bluuebunny/crossref_metadata_2025 huggingface dataset:
Findings from a Diabetes Support Group—A Pilot Study
Authors: MALONEY LORI MCLEER , FLOOD JEREMY , ALAMUDDIN NAJI , MUKADDAM MONA AL
Published: June 2018

Purpose: Diabetes Self-Management Education (DSME) is a crucial aspect of treating type 2 diabetes mellitus (T2DM). Daily individual decisions affect patient health, well-being, and long term outcomes. This pilot study evaluated what best educates and motivates patients to improve glucose control.

Method: 17 participants with T2DM were recruited from Penn Rodebaugh Diabetes Center to attend 3 monthly diabetes support group meetings, and receive American Association of Diabetes Educators education. Weight and hemoglobin A1C (A1C) were measured at baseline and completion. Fitbit Activity Trackers were provided, as well as bi-weekly communication to reinforce behavior change. Pre and post-study surveys assessed nutrition, activity, monitoring blood glucose, and taking medication. Two sided paired t-test was performed to compare change in A1C and weight. A type I error rate of 0.was used for statistical significance.

Results: 15 participants completed the study. DSME interventions resulted in a statistically significant decrease in mean A1C from 8.5% to 7.7% with a mean A1C reduction of 0.8% in 3 months (p-value=0.01). Mean weight decreased 4.80 lb (p-value=0.0001). 11 remained on same medications, and 1 required reduced insulin. 3 added a glucagon-like peptide receptor agonist (GLP-1RA), with 1 adding a sodium-glucose cotransporter-2 inhibitor. 7 increased daily steps wearing Fitbit, while 8 reported no motivation. 10 increased weekly exercise, and 11 increased daily activity. All benefited from bi-weekly reinforcement, and reported improved nutrition. Food replica models aided visual reinforcement.

Conclusion: DSME in a group setting can motivate self-care and reduce both A1C and weight, however, the study met challenges. Time per patient spent coordinating was substantial. Food models and phone communication to reinforce lifestyle modification were useful. Research is needed to determine what provides long-term sustainability in a busy clinical practice.

Disclosure

L. McLeer Maloney: None. J. Flood: None. N. Alamuddin: Consultant; Self; Novo Nordisk Inc.. M. Al Mukaddam: None.
Adherence to Insulin Therapy Assistance Program (iTAP) among Indian Type 2 Diabetes Mellitus (T2DM) Patients
Authors: RAJ PRAVEEN , PAWAR DILIP , JABEEN SARAH , SHIVARAM VS
Published: June 2018

Introduction: Patients adhering to insulin therapy is a challenge especially in developing countries(India) due to factors challenged by patients and physicians.

Objective: iTAP is a patient support program (PSP) designed by Biocon for T2DM patients receiving insulin therapy. PSP aimed to improve the adherence by educating patients on diabetes.

Methods: The data collected in iTAP depicts real world setting with minimal intervention. Almost 10426 T2DM patients were registered with a run-in period of 4 years. Each visit is structured into, demonstration and initiation of insulin usage (Visit-0 or baseline) recap of visit-0 (Visit-1) diabetes overview (Visit-2) importance of exercise (Visit-3), healthy diet and lifestyle (Visit-4), education on foot care (Visit-5) and reinforcement of earlier training (Visit-6).

Results: A total of 7234 patients were analysed. Patients adhere to therapy were longer when they complete 6 educational visits (p<0.001, ANOVA) compared to one and three visits.

Conclusion: PSP plays a critical role for patient’s adherence and brings down the complication especially in chronic segment like diabetes. It’s important for HCPs to consider PSPs, this outcomes research emphasizes the effective patient—provider communication in overcoming some of the barriers to adherence especially in countries like India.Relation between visit and adherence to therapy *TOT - Time on TherapyNumber of Visit(s)Mean TOT* in patients with insulin therapy (Months)Median TOT* in patients with insulin therapy (Months)One visits11.28Three visits12.708Six visits25.3724

Disclosure

P. Raj: Employee; Self; Biocon. D. Pawar: Employee; Self; Biocon. S. Jabeen: Employee; Self; Biocon. S. Vs: Employee; Self; Biocon.
Comparing Patch vs. Pen Bolus Insulin Delivery in Type 2 Diabetes Using Continuous Glucose Monitoring Metrics and Profiles
Authors: JOHNSON MARY L. , DREON DARLENE M. , LEVY BRIAN L. , RICHTER SARA , MULLEN DEBORAH , BERGENSTAL RICHARD M.
Published: June 2018

Patients with T2D (N=97, A1c ≥7.5% on basal insulin) used DexCom G4 CGM in a substudy of a large RCT (N=278) to evaluate bolus insulin delivery by patch (Calibra Medical) vs. pen (Novolog Flexpen®) using an SMBG-based titration algorithm.

There was a significant improvement (p<0.0001) in A1c and all CGM metrics at week 24, but no difference between groups (Table). CGM profiles (Figure) demonstrate it is possible to optimize basal-bolus therapy, dramatically increasing time-in-target range (70-180 mg/dL) with minimal significant hypoglycemia (<54 mg/dL) while achieving a flat bedtime to AM glucose profile.

This is one of the first trials to clearly demonstrate how using CGM metrics and CGM profiles in T2D can provide a more clinically relevant comparison of different approaches to optimizing glucose management.Table: CGM Metrics for Patch (49) and Pen (48), Baseline and Week 24Patch BaselinePatch Week 24Pen BaselinePen Week 24Central Lab A1c, % (± SD)8.54 ± 0.906.82 ± 0.958.75 ± 1.036.70 ± 0.79CGM Average Glucose, mg/dL (± SD)188.9 ± 40.9142.4 ± 31.4200.3 ± 41.4140.4 ± 28.3CGM Glucose >250 mg/dL, % time (± SD)18.3 ± 18.35.6 ± 9.723.4 ± 21.84.6 ± 8.3CGM Glucose >180 mg/dL, % time (± SD)50.4 ± 26.121.1 ± 19.956.7 ± 24.819.7 ± 17.5CGM Glucose 70-180 mg/dL, % time (± SD)48.4 ± 25.274.1 ± 18.742.4 ± 23.875.2 ± 16.1CGM Glucose <70 mg/dL, % time (± SD)1.2 ± 2.44.7 ± 5.20.9 ± 3.25.1 ± 5.8CGM Glucose <54 mg/dL, % time (± SD)0.2 ± 0.71.1 ± 2.00.2 ± 1.21.2 ± 2.0

Disclosure

M.L. Johnson: Research Support; Self; Calibra Medical, Medtronic, Sanofi, Novo Nordisk Inc., Abbott, POPS! Diabetes Care, National Institute of Diabetes and Digestive and Kidney Diseases, Dexcom, Inc., Hygieia, JDRF. D.M. Dreon: Employee; Self; Calibra Medical. B.L. Levy: Employee; Self; LifeScan, Inc.. S. Richter: None. D. Mullen: None. R.M. Bergenstal: Research Support; Self; Johnson & Johnson Services, Inc.. Consultant; Self; Johnson & Johnson Services, Inc.. Research Support; Self; Abbott. Advisory Panel; Self; Abbott. Research Support; Self; Becton, Dickinson and Company. Consultant; Self; Becton, Dickinson and Company. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., AstraZeneca, Takeda Pharmaceuticals U.S.A., Inc., Dexcom, Inc.. Stock/Shareholder; Self; Merck & Co., Inc.. Research Support; Self; Eli Lilly and Company, Sanofi. Advisory Panel; Self; Sanofi, Roche Pharma. Research Support; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Medtronic. Consultant; Self; Medtronic. Research Support; Self; Hygieia. Advisory Panel; Self; Hygieia, Glooko, Inc.. Research Support; Self; JAEB Center For Health Research, JDRF, National Institute of Diabetes and Digestive and Kidney Diseases.
Fourteen-Day Study of Praliciguat, a Soluble Guanylate Cyclase Stimulator, in Patients with Diabetes and Hypertension
Authors: HANRAHAN JOHN P. , WAKEFIELD JAMES D. , WILSON PHEBE J. , MILLER PAUL , CHICKERING JENNIFER , MORROW LINDA , HALL MICHAEL L. , CURRIE MARK , MILNE G. TODD , PROFY ALBERT T.
Published: June 2018

Background: Praliciguat (IW-1973), a soluble guanylate cyclase stimulator, has been shown to augment nitric oxide (NO) signaling and reduce fasting plasma glucose and proteinuria in an animal model of diabetic nephropathy. In healthy adults, repeated oral doses of 15-40 mg were tolerated and lowered blood pressure (BP).

Methods: This Phase 2a, double-blind, placebo (PBO)-controlled study assessed the effects of oral praliciguat in 26 patients with type 2 diabetes mellitus (T2DM) and hypertension on stable glycemic and BP-lowering therapy. Most (69%) were also on statins. Two praliciguat regimens were tested: (1) 40 mg QD for days 1-14 (N=10), and (2) 20 mg BID for days 1-7 then 40 mg QD for days 8-14 (N=10). Assessments included serum chemistry, fasting plasma glucose, BP and heart rate, platelet function, reactive hyperemia index (RHI), plasma biomarkers, and adverse events (AEs).

Results: Results were similar for both praliciguat regimens and are here combined. After 14 days of treatment, praliciguat-treated patients had notable differences in least squares mean change from baseline (95% CI) relative to PBO in 24-hour mean arterial pressure [-4.7 mmHg (-10, 0.8)], heart rate [2.9 bpm (-0.7, 6.5)], fasting glucose [-13 mg/dL (-32, 7)], HOMA-IR [-26 (-58, 7)], total serum cholesterol [-26 mg/dL (-44, -7)], and LDL cholesterol [-20 mg/dL (-37, -3)]. Praliciguat had no effect on platelet function or RHI. Among the exploratory biomarkers tested, levels of the endogenous NO synthase inhibitor asymmetric dimethylarginine were lower in praliciguat vs. PBO recipients. Both praliciguat dose regimens were generally well tolerated. Except for one serious AE of upper gastrointestinal hemorrhage, AEs in praliciguat-treated patients were mild.

Conclusion: In this initial trial, praliciguat had beneficial effects on BP and metabolic parameters in T2DM patients with hypertension on standard therapies. Further clinical investigation of praliciguat in T2DM patients is warranted.

Disclosure

J.P. Hanrahan: Employee; Self; Ironwood. J.D. Wakefield: Employee; Self; Ironwood Pharmaceuticals, Inc.. Stock/Shareholder; Self; Ironwood Pharmaceuticals, Inc.. P.J. Wilson: None. P. Miller: None. J. Chickering: None. L. Morrow: Stock/Shareholder; Self; ProSciento. Employee; Spouse/Partner; Eli Lilly and Company. M.L. Hall: Employee; Self; Ironwood Pharmaceuticals, Inc.. Stock/Shareholder; Self; Ironwood Pharmaceuticals, Inc. M. Currie: Employee; Self; Ironwood Pharmaceuticals, Inc. G. Milne: Employee; Self; Ironwood Pharmaceuticals, Inc.. Stock/Shareholder; Self; Ironwood Pharmaceuticals, Inc.. Employee; Spouse/Partner; Catabasis Pharmaceuticals. Stock/Shareholder; Spouse/Partner; Catabasis Pharmaceuticals. A.T. Profy: Other Relationship; Self; Ironwood Pharmaceuticals.
Maintenance of Changes in Glycemic Control and Blood Lipids following 12 Weeks of Underwater Treadmill Training in Adults with Type 2 Diabetes
Authors: CONNERS RYAN T. , COONS JOHN M. , FULLER DANA K. , KIM YOUNGDEOK , COCHRUM ROBBIE G. , MORGAN DON W.
Published: June 2018

Objective: To document short- and long-term effects of a 12-week aquatic exercise walking program on glycemic control and blood lipid profile in middle-aged adults with type 2 diabetes.

Research Design and Methods: Thirteen adults with type 2 diabetes (age = 59.5 ± 4.5 years; 7 females, 6 males) completed 12 weeks of underwater treadmill training (UTT) (3d·wk-1), followed by a 12 weeks of no UTT. During UTT, exercise intensity and duration were systematically and progressively increased from 40-50% of heart rate reserve (HRR) and 30 minutes (3 x 10-min bouts) in Week 1 to 50-70% HRR and 60 minutes (3 x 20-min bouts) in Week 12. During the 12-week period following completion of UTT, study participants were asked to maintain their current diet and allowed to engage in any type or volume of physical activity, with the exception of structured exercise programming. Primary outcome variables included glycosylated hemoglobin (HbA1c), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglycerides (TG), and the TG/HDL ratio (TG/HDL). Data obtained before UTT, immediately following UTT, and 3 months after the end of UTT were analyzed using 1-way repeated measures analysis of variance.

Results: Compared to baseline values, HbA1c was reduced (7.8% to 7.3%) and HDL-C was increased (43.5 mg/dl to 50.6 mg/dl) following UTT (p < .05). After completion of the 3-month maintenance period, HbA1c was lower (p < .05) compared to baseline (7.4% vs. 7.8%), but HDL-C was not different (p > .05) from the pre-UTT level (48.4 mg/dl vs. 43.5 mg/dl).

Conclusions: Our findings demonstrate that among middle-aged adults with type 2 diabetes, improvement in glycemic control after 12 weeks of underwater treadmill training persisted three months following cessation of UTT, but training-induced increases in HDL were not maintained.

Disclosure

R.T. Conners: None. J.M. Coons: None. D.K. Fuller: None. Y. Kim: None. R.G. Cochrum: None. D.W. Morgan: None.
Effect of Exercise on Glycemic Control in Type 1 Diabetes
Authors: REDDY RAVI , WITTENBERG AMANDA , BRANIGAN DEBORAH , WINTERS-STONE KERRI , CASTLE JESSICA R. , EL YOUSSEF JOSEPH , JACOBS PETER G.
Published: June 2018

Regular exercise is recommended to individuals with type 1 diabetes (T1D) as it is associated with improved longevity and reduced diabetes-related complications, yet the effects of exercise on glucose control have not been proven. We evaluated the impact of different modes of exercise on glycemic control in people with T1D during a 24-hour period following exercise. In a 3-week crossover trial, 10 adults with T1D who self-managed their glucose levels with their own insulin pump (4 M, 6 F; age 33 ± 6 years, HbA1c 7.4 ± 1%) were randomized to perform aerobic, resistance or no exercise (control). During each exercise week, participants completed two monitored in-clinic 45-minute sessions. Participant’s insulin pump data were downloaded, glucose sensor data was recorded using a continuous glucose monitor and meal intake was recorded using a custom phone app including photographs of the meals which were analysed post-hoc by a nutritionist. The primary outcome was percentage of time in euglycemia (70mg/dL <=glucose<=180 mg/dL) for the 24 hours after each bout of exercise as compared with the same period during the control week. Time in range following resistance exercise was significantly greater than during the control period (70% vs. 56%, respectively, p<0.05) while time in range following aerobic exercise (60%) was not statistically different.

Results from this study indicate that resistance exercise could improve glycemic control in adults with T1D.

Disclosure

R. Reddy: None. A. Wittenberg: None. D. Branigan: None. K. Winters-Stone: None. J.R. Castle: Consultant; Self; Zealand Pharma A/S. Advisory Panel; Self; Novo Nordisk Inc.. J. El Youssef: None. P.G. Jacobs: Stock/Shareholder; Self; Pacific Diabetes Technologies.
Novel Combination of a Long-Acting GLP-1/GIP/Glucagon Triple Agonist (HM15211) and Once-Weekly Basal Insulin (HM12460a) Offers Improved Glucose Lowering and Weight Loss in a Diabetic Animal Model
Authors: KIM JUNG KUK , LEE JONG SUK , CHOI JAEHYUK , JUNG SUNG YOUB , LEE SANG HYUN , CHOI IN YOUNG , KIM SUN JIN
Published: June 2018

Obesity is an established risk factor for prediabetes, diabetes and the aggravation of preexisting diabetes by negatively affecting lipid metabolism, insulin response, and β-cell function. Thus, effective body weight loss not only prevents or delays the onset of T2DM, but also enhances the response to diabetes drugs including basal insulin in T2DM patients. Recently, we have developed a novel long-acting GLP-1/GIP/Glucagon triple agonist, HM15211, which showed potent weight loss in obese animal models. When combined with basal insulin, HM15211 might maximize the insulin response and provide additional weight loss. Here, we investigated the PK/PD properties of HM15211 and HM12460A (once weekly basal insulin developing in clinical stage) combination in animal models to evaluate the therapeutic benefits of this novel combination in diabetes. Firstly, drug-to-drug interaction (DDI) was evaluated to assess the changes in intrinsic activity and PK of the individual components. In vitro human insulin receptor phosphorylation by HM12460A was not affected by concomitant HM15211 treatment. Similarly, cAMP accumulation by HM15211 was unaffected. Analysis of PK demonstrated that the administration of HM15211 and HM12460A, either alone or in combination, did not change their extended half-lives in SD rats. Secondly, the glucose lowering and body weight loss by HM15211 in combination with HM12460A was evaluated in db/db mice. After 4 weeks treatment, a combination of HM15211 and HM12460A reduced the HbA1c more than the mono-treatment. Moreover, potent weight loss by HM15211 was well maintained even when combined with HM12460A. Based on these observation, we propose that HM15211 might be an additional combination partner for long-acting basal insulin such as HM12460A providing improved glycemic control and more favorable weight loss.

Disclosure

J. Kim: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical. J. Lee: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical. J. Choi: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical. S. Jung: None. S. Lee: Employee; Self; Hanmi Pharmaceutical. I. Choi: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical. S. Kim: Employee; Self; Hanmi Pharmaceutical. Stock/Shareholder; Self; Hanmi Pharmaceutical.
Effect of Reduced Intake of Branched-Chain Amino Acids (BCAA) on Insulin Secretion and Sensitivity in Type 2 Diabetes
Authors: KARUSHEVA YANISLAVA , VAN GEMERT THERESA , SIMON MARIE-CHRISTINE , MARKGRAF DANIEL F. , STRASSBURGER KLAUS , SCHMOLL DIETER , BURKART VOLKER , MÜSSIG KARSTEN , SZENDROEDI JULIA , RODEN MICHAEL
Published: June 2018

Circulating BCAA (valine, leucine, isoleucine) are increased in insulin resistant states and predict type 2 diabetes (T2D) suggesting a role of BCAA in the development of insulin resistance. Thus, we hypothesized that a dietary decrease of BCAA improves insulin sensitivity (IS) and oxidative phosphorylation in T2D and increases the levels of the hepatic metabolic regulator fibroblast-growth factor (FGF-21). In a randomized, placebo-controlled, double-blinded study, 12 patients (8 male, 4 female; age 54±4 years, body mass index 30.8±2.8 kg/m2, HbA1c 6.6±0.9%, 49±10 mmol/mol) with known T2D duration of <5 years, received a 4-week isocaloric diet with constant protein intake of 1 g/kg body weight. In a cross-over design, their diet comprised either the complete amino acid set (BCAA+) or a 60% reduction in BCAA (BCAA-) for 1 week. Whole body IS was assessed by hyperinsulinemic-euglycemic clamps and beta-cell function by mixed-meal tolerance tests (MMT). Mitochondrial efficiency was assessed from the respiratory control ratio (RCR) measured by high-resolution respirometry in muscle and adipose tissue. FGF-21 serum levels were quantified by ELISA. IS was lower after BCAA- diet (3.1±1.7 mg*kg-1*min-1) compared to BCAA+ diet (3.5±1.8 mg*kg-1*min-1, p<0.01). However, this difference disappeared after normalization for prevalent insulin levels. MMT showed lower increases in insulin and C-peptide after BCAA- than BCCA+ diet (incremental insulin area under the curve: 21±11 vs. 29±19 mU*ml-1*4 h-1, p<0.01). RCR in adipose tissue was 1.7-fold higher after BCAA- diet (p<0.05), but unchanged in skeletal muscle. The BCAA- diet also increased FGF-21 levels (from 323±189 to 405±233 pg/ml, p<0.05) which likely contributes to the effect on energy metabolism.

In conclusion, short-term dietary reduction of BCAA decreases meal-induced insulin and C-peptide secretion, increases FGF-21 levels and stimulates mitochondrial efficiency in adipose tissue, but fails to improve IS in T2D.

Disclosure

Y. Karusheva: None. T. van Gemert: None. M. Simon: None. D.F. Markgraf: None. K. Strassburger: None. D. Schmoll: Employee; Self; Sanofi-Aventis Deutschland GmbH. V. Burkart: None. K. Müssig: None. J. Szendroedi: None. M. Roden: Speaker's Bureau; Self; Boehringer Ingelheim GmbH. Research Support; Self; Boehringer Ingelheim GmbH. Consultant; Self; Poxel SA. Research Support; Self; Danone Nutricia Early Life Nutrition, GlaxoSmithKline plc., Nutricia Advanced Medical Nutrition, Sanofi.
Reduced Energy Intake Is Associated with Sarcopenia in Elderly Patients with Type 2 Diabetes–Kamogawa-DM Cohort Study
Authors: OKAMURA TAKURO , HASHIMOTO YOSHITAKA , SAKAI RYOSUKE , USHIGOME EMI , HAMAGUCHI MASAHIDE , YAMAZAKI MASAHIRO , FUKUI MICHIAKI
Published: June 2018

Objectives: Elderly patients with type 2 diabetes is increasing and sarcopenia is becoming an important problem. Nutrition is important to protect sarcopenia. However, the relationship between energy intake and sarcopenia in elderly patients with diabetes has been unclear.

Research Design and Methods: In this cross-sectional study of 316 patients (181 men and 135 women), we investigated the relationship between nutrient intake and sarcopenia. Nutrient intake was evaluated by the brief-type self-administered diet history questionnaire and body composition was evaluated by bioimpedance analysis. Sarcopenia was defined as having both grip strength of <26kg for men and <18kg for women, and skeletal muscle mass index of <7.0kg/m2 for men and <5.7kg/m2 for women.

Results: Patients with sarcopenia were aged and lower BMI than those without. In addition, energy intake of patients with sarcopenia was lower than that without (Table). Energy intake (per 100 kcal/day) was negatively associated with the presence of sarcopenia (OR: 0.86, 95% CI 0.75-0.99, p=0.041), whereas protein intake (g/kg body weight/day) was not associated with the presence of sarcopenia (1.32, 0.39-4.44, p=0.658) after adjusting for age, sex, exercise, smoking, HbA1c and BMI category.

Conclusion: Energy intake was negatively associated with the presence of sarcopenia in elderly patients with type 2 diabetes.

Disclosure

T. Okamura: None. Y. Hashimoto: Research Support; Self; Asahi Kasei Corporation, Fuji Foundation for Protein Research, Japan Society for the Promotion of Science, MSD K.K.. R. Sakai: None. E. Ushigome: Research Support; Self; Grant-in-Aid for Young Scientists (B), AstraZeneca, Daiichi Sankyo Company, Limited, Novo Nordisk Foundation, Ono Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd.. M. Hamaguchi: None. M. Yamazaki: None. M. Fukui: Research Support; Self; Grant-in-Aid for Scientific Research (C), Ono Pharmaceutical Co., Ltd., AstraZeneca, Astellas Pharma US, Inc., Daiichi Sankyo Company, Limited, Eli Lilly and Company, Kyowa Hakko Kirin Co., Ltd., Kissei Pharmaceutical Co., Ltd., MSD K.K., Novo Nordisk Foundation.
Continuous Reduction of Blood Glucose Average during One Year of Glucose Monitoring Using a Digital Monitoring System in a High-Risk Population
Authors: HERSHCOVITZ YIFAT , DAR SHARON , FENIGER EITAN
Published: June 2018

Patients with high average of blood glucose levels (above 180mg/dL) are at high risk for developing clinical complications. Digital engagement is playing a pivotal role in the care of patients with diabetes, assisting to enhance their compliance. The Dario Blood Glucose Monitoring System (BGMS) connects physically to a smart mobile device and automatically logs blood glucose measurements into designated App. The data captured on the App is transmitted to the Dario cloud. The study is looking at high risk patients’ data over one year of Dario use.

Methods: An exploratory data analysis study reviewed a population of high risk active type 2 diabetic users with initial 30 days glucose average above 180 mg/dL during a full calendar year. The study assessed the average blood glucose readings along a year of usage. The average of glucose readings was calculated per user in periods of in 30 days intervals from 30-60 to 330-360 days and compared to the first 30 days as the starting point baseline of analysis.

Results: Overall of 238 highly engaged T2D users (more than one daily measurement in average) whose average blood glucose level was above 180mg/dL in the first 30 days of measurements (225±45 mg/dL) showed continuous reduction in glucose level average vs. baseline. Reduction in blood glucose average level was demonstrated gradually, in the succeeding 3, 6 and 12 months showing average decrease of 7%, 11% and 14% vs. baseline, respectively. Furthermore, 76% of the entire population (180 out of 238 users) improved their average blood glucose level over a year. Those 180 users (average blood glucose 228±46) showed an average decrease of 10%, 16% and 24% in their glucose average following 3, 6 and 12 months, respectively.

Conclusions: The use of a digital smartphone-based blood glucose monitoring system in high risk patients has the potential to promote behavioral modification and enhanced adherence to diabetes blood glucose levels management in T2D patients.

Disclosure

Y. Hershcovitz: Employee; Self; DarioHealth. S. Dar: Employee; Self; DarioHealth. E. Feniger: Employee; Self; DarioHealth.
Detecting Insulin Sensitivity Changes for Individuals with Type 1 Diabetes
Authors: LEWIS DANA M. , LEIBRAND SCOTT , STREET TIM J. , PHATAK SAYALI S.
Published: June 2018

Background: A method to calculate changes in insulin needs was developed in the OpenAPS (Open Source Artificial Pancreas System) community. Individuals have natural fluctuations in insulin needs, but excessive periods of sensitivity or resistance may indicate ongoing physiological trends and therefore impact T1D management.

Methods: Autosens analyzes each CGM data point for 24 hours, comparing observed change to expected impact from insulin. Autosens calculates the deviation for the median of the last 8 and 24 hours of CGM data points and determines the sensitivity ratio (SR) required to neutralize the median deviation. Autosens was run retrospectively to obtain an hourly SR value (first calculated SR every hour) for (N=1)*16 individuals using OpenAPS; with M=5393 data points, and range=922 to 20,473. A SR of >1.0 indicates resistance; <1.0 indicates sensitivity. Histograms were created to visualize SR for each participant. Mean SR ± SD was calculated and those falling beyond ± 10% of 1.0 were classified as being resistant and sensitive respectively.

Results: Mean SR for 12 individuals fell within ±10% of 1.0. 1 individual tended toward sensitivity [0.79 ± 16]. 3 individuals tended toward resistance [1.2 ± 0.28; 1.33 ± 0.30; 1.41 ± 0.37].

Conclusion: Such idiographic visualization of SR can be useful for detecting overall patterns of sensitivity/resistance potentially unaccounted for by the user’s pump settings.

Disclosure

D.M. Lewis: Consultant; Self; Tandem Diabetes Care, Inc.. S. Leibrand: None. T.J. Street: None. S.S. Phatak: None.
Effect of Resistant Starch on Postprandial Glucose Levels in Sedentary, Abdominally Obese Persons
Authors: MA TONGYU , LEE CHONG-DO
Published: June 2018

Background: Although the resistant starch (RS) supplementation has shown promise in lowering postprandial glucose in healthy non-obese persons, little is known about the effect of RS on postprandial glucose levels in abdominally obese persons.

Objective: This study examined the effect of RS-supplemented muffins on postprandial glucose levels in sedentary, abdominally obese individuals as compared with digestible carbohydrates-matched oral glucose solution.

Method: A total of 8 sedentary, abdominally obese participants were randomly assigned to two sequences of treatments (AB, BA) using a 2 x 2 randomized cross-over design. The treatment effect tested with a muffin that contained 75 g of digestible carbohydrates and 30 g of RS (TRT), while the control tested using a 75-g oral glucose solution as a control condition (CON). Linear mixed models were used to test the treatment effect (TRT vs. CON) on glucose values and area under the curve (AUC).

Results: The 2-h postprandial glucose AUC was significantly lower in the TRT than in the CON (12.5±1.6 mmol/L·h vs. 15.6±3 mmol/L·h, P=0.002). The glucose levels were also significantly lower in the TRT than in the CON at 30 minutes (6.6±0.8 vs. 8.3±1.3 mmol/L, P=0.001), 60 minutes (6.6 ± 1.1 vs. 8.5 ± 2.1 mmol/L, P=0.004), and 90 minutes (6.3±1.1 vs. 8.1±1.8 mmol/L, P=0.003). The 2-h postprandial insulin AUC was also significantly lower in the TRT than in the CON (1354.5±6vs. 1788.9±522.8 pmol/L·h, P<0.001). Based on the 2-h glucose incremental AUC values, the calculated glycemic index of the RS-supplemented muffins was 48 (glucose=100).

Conclusion: The RS muffins supplemented with 30 g of RS could reduce postprandial glucose and insulin responses in abdominally obese adults.

Disclosure

T. Ma: None. C. Lee: None.
Clinical Relevance of the Behavioral Stages of Change with the Efficacy of Multifaceted Interventions on the Drop-Out from Regular Medical Care in Patients with Diabetes—The Japan Diabetes Outcome Intervention Trial-2 (J-DOIT2)
Authors: BOUCHI RYOTARO , NODA MITSUHIKO , HAYASHINO YASUAKI , YAMAZAKI KATSUYA , SUZUKI HIKARI , GOTO ATSUSHI , FURUKAWA TOSHI A. , IZUMI KAZUO , KOBAYASHI MASASHI ,   J-DOIT2 STUDY GROUP
Published: June 2018

Background: To examine the impact of lifestyle intervention by telephone (TSC) and face-to-face (FFA) according to the stages of lifestyle change (SLC) on the drop-out from regular medical care of diabetes

Methods: Secondary analysis was performed on data from the Japan Diabetes Outcome Intervention Trial-2 large trial (J-DOIT2-LT), which was a 1-year, prospective, cluster randomized, intervention trial. 11 district medical associations were divided into two subregions (clusters), in which patients were registered, and then were randomized to an intervention group (TSC or FFA) or control group (CG). Lifestyle advisors reminded patients of medical visits to the primary care physician (PCP) and gave lifestyle advice by TSC or FFA. The CG received usual medical care. The outcome of this analysis was the drop-out rate from regular medical care. We estimated the HR and 95% CI of either TSC or FFA relative to CG according to the SLC (stage 1/2/3/4/5: pre-contemplation/contemplation/preparation/action/maintenance).

Results: A total of 2,071 participants (mean age: 57 ± 6 years; 38% female) were studied. 1170, 616, and 285 patients were divided into CG, TSC, and FFA. In the stage 1-3 of diet, TSC (HR:0.47; 95% CI:0.27-0.82) and FFA (HR:0.20; 95% CI:0.07-0.55) were significantly associated with a low risk of the drop-out after adjusting for covariates. The similar association was observed in the stage 1-3 of exercise. In contrast, neither TSC nor FFA reduced the risk for drop-out in the stage 4-5 of diet. TSC (HR:0.12; 95% CI:0.02-0.95) but not FFA (HR:0.37; 95% CI:0.09-1.62) was associated with a low risk for the drop-out in the stage 4-5 of exercise.

Conclusions: FFA could be more effective than TSC to reduce the risk for drop-out from regular medical care of diabetes at the stage 1-3. In contrast, TSC may be enough to reduce the risk for the drop-out in the stage 4-5.

Disclosure

R. Bouchi: None. M. Noda: None. Y. Hayashino: None. K. Yamazaki: None. H. Suzuki: None. A. Goto: None. T.A. Furukawa: None. K. Izumi: None. M. Kobayashi: None.
Patient-Reported Outcomes in T2D Patients Inadequately Controlled by Metformin Are More Favorable for Dapagliflozin plus Saxagliptin vs. Insulin Glargine
Authors: TESTA MARCIA A. , SIMONSON DONALD C. , EKHOLM ELLA , MAXWELL SU , JOHNSSON EVA K.
Published: June 2018

Patients with T2D inadequately controlled by metformin require additional oral antidiabetes agent(s), injected GLP-1 or basal insulin. Although insulin has greater effect on A1C than a DPP-4 or SGLT2 inhibitor, its higher rates of hypoglycemia, weight gain and regimen burden might decrease satisfaction and quality of life. We analyzed patient-reported outcomes (PRO) from patients with T2D inadequately controlled by metformin ± sulfonylurea during an international, randomized, 24-week, open-label, non-inferiority trial (NCT02551874) of dapagliflozin plus saxagliptin add-on (DAPA + SAXA, n = 324) compared to titrated insulin glargine add-on (INS, n = 319). A1C and PRO questionnaires were obtained at baseline and weeks 12 and 24. Baseline data were: 54.0% male; 80.4% white; 60.7% working ≥3 days/week; age 55.5 ± 9.6 years; A1C 9.0 ± 1.0%; BMI 32.2 ± 5.3 kg/m2; diabetes duration 9.4 ± 6.3 years. Overall Satisfaction, Regimen Acceptance and its eight subscales, Net Benefit and Preference subscale, and Weight Concern all favored DAPA + SAXA at week 24 (Table). Quality of life scales favored DAPA + SAXA at week 12, but were not different at week 24. Compared to INS, DAPA + SAXA had greater treatment satisfaction and acceptance, better short-term quality of life, and less burden and concern about weight gain, hypoglycemia and pain despite comparable A1C.

Change from baseline in HbA1c and PRO at Wk 24 [LS Mean (SE)]: Higher value denotes better outcomeWk-24 EndpointDAPA + SAXA + MetforminINS + MetforminP-valueWk-24 EndpointDAPA + SAXA + MetforminINS + MetforminP-valueHbA1c (%)−1.67 (0.06)−1.54 (0.06)0.118-- Interference6.45 (0.98)2.75 (1.00)0.009Overall Satisfaction10.14 (0.63)6.19 (0.64)<0.0001-- Social4.32 (0.83)0.62 (0.85)0.002- Regimen Acceptance7.00 (0.72)2.28 (0.73)<0.0001-- Pain4.41 (0.94)−1.93 (0.96)<0.0001-- Burden7.70 (0.85)2.48 (0.86)<0.0001-- Side Effects6.(0.99)0.17 (1.00)<0.0001-- Convenience8.01 (0.89)2.95 (0.91)<0.0001- Net Benefit17.36 (0.67)15.34 (0.68)0.035-- Flexibility9.91 (1.01)4.69 (1.02)<0.001-- Preference30.69 (1.24)26.26 (1.26)0.012-- Hassle5.92 (0.94)1.83 (0.95)0.002Weight Concern17.68 (2.46)10.38 (2.50)0.038

Disclosure

M.A. Testa: Stock/Shareholder; Spouse/Partner; GI Windows, Inc.. Stock/Shareholder; Self; Phase V Technologies, Inc. D.C. Simonson: Advisory Panel; Self; GI Windows, Inc.. Stock/Shareholder; Self; GI Windows, Inc.. Stock/Shareholder; Spouse/Partner; Phase V Technologies, Inc. E. Ekholm: None. M. Su: None. E.K. Johnsson: Employee; Self; AstraZeneca.
Acceptability of a Self-Regulation Theory-Based mHealth Behavior Intervention for Older Adults with Type 2 Diabetes and Obesity
Authors: ZHENG YAGUANG , WEINGER KATIE , GREGAS MATT C. , GREENBERG JORDAN , LI ZHUOXIN , BURKE LORA E. , QI CHENFANG , SLYNE CHRISTINE , GREAVES TORI , MUNSHI MEDHA
Published: June 2018

Background: The successful use of mobile health (mHealth) in lifestyle changes for older adults with type 2 diabetes is unknown. We report here acceptability of a mHealth intervention for older adults.

Method: We used a one-group pre-posttest design. Participants received an 8-week theory-based mHealth intervention, using the Lose It! App for daily self-monitoring of food intake, a Fitbit, and Bluetooth-enabled glucometers and weighing scales. Linear mixed models were used for analysis.

Results: The sample (N=9) was white (88.9%), female (44.4%), with a mean age of 76.4±6.0 years (range: 69-89), 15.7±2.0 years of education, BMI of 33.3±3.1 kg/m2 and HbA1c 7.4%±0.8. The Montreal Cognitive Assessment score was 24.6±2.7, indicating no severe cognitive impairment. Over 56 days, the % days of using the Lose It!, Fitbit, glucometer, and scales were 92.7±7.9, 93.7±10.6, 76.4±23.5, 52.4±37.8, respectively. The data showed a significant % weight loss (b=-0.04, p<.001), decreased calorie intake (b=-4.6, p=.0004) and increased steps (b1=34.0, b2=-1.0, p=.02) over time. The mean % weight loss from baseline was 4.44%±3.19. The dose of oral hypoglycemic agents or insulin was reduced among 4 participants.

Conclusion: Older adults are able to use mHealth to improve outcomes. The additional 3-month follow-up is ongoing to provide insight into long-term feasibility and acceptability.

Disclosure

Y. Zheng: None. K. Weinger: None. M.C. Gregas: None. J. Greenberg: None. Z. Li: None. L.E. Burke: None. C. Qi: None. C. Slyne: None. T. Greaves: None. M. Munshi: Consultant; Self; Sanofi.
The Effects of a Sleep Extension Intervention on Glucose Control in Youth with Type 1 Diabetes
Authors: PERFECT MICHELLE , FRYE SARA , BLUEZ GRAI P.
Published: June 2018

Although the 2017 Standard of Diabetes Care introduced recommendations to assess sleep patterns in individuals with type 2 diabetes, they do not contain such recommendations for individuals with type 1 diabetes (T1DM). We conducted a randomized clinical trial (RCT) to examine whether increasing sleep duration over a one-week period in youth’s natural environment improved glucose control and neurobehavioral performance. The primary outcomes of glycemic control (percent time in target range and average glucose levels) were assessed via a continuous glucose monitor (CGM) before and after being randomized to a sleep extension condition or a fixed sleep duration condition. Participants between the ages of 10 and 16 were 111 youth with almost half female; 35% were Latino/a, 51% Caucasian, and 14% mixed raced. The majority (80%) increased their sleep by more than 15 minutes; one-third achieved an increase of one hour of additional of sleep. Using actigraphy (wrist-like device that measures movement to estimate sleep) and a sleep diary, the average increase in sleep duration is 43.0 minutes vs. .30 minutes. Comparatively, research has noted that medications are considered to have a benefit to improve sleep if the individual increases sleep by 15 or more minutes. Controlling for baseline, extension participants differed from the fixed sleep duration group by 17mg/dl points, F(1, 102) = 9.55, p = .003, η2 = .39. During the Sleep Modification week, those in the Sleep Extension condition showed a 7.4% improvement in glucose levels, accounting for 11 hours more in the target range than those in the Fixed Sleep condition. These data will contribute to the long-term goal of establishing research evidence that sleep contributes to diabetes clinical care.

Disclosure

M. Perfect: None. S. Frye: None. G.P. Bluez: None.
Adults with T1D Report Half-Unit Pen Prevents Hyperglycemia and Hypoglycemia with Less Worry and Anxiety
Authors: DE OLIVEIRA CAROLINA PIRAS , MITCHELL BETH , FAN LUDI , GAREY COLLEEN , LIAO BIRONG , BISPHAM JEOFFREY , VINT NAN , PEREZ-NIEVES MAGALY , MCAULIFFE-FOGARTY ALICIA H.
Published: June 2018

People with type 1 diabetes (PWD) that strive for lower glucose targets are in need of more precise dosing and may require smaller insulin dose adjustments. Most currently available pens deliver insulin in one unit (U) increments, and few deliver half (0.5) U. There is a need to better understand who is using half unit pens (HUP) and their potential benefit for patients in the real world. This study aims to characterize PWD who have used (current/former=EVER users) HUP vs. those PWD that have never used HUP (NEVER users). This research also identified the main factors driving benefit from PWD perspective. An observational, cross-sectional survey was completed through T1D Exchange’s online patient community, myGlu.org. Chi square test, Fisher’s exact test, and t-tests were used for analyses. A total of 278 PWD (156 EVER, 122 NEVER users) over the age of 18 were recruited for the study (mean age: 42±13 years old, gender: 55% male, mean BMI (kg/m2): 26.0 ±3.8, and mean A1c (%): 6.3± 0.9), EVER users had diabetes a shorter duration (p<.001). NEVER users were more likely to use an insulin pump (p<.001). EVER users self-reported a significantly lower upper fasting glucose target compared to NEVER users (p<.001), and a lower overall post-prandial glucose target (p<.001). NEVER users were more likely to start to treat low blood sugar at lower readings (p<.001), and they were more confident in avoiding severe hypoglycemia (p<.001). Based on PWD experience, the greatest benefits of using HUP were prevention of hypo and hyperglycemia events and less worry and anxiety. HUP is an option for PWD that wish to maintain tighter management of their diabetes, avoiding hypo and hyperglycemic events while decreasing their level of worry and anxiety about their disease. It is important for PWD and health care providers to understand the benefits of this insulin delivery device to appreciate options for making diabetes management easier.

Disclosure

C. Piras de Oliveira: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. B. Mitchell: Stock/Shareholder; Spouse/Partner; Eli Lilly and Company. L. Fan: Employee; Self; Eli Lilly and Company. C. Garey: None. B. Liao: Employee; Self; Eli Lilly and Company. J. Bispham: None. N. Vint: Employee; Self; Eli Lilly and Company. M. Perez-Nieves: Employee; Self; Eli Lilly and Company. Stock/Shareholder; Self; Eli Lilly and Company. A.H. McAuliffe-Fogarty: Advisory Panel; Self; Novo Nordisk Inc..
Novel Small Molecule TXNIP Inhibitor Protects Against Diabetes
Authors: THIELEN LANCE , CHEN JUNQIN , XU GUANLAN , JING GU , GRAYSON TRUMAN , JO SEONGHO , SHALEV ANATH
Published: June 2018

Loss of functional beta cell mass represents a major factor in the pathogenesis of diabetes. Currently, there are no therapies that halt this process; however, thioredoxin-interacting protein (TXNIP) has recently emerged as a promising therapeutic target. TXNIP was found to be the top glucose-induced gene in a human pancreatic islet microarray, is increased in diabetes, and TXNIP overexpression results in beta cell apoptosis. TXNIP reduction has shown favorable effects in vivo, where whole body TXNIP-deficient and beta cell-specific TXNIP knockout mice have decreased beta cell apoptosis, increased beta cell mass, elevated insulin levels, and are protected from diabetes. We have also shown that pharmacologic TXNIP inhibition, via the anti-hypertensive medication verapamil, was able to mimic the protective effects of genetic TXNIP deletion and reversed overt diabetes in mice. In addition, it has been established that TXNIP downregulation is beneficial in multiple tissues, making it unnecessary and even undesirable to have a beta cell-specific TXNIP inhibitor and suggesting that detrimental off target effects are unlikely. We have since undertaken a high-throughput screen of 300,000 small molecules that has yielded a novel compound, TI-37330, which is more effective than verapamil in inhibiting TXNIP expression. Moreover, TI-37330 protected primary human islets and INS-1 beta cells against glucose- and cytokine-induced TXNIP and beta cell apoptosis. TI-37330 has also shown in vivo potential as it was found to have good pharmacokinetic properties and was well tolerated in healthy mice. In the context of streptozotocin-induced diabetes, oral administration of TI-37330 promoted beta cell survival, prevented diabetes, and even significantly improved overt diabetes. Collectively, these data establish small molecule TXNIP inhibitors, especially TI-37330, as robust candidates for further development.

Disclosure

L. Thielen: None. J. Chen: None. G. Xu: None. G. Jing: None. T. Grayson: None. S. Jo: None. A. Shalev: None.
An Examination of the Presence of Mental Health Diagnoses in a Clinical Sample of Individuals with Type 1 Diabetes
Authors: STANEK KELLY R. , MAJIDI SHIDEH , YOUNGKIN ERIN M. , VOGELI JO M. , DRISCOLL KIMBERLY A.
Published: June 2018

Objective: To examine demographic and mental health diagnostic characteristics for individuals with type 1 diabetes (T1D) and current mental health diagnoses.

Methods: The medical records of 397 individuals ages 10-25 with T1D (mean age = 15.3±3.1 years, mean T1D duration = 6.0±4.5 years) who were screened during routine T1D clinic visits for depressive symptoms using the Patient Health Questionnaire-9 (PHQ-9) were reviewed for current DSM-5 diagnoses, demographic information, and T1D management data.

Results: Of those screened, 29% had a mental health diagnosis; 56% had 1 diagnosis, 26% had 2, and 18% had 3+. The most common diagnoses were depression (16% of total screened), anxiety (15%), and attention-deficit/hyperactivity disorder (10%). Other diagnoses included mood, learning, and eating disorders. Those with a mental health diagnosis were slightly older and they had higher PHQ-9 scores and higher HbA1c (Table). Sex, race, insulin regimen, continuous glucose monitor use, T1D duration, and insurance were not significantly different.

Conclusions: Mental health diagnoses are common in adolescents and young adults with T1D. Those with mental health conditions may experience greater difficulties in T1D management, contributing to higher HbA1c. There is a need to develop tailored interventions to improve T1D management when specific mental health conditions are present.

Differences in Characteristics between T1D youth with and without a Mental Health Diagnosis.Mental Health Diagnosis (n=116)No Mental Health Diagnosis (n=281)p-valueAge (years)15.8±2.915.0±3.20.023PHQ-9 Score7.5±6.43.8±4.3<0.001A1C9.88±2.59.17±2.10.004

Disclosure

K.R. Stanek: None. S. Majidi: None. E.M. Youngkin: None. J.M. Vogeli: None. K.A. Driscoll: None.
Diabetes Prevention within a Large Health Care System
Authors: AZAR KRISTEN M.J. , NASRALLAH CATHERINE , SZWERINSKI NINA , CHOPRA VIDITA , HALLEY MEGHAN , ROMANELLI ROBERT
Published: June 2018

Background: The Group Lifestyle Balance™ (GLB) program is an adaption of the landmark Diabetes Prevention Program that has been recognized by the CDC as a model curriculum for diabetes prevention. The implementation of GLB at 8 predominantly autonomous and highly diverse clinics within a single, large multi-specialty healthcare organization provides a unique opportunity to evaluate the program in a real-world setting.

Methods: We conducted structured interviews with GLB facilitators at Sutter Health, a Healthcare Delivery System in Northern California, using snowball sampling. Interview questions were based on the RE-AIM framework to explore the reach, effectiveness, adoption, implementation and maintenance of the program between sites. We focused this analysis on a single regional affiliate of Sutter, with 8 clinic sites offering GLB to examine potential within-region variation.

Results: Ten GLB facilitators were interviewed, representing 8 clinical sites within the Sutter Health regional affiliate. All the facilitators were diabetes educators; 9 were registered dietitians and 1 was a registered nurse. Five sites began offering GLB in 2010, followed by two sites in 2013 and one in 2015. Eligibility criteria were the same across sites, and included all patients regardless of risk factors, except pregnant women. While all sites consistently offer 12 weekly “core” sessions over a 3-month period, the maintenance sessions are optional and are only offered at half of the sites. Almost all facilitators (n= 9) reported that they use a modified version of the curriculum developed by the University of Pittsburgh and all mentioned that they provide participants with additional information.

Conclusion: These preliminary data suggest that the GLB program has been implemented within a regional affiliate of a healthcare system, consistently, yet with some variation in the use of the post-core maintenance curriculum. Future work will examine the effectiveness of GLB based on the type of curriculum and duration of the program.

Disclosure

K.M.J. Azar: Research Support; Self; Janssen Scientific Affairs, LLC., Regeneron Pharmaceuticals, Inc..C. Nasrallah: None. N. Szwerinski: None. V. Chopra: None. M. Halley: None. R. Romanelli: Research Support; Self; Janssen Scientific Affairs, LLC., Regeneron Pharmaceuticals, Inc., Pfizer Inc..