outcome. In terms of safety, the frequency of serious adverse events across the three groups, respectively, were: 50%, 50%, and 54%. Despite the documented risks of ICT for type 1 diabetes primarily due to the chronic use of immunosuppression, many patients may potentially benefit in terms of eliminating SHEs and optimizing glycemic control.

Disclosure

K.K. Danielson: None. Y. Li: None. J. Oberholzer: Research Support; Self; JDRF. Stock/Shareholder; Self; Sigilon Therapeutics. Other Relationship; Self; CellTrans Inc., Sigilon Therapeutics.

Funding

American Diabetes Association (1-16-ICTS-022 to K.K.D.); National Institutes of Health (U42RR023245, UL1RR029879, UC4DK114839, U01DK070431, R01DK091526)
1187-P: Patient Demographics and Clinical Outcomes among Type 1 Diabetes (T1D) Patients Using Continuous Glucose Monitors (CGMs): A Study from the Largest Cohort of T1D Patients in the U.S.
Authors: NOOR NUDRAT , RIOLES NICOLE , MAJIDI SHIDEH , CORATHERS SARAH , MCDONOUGH RYAN , POLSKY SARIT , GREENFIELD MARGARET , OBRYNBA KATHRYN , EBEKOZIEN OSAGIE , DESALVO DANIEL
Published: June 2020

Background: CGM devices have been shown to improve glycemic control in patients with T1D. Despite existing clinical evidence and improved performance of CGM devices, only a small proportion of patients are using CGM.

Methods: The T1D Exchange QI Collaborative (T1DX-QI) is a large cohort with twelve national clinics engaged in data sharing and quality improvement to improve outcomes. This analysis used the T1DX-QI database to examine patient attributes associated with CGM device use. Patients with one or more completed clinic encounters during the years 2017-2019 were included (N=16,414) and classified as CGM users if they indicated information on a device start date, model or company within the past one year of their most recent diabetes clinic visit. We examined the frequency of CGM device use and distribution of socio-demographic factors, as well as clinical outcomes, among CGM users versus non-users.

Results: In this cohort, 27.4% of T1D patients were CGM users, with patients aged ≤26 years being more likely to use CGM. Among CGM users, 75% used a real-time device, a 3% intermittent scanning device, and 22% device type was unknown. CGM use was more likely among Non-Hispanic Whites (75%) and patients on private health insurance (72%) relative to Non-Hispanic Black patients (3%) and those on public health insurance (27%) [p<0.001]. HbA1c levels among CGM users were lower relative to non-users after adjusting for age, race/ethnicity and insurance status (8.3%± 1.7% vs. 8.8%±1.9%) [p<0.001].

Conclusion: This study highlights patient factors and clinical outcomes among CGM users in the T1DX-QI Collaborative, one of the largest sources of real world data for T1D available to-date. The findings shed light on socio-demographic variability in CGM uptake with implications for targeted interventions to promote device use in this subset of the T1D population.

Disclosure

N. Noor: None. N. Rioles: None. S. Majidi: Advisory Panel; Self; Companion Medical. S. Corathers: None. R. McDonough: None. S. Polsky: None. M. Greenfield: None. K. Obrynba: None. O. Ebekozien: None. D. DeSalvo: Consultant; Self; Dexcom, Inc., Insulet Corporation.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust
1196-P: Impact of Pharmacist-Driven Access to Therapy in Type 2 Diabetes Mellitus
Authors: ALLISON MARGARET
Published: June 2020

The Diabetes Care guidelines recommend glucagon-like peptide 1 receptor agonists (GLP-1RA) as second line therapy in the setting of established atherosclerotic cardiovascular disease (ASCVD) and sodium glucose cotransporter 2 inhibitors (SGLT2i) as second line in the presence of chronic kidney disease or heart failure (HF). Formularies are often restrictive of these classes of medications and most require prior authorization (PA), which is a barrier to initiation of therapy. A pharmacist (PharmD) in the ambulatory setting is in an optimal position to navigate insurance formulary and medication cost issues. In addition, with knowledge of evidence-based medicine, a PharmD can provide the justification needed for a medication that adheres to guideline recommendations regardless of formulary status. This retrospective review evaluates if the PharmD in Endocrinology (Endo) clinic improved HbA1c through resolution of medication access problems allowing for initiation of guideline-based therapies. The PharmD documented on 190 patients with T2DM from 11/2018 to 11/2019. Average time managed by Endo was 1.4 years (median 9.4 months) and 38% of patients were previously prescribed or established on SGLT2 or GLP-1RA therapy for an average of 1.4 years (median 11.5 months). The majority of patients had Medicare or Medicaid plans (73%). ASCVD or HF was present in 30% of patients. HbA1c was <7% in 17.8% of patients. The PharmD assisted with initiation of GLP-1RA or SGLT2 for 74% of the patients through test claims, education, prior authorizations and appeal letters. Of the patients with CV disease, 79% (45/57) were prescribed one of the agents with proven CV benefits with the help of the PharmD. Average HbA1c prior to PharmD was 8.9% and average most recent HbA1c was 8.05% (-0.85, p<0.05). Time between HbA1c values was an average of 5.4 months. Most recent HbA1c was <7% in 36% of patients. The PharmD contributed to a significant HbA1c change through navigation of formulary requirements combined with knowledge of clinical evidence.

Disclosure

M. Allison: None.
1198-P: Hospital Use and Cost among Minority Women Enrolled in the Women in Control (WIC) Virtual World Diabetes Self-Management Education (DSME) Comparative Effectiveness Trial
Authors: MITCHELL SUZANNE , BRAGG ALEXA , HOWARD JESSICA M. , GARDINER PAULA
Published: June 2020

Background: DSME improves diabetes outcomes, however participation is low. Virtual world (VW) technology is a scalable and engaging platform for DSME. The WIC study compared the effectiveness of DSME Medical Group Visits conducted in a VW platform vs. in-person to improve diabetes outcomes for minority women with uncontrolled type 2 diabetes (T2DM).

Objective: To assess the impact of WIC DSME intervention on hospital use and associated costs (inpatient, observation stays, ED visits).

Methods: Hospital utilization and billing data of the WIC-DSME intervention was analyzed 6-months pre-to-post enrollment for the study cohort and by study arm for a subset of 142 minority women with T2DM who completed the study. The percent change in the number of hospital utilizations from pre-to-post enrollment was calculated and associated costs were estimated from billing data and compared by study arm, utilization type and for the cohort as a whole.

Results: Total utilization among all 142 WIC program completers decreased by 25% from 114 events (57 events per arm) in the 6-months prior to WIC enrollment to 86 events (n=38 in-person; n=48 VW) in the 6-months post-enrollment. Hospital charges also decreased from $767,730 to $601,446 (22%). Among VW DSME participants, there was a 16% reduction in total utilization compared to a 33% reduction in the in-person DSME arm. Among VW participants, there was a 46% decrease in the number of high cost utilizations (observations and inpatient) and a 36% decrease in Emergency Department (ED) visits post-enrollment. Among in-person participants, there was no change in total high cost utilizations and a 68% decrease in ED visits. Total hospital charges for the WIC in-person DSME arm decreased by $24,625 (-6%) and $141,659 (-37%) for the WIC virtual world arm.

Conclusion: Both in-person and VW DSME are associated with lower hospital utilization and costs among minority women with uncontrolled T2DM.

Disclosure

S. Mitchell: Speaker’s Bureau; Self; Merck Sharp & Dohme Corp. Stock/Shareholder; Self; See Yourself Health, LLC. A. Bragg: None. J.M. Howard: None. P. Gardiner: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (R01DK106531)
1201-P: Impact of a Nursing Strike on Glycemic Control of Hospitalized Patients with Diabetes
Authors: SHEAHAN KELSEY , TOMPKINS BRADLEY , KENNEDY AMANDA G. , REPP ALLEN B. , GILBERT MATTHEW P.
Published: June 2020

Introduction: Inpatient maintenance of glycemic control relies heavily on nurse-directed care. In July 2018, our academic medical center experienced a nursing strike. Replacement staff were employed during the strike. The purpose of this study was to investigate the impact of a disrupted nursing workforce on glycemic control of hospitalized patients with diabetes.

Methods: This was a retrospective cohort study of glycemic control during a nursing strike. Data included three, 48-hour periods: pre-strike, strike, and post-strike. All adult hospitalized patients with diabetes were eligible. Patients were excluded if they were in the intensive care unit. The primary outcome was the frequency of hyperglycemia, defined as average percentage of point-of-care finger stick tests > 180 mg/dL per patient. Hypoglycemia was defined as average percentage of tests < 70 mg/dL per patient. Data were analyzed using Wilcoxon rank sum tests with P<0.05 considered statistically significant.

Results: Two hundred and eleven patients were included in the analysis: 65 patients (30.8%) in the strike period and 146 patients (69.2%) during the comparative periods. There were no differences in age, sex, race, or body mass index between groups. During the strike period, a mean of 35.5% of patients’ glucose tests met criteria for hyperglycemia, versus a mean of 31.2% of tests in the comparative periods (P=0.46). A mean of 1.4% of glucose tests met criteria for hypoglycemia during the strike period, versus a mean of 0.2% during normal operations (P=0.02).

Conclusions: Hyperglycemia did not vary significantly with a short-term disruption in nursing workforce. There was a suggestion of increased hypoglycemia, however this was a rare event and should be interpreted with caution.

Disclosure

K. Sheahan: None. B. Tompkins: None. A.G. Kennedy: None. A.B. Repp: None. M.P. Gilbert: Advisory Panel; Self; Corcept Therapeutics. Consultant; Self; Novo Nordisk Inc.
1205-P: Diabetes Medical Care Quality Index (ICAD): A Nationwide Experience of Continuous Improvement in Primary Health Care Clinics
Authors: GALLARDO HECTOR , SUAREZ-IDUETA LORENA , LOMELIN-GASCON JULIETA , MONTOYA ALEJANDRA , MUJICA-ROSALES RICARDO , TAPIA-CONYER ROBERTO C. , SAUCEDO-MARTINEZ EDUARDO R.
Published: June 2020

Digital health and robust analytics have shown to improve the quality of care by enabling data-driven decision making and accurate allocation of resources. Due to the fast-growing burden of T2D in Mexico, we created the Diabetes Medical Care Quality Index (ICAD) to favor the continuous improvement of care in primary healthcare clinics (PHC).The ICAD assesses three components: patient retention (PR), adherence with clinical guidelines (ACG), and T2D control (DMC) through a 100-point score, to estimate the percentage of patients that regularly visit their clinic, the medical actions provided each visit, and the percentage of patients with A1c <7%, respectively. We monthly computed ICAD of 9,958 Mexican PHC from June 2016 to October 2018 through the NCDs Information System (SIC) with up to 537,752 T2D patients. In June 2016, the national ICAD score was 54.6, with PR of 46.6, ACG of 69.9, and DMC of 40.9. As of October 2018, after monthly emailing ICAD to each clinic in a meaningful and transparent performance report, we found a significant increase in ICAD overall score and its components: ICAD of 66.0 (+21.0% p<0.001); PR of 64.0 (+37.4% p<0.001), ACG of 79.3 (+13.5% p<0.001), and DMC of 60.0 (+24.7% p<0.001).When compared to data collected through the National Infrastructure Inventory, we found that the major determinants related to the improvement of the ICAD are: community screening programs (β = 4.06 95%CI 3.50-4.62), availability for CBG testing (β=3.08, 95%CI 2.83-3.34) and A1c point of care testing (β =2.52 95% CI 2.40-2.63); availability of insulin (β=3.05 95%CI 2.94-3.16) and oral hypoglycemic drugs (β=1.51 95%CI 1.40-1.63), as well as online continuing medical education for providers (β=0.92, 95%CI 0.79-1.1) and IT infrastructure (β=0.57, 95%CI 0.44-0.72). In sum, we creates, measured and systematically communicated ICAD, enabling interventions in PHC that improved the quality of care and health outcomes for T2D patients.

Disclosure

H. Gallardo: None. L. Suarez-Idueta: None. J. Lomelin-Gascon: Other Relationship; Self; Lilly Global Health Partnership. A. Montoya: None. R. Mujica-Rosales: None. R.C. Tapia-Conyer: None. E.R. Saucedo-Martinez: None.
121-OR: Immunosuppressant-Related Quality of Life and Lifestyle of Insulin Independent T1D Pancreas Transplant Recipients
Authors: KAUR RAVINDER JEET , REID COREY , RIZVI SHAFAQ RAZA , BATTHULA SREEDHAR , MCCRADY-SPITZER SHELLY K. , SMITH BYRON H. , KREMERS WALTER K. , DEAN PATRICK , KUKLA ALEKSANDRA , STEGALL MARK D. , KUDVA YOGISH C.
Published: June 2020

Background: Pancreas Transplantation (PT) provides insulin independence and improves quality of life in patients with type 1 diabetes (T1D). However, PT recipients require lifelong immunosuppression resulting in immunosuppression related side-effects.

Methods: After IRB approval, we prospectively studied 15 PT recipients at least 1 year after PT. Subjects completed DEXA for body composition, actigraph for 1 week, the modified Transplant symptom occurrence and distress scale (MTSOSD) and VioFFQ - VIOCARE Food Frequency questionnaires.

Results: PT recipient were 53.1 ± 10.6 years old, 12F, BMI (Kg/m2) 30.8 ± 6, 33 ± 12.3 years of T1D and 6 ± 5 years (1-17years) time interval from PT. Lab values were HbA1c 5.4 ± 0.6 %, fructosamine 233 ± 27 µmol/L, fasting glucose 94.3 ± 17.5 mg/dl, C-peptide 2.5 ± 0.9 ng/ml and eGFR 56.3 ± 25.5 ml/min. DEXA revealed 41.1 ± 8.3 % total fat with 41.2 ± 10.2 % in Arms, 39.0 ± 9.8 % Legs and 43.7 ± 10.3 % Trunk. Actigraph revealed 1.6 ± 0.3 MET rate, 13428.7 ± 4649.0 average steps/day and 58.1 ± 12.9 % in Sedentary, 26.3 ± 7.3 % in Light and 15.6 ± 6.2 % in moderate grade physical activity respectively . Viocare revealed 81.9% calories of Estimated Energy Requirement with 44.9 ± 7.1 % CHO, 36.7 ± 5.6 % total Fat, 13.5 ± 3.2 % saturated fat and 17.9 ± 3.1 % protein calories with Omega-3 and dietary fiber intake 0.1 ± 0.11 g and 23.1 ± 9.1 g respectively. On MTSOSD, at least one side effect (SE) was reported by every subject with range varying from 1 to 53 SE out of 59 in the questionnaire. Four (33%) subjects reported at least one grade 4 symptom (high distress); 1 reported grade 4 for 24 items out of 59 in questionnaire and the other 3 grade 4 for 1.7 ± 1.2 symptoms. For grade of symptoms ranging from 0 to 3, 30 ± 14 SE were reported by the 12 subjects.

Conclusions: PT recipients that are insulin independent for long periods of time have suboptimal body composition and some immunosuppression related SE but perform better than average physical activity.

Disclosure

R. Kaur: None. C. Reid: None. S. Rizvi: None. S. Batthula: None. S.K. McCrady-Spitzer: None. B.H. Smith: None. W.K. Kremers: Research Support; Self; AstraZeneca. P. Dean: None. A. Kukla: None. M.D. Stegall: None. Y.C. Kudva: Research Support; Self; Dexcom, Inc., Roche Diabetes Care. Other Relationship; Self; Abbott.
1211-P: Real-World Use of SGLT2 Inhibitors in a Large U.S. Safety-Net Health System
Authors: GUNASEKARAN UMA , MCNULTY JACQUELINE N. , LINGVAY ILDIKO , MENEGHINI LUIGI
Published: June 2020

SGLT2 inhibitors (SGLT2i) have demonstrated benefit in high risk populations, although clinical uptake is often delayed. We sought to assess prevalent use of SGLT2i in type 2 diabetes within our health system to inform future quality improvement (QI) initiatives. From Sep 2016 to Oct 2019 a total of 1481 patients were prescribed an SGLT2i, of which 65% had prior ASCVD or heart failure (HF). Of all patients with diabetes and a diagnosis of ASCVD or HF (N=8448), only 11% were prescribed an SGLT2i during this time. These patients were on average 59±10 years old, 46% female, 43% Hispanic (see Table for additional details). Prescribing services included Internal Medicine (55%), Cardiology (26%) and Endocrinology (13%); the large majority of these patients (45%) received charity care from the health system. Descriptively, Hispanics, those with commercial insurance and nephropathy were more likely to receive an SGLT2i, while Blacks, Medicare and presence of co-morbidities less likely.

In summary, the use of SGLT2i in a high-risk population remains low (11%), especially in certain groups, such as Blacks and Medicare recipients. In our system, cardiologists contribute substantially to targeted use of SGLT2i, which should be encouraged elsewhere. This baseline data will inform our QI strategy and efforts in increasing evidence-based use of SGLT2i across the health system while targeting identified delivery inequalities.

Disclosure

U. Gunasekaran: None. J.N. McNulty: None. I. Lingvay: Consultant; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Intarcia Therapeutics, Janssen Pharmaceuticals, Inc., MannKind Corporation, Novo Nordisk A/S, Sanofi, TARGET PharmaSolutions, Valeritas, Inc. Other Relationship; Self; Novo Nordisk A/S. L. Meneghini: Advisory Panel; Self; Novo Nordisk Inc., Sanofi US. Consultant; Self; Applied Therapeutics, Sanofi US.
1216-P: Randomized Controlled Trial of Technology-Intensified Diabetes Education Study (TIDES) in African Americans with Type 2 Diabetes
Authors: EGEDE LEONARD E. , KNAPP REBECCA G. , WALKER REBEKAH J. , GARACCI EMMA , WILLIAMS JONI S.
Published: June 2020

Evidence suggests multicomponent interventions are essential to improve outcomes in minority groups. This RCT tested a multicomponent intervention (TIDES) including diabetes education and skills training by telephone and a telehealth system to monitor glycemic and blood pressure control in African Americans (AA) with poorly controlled type 2 diabetes. Two hundred AA with HbA1c >= 8 were randomized to TIDES or usual care with primary outcome HbA1c at 12-months in the intent to treat population. Baseline adjusted random intercept model evaluated reduction in HbA1c for TIDES compared to usual care. Per protocol samples and baseline adjusted marginal models were used as sensitivity analyses. Study maintained a 90% retention rate at 12-months. HbA1c at 3 months was marginally statistically significantly lower compared to usual care (p=0.06), however, at 12-months there was no statistically significant difference (p=0.67). See Figure 1. Per protocol samples and marginal models showed similar results. Results from a multicomponent RCT found a more immediate drop in HbA1c during the intervention period compared to usual care, but no significant differences at 12-months. Possible co-interventions occurring in the primary care clinic at the time of the study and low intensity booster sessions may explain results and have implications for future diabetes education trials.

Disclosure

L.E. Egede: None. R.G. Knapp: None. R.J. Walker: None. E. Garacci: None. J.S. Williams: None.

Funding

National Institutes of Health (R01DK098529)