bluuebunny/crossref_metadata_2025 huggingface dataset:
760-P: Telephonic Coaching Is Associated with Improved Patient Activation in Diabetes Self-Management
Authors: BUSKIRK ANN , BIGGS WILLIAM C. , BORSA LENA , LYDEN MAUREEN R. , PARKIN CHRISTOPHER
Published: June 2020

Appropriate diabetes self-management is essential to achieving optimal clinical outcomes. The Patient Activation Measure (PAM) is a validated, 100-item questionnaire that assesses patient activation (scored: 0=low, 100=high) and reveals four levels of activation relevant to diabetes self-management: Level 1 - disengaged and overwhelmed; Level 2 - becoming aware but still struggling; Level 3 - taking action and gaining control; and Level 4 - maintaining behaviors and pushing forward. This 12-month, observational, self-controlled multi-site study combined retrospective (6 months pre-baseline) and prospective (6 months post-baseline) to assess the impact of the Diabetes Health Partnership (DHP) program, a telephonic coaching program, on patient activation among 57 suboptimally controlled at baseline (8.4±1.1% A1C). Mean PAM total scores increased from 61.8±12.1 at baseline to 71.3±12.7 at study endpoint (p<0.0001). The downward shift in Level 1 and upward shift in Level 4 were most notable. (Figure 1) Significant increases in participant confidence in managing their diabetes (p<0.0001) and in having a clear plan for self-management (p=0.0004) were observed. Participation in the DHP program was associated with increased activation and greater confidence in participants’ ability to manage their diabetes.

Disclosure

A. Buskirk: Employee; Self; Roche Diabetes Care. W.C. Biggs: Consultant; Self; Roche Diabetes Care. Research Support; Self; Dexcom, Inc., Gan & Lee Pharmaceuticals, Mylan, Novo Nordisk A/S, Sanofi US. L. Borsa: None. M.R. Lyden: None. C. Parkin: Consultant; Self; Abbott, CeQur Corporation, Dexcom, Inc., DreaMed Diabetes, Novo Nordisk Inc., Onduo, Roche Diabetes Care, Valeritas, Inc.
765-P: The Effects of CLC on Indirect Users: Sleep Improvement in Parents of Young Children with T1D
Authors: BISIO ALESSANDRO , BROWN SUE A. , MCFADDEN RYAN , BONNER HEATHER , YU PEARL L. , CHERÑAVVSKY DANIEL R. , DEBOER MARK D. , KHURSHID OMAR , KURTZ NICOLE , OLIVERI MARY C. , PAJEWSKI MICHAEL , SCHOELWER MELISSA , VOELMLE MARY K. , WAKEMAN CHRISTIAN A. , GONDER-FREDERICK LINDA
Published: June 2020

Background and Aim: Studies have increasingly identified sleep disturbances in people with T1D. Parents of young children with T1D may also be a particularly vulnerable population to sleep disturbances. Anecdotally, it is reported that use of CLC improves sleep quality and quantity in users but objective data on indirect users are not available. This study assesses sleep outcomes of CLC compared to SAP therapy in parents of children with T1D.

Methods: Thirteen parents and their young children (ages 6-10) on insulin pump therapy were enrolled. Children completed an initial 4-week study with SAP using their own pump and a study CGM (Dexcom G6) followed by a 4-week phase of CLC (Control-IQ, Tandem Diabetes Care). Sleep was assessed in parents using actigraphy watches worn the last 10 days of each study phase. The Pittsburgh Sleep Quality Index (PSQI) questionnaire and the Hypoglycemia Fear Survey (HFS) were administered at baseline (BL) and following each study phase.

Results: A statistically significant decrease was noted from BL to the end of the CLC phase of PSQI score (p=0.009) and the behavioral (p=0.005) and worry (p=0.045) HFS subscales. Even though statistical power was reduced by the number of participants, actigraphy data showed strong trends on several variables including an average increase of 14 minutes of total sleep time from SAP to CLC (p=0.068) and in people with high PSQI scores at BL (>median) a higher sleep efficiency (p=0.098) and lower wake after sleep onset (p=0.100). Notably, children significantly reduced their time spent in hypoglycemia (<70 mg/dl) at night from SAP to CLC (p=0.015).

Conclusions: Though preliminary, these results suggest that use of CLC has a positive impact on both the quality and quantity of sleep in parents of children with T1D. A decrease in fear of hypoglycemia, endorsed by fewer nocturnal hypoglycemic episodes, might be associated with sleep improvement since previous studies have reported poorer sleep quality in parents with high levels of fear of hypoglycemia.

Disclosure

A. Bisio: None. S.A. Brown: Research Support; Self; Dexcom, Inc., Insulet Corporation, Roche Diabetes Care, Tandem Diabetes Care, Tolerion, Inc. R. McFadden: None. H. Bonner: None. P.L. Yu: None. D.R. Cherñavvsky: Employee; Self; Dexcom, Inc. M.D. DeBoer: Research Support; Self; Tandem Diabetes Care. O. Khurshid: None. N. Kurtz: None. M.C. Oliveri: None. M. Pajewski: None. M. Schoelwer: Research Support; Self; Tandem Diabetes Care. M.K. Voelmle: Consultant; Self; Dexcom, Inc. C.A. Wakeman: Stock/Shareholder; Self; Dexcom, Inc., Tandem Diabetes Care. L. Gonder-Frederick: Other Relationship; Self; HFS-Global, LLC.

Funding

Virginia Research Investment Fund
766-P: Factors Related to Subjective Cognitive Symptoms in People with Type 2 Diabetes: A Quantile Regression Analysis
Authors: KIM MIN JUNG , PARK CHANG G. , ZHU BINGQIAN , FRITSCHI CYNTHIA
Published: June 2020

Objectives: Early cognitive impairment is common in people with type 2 diabetes (T2DM). Subjective cognitive symptoms (SCS) have been associated with higher risks for early dementia and mild cognitive impairment and may be an early indication of further cognitive decline. Our goal was to identify factors related to SCS in people with T2DM to facilitate early screening for cognitive impairment in this population.

Methods: A convenience sample of 115 adults with T2D was included. The cognitive symptom subscale of the Diabetes Symptom Checklist-Revised was used. Potential factors were measured using the Patient-Reported Outcomes Measurement Information System including depression, fatigue, and sleep. Data were analyzed using quantile regression which accounts for non-normal distribution of the dependent variable. Quantile regression was useful to examine the relationships along the continuum of SCS severity that may be missed in traditional linear regression.

Results: The mean age of the participants was 58.64 (SD 8.64), and 53.9% were females. The mean score of the cognitive symptom subscale was 1.45 (SD 1.14, range 0 to 5). Using quantile regression, we found that increased sleep impairment (r = .02), sleep disruption (r = .02 to .05), and body mass index (r = .02) were significantly associated with increased SCS when the participants’ cognitive symptoms were in the lower quantiles (from .05 to .30). In contrast, increased depressive symptoms (r = .05 to .07) and fatigue (r = .04 to .06) were significantly associated with increased SCS in the higher quantiles of cognitive symptoms (from .70 to .95).

Conclusions: In adults with T2DM, the level of SCS is differentially associated with common diabetes factors and should be considered when screening and intervening for cognitive impairment. Sleep and weight should be considered for patients reporting fewer cognitive symptoms, whereas depression and fatigue should be considered for patients reporting more cognitive symptoms.

Disclosure

M. Kim: None. C.G. Park: None. B. Zhu: None. C. Fritschi: None.

Funding

National Institute for Nursing Research (K99R00NR012219); University of Illinois at Chicago College of Nursing
770-P: Behavioral Outcomes of High-Risk Spanish Speaking Latino Patients with Type 1 Diabetes Participating in a Novel Culturally Sensitive Shared Medical Appointment Model
Authors: JENSEN RYAN , SUTTIRATANA SAKINAH , NARANJO DIANA , GONZALEZ ANDREA GERARD
Published: June 2020

Objective: Spanish speaking (SS), Latino patients (LP) with type 1 diabetes (T1D) face cultural, language and socioeconomic barriers that add to the risk of complications and higher distress. Shared medical appointments (SMAs) are effective models of care to help overcome these barriers. Behavioral outcomes of SS LP with T1D attending a novel culturally sensitive SMA pilot were analyzed.

Methods: Patients 1-20 years old and caregivers participated in the SMA pilot program. Pediatric Quality of Life (PedsQL), Diabetes distress (Problem Areas in Diabetes-PAID) surveys and satisfaction scores were obtain baseline and yearly. Higher scores on PedsQL indicate a better overall QoL.

Results: Mean A1C at baseline was 9.6% (sd=2.3). Mean distress scores for children and teens decreased from Baseline to Year 2 (47.4 vs. 37.9; p=0.21 and 54.1 vs. 51.8; p=.002, respectively) and showed improvement (not statistically significant) on mean overall QoL. Diabetes specific QoL improved from Baseline to Year 1 (78.4 vs. 81.5, p=0.46 and 68.2 vs. 73.2, p=0.24, respectively). For caregivers from Baseline to Year 2 there was significant increase in distress (39.5 vs. 65.1, p<0.001), had no change in overall QoL, Diabetes specific QoL worsen from Baseline to Year 1 (64.5 vs. 57.9, p=0.04). Children, teens and parents all reported high levels of program satisfaction (means ranged from 41-46/50) with no significant change over time.

Conclusions: The novel culturally sensitive SMA model seems an effective strategy to lessen overall distress and increase QoL for High-risk SS LP youth. Parent’s final PAID scores correlated to children’s baseline A1C. It is likely that parent’s data was a result of increased education and awareness of disease seriousness. Sample size was small. Data from continued participation should be further analyzed.

Disclosure

R. Jensen: None. S. Suttiratana: Employee; Spouse/Partner; CVS Caremark. D. Naranjo: None. A. Gerard Gonzalez: None.

Funding

The Leona M. and Harry B. Helmsley Charitable Trust (2015PG-T1D060)
771-P: Impact of Maintenance Session Attendance and 6-Month Weight-Loss Goal Achievement on Weight-Loss Success in a One-Year Community Diabetes Prevention Program (DPP) Program
Authors: NAPOLEONE JENNA , MILLER RACHEL G. , DEVARAJ SUSAN , ROCKETTE-WAGNER BONNY , ARENA VINCENT C. , VENDITTI ELIZABETH M. , KRAMER KAYE , KRISKA ANDREA
Published: June 2020

The DPP lifestyle intervention showed that meeting weight loss (WL) and activity goals can prevent/delay T2D. The success of community translated versions of it (e.g., Group Lifestyle Balance, DPP-GLB) has led to Medicare reimbursement based on session attendance (at 6 and 12 months) and participant success at meeting a 5% WL goal at 12 months. Although attendance has been suggested to be related to WL success, the impact of the 6 monthly maintenance sessions (mos 7-12) after the more frequent 16 core sessions (mos 0-6) on one-year WL is not known. This effort examines how maintenance session attendance and WL goal status at 6 months in DPP-GLB affects achievement of the 12-month 5% WL goal. Data were combined from two identical intervention trials that delivered the 12-month DPP-GLB in a community setting to overweight/obese adults (mean age 62 years, 76% women) with prediabetes and/or metabolic syndrome. Participants who attended ≥4 core sessions during the first 6 months and had complete data on maintenance attendance and WL were included (n=238). Meeting the 6-month WL goal was associated with greater odds of meeting the 12-month WL goal (p<.0001). Odds of meeting the 12-month 5% WL goal were significantly greater for those who attended ≥4 maintenance sessions vs. those who did not (OR=6.0, 95% CI: 2.4-15.0). When stratified by achieving the 5% WL goal at 6 months, those who attended ≥4 maintenance sessions and met the 6-month WL goal were more likely to meet the WL goal at 12 months (OR=11.4, CI: 3.2- 40.7) compared to those who failed to meet the WL goal at 6 months (OR=1.5, CI: 0.3-7.5). Adjustment for age, gender and 6-month physical activity yielded similar results. Attending DPP-GLB maintenance sessions and meeting the 6-month WL goal increased the odds of meeting ≥5% WL at 12 months. For those who failed to meet the 6-month WL goal, attending maintenance sessions did not significantly improve their chance of 12-month WL success.

Disclosure

J. Napoleone: None. R.G. Miller: None. S. Devaraj: None. B. Rockette-Wagner: None. V.C. Arena: None. E.M. Venditti: None. K. Kramer: None. A. Kriska: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases (R18DK100933, R18DK081323)
78-OR: Glycaemia, Beta-Cell Function, and Incretin Hormones Post-OGTT One Year after Gastric Bypass and Sleeve Gastrectomy in Patients with Morbid Obesity and Type 2 Diabetes: An RCT (Oseberg Study)
Authors: FATIMA FARHAT , HJELMESÆTH JØRAN , BIRKELAND KARE I. , GULSETH HANNE L. , HERTEL JENS K. , SVANEVIK MARIUS , SANDBU RUNE , HARTMANN BOLETTE , HOLST JENS J. , HOFSØ DAG
Published: June 2020

The Oseberg study demonstrated a higher one year remission rate of type 2 diabetes after Roux-en-Y gastric bypass (RYGB) than after sleeve gastrectomy (SG). To explore mechanisms for the superiority of RYGB we assessed changes in glucose, C-peptide and incretin hormones after a 25 g OGTT and an IVGTT and calculated Disposition Indexes (DI) of beta cell function (DIIVGTT and DIOGTT). We used linear mixed models for repeated measures. Patients randomized to either RYGB (n=54) or SG (n=55), had a mean (SD) age of 48 (10) years, BMI 42.3 (5.3) kg/m², HbA1c 66 (18) mmol/mol, and 72 (66%) were women. OGTT and IVGTT were performed in 97% and 91% of patients respectively. At one year, the OGTT-derived glucose levels at 60-120 minutes were significantly lower after RYGB than after SG (all p<0.05). The OGTT-derived increase in measures of C-peptide, GIP and GLP-1 from 0 to 15 minutes were significantly higher in the RYGB group, mean (95% CI) between group difference: C-peptide 257 (66, 448) pmol/L, p=0.008; GIP 11 (4, 19) pmol/L, p=0.005; and GLP-1 29 (20, 38) pmol/L, p<0.001. DIIVGTT and DIOGTT increased three- to fivefold in both groups with no significant difference between groups. Post-OGTT glucose levels were significantly lower after RYGB as compared with SG, possibly mediated by a greater increase in GIP, GLP-1 and C-peptide levels.

Disclosure

F. Fatima: Other Relationship; Self; South-Eastren Reagional Health Authority Norway. J. Hjelmesæth: Advisory Panel; Self; Novo Nordisk A/S. K.I. Birkeland: None. H.L. Gulseth: None. J.K. Hertel: None. M. Svanevik: None. R. Sandbu: None. B. Hartmann: None. J.J. Holst: Advisory Panel; Self; AstraZeneca, Merck Sharp & Dohme Corp., Novo Nordisk A/S, Zealand Pharma A/S. Other Relationship; Spouse/Partner; Antag Therapeutics. D. Hofsø: None.
780-P: Novel Application of Patient-Centered Design in Minority Young Adults (YA) with Type 2 Diabetes (T2D)
Authors: PARK TINA , OSAKI MIYA Z. , QURESHI MAHAM , JANG ALYSSA , AGARWAL SHIVANI
Published: June 2020

The current epidemic of youth-onset T2D in minority YA requires changes to lifestyle modification recommendations that are achievable and developmentally appropriate. We used a unique approach of combining patient-centered design and conventional qualitative methods to examine lived and healthcare experiences of minority YA with T2D from an underserved area. The design team used a journey map with probes for YA to use reflective storytelling to share their diabetes journey. YA recorded important events, persons, challenges, and achievements living with T2D (Figure 1), followed by videoconference interviews. Design phase themes were used to inform a conventional qualitative interview guide for semi-structured individual interviews in a larger ongoing study. We recruited five YA with T2D for the design phase (mean age 20 yrs; 3 female; 3 Black, 1 Hispanic, 1 Asian; median HbA1c 10.8%). The design approach revealed new themes versus traditional methods: 1) surprise of T2D diagnosis and difficulty prioritizing health despite understanding need; 2) competing priority of familial financial and childcare duties; and 3) lack of guidance from healthcare providers on realistic goals for diet and weight loss. Patient-centered design is a feasible, efficacious method that enhances qualitative research to uncover breadth of themes, and should be used more often in vulnerable groups with diabetes.

Disclosure

T. Park: None. M.Z. Osaki: None. M. Qureshi: None. A. Jang: None. S. Agarwal: None.
782-P: Diabetes Stigma and Associations with Medication Adherence and Glycemic Control
Authors: CAVANAUGH KERRI , BEACH LAUREN B. ,   ESQ., HACKSTADT AMBER J. , WALLSTON KENNETH , ELASY TOM , MAYBERRY LINDSAY S.
Published: June 2020

Diabetes stigma is an emerging determinant of behaviors and outcomes. The theoretically-informed validated Comprehensive Diabetes Stigma Scale (CDSS), evaluates diabetes stigma and includes four subscales measuring enacted, perceived and self-stigma and concealment. This study tested associations between CDSS scores, medication adherence and HbA1c in a prospective cohort. We hypothesized that greater diabetes stigma would be associated with worse diabetes medication adherence and HbA1c. Pearson’s correlations and multivariable linear regression models adjusting for age, sex, race, education, insurance, partner status, diabetes duration and insulin use quantified the association of baseline CDSS scores and with ARMS-D scores and HbA1c assessed 3-6 months after enrollment. Participants (n=254) were 60 (SD 11) years old, 53% female, 80% White, 61% used insulin, mean HbA1c 7.7% (SD 1.6), and were living with diabetes for 14 (SD 9) years. CDSS scores and bivariate correlations shown in the Table. In adjusted models, CDSS overall score was associated with worse medication adherence (β 95%CI: 0.70, 0.01 - 1.39; p=0.05), but not with HbA1c (0.21, -0.05- 0.47; p=0.45). Only concealment was associated with worse HbA1c (0.48, 0.18-0.78; p=0.01). Prospective adjusted associations underline the importance of addressing concealment as a behavioral response to stigma leading to worse clinical outcomes in diabetes.

Disclosure

K. Cavanaugh: None. L.B. Beach: None. A.J. Hackstadt: None. K. Wallston: None. T. Elasy: None. L.S. Mayberry: None.

Funding

National Institutes of Health (P30DK92986-09, P30DK020593, UL1TR002243, K12HL143959)
783-P: Can Mood and Energy Levels Be Predicted by Preceding Glucose Values? Combining Ecological Momentary Assessment (EMA) and Continuous Glucose Monitoring (CGM)
Authors: EHRMANN DOMINIC , SCHMITT ANDREAS J. , RUBERTUS PAULA , KULZER BERNHARD , HERMANNS NORBERT
Published: June 2020

For association with glycemic control, psychosocial research almost exclusively used retrospective questionnaire data to assess psychosocial outcomes. Little is known about the immediate, real-time effects of glucose values on psychosocial outcomes. In an observational study, 152 people with type 1 diabetes were equipped with CGM and completed a Smartphone-based EMA-survey 4-times a day over 18 days. Participants rated their mood and energy level separately on a single-item scale from 0 (very poor) to 10 (very good). Glucose data 90 minutes prior to each rating was extracted and mean glucose, time in range, time in hypoglycemic ranges (<70, <55 mg/dl), time in hyperglycemic ranges (>180, >250 mg/dl), and the mean absolute difference (MAD) of consecutive glucose values were calculated. Multilevel regression analyses were conducted with mood and energy levels as dependent variables and each parameter of glycemic control (90min prior) as independent variable, controlled for the overall level of glycemic control. Better mood was significantly predicted by lower mean glucose levels (p=.003), higher time in range (p=.003), and less hyperglycemic values (>180 mg/dl: p=.021; >250 mg/dl: p=.002). No significant associations were found for hypoglycemic values and MAD. Higher energy levels were significantly predicted by lower mean glucose levels (p=.012), higher time in range (p=.001), less hypoglycemic values (<70 mg/dl: p<.001; <54 mg/dl: p=.023), less values in the severe hyperglycemic range (>250 mg/dl: p<.001). Lower MAD predicted higher energy levels (p=.047). Ratings of mood and energy were significantly affected by immediately preceding glucose levels. While hyperglycemic values were more important for mood, hypoglycemic values were more important for energy. These preliminary findings have important implications for our understanding of real-time effects of hypo- and hyperglycemic glucose levels.

Disclosure

D. Ehrmann: Speaker’s Bureau; Self; Abbott, Berlin-Chemie AG, Glooko, Inc. Other Relationship; Self; Dexcom, Inc., Roche Diabetes Care. A.J. Schmitt: None. P. Rubertus: None. B. Kulzer: Research Support; Self; Abbott, AstraZeneca, Berlin-Chemie AG, Roche Diabetes Care. Speaker’s Bureau; Self; Abbott, Ascensia Diabetes Care, Berlin-Chemie AG, Eli Lilly and Company, Medtronic, Novo Nordisk Inc., Roche Diabetes Care. N. Hermanns: Advisory Panel; Self; Roche Diabetes Care. Research Support; Self; Abbott, AstraZeneca, Berlin-Chemie AG.

Funding

German Center for Diabetes Research (FKZ82DZD1102A)
785-P: Number of Years Lost within 30-Year Work Life Spans of People with Type 1 and Type 2 Diabetes
Authors: NEXO METTE A. , PEDERSEN JACOB , CLEAL BRYAN , ANDERSEN INGELISE , BJORNER JAKOB B.
Published: June 2020

Background and Aims: To our knowledge, no study has yet examined diabetes related work disability from a life course perspective. This study estimated the number of years people with type 1 and type 2 diabetes lost in a 30-year work life span compared to people without diabetes.

Method: Individuals aged 18-65 years, diagnosed with type 1 (n=33,188) or type 2 diabetes (n=81,930) were identified from national registers from the entire Danish population and age and gender matched with controls without diabetes (n=663,656), for period 2000-2017. Work Life Expectancies (WLE) in years were estimated as time in employment from age 35 to 65. We used a life table approach with multi-state Cox proportional hazard modelling (95% Confidence Intervals: CI). Age was the underlying time-axis. Inverse probability weights accounted for differences between populations. Analyses were performed separately for sex, educational status, and types of diabetes in 5-year age intervals.

Results: Individuals with type 1 diabetes and type 2 diabetes had significantly shorter WLE compared to people without diabetes in the 30-year span. Type 1 diabetes: WLE ranged from 8 years shorter among women with low education [-8.0; CI: -11/-5.0] to 4 years shorter [-4.4; CI: -6.6/-2.3] with high education; WLE in men ranged from -6.4 [CI:-8.7/-4.0] with low education to -3.0 [CI:-4.5/-1.5] with high education. Type 2 diabetes: WLE ranged from -6.5 [CI: -8.9/-4.0] in women with low education to -2.9 [CI:-4.5/-1.3] with high education. WLE in men ranged from -7.0 [CI: -9.4/-4.5] with low education to -3.7 [CI: -5.4/-2.0] with high education.

Conclusion: The substantial number of years lost in 30-year work life span of people with type 1 or type 2 diabetes highlight needs to prevent individual and societal consequences of diabetes related disability. Preventive strategies are particularly relevant for people with low education.

Disclosure

M.A. Nexo: None. J. Pedersen: None. B. Cleal: None. I. Andersen: None. J.B. Bjorner: None.
802-P: Barriers to Medication Taking in African American Patients with Comorbid Diabetes and Hypertension: The Potential Role of Mild Cognitive Impairment
Authors: CUMMINGS DOYLE M. , SINGH SUNIDHI , ADAMS ALYSSA , PATIL SHIVAJIRAO P. , HART STEPHANIE , CHERRINGTON ANDREA , HALLADAY JACQUIE , RINGEL JOANNA B. , BAQUERO ELIZABETH , SAFFORD MONIKA
Published: June 2020

Both diabetes and hypertension increase risk for mild cognitive impairment (MCI) and both rely on medications for control. MCI may impede medication adherence, but this has not been well studied. We examined the association between MCI, defined as missing ≥3 items on the validated Six-Item Screener (SIS), and 19 self-reported barriers to medication taking. Negative binomial logistic regression adjusted for demographic characteristics, physical and mental health, social support, depressive symptoms, and total medication count. Participants in a cluster randomized trial (n=1243; all African Americans with persistently uncontrolled hypertension; 62% female; 43% with diabetes) testing interventions to improve BP control, were studied at baseline. Patients with diabetes were older (59 vs. 56 yrs.), took more medications (14 vs. 9), and were significantly more likely to report too many daily doses (20% vs. 14%; p<0.01) and difficulty affording medications (29% vs. 22%; p<0.01) than those without diabetes. The prevalence of MCI was similar in those with (15.2%) and without (13.4%) diabetes (p=0.35). Regardless of MCI status, 29% of patients with diabetes reported medication side effects and 32% reported allowing medications to run out. In patients with diabetes, those with MCI were significantly more likely to report concern over too many daily doses (30 vs. 18%; p=0.02) and not knowing what their medications were for (25% vs. 12%; p<0.01). In fully adjusted models in patients with diabetes, those with MCI were at high risk for not knowing what their medications were for (OR 2.06; 95% CI 1.09-3.89) and reported modestly more medication barriers although this did not achieve statistical significance (PR = 1.12; 95% CI 0.92-1.36, p=0.26). These findings suggest that patients with diabetes report multiple barriers with medications and those with MCI, which may not be clinically apparent, may require more assistance to optimize adherence.

Disclosure

D.M. Cummings: Research Support; Self; Novo Nordisk Inc. S. Singh: None. A. Adams: None. S.P. Patil: Research Support; Self; Novo Nordisk Inc. S. Hart: None. A. Cherrington: None. J. Halladay: None. J.B. Ringel: None. E. Baquero: None. M. Safford: None.

Funding

National Heart, Lung, and Blood Institute (4UH3HL130691)
813-P: The Use and Effectiveness of Incentives in Chronic Disease Lifestyle Change Programs
Authors: ATKINS CHARISMA , HULBERT LASHONDA , SKEETE RENEE , MICHAEL SHANNON L. , SMITH BRYCE , CANNON MICHAEL
Published: June 2020

The National Diabetes Prevention Program (National DPP) helps individuals with prediabetes make lifestyle changes to prevent type 2 diabetes. Some lifestyle change programs use incentives to promote health goals, but the impact of incentives in these settings has not been systematically assessed. We conducted a systematic literature review to assess the effectiveness of incentives in programs similar to the National DPP lifestyle change program. Manuscripts were included if they focused on the use of incentives in chronic disease lifestyle change programs in adults; occurred in high-to-middle income countries; were published in 2008-2019; and were written in English. Manuscripts were excluded if they focused on diet- or walking-only programs; medical interventions; screenings, pharmaceutical treatments, or one-time services; or had no comparison group. We examined the effectiveness of incentives for improving the following measures: weight, BMI, blood pressure, cholesterol, and HbA1c. We identified 21 studies that met our inclusion/exclusion criteria. Nearly all studies were randomized controlled trials, with general wellness programs in the workplace being the most common. The most common incentive characteristics by category were: type—cash (10/21); amount--$1-$25 (10/21); frequency—multiple times (17/21); amount variability—fixed (8/21); and certainty—criteria-based guaranteed (12/21). The direction of effect for incentives was favorable for 94/111 (85%) comparisons for the five health-related measures, of which 47/94 (50%) were statistically significant (p<0.05). Only 2/111 (2%) comparisons were unfavorable and statistically significant. We did not identify particular incentive characteristics that were predictive of effectiveness, and we did not assess cost-effectiveness of incentives. Incentives may be useful for reaching health goals in lifestyle change programs and should be evaluated for cost-effectiveness if they are used.

Disclosure

C. Atkins: None. L. Hulbert: None. R. Skeete: None. S.L. Michael: None. B. Smith: None. M. Cannon: None.
822-P: Diabetes Prevention Care Preferences among People with Severe Mental Illness Taking Antipsychotic Medications
Authors: ITURRALDE ESTI , JONES ASHLEY L. , SLAMA NATALIE , KLINE-SIMON ANDREA H. , STERLING STACY , SCHMITTDIEL JULIE
Published: June 2020

Background: People with severe mental illness (SMI), i.e., psychotic and major affective disorders, face twice the risk for developing type 2 diabetes. Antipsychotic medication treatment contributes to elevated risk through weight gain and other metabolic side effects. Although clinical trial evidence supports both lifestyle and pharmacological approaches to mitigate medication-induced weight gain and diabetes risk in SMI, research on patient preferences is lacking.

Methods: We conducted semi-structured interviews with adults who had SMI, were on antipsychotic medications, had no diagnosed diabetes, and were receiving psychiatric care in a large nonprofit health care system.

Results: A total of 36 individuals participated (72% women; ages 19-63 years; 42% non-White; 17% Medicaid). They were prescribed quetiapine (53%), olanzapine (31%), or risperidone or iloperidone (17%). Metabolic risk factors were common (obesity 67%, prediabetes 28%); 64% rated physical health as poor to fair; 89% cited excess weight or weight gain as a major health concern. Most (86%) reported past efforts at lifestyle modification to manage weight, with a third pursuing related health services (nutrition counseling, health classes). Barriers to lifestyle modification included time constraints, fluctuating motivation, and excess costs. We found low patient awareness of pharmacological strategies to manage diabetes risk (e.g., metformin), despite the majority of participants describing interest in this option. Participants perceived a role for both psychiatrists and primary care physicians in helping them manage diabetes risks.

Conclusions: Patients with SMI are receptive to multiple evidence-based diabetes prevention strategies that span primary care and specialty mental health care domains, including both medication and motivational supports, available at low cost and at convenient times.

Disclosure

E. Iturralde: None. A.L. Jones: None. N. Slama: None. A.H. Kline-Simon: None. S. Sterling: None. J. Schmittdiel: None.

Funding

National Institute of Diabetes and Digestive and Kidney Diseases; Health Delivery Systems- Center for Diabetes Translational Research (NIDDK HDS-CDTR)
825-P: Effects of Family-Related Factors on Diabetes Self-Management Behaviors
Authors: LIN KEKE , QUINN LAURIE T.
Published: June 2020

Many diabetes self-management behaviors (DSMB) take place in family settings, which highlights the importance of examining family-related factors associated with DSMB. Most current research has focused on the impact of family support on DSMB. Yet, how multiple family-related factors collectively affect DSMB remains unknown. The purpose of our study is to examine effects of positive family support, attitudinal familism, and perceived role demands associated with house chores and caregiving responsibilities on DSMB among a group of Chinese adults with type 2 diabetes mellitus (T2DM). A convenience sample of 210 patients with T2DM was recruited from a community health center in Beijing, China. Instruments included Diabetes Self-management Scale, Self-efficacy Scale for Patients with T2DM, Perceived Role Demands Scale, Attitudinal Familism Scale, and Diabetes Family Behavior Checklist-II. Findings from structural equation modelling showed that attitudinal familism, perceived role demands associated with house chores and caregiving responsibilities, and self-efficacy had direct impacts on DSMB. Attitudinal familism and positive family support both also had indirect effects on DSMB through self-efficacy (X2=3.31, p>0.05; RMSEA=0.022, CFI=0.998, SRMR=0.013). The indirect effect of positive family support on DSMB was 0.24, Bootstrap standard error=0.13, z=5.08, p<0.001; The indirect effect of attitudinal familism on DSMB was 0.15, Bootstrap standard error=0.04, z=3.44, p<0.01. Our findings suggest that it will be beneficial to improve patients’ self-efficacy in order to achieve optimal DSMB, especially for those who have less family support and lower attitudinal familism scores. It also indicates that more perceived role demands associated with house chores and caregiving responsibilities leads to less adherence to DSMB, and this relationship cannot be mediated by self-efficacy. Other strategies should be developed to help those with heavy role demands to achieve optimal DSMB.

Disclosure

K. Lin: None. L.T. Quinn: None.
828-P: Challenges in Care Relationships in Diabetic Setting: The Diabetologists’ Perspective
Authors: MARCHINI FRANCESCO , LANGHER VIVIANA , CAPUTO ANDREA , GIULIANI CHIARA , CONVERTINO ALESSIO , NAPOLI ANGELA
Published: June 2020

Purpose: Poor medication adherence in persons with diabetes is a well documented issue, overall leading to worse glycemic control and quality of life. Previous studies have shown that the quality of the patient-provider relationship is a crucial factor for patient diabetes management and self-care. Most of research has focused on patient perspective, with poor attention to providers’ relational skills to handle interpersonal difficulties concerning care challenges. The purpose of the present study was to explore providers’ subjective perspective about care relationship so to detect some clues that may contribute to better manage patient medication adherence.

Methods: A purposive sample of 18 Italian diabetologists participated in the study. Face-to-face interviews on providers’ emotional experience about care relationship were collected, digitally recorded, and transcribed. A computer-aided text analysis based on word co-occurrences was performed through T-Lab software, by using the conceptual model of Emotional Text Analysis. This allowed the identification of thematic domains pertaining to implicit sense-making processes, beyond the cognitive discourse organization.

Results: Six thematic domains were identified across interviews, which respectively referred to: (1) preoccupation, in terms of separation anxiety and desire for contact; (2) control, focused on hypervigilance and conflict management; (3) fear for excessive closeness and effort to distance; (4) proud self-affirmation in opposition to care burden; (5) guilt feelings and over-involvement; (6) strive for achievement and satisfaction gain.

Conclusions: The findings suggest the importance of providers’ awareness about potential defensive strategies in facing care challenges, from distancing to intrusive reactions, which may interfere patient health engagement and capacity to self-regulate in care behaviors, respectively.

Disclosure

V. Langher: None. A. Caputo: None. C. Giuliani: None. A. Convertino: None. A. Napoli: None.
829-P: Socioeconomic Barriers to T2D Management: Patient Perspectives on Opportunities for Intervention
Authors: STOTZ SARAH A. , RICKS KATHARINE A.B. , EISENSTAT STEPHANIE A. , WEXLER DEBORAH J. , BERKOWITZ SETH A.
Published: June 2020

Socioeconomic status (SES) challenges are common barriers to type 2 diabetes (T2D) management. We sought to obtain patient perspectives on T2D interventions sensitive to SES barriers. We conducted focus groups (n=8) with a socioeconomically diverse sample of adults with T2D (n=53). Focus groups used a semi-structured moderator guide and were recorded and transcribed verbatim. We utilized the constant-comparison method for qualitative content analysis. Findings revealed three primary themes: 1) gaps in food and nutrition resources, 2) challenges to healthful eating, and 3) potential interventions to address barriers noted in Themes 1 and 2. Supporting categories for Theme 1 included: lack of structured food resource management education (e.g., healthy eating on a limited budget), need for peer-based or health coaching support specific to low SES circumstances (e.g., facing trade-offs between buying food and paying for medications), and mixed experiences with nutrition counseling (e.g., lack of sensitivity to challenges of healthy eating, behavior change). Supporting categories for Theme 2 included challenges related to stress, mental health, comorbidities, and insufficient food insecurity interventions. To help overcome these barriers, participants described three broad categories of preferred intervention strategies. First, they endorsed SES-informed lifestyle intervention (e.g., focusing on food resource management, sensitive health coaching and nutritional counseling). Second, they expressed enthusiasm for group-based learning opportunities, such as cooking classes and support groups conducted among peers with similar SES. Third, they suggested provision of additional resources such as meal delivery programs, healthy food subsidies, and assistance in accessing food aid. These interventional strategies can be tested and refined to help improve health for disadvantaged individuals with T2D.

Disclosure

S.A. Stotz: None. K.A.B. Ricks: None. S.A. Eisenstat: None. D.J. Wexler: Other Relationship; Self; Novo Nordisk A/S. S.A. Berkowitz: None.

Funding

DK109200, DK092923
845-P: Changes in Plasma Levels of Liver Enzymes in Response to Dapagliflozin, Metformin, or Exercise in People with Prediabetes: The PRE-D Trial
Authors: BLOND MARTIN B. , CLEMMENSEN KIM K. , AMADID HANAN , NIELSEN LEA B. , RIED-LARSEN MATHIAS , KARSTOFT KRISTIAN , PERSSON FREDERIK , JØRGENSEN MARIT E. , FAERCH KRISTINE
Published: June 2020

Background: Plasma levels of liver enzymes are elevated in prediabetes but may improve in response to weight loss and glucose-lowering interventions. We examined the effects of dapagliflozin, metformin, or exercise on plasma levels of alanine transferase (ALT), aspartate aminotransferase (AST), and gamma-glutamyl transferase (GGT) in people with prediabetes.

Methods: 120 adults with prediabetes (30-70 years, BMI≥25 kg/m2, HbA1c 5.7-6.4%) were randomized to 13 weeks of dapagliflozin (10 mg once daily), metformin (850 mg twice daily), exercise (30 min, 5 days/week) or control (habitual living). Fasting plasma levels of ALT, AST, and GGT were measured at baseline and after 6 and 13 weeks of intervention and after 26 weeks of follow-up. Linear mixed-effects models were performed.

Results: At baseline, median (Q1;Q3) HbA1c was 5.9% (5.7; 6.1). 17% had elevated ALT levels, 3% elevated AST levels, and 6% elevated GGT levels. ALT and AST levels did not change in response to the interventions (Table 1). Small within-group changes in GGT were observed in the active groups after 6, 13 or 26 weeks, but they did not differ from the control group (P≥0.09 for all comparisons).

Conclusions: 13 weeks of treatment with dapagliflozin, metformin or exercise was not associated with changes in liver function markers compared with habitual living in people with prediabetes.

Disclosure

M.B. Blond: None. K.K. Clemmensen: Research Support; Self; AstraZeneca, Novo Nordisk Foundation. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. H. Amadid: None. L.B. Nielsen: None. M. Ried-Larsen: None. K. Karstoft: Employee; Spouse/Partner; Novo Nordisk A/S. F. Persson: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S. Research Support; Self; Amgen, AstraZeneca, Novo Nordisk A/S. Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Merck Sharp & Dohme Corp., Mundipharma International, Novo Nordisk A/S. M.E. Jørgensen: Research Support; Self; Amgen, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Sanofi-Aventis. Stock/Shareholder; Self; Novo Nordisk A/S. K. Faerch: None.

Funding

Novo Nordisk Foundation; AstraZeneca; University of Copenhagen; Innovation Foundation
873-P: Flash Glucose Monitoring: Effect on Glycaemic Control, Hypoglycaemia, Diabetes-Related Distress, and Resource Utilization: A Nationwide Study
Authors: DESHMUKH HARSHAL , WILMOT EMMA G. , PATMORE JANE , WALTON CHRISTOPHER , HERRING ROSELLE , RYDER ROBERT E. , SATHYAPALAN THOZHUKAT
Published: June 2020

Aim: The FreeStyle Libre (FSL) flash glucose monitoring device was made available on the UK National Health Services (NHS) drug tariff in 2017. This study aims to explore the UK real-world experience of FSL and the impact on glycaemic control, hypoglycaemia, diabetes-related distress and hospital admissions.

Methods: Clinicians from 102 National Health Service hospitals in the United Kingdom submitted FSL user data, collected during routine clinical care, to a secure web-based tool. T-tests and Mann-Whitney-U tests were used to compare the baseline and follow-up HbA1c and other baseline demographic characteristics. Linear regression analysis was used to identify predictors of change in HbA1c following the use of FSL. Within-person variations of HbA1c calculated adj-HbA1c-SD=SD/sq. Root [n/(n−1)].

Results: Data were available for 10,370 (97% with type 1 diabetes) FSL users; age 38 (±18.7) years, 54% female, diabetes duration 16 (±49) years, and BMI of 25.2 (±16.5) kg/m2. The baseline HbA1c was 69.8 (±18.2) (8.5%), and after a mean follow-up of 7.6 (±23)months (n=3182) HbA1c reduced to 62.3 (±18.5) (7.9%) mmol/l (P<0.0001)). HbA1c reduction was greater in those with initial HbA1c ≥69.5 (>8.5%) mmol/mol, HbA1c reduced from 85.5mmol/mol (±16.07) (10%) to 73.1 mmol/mol (±15.8) (8.8%)) (P<0.0001). The baseline Gold score (score for hypoglycaemic unawareness) was 2.7 (±1.8) and reduced to 2.4 (±1.7) (P<0.0001) at follow-up. 53% of those with a Gold score of ≥4 at baseline, regained hypoglycaemic awareness at follow-up. FSL use was also associated with a reduction in diabetes distress (P<0.0001). Use of FSL was associated with significantly reduced paramedic callouts and hospital admissions due to hypoglycaemia and to hyperglycaemia/Diabetic Ketoacidosis (DKA).

Conclusion: We show that the use of FSL was associated with significantly improved glycaemic control and hypoglycaemia awareness, and a reduction in hospital admissions.

Disclosure

H. Deshmukh: None. E.G. Wilmot: Advisory Panel; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic. Speaker’s Bureau; Self; Abbott, Eli Lilly and Company, Insulet Corporation, Novo Nordisk Inc., Sanofi. J. Patmore: None. C. Walton: Speaker’s Bureau; Spouse/Partner; Celgene, LEO Pharma, Novartis Pharmaceuticals Corporation. R. Herring: None. R.E. Ryder: Consultant; Self; GI Dynamics Inc. Other Relationship; Self; Novo Nordisk A/S. T. Sathyapalan: Research Support; Self; Amgen, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Novo Nordisk A/S. Other Relationship; Self; Ipsen Biopharmaceuticals.
877-P: Limits of Correlation Coefficient Analysis in Determining the Minimal Duration of CGM Data Needed to Estimate Time Below Range
Authors: CAMERLINGO NUNZIO , VETTORETTI MARTINA , CIGLER MONIKA , FACCHINETTI ANDREA , SPARACINO GIOVANNI , MADER JULIA K. , CHOUDHARY PRATIK , FAVERO SIMONE DEL ,   ON BEHALF OF THE HYPO-RESOLVE CONSORTIUM
Published: June 2020

To design a clinical trial it is important to know for how long CGM data should be collected to accurately assess time in different glucose ranges (time in ranges). Several studies approached this problem through the computation of the correlation coefficient (R2) between a metric computed in a month-long trial and in several shorter windows of increasing duration. The minimal duration (MD) granting R2>threshold (e.g., 0.9) is then used to estimate the long-term metric.

Here, we focus on time below range (TBR), defined as time <70 mg/dl [%]. We first implemented the R2-based analysis on trials of different duration: A1, A2, A3, lasting 100, 200, 300 days (d), respectively, obtained selecting portions of the same Study A (n=45, duration=360 d, sensor=Abbott Freestyle Libre). Table 1 shows that the longer the trial duration, the larger the resulting MD. Notably, all the obtained trial duration fractions are similar. Then, the analysis was repeated for other two trials of equal duration: Study B (n=85, duration=240 d, sensor=Dexcom G5) and A4, obtained selecting 240 d from Study A. Although B and A4 refer to different T1D populations and different sensors, the resulting trial duration fraction is the same.

In conclusion, the R2-based analysis yields different results based on the duration of the considered dataset, and seems to identify only the fraction of data needed to match the reference TBR.

Disclosure

N. Camerlingo: None. M. Vettoretti: None. M. Cigler: None. A. Facchinetti: None. G. Sparacino: None. J.K. Mader: Advisory Panel; Self; Becton, Dickinson and Company, Eli Lilly and Company, Medtronic, Prediktor Medical, Sanofi-Aventis. Speaker’s Bureau; Self; Abbott, Eli Lilly and Company, Medtronic, Novo Nordisk A/S, Roche Diabetes Care, Sanofi-Aventis. P. Choudhary: Advisory Panel; Self; Abbott, Eli Lilly and Company, Insulet Corporation, Medtronic. Research Support; Self; European Union, JDRF. Speaker’s Bureau; Self; Dexcom, Inc., Novartis AG, Novo Nordisk A/S, Sanofi-Aventis. S. Del Favero: Research Support; Self; Dexcom, Inc.

Funding

Innovative Medicines Initiative 2 Joint Undertaking (777460); European Union; European Federation of Pharmaceutical Industries and Associations; T1D Exchange; JDRF; International Diabetes Federation; The Leona M. and Harry B. Helmsley Charitable Trust
896-P: Putting the Pieces Together: Building a Nonenzymatic Wearable Glucose Sensor Using Silicon Microneedle Arrays
Authors: PENNATHUR SUMITA , KIM HYUNJIN , WANG BING , QUEENAN BRIDGET N. , HUBER DAVID
Published: June 2020

We developed the technology to build a novel painless CGM that is an on-body, wirelessly transmitting device that extracts interstitial fluid with a dime-sized patch of microneedles and optically detects glucose from extremely small fluid volumes. We not only developed an innovative method for fabricating silicon microneedles, sharp and small enough to penetrate skin without pain (160 µm in height, 50 µm in diameter, and 100 µm in width), but also demonstrated that our microneedle fabrication is repeatable and reliable. Next we developed an entirely new, stable, non-enzymatic glucose-sensing method based on a variation of the well-known fluorescent-based boronic acid sensor, and further refined this sensor to allow for conductivity based sensing as well as ratiometric sensing of glucose (Figure 1, left). Finally, we built a novel integrated silicon buried dual-junction (BDJ) photodiode-based system with which to detect glucose with our sensor. The Figure attached shows our latest successes with ratiometric sensing of tartaric acid using our microfabricated device (Figure 1, right). Given our results, we believe this technology can now be transitioned to industry, and we are moving on to developing a wearable microfluidic-based patch pump that can allow for a truly affordable artificial pancreas based diabetes management solution.

Disclosure

S. Pennathur: Board Member; Self; Laxmi Therapeutic Devices. Employee; Self; Laxmi Therapeutic Devices. Research Support; Self; American Diabetes Association, Leona M. and Harry B. Helmsley Charitable Trust. Stock/Shareholder; Self; Laxmi Therapeutic Devices. H. Kim: None. B. Wang: None. B.N. Queenan: None. D. Huber: None.

Funding

American Diabetes Association/Pathway to Stop Diabetes (1-17-VSN-18 to S.P.)