bluuebunny/crossref_metadata_2025 huggingface dataset:
Accuracy Evaluation of the WaveForm Cascade CGM System vs. Dexcom G5 Sensors
Authors: REBEC MIHAILO , ANDERSON ELLEN M. , DUTT-BALLERSTADT RALPH , HAIDAR AHMAD , JANEZ ANDREJ
Published: June 2018

Objective: WaveForm is actively pursuing a commercial launch with a new trocar-free CGM system. The Cascade CGM device is based on a variant of an amperometric GOx-based technology. Finishing the algorithm and validating the clinical performance of the device is the final development stage. We are reporting on the outcome of a 10-day clinical study that was used to compare the accuracy of the Dexcom G5 CGM device and our Cascade CGM.

Method: The Clinical study that was used to evaluate the two CGM systems included 15 subjects with type 1 and 2 diabetes. On day 1, 4, 7 and 10, 12-hour in-clinic CGM accuracy studies were performed. Each subject wore two Cascade CGM devices and one Dexcom G5 sensor in the abdominal area. YSI glucose measurements were performed on plasma from venous blood sampled every 15 minutes. The Dexcom device was inserted at the beginning of day 4 in-clinic day and was worn through day 10 of the study (7 days). The overall MARD and MAD calculation for the Cascade CGM was evaluated for the four in-clinic days by prospectively applying an advanced algorithm to data generated during the study. The comparison of accuracy performance between the Cascade and the Dexcom G5 sensors was conducted over 7 days which included 3 in-clinic days for each CGM device.

Result: Head-to-head MARD comparison between the WaveForm and Dexcom sensor over 7 days showed that MARD for the Cascade CGM was better (11.0% vs. 12.2%). Consensus error grid analysis for Cascade device showed that 99% of data points were in zone A and B, with the remaining 1% in zone C.

Conclusions: Overall performance of the Cascade CGM device over 10 days meets the clinical expectations of a commercial device. Direct comparison with the Dexcom G5 sensor - regarded as the current benchmark in the CGM market - shows that the WaveForm device met and even surpassed the performance level of it in this study. The Cascade CGM will be launched as 14-day wear CGM system.

Disclosure

M. Rebec: Employee; Self; Agamatrix LLC. E.M. Anderson: Employee; Self; AgaMatrix LLC. R. Dutt-Ballerstadt: Employee; Self; WaveForm Technology. A. Haidar: Consultant; Self; Eli Lilly and Company. Research Support; Self; AgaMatrix, Medtronic MiniMed, Inc.. A. Janez: None.
Sleep and Glycemia in Adolescents with Type 1 Diabetes
Authors: GREY MARGARET , RECHENBERG KAITLYN
Published: June 2018

Nearly 70% of adolescents have chronic sleep problems (quality, quantity, and/or altered circadian rhythm). Adolescents with type 1 diabetes (T1D) are subject to nocturnal blood glucose fluctuations that may result in restless sleep and require self-care that disrupts sleep. Deficient sleep may also contribute to insulin resistance. Few studies of sleep characteristics and their association with glycemic control have been conducted. Our aim was to describe sleep characteristics in adolescents with T1D and its relationship with glycemic control.

Adolescents with T1D (ages 10-16) were recruited from the Yale Program. For 7 days, participants wore a wrist actigraph, which was used to calculate sleep/wake cycles using 30-second epochs, and a continuous glucose monitor (CGM). The Pittsburgh Sleep Quality Index (PSQI) was used to assess subjective sleep reports. The sample included 30 participants age 13.4+1.9, 67.9% female, 29.2% minority, BMI percentile 75+25%, diabetes duration 7.4+ 4.5 years, and 97% on insulin pumps.

Hemoglobin A1c (A1c) levels (8.29+1.38%) and CGM (46.3+14.9% time in hyperglycemia) indicated poor glycemic control. Actigraphy showed inadequate total sleep time (7.33+19 hours), but good sleep efficiency (80.0+20.3%). Higher MESOR (rhythm adjusted mean) (r=0.25) and lower circadian quotient (r=-0.31) were associated with higher A1c. Greater circadian quotient was associated with more glucose variability (r=0.41). Greater WASO (wake after sleep onset) was associated with higher glucose (r=0.26), HBGI (high blood glucose index) (r=0.27), and more hyperglycemia (r=0.25). Higher MESOR was associated with lower LBGI (low blood glucose index) (r=-0.39) and less hypoglycemia (r=-0.42). Higher amplitude was associated with lower LBGI (-0.35) and less hypoglycemia (r=-0.39).

These results suggest that insufficient sleep is common among adolescents with T1D and is associated with poorer glycemic control. Further research is required to determine if improving sleep will improve glycemic control.

Disclosure

M. Grey: None. K. Rechenberg: None.
How Does Risk Screening for Kidney Disease Influence Diabetes Distress?
Authors: JOENSEN LENE E. , MADSEN KRISTOFFER P. , FRIMODT-MOLLER MARIE , TOFTE NETE , WILLAING INGRID , LINDHARDT MORTEN , ROSSING PETER
Published: June 2018

Background: Screening for future risk of diabetic kidney disease (DKD) in people with type 2 diabetes (T2D) and normal kidney function was conducted in the clinical multicenter intervention trial PRIORITY (Proteomic prediction and Renin angiotensin aldosterone system Inhibition prevention Of early diabetic nephRopathy In TYpe 2 diabetic patients with normoalbuminuria). Risk screening was based on a urinary proteomic analysis categorizing the patients at high or low risk for DKD. Little is known about how risk-assessments affect patients. However, screening for DKD is likely to increase diabetes distress (DD), as DD is linked to specific diabetes stressors such as worrying about complications.

Aim: To investigate to what extent DD was affected by screening and individualized information about future risk of DKD.

Methods: Of 436 participants in the Danish part of PRIORITY, 217 were asked to complete a full diabetes distress scale (DDS) and 139 completed DDS at screening visit (T1) and after provision of screening results (T2, 6 weeks after T1). DDS was repeated in 84 at a follow-up visit (T3, 12 months after T2). DD differences were explored with wilcoxon signed-rank test and subgroup differences with paired t-test.

Results: Participants’ mean age was 61 years, 37 % women, mean diabetes duration 10 years, mean HbA1c 54mmol/mol, 4 % had high overall DD and 12 % were categorized as having high risk of DKD. No significant changes were found in DD between T1, T2 and T3. Mean DD differences [SD] between T1 to T2 was 0.02 [0.38], p=0.65 and between T2 and T3 0.01 [0.35], p=0.88. No significant differences in DD changes were found when comparing participants with high vs. low initial DD or when comparing participants in high vs. low risk of DKD. However, few participants had high DD at T1 and few had high risk of DKD.

Conclusions: The study indicated that screening for future risk of DKD does not increase DD in people with T2D. Future studies should explore potential subgroup differences further as well as the mechanisms behind the results.

Disclosure

L.E. Joensen: None. K.P. Madsen: None. M. Frimodt-Moller: None. N. Tofte: None. I. Willaing: None. M. Lindhardt: None. P. Rossing: Advisory Panel; Self; Novo Nordisk A/S, AstraZeneca, Boehringer Ingelheim GmbH. Research Support; Self; AstraZeneca, Novo Nordisk A/S. Advisory Panel; Self; Astellas Pharma US, Inc.. Stock/Shareholder; Self; Novo Nordisk A/S. Advisory Panel; Self; Bayer AG.
Education for Family Members Is Effective for Improved Glycemic Control of Patients with Type 2 Rather than Type 1 Diabetes Mellitus—A Meta-analysis
Authors: KODAMA SATORU , FUJIHARA KAZUYA , ISHIGURO HAJIME , HORIKAWA CHIKA , YACHI YOKO , ISHIZAWA MASAHIRO , MATSUNAGA SATOSHI , TANAKA SHIRO , KATO KIMINORI , SONE HIROHITO
Published: June 2018

Although the importance of support of patients by family members is emphasized for diabetes care, evidence of achieving adequate glycemic control (GC) through instructing family members to help in self-management care of diabetes patients has not been established. This meta-analysis assessed the effect of family-oriented diabetes programs on GC. The pooled A1C change shown in 31 studies that were retrieved from systematic literature searches for clinical trials presenting data on the net effect of family education on the reduction in glycohemoglobin A1C (A1C) (i.e., difference in A1C change between intervention groups involving family members and that not involving family members [control group]) was -0.45% (PP<0.001). When separating trials limited to type 1 and type 2 diabetes, the pooled A1C values were -0.35% (P=0.001) and -0.71% (P<0.001), respectively (Figure). Current meta-analysis indicates that involving family members in diabetes education programs is an effective strategy for improved GC predominantly in patients with type 2 diabetes. Figure legend: Forest plot of differences in changes in A1C between intervention and control groups. Effect size below zero indicates an A1C reduction larger in the intervention group than in the control group.

Disclosure

S. Kodama: None. K. Fujihara: None. H. Ishiguro: Research Support; Self; MSD K.K., Sanofi K.K., Eli Lilly and Company. C. Horikawa: None. Y. Yachi: None. M. Ishizawa: None. S. Matsunaga: None. S. Tanaka: None. K. Kato: None. H. Sone: Research Support; Self; Novo Nordisk Inc., Eli Lilly and Company, MSD K.K., Chugai Pharmaceutical Co., Ltd., Taisho Pharmaceutical Co., Ltd., Takeda Development Center Asia, Pte. Ltd., Daiichi Sankyo Company, Limited, Ono Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Sanofi, Kowa Pharmaceuticals America, Inc., Eisai Inc..
Prevalence and Factors Associated with Sleep Disorders in Japanese Patients with Type 2 Diabetes
Authors: OTAKA HIDEYUKI , MURAKAMI HIROSHI , MIZUSHIRI SATORU , KAMBA AYA , DAIMON MAKOTO
Published: June 2018

Background: Sleep disorders are frequently reported in patients with type 2 diabetes. However, there are few reports on the prevalence and correlates of sleep disorders in diabetics. This study investigated the prevalence and factors associated with sleep disorders in type 2 diabetics.

Research Design and Methods: In total, 544 patients with type 2 diabetes mellitus (311 males, 233 females; age 63.9 ± 12.6-years-old; HbA1c, 7.1 ± 0.9%) and 1,161 control subjects (38.1% males; 54.5 ± 15.4-years-old; HbA1c 5.8 ± 0.6%) were included. Participants used self-administered questionnaires on sleep attitude (Pittsburgh Sleep Quality Index; PSQI), quality of life (the Short Form 36 Health Survey; SF-36), depression (the Center for Epidemiologic Studies-Depression scale), and personality (Ten Item Personality Inventory). The socio-demographics, laboratory data, and medical history were collected from medical records.

Results: The number of subjects with sleep disorders (PSQI > 5) was higher in diabetic patients (25.9%) than control subjects (20.6%) (p = 0.02), although sleeping time was significantly longer in diabetic (7.42 hours) than in control subjects (7.09 hours) (p < 0.01). Among diabetic patients, the sleep disorders group showed higher percentages of females (p < 0.01), spouseless subjects (p < 0.01), insulin users (p < 0.01), depression (p < 0.01), overactive bladder (p = 0.01), and benign prostatic hyperplasia (p < 0.01). Diabetic patients with sleep disorders scored higher on the neuroticism scale than patients without sleep disorders (p < 0.01). All SF-36 scores were lower in patients with sleep disorders. No differences were found in age, body mass index, HbA1c, stage of diabetic retinopathy, and nephropathy between patients with the presence or absence of sleep disorders.

Conclusions: The prevalence of sleep disorders was high in patients with type 2 diabetes, and their quality of life was impaired. Therefore, clinicians should monitor sleep disorders among these patients.

Disclosure

H. Otaka: None. H. Murakami: None. S. Mizushiri: None. A. Kamba: None. M. Daimon: None.
Pancreatic Beta Cell O-GlcNAc Transferase Overexpression Increases Susceptibility to Streptozotocin- and High-Fat Diet–Induced Diabetes in Female Mice
Authors: MOHAN RAMKUMAR , RUAN HAI-BIN , YANG XIAOYONG , ALEJANDRO EMILYN
Published: June 2018

The nutrient-sensor O-GlcNAc transferase (OGT), the sole enzyme that adds an O-GlcNAc-modification onto proteins, was shown to regulate β-cell survival and function as β-cell deletion of OGT induces diabetes and islet failure in mice. We hypothesized that β-cell OGT overexpression (Rip-cre;OgtOE) would confer protection from streptozotocin (STZ)-induced β-cell failure and high-fat diet (HFD)-induced diabetes. Female mice are typically resistant from HFD- or STZ-induced diabetes. However, the molecular mechanisms underlying this sexual dimorphism are unclear. Here, we uncovered that Rip-cre;OgtOE mice show normal peripheral insulin sensitivity and glucose tolerance in normal chow but when challenged female transgenic mice alone develop glucose intolerance post 8-weeks of HFD and severe hyperglycemia 1-week post STZ treatment. Surprisingly, male transgenic mice are neither protected nor impaired when compared to controls in both treatments. Molecular interrogation of islets validated efficient overexpression of OGT in both sexes by confirming protein expression of the reporter transgene (GFP). However, significant increase in OGT protein was observed only in islets of female Rip-cre;OgtOE mice, suggesting sex difference in OGT protein regulation. Transcriptome analysis by RNA sequencing shows increased expression levels of genes involved in acute inflammation (Ggt5, Ncf1, Ptgs1, Alox5ap) and immune response via agranulocyte adhesion and diapedesis (Glycam1) in islets of female Rip-cre;OgtOE mice, providing a mechanism of susceptibility to STZ and HFD-induced islet failure. Indeed, pancreas analysis shows increased islet infiltrating lymphocytes in female Rip-cre;OgtOE compared to control post 22 weeks of HFD treatment. Together, these data highlight the novel role of OGT in inflammation induced by STZ and HFD in islets and emphasize the importance of OGT dosage and O-GlcNAc cycling in β-cell survival.

Disclosure

R. Mohan: None. H. Ruan: None. X. Yang: None. E. Alejandro: None.
Markup Methodology to Culturally Tailor Preexisting Preconception Counseling (PC) Program for Latina Adolescent Girls with Diabetes and Their Mothers
Authors: ABUJARADEH HIBA , PETERSON-BURCH FRANCES M. , OLSHANSKY ELLEN , MONTGOMERY KEIRSTEN , CHARRON-PROCHOWNIK DENISE
Published: June 2018

Latinas with diabetes are at a higher risk for reproductive health (RH) complications. READY-Girls is an evidence-based PC program recommended by the ADA for adolescent girls. PC should be culturally tailored for the Latina population. This reports on qualitative data, including markups of the existing READY-Girls book, that informed the tailoring of READY-Girls PC program. Key pages of READY-Girls book were given to Latina mothers (M) and their daughters (D) with diabetes in either English or Spanish [(18 D: 6 reviewed both, 12 English); (12 M: 4 reviewed both, 2 English, 6 Spanish)]. Daughters were 13 to 21 years old, 44% had T1D. Participants were given paper-and-pencil open-ended questions about readability, understanding and sensitivity to the Hispanic culture; and asked to markup the book by writing comments on the pages and using assigned symbols to communicate thoughts (e.g., * = liked this, ? = don’t understand, XX phrase = inappropriate). Responses to questions and markups were written verbatim, clustered and analyzed to identify major themes, using a qualitative descriptive method, 4 researchers discussed themes and reached consensus. Findings: 1) book was: a) easy to read, understand, and interesting; b) acceptable to Latina culture, but add topics, “talking with parents about being sexually active”, “resources to prevent teen pregnancy”, and c) taught the importance of PC. 2) Illustrations were: a) informative, but removing those of bodily changes during puberty could be less offensive to Latina culture; b) adding facial pictures.

Conclusion: Markup methodology was effective in communicating thoughts about modifying the book and adapting it for Latinas. This methodology could enhance qualitative data collection especially when inquiring about sensitive topics such as reproductive health. Overall, M-D participants liked the program, found it useful and provided helpful suggestions for cultural modifications.

Disclosure

H. Abujaradeh: None. F.M. Peterson-Burch: None. E. Olshansky: None. K. Montgomery: None. D. Charron-Prochownik: None.
How Improving Stress Improves Glucose Control
Authors: SAKKAL SAAD
Published: June 2018

Background: 90% of people with diabetes have stress, insomnia, decreased energy, temperature, appetite, weight, libido changes, and sympathetic/parasympathetic disturbance. These hypothalamic stress response disturbances result in impaired glucose control.Treating stress, sleep in short term studies(1-6 weeks) improves lifestyle, nutrition, exercise, and glucose control. Few studies have tested the hypothesis that improving stress will improve glucose control in long-term treatment.

Methods: We compared 80 stress-Rx adherent patients who achieved better sleep quality with 80 who did not. We recommend stress-Rx techniques four times daily like Benson’s relaxation exercises, deep breathing, meditation, and prayers. We quantified feeling of well-being, sleep duration extension, measured glucose control with AM insulin/glucose ratio, HgA1c, and in-target glucose when CGMS was available (16 patients). All patients followed our standard diabetes treatment protocol for type 2 including MIND nutrition plan and aerobic exercise 10 minutes after each meal (HIIT).

Results: At 12 months, adherents to Stress-Rx who achieved improved sleep improved the feeling of well-being by 78%, sleep increased 28 minutes, sleep onset latency decreased by 8 minutes. Insulin/glucose ratio was 16/133=0.12, HgA1c 7.1%, HgA1c<7 in 69%, and in-target glucose in 76% on CGMS (9 patients). On the other hand, in 80 patients who did not follow Stress-Rx and did not achieve improved sleep quality, feeling of well-being in 40%, sleep increased by 4 minutes,sleep onset latency decreased by 2 minutes. Insulin/Glucose ratio was 27/160=0.17, HgA1c 7.7%, HgA1c< 7 in 46%, and in-target-glucose in 58% on CGMS (7 patients.) Medications were 3 in both groups. Percentage needing basal insulin at the end was 8% in the good stress-Rx group, 16% in the non-improved sleep group.

Conclusion: Stress-Rx Improved insulin resistance with improved glucose control. Improved sleep, exercise, nutrition, and sympathetic outflow probably contributed 30%.

Disclosure

S. Sakkal: None.
Effectiveness of Digital Interventions for Improving Glycemic Control in Persons with Poorly Controlled Type 2 Diabetes—A Systematic Review and Meta-regression Analysis
Authors: KEBEDE MIHIRETU M. , ZEEB HAJO , PETERS MANUELA , HEISE THOMAS L. , PISCHKE CLAUDIA R.
Published: June 2018

Objective: Digital interventions may assist patients with type 2 diabetes with improving glycaemic control. We aimed to synthesize effect sizes of digital interventions on glycated hemoglobin (HbA1c) levels and to identify effective features of digital interventions targeting patients with poorly controlled type 2 diabetes.

Research Design and Methods: MEDLINE, ISI Web of Science and PsycInfo were searched for randomized controlled trials (RCTs) comparing the effects of digital interventions with usual care. Two reviewers independently assessed studies for eligibility and determined study quality, using the Cochrane risk of bias assessment tool. The Behavioural Change Technique Taxonomy v1 was employed to identify behavior change techniques (BCTs) employed in interventions. Mean HbA1c differences were pooled using Analysis of Covariance to adjust for baseline differences and pre-post correlations. To examine effective intervention features and to evaluate differences in effects sizes across groups, meta-regression and subgroup analyses were performed.

Results: Twenty three arms of 21 RCTs were included in the meta-analysis (n= 3787 patients, 52.6% in intervention arms). The mean HbA1c baseline differences ranged from -0.2% to 0.64%. The pooled mean HbA1c change was statistically significant (-0.39 (95% CI: [-0.51, -0.26]) with substantial heterogeneity (I-squared statistic, 80.8%)) and a significant HbA1c reduction was noted for web-based interventions. A baseline HbA1c level above 7.5%, β=-0.44 (95% CI: [-0.81, -0.06]) and the BCTs ’problem solving’, β=-1.30(95% CI: [-2.05, -0.54]) and ’self-monitoring outcomes of behavior’, β=-1.21 (95% CI: [-1.95, -0.46]) were significantly associated with reduced HbA1c levels.

Conclusions: Digital interventions appear effective for reducing HbA1c levels in patients with poorly controlled type 2 diabetes.

Disclosure

M.M. Kebede: None. H. Zeeb: None. M. Peters: None. T.L. Heise: None. C.R. Pischke: None.
The Three I's of Diabetes Integration in Emerging Adulthood—Developing a Framework to Individualize Diabetes Care
Authors: MARKOWITZ BENJAMIN , PRITLOVE CHERYL , MUKERJI GEETHA , LAVERY JAMES V. , PARSONS JANET A. , ADVANI ANDREW
Published: June 2018

Transition of care occurs within the developmental context of emerging adulthood (EA; 18-24 years), in which diabetes self-management is challenged as an individual learns to cope with diabetes and develop their independence. With the goal of helping providers individualize support as patients begin adult care, we conducted a qualitative study with 33 emerging adults with type 1 diabetes (51% female, age 20.6±0.3 years, diabetes duration 12±1 years). Individual semi-structured interviews allowed participants to depict their lived experiences with diabetes. We employed a narrative approach to the analysis of interview transcripts and constant comparison was used to identify similarities and differences in narrative typology and thematic content. We identified that participants’ accounts of living with diabetes could be grouped into three broad categories: Ingrained (n=14), Intrusive (n=12) and Inconspicuous (n=7). We interpreted these accounts as different “lenses” through which individuals perceive their diabetes during EA. Participants conveying an Ingrained lens perceived diabetes to be comfortably settled within their daily lives and described self-confidence for management. Participants conveying an Intrusive lens perceived diabetes as disrupting their daily living and described moral sensitivity towards management (i.e., being seen as a ’good’ or ’bad’ self-manager). Participants conveying an Inconspicuous lens told stories that demonstrated their efforts to minimize their diabetes and described disregard for management. HbA1c levels were lower in participants conveying an Ingrained lens (HbA1c (%), Ingrained 7.4±0.2, Intrusive 9.3±0.5 (p<0.01 vs. Ingrained), Inconspicuous 8.4±0.3). Although movement between these domains may be fluid, mixed or incomplete, this framework provides a heuristic strategy to recognize emerging adults’ varying views of their diabetes and presents opportunities for individualizing care accordingly.

Disclosure

B. Markowitz: None. C. Pritlove: None. G. Mukerji: None. J.V. Lavery: None. J.A. Parsons: None. A. Advani: Research Support; Self; AstraZeneca, Boehringer Ingelheim GmbH. Other Relationship; Self; Boehringer Ingelheim GmbH.
What Is Health-Related Quality of Life? Perspectives from Diabetes Care Providers
Authors: CAO VIENA T. , ESHTEHARDI SAHAR S. , MCKINNEY BRETT M. , ANDERSON BARBARA , MARRERO DAVID G. , THOMPSON DEBBE , HILLIARD MARISA E.
Published: June 2018

Background: While health-related quality of life (HRQoL) is gaining recognition as an important patient-reported outcome, little is known about how diabetes care providers define or apply HRQoL in practice. The purpose of this study was to identify how diabetes care providers conceptualize HRQoL for youth and adults with type 1 diabetes (T1D) to help guide efforts to more routinely assess and intervene to improve HRQoL.

Methods: As part of a larger qualitative study on T1D-specific HRQoL, semi-structured qualitative interviews were conducted with 8 diabetes care providers (5 pediatric providers, 3 adult providers, 62.5% male) via focus groups or individually. Sessions were audio-recorded, transcribed, and coded to derive common themes.

Results: Providers identified three key components of T1D-specific HRQoL: (1) their patients’ day-to-day functioning, including the ability to engage in everyday activities and its impact on their emotional well-being; (2) their patients’ medical management, including diabetes self-management behaviors and presence of complications and hypo/hyperglycemia; and (3) the impact of T1D on their patients’ personal relationships, including the impact on the HRQoL of their parents/partners.

Conclusion: Providers described three aspects of T1D-specific HRQoL: everyday functioning, medical considerations, and interpersonal relationships. This extends the HRQoL literature from other chronic condition populations, which has not emphasized provider perceptions of HRQoL, has primarily identified medical domains such as disease-specific symptoms/complications, and provides little understanding of HRQoL of other family members. Together with findings about patient/family perspectives on HRQoL from the larger study, the current findings about how diabetes care providers conceptualize diabetes-specific HRQoL are necessary to help guide clinical processes to routinely assess and enhance HRQoL across the lifespan.

Disclosure

V.T. Cao: None. S.S. Eshtehardi: None. B.M. McKinney: None. B. Anderson: Advisory Panel; Self; Sanofi-Aventis. D.G. Marrero: None. D. Thompson: None. M.E. Hilliard: None.
Factors Affecting Long-Term Healthy Behaviors and Posttraumatic Growth in Type 2 Diabetes Patients
Authors: KAYANO AYAKO , YAMAZAKI MASAHIRO , TAKU KANAKO , SAKAI RYOSUKE , HIGO NAOKO , ASANO MAI , HOSOKAWA TOYOSHI , KAWASE MASATOSHI , FUKUI MICHIAKI
Published: June 2018

Background/Purpose: Constant self-management is important for type 2 diabetes patients to improve or maintain their quality of life, however it can become difficult and burdensome. The purpose of the current study is to qualitatively investigate the mechanisms of psychological adaption to a type 2 diabetes diagnosis and the factors affecting long-term healthy behaviors by referring to a theoretical framework of Posttraumatic Growth (PTG), that is, personal growth resulting from struggle with trauma.

Methods: A series of semi-structured interviews were conducted with adult patients (N = 10) who were diagnosed with type 2 diabetes over two years prior, maintaining an HbA1c of under 8% stable over 6-months, and showed a relatively higher level of PTG in a screening test using the extended version of the PTG Inventory.

Results: Interviews were analyzed by the Grounded Theory Approach. Three main mechanisms were identified. (1) Some were able to continue healthy behaviors because they experienced PTG as a result of single major life event that occurred prior to diagnosis. (2) Some were able to continue healthy behaviors because they experienced PTG as a result of a number of minor but stressful life events that occurred in succession prior to diagnosis. (3) Others were able to continue healthy behaviors because they experienced PTG directly as a result of the diagnosis of diabetes. Overall, patients included in the current analyses were not overly conscious of their diagnosis or treatment in their daily lives, and did not seem to struggle with identity conflicts relating to their diagnosis.

Conclusion: Current study identified three paths leading to healthy behaviors. Regardless of the triggering events, PTG experiences seem to transform cognitive processes and increase stress tolerance, resiliency, and perhaps purpose in life and a sense of identity, and thus enable them to maintain healthy behaviors. Future study should explore the paths among patients who have not experienced PTG.

Disclosure

A. Kayano: None. M. Yamazaki: None. K. Taku: None. R. Sakai: None. N. Higo: None. M. Asano: None. T. Hosokawa: None. M. Kawase: 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.
The Influence of Daily Stress on Glycemic Control and Mortality in Adults with Diabetes
Authors: WALKER REBEKAH J. , GARACCI EMMA , CAMPBELL JENNIFER A. , EGEDE LEONARD E.
Published: June 2018

Background: Daily stress may compound the burden of diabetes. This analysis investigated whether frequency or severity of stress had an influence on glycemic control (HbA1c) and mortality in adults with diabetes.

Methods: Data from the second and third wave of the national longitudinal survey of Midlife Development in the United States (MIDUS), conducted between 1995 and 2014, was used. A total of 141 adults with diagnosed and undiagnosed diabetes, based on HbA1c and self-report of diagnosis, completed the national study of daily experiences (NSDE) project during which questions were asked about daily stress type, frequency, and impact for eight consecutive nights. General linear models investigated the relationship between stress and HbA1c. Cox proportional hazard models estimated hazard ratios using national death index information linked to MIDUS data.

Results: On average, this population of adults with diabetes reported 3.1 days with a stressor and 3.9 stressors in an 8-day period. While 21.9% reported only one stressor type, 72.3% reported more than one stressor type. No significant relationships existed between number of days with stressor, average number of stressors, or number of stressor types. Average physical symptom severity reported in relationship to stressful events was negatively associated with HbA1c (-0.20, p=0.04). The average stressor severity and average stressor negative affect were both significantly associated with mortality (HR=0.45, p=0.04 and HR=0.17, p=0.03, respectively).

Conclusions: Daily stress may influence outcomes for adults with diabetes; in particular, severity of stressors experienced, severity of physical symptoms related to stressors, and negative affect (negative emotions and poor self-image) related to stressors. Interventions addressing psychosocial factors, such as daily stress, in individuals with diabetes may need to focus on helping individuals mitigate the impact of stress rather than decrease the amount of stress in their lives.

Disclosure

R.J. Walker: None. E. Garacci: None. J.A. Campbell: None. L.E. Egede: Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases. Advisory Panel; Self; Novo Nordisk Inc..
Psychological Distress Mediates the Association between Poor Sleep Quality and Prediabetes
Authors: LI LI
Published: June 2018

Background: Evidence indicates that poor sleep quality increases risk for prediabetes. Psychological distress may be a potential mechanism through which poor sleep quality affects glucose metabolism. Sleep, prediabetes, and distress are linked to type 2 diabetes. We examined the relations between poor sleep quality and prediabetes, and tested whether psychological distress mediates their relation in a cross-sectional study.

Methods: Subjects were 133 men (n=49) and women (n=84) aged 37.9±12.5 years with body mass index (BMI) between 30.3±6.9kg/m2. Subjective sleep quality was determined by the Pittsburg Sleep Questionnaire Index (PSQI). Subjects were stratified based on PSQI score into normal (NSQ; PSQI≤5, n=68) vs. poor sleep quality (PSQ; PSQI>5, n=65). Two hour-oral glucose tolerance test (OGTT) was conducted in each subject, and prediabetes was diagnosed using the ADA diagnostic criteria. Psychological distress was assessed using the Childhood Trauma Questionnaire, and depression was self-evaluated using Beck Depression Inventory. PROCESS Macros method was used to assess the direct relation between sleep quality and prediabetes, and the potential mediating effects of psychological distress on that relation. All data analysis was adjusted for age, gender, race, education, employment status, depression and BMI.

Results: Experiencing poor sleep quality was associated with higher fasting glucose levels (95.9±7.6 vs. 98.0±10.2, p<0.01) and 2h-post prandial glucose levels (102.8±24.7 vs. 108.7±30.5, p<0.01) compared to NSQ group. PSQ group also had greater OGTT-derived QUICKI (p<0.05). Psychological distress mediated the relation between poor sleep quality and prediabetes with adjustment for co-variables.

Conclusions: Poor sleep quality is associated with prediabetes through psychological distress. Efforts to improve sleep quality and decrease psychological distress may yield lower type 2 diabetes rate in this high-risk prediabetic population.

Disclosure

L. Li: None.
Building Infrastructure for Diabetes Self-Management Support in Church-Based Settings—Results of a 15-Month Cluster-Randomized Controlled Trial
Authors: KOSCIELNIAK NIKOLAS J. , FUNNELL MARTHA , PIATT GRETCHEN
Published: June 2018

Diabetes self-management support (DSMS) is not a covered benefit in the U.S. health system, and little is known about the infrastructure needed to provide effective DSMS in organizations without existing diabetes self-management education (DSME) programs. The Praise study is a 15-month cluster-randomized controlled trial in 9 African American (AA) churches in metro-Detroit, as a conduit to build infrastructure for DSMS in low-resource communities. From 2013-2015, Praise examined the effects of peer-led DSMS on A1C and diabetes distress (DD) at 3, 9, and 15 months. CDEs trained peer leaders (PL) (n=12) and parish nurses (PN) (n=3) on goal setting, skills development, and group facilitation. Following professionally-delivered DSME, 6 monthly DSMS groups were independently planned and facilitated by 12 PL (mean age: 61.9 years, 100% AA, 25% male), followed by an additional 6 months of ongoing support to assess the logistical feasibility of sustaining DSMS efforts. Churches (and their participants, n=94) were randomized to 3 parallel groups: 1) PL only DSMS (n= 28), 2) PN + PL DSMS (n= 36), or 3) enhanced usual care (n= 30). Over time, a significant increase in A1C (p=.03) was observed across groups overall, but not within study groups. After adjusting for multiple factors, younger age (β=-.04; p=.004) and lower levels of DD (p=.04) were associated with improvements in A1C over time, while insulin use (p= .032) was associated with increases in A1C. A marked improvement in DD was observed (p=.04) overall. PL only (p= .003), PL+PN (p=.01), and A1C (p=.02) were significantly associated with improvements in DD. Results suggest DD is a significant indicator of improvement in A1C levels. DD levels also improved following a faith community-based DSME intervention and were sustained by using the PL and PN DSMS infrastructure of the church. Opportunities to expand the DSMS infrastructure beyond churches and into other community organizations is needed.

Disclosure

N.J. Koscielniak: None. M. Funnell: Advisory Panel; Self; Sanofi US, Intarcia Therapeutics, Inc.. G. Piatt: None.
The Emotional Side of Diabetes and Glycemic Control in a Brazilian Sample of Adults with Type 1 Diabetes
Authors: SILVEIRA MÔNICA S.V..M. , PARISI MARIA C. , RUPPERT KRISTINE , ARNALDO MOURA NETO , SIMINERIO LINDA M. , SPOSITO ANDREI C. , FUNNELL MARTHA , PAVIN ELIZABETH J. , FISHER LAWRENCE
Published: June 2018

Adults with type 1 diabetes (T1D) have a higher risk of developing depression symptoms during their lives and new research shows that over 40% of T1Ds experience elevated diabetes-related distress (DD). Psychosocial assessment is recommended as a critical part of patient-centered care in order to promote better diabetes outcomes and psychosocial well-being. The goals of this study were to document the prevalence of and relationships among Major Depressive Disorder (MDD), depression symptoms and DD, and to determine the linkage each of these measures with glycemic control in a Brazilian sample of adults with T1D at The State University of Campinas, Brazil. In a cross-sectional study, 70 T1D adults were evaluated. Inclusion criteria were age ≥18 and diagnosis of T1D ≥ 6 months. Exclusion criteria were cognitive impairment, history of major psychiatric disorders (e.g., schizophrenia, drug addiction, dementia), and severe diabetes-related complications (blindness, need for hemodialysis, limb amputations, stroke). Diagnoses of MDD was made using DSM-5 criteria. Depression symptoms were evaluated by the depression subscale of the Hospital Anxiety and Depression scale (HAD-D). The Diabetes Distress Scale (DDS) assessed DD. Metabolic control was evaluated by HbA1c. The latest lipid panel results were recorded and BMI was calculated. Number of complications was obtained from medical records. Forty percent of T1Ds were male, mean age 31(±8,8), mean number of complications was 1 (± 1.2), and mean HbA1c was 10.0%(±2). Frequency of MDD was 30,0% and 35,7% reported high depression symptoms. Fifty-two percent reported high DD. Only DD and depression symptoms were each significantly and positively associated with HbA1C (p < .05). This study shows that several measures that reflect the emotional side of diabetes are related to glycemic control. They emphasize the need to incorporate the emotional side of diabetes into strategies of care for adults with T1D.

Disclosure

M.S.M. Silveira: None. M.C. Parisi: None. K. Ruppert: None. A. Moura Neto: None. L.M. Siminerio: None. A.C. Sposito: None. M. Funnell: Advisory Panel; Self; Sanofi US, Intarcia Therapeutics, Inc.. E.J. Pavin: None. L. Fisher: Consultant; Self; Eli Lilly and Company, Abbott, Merck & Co., Inc..
Clinical Practice Factors That Define Insulin Pump Readiness
Authors: PUCKETT CASSIDY , WONG JENISE C.
Published: June 2018

The American Association of Clinical Endocrinologists/American College of Endocrinology and Endocrine Society guidelines on insulin pump use emphasize patient assessment to determine pump readiness for patients with type 1 diabetes (T1D). While guidelines mention the importance of the clinical practice context, such as the presence of a comprehensive pump management program and prescribing provider expertise in pump therapy, primary emphasis is placed on the measurement of patient knowledge of diabetes management, their mental and psychological status, and adherence to self-care. But how clinics define and assess “pump readiness” is not standardized, and the extent to which this process is linked to systematic differences in the allocation of healthcare technologies by race and class is unclear. In this comparative qualitative study, we describe how two ADA recognized pediatric endocrinology centers with different prevalences of patient pump use (32% vs. 77% of patients with T1D) also differ in how they determine pump readiness. In the clinic with higher overall pump use, there are no differences in frequency of pump use between non-Hispanic white and ethnic minority patients, and differences by insurance status are small. In contrast, in the clinic with lower overall pump use, there are large differences in pump use by race and insurance status. To explore these trends, we conducted over 400 hours of observations of clinical encounters and decision-making processes and fifteen 30-minute interviews with pediatric endocrinologists, nurses, certified diabetes educators, and other staff and coded the data using Atlas.ti. Findings suggest pump allocation is shaped by how: 1) providers respond to patient “cultural capital” or interaction styles, 2) clinics frame and engage with medical technologies (e.g., “pro-tech” practices such as ongoing provider and patient education to support new devices), and 3) clinics organize provider care and decision making processes (e.g., professional opinion vs. use of metrics).

Disclosure

C. Puckett: None. J.C. Wong: Research Support; Self; Dexcom, Inc.. Other Relationship; Self; Tidepool Project.
Gender Differences in Contributions of Mutable and Immutable Factors on Quality of Life in Adults with Type 2 Diabetes
Authors: WILLIAMS JONI S. , EGEDE LEONARD E.
Published: June 2018

Background: The aim of this study was to assess contributions of mutable and immutable factors on quality of life (QoL) in men and women with type 2 diabetes.

Methods: Cross-sectional study of 615 adults from two clinics in the southeastern U.S. Hierarchical models were performed for the full sample, women, and men using the physical component score (PCS) and mental component score (MCS) of QoL as dependent variables, adjusting for sociodemographic, socioeconomic, psychosocial, built environment, clinical, and self-care factors and diabetes knowledge.

Results: For women, significant associations were found between PCS QoL and neighborhood aesthetics (β=0.09; p=0.009) and exercise environment (β=-0.03; p=0.010), accounting for 25% of the variance and MCS QoL and serious psychological distress (SPD) (β=-0.12; p=0.001), perceived health status, (β=-0.54; p=0.040) and diabetes knowledge (β=0.11; p=0.046), accounting for 36% of the variance. For men, significant associations were seen between PCS QoL and SPD (β=0.02; p=0.031), neighborhood crime (β=-0.17; p=0.041), neighborhood comparison (β=0.17; p=0.012), and kidney problems (β=0.25; p=0.045), accounting for 12% of the variance and MCS QoL and depression (β=-0.08; p=0.004), SPD (β=-0.07; p=0.002), perceived stress (β=-0.14; p=0.001) diabetes duration (β=0.03; p=0.015), comorbidity (β=-0.15; p=0.014), and perceived health status (β=-0.28; p=0.045), accounting for 51% of the variance.

Conclusions: Significant associations were observed between QoL and mutable factors, suggesting areas amenable to health interventions. For women, interventions should focus on improving the built environment, decreasing SPD, and improving diabetes knowledge. For men, interventions should focus on the built environment, mental health, and comorbid conditions.

Disclosure

J.S. Williams: None. L.E. Egede: Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases. Advisory Panel; Self; Novo Nordisk Inc..
Timely Initiation of Human Insulins—Interim Analysis on Knowledge and Attitude from Indian Human Insulin Registry (INHIRIT)
Authors: PAWAR DILIP , BOSE SAPTARSHI , JABEEN SARAH , SANDEEP S. , KARADI VEERANNA
Published: June 2018

INHIRIT, India’s one of the largest human insulin registries encompassing 300 Health Care Professionals(HCPs) and 9000 patients with an objective to identify the factors for timely insulin initiation in T2DM patients. A Multicentric, open label, cross sectional survey in assessing the knowledge and attitude among 112 HCPs through e-questionnaire, validated by a panel of experts. The primary objective is to understand the knowledge, attitude and practice of timely insulin initiation whereas adherence and treatment satisfaction are being assessed as secondary objectives.

Results: Key factors identified for timely insulin initiation were patients uncontrolled on existing therapy (OHA) (91.96%), diabetes duration (66.07%) and presence of comorbidities (57.14%). The comorbidities influencing HCPs to initiate timely insulins are CKD (59.71%), foot ulcer (58.93%), and CAD (52.68%). Affordability and similar efficacy were two important reasons for HCPs to prefer human insulins [median (IQR): 70% (60-75)] over to analogues [30% (25-40)] in day to day practice. HCPs opined to initiate insulin as second and third line therapy in 42.5% of their patients. While intensifying from basal supported oral therapy, 91.49% clinicians preferred premixed human insulins over basal-bolus therapy. Major aspects that deter insulin initiation were patient’s factors (86.61%), newer antidiabetic drugs (58.93%), and physician’s inertia (41.96%). Patient support programs such as insulin injection techniques (34.58%), counselling (33.64%) and educational materials (15.89%) etc. were preferred by HCPs while initiating insulins.

Conclusion: Primary analysis of INHIRIT study provides key insights on timely insulin initiation i.e., patients uncontrolled on OADs, duration of diabetes and comorbid conditions. Similarly patient support programs help HCPs to set individualized glycaemic strategy which helps in better health and economic outcomes in their patients.

Disclosure

D. Pawar: Employee; Self; Biocon. S. Bose: Employee; Self; Biocon. S. Jabeen: Employee; Self; Biocon. S. S.: Employee; Self; Biocon.V. Karadi: None.
Insulin Pump Therapy with Simple Scheme in Insufficiently Controlled Patients with Type 2 Diabetes on Intensive Injection Therapy—A Real-Life Study
Authors: DE VALK HAROLD W.
Published: June 2018

Background and Aims: Many patients with type 2 diabetes mellitus on intensive insulin injection therapy (MDI) do not reach adequate glycemic control. A randomized controlled trial has shown that continuous subcutaneous insulin infusion (CSII) using a simple scheme with one basal rate, improves glycemic control (Lancet 2014; 384: 1265-72). We studied effectiveness of this scheme in a real life setting.

Materials and Methods: Patients with type 2 diabetes with HbA1c ≥ 64 mmol/mol on MDI with insulin requirement between 0.7 and 2.2 U/day were eligible. Hourly basal rate was 50% of the total daily dose (TDD) divided by 24; 50% of TDD was divided equally between three meals. Trial duration 6 months.

Results: Sixty-seven patients participated. Mean age: 61.3±0.9 years, 42% female; duration of disease: 16.0±7.6 years; weight: 10.7.4±21.9 kg; BMI: 35.8±6.9 kg/m2, baseline TDD: 135.5±62.3 U/day. Mean HbA1c fell from 80.1 ± 15.2 to 62.4 ±10.0 mmol/mol (p<0.001); mean change in HbA1c -17.7±2.1 mmol/mol. After exclusion 3 outliers (ΔHbA1c >-50 mmol/mol), the results were comparable: HbA1c fell from 78.0±11.8 to 63.0 ±9.7 mmol/mol (p<0.001); mean change -15.0±1.5 mmol/mol. Total cholesterol decreased slightly (4.33±0.13 to 4.21±0.13 mmol/l, p<0.05); no changes in other lipid parameters or blood pressure. Body weight increased from 106.2±19.5 to 109.3±20.61 kg (p<0.001).

Conclusion: This real-life study shows that introducing CSII with simple insulin schema in patients with insufficiently-controlled type 2 diabetes on MDI, leads to major improvement of glycemic control, at the expense of some weight gain. This approach provides a worthwhile alternative in patient with poorly-controlled DM2 and considerable insulin resistance. Nutritional counselling deserves attention to diminish weight gain.

Disclosure

H.W. de Valk: None.
A Real-World Evidence in Understanding the Barriers and Behaviours of Insulin Therapy among Indian Type 2 Diabetes Mellitus (T2DM) Patients
Authors: RAJ PRAVEEN , PAWAR DILIP , JABEEN SARAH , VS SHIVARAM
Published: June 2018

Introduction: American Diabetes Association categorizes barriers to adherence as either patient barriers, medication factors, or system factors. The aim of the study is to understand the barriers and behaviors of insulin therapy among T2DM patients in India from a real world setting.

Methods: The data is collected from an ongoing patient support program called as iTAP (Insulin Therapy Assistance Program) designed by Biocon in patients with T2DM receiving insulin. It’s an open label, multicentric, real world data depicting 10426 T2DM patients, of which 3192 (30.61%) patients have moved on to various therapies observed over 9 months. Data of these 3192 patients were analyzed to understand the reasons for shift in therapy.

Results: The prime behavioral change is from insulin to oral hypoglycaemic drugs (64.35%) and others are, short term insulin therapy (12.81%), and change/shift from an ampoule to vial dosage (6.11%). The primary barriers in insulin therapies were hypoglycaemic episodes (25.9%), stress (17.1%), fear of injection (10.3%) and cost (7.4%).

Conclusion: There is an underwhelming amount of data on interventions to addressing those barriers or even aimed at improving insulin adherence in general. Education and empowerment (stress, fear of injection and cost) through shared decision-making allow patients’ preferences to be presented and considered and subsequently generate the best individualized treatment plan for each patients.

Disclosure

P. Raj: Employee; Self; Biocon. D. Pawar: Employee; Self; Biocon. S. Jabeen: Employee; Self; Biocon. S. Vs: Employee; Self; Biocon.