bluuebunny/crossref_metadata_2025 huggingface dataset:
Impact of rtCGM Usage on a Combined Patient Reported Outcome—A Post-Hoc Analysis of the HypoDE Study
Authors: EHRMANN DOMINIC , HEINEMANN LUTZ , FRECKMANN GUIDO , WALDENMAIER DELIA , HERMANNS NORBERT
Published: June 2018

The HypoDE study, a randomized multi-center trial, showed that rtCGM use reduces the number of low glucose events (<55 mg/dl for at least 20 min) per 28 days significantly from 10.4 to 3.4 events compared to SMBG (13.5 to 13.2 events) in MDI-treated type 1 diabetic patients with hypoglycemia problems. We analyzed the impact of rtCGM use on patient-reported-outcomes (PRO). A combined PRO consisting of a specific measure of satisfaction with glucose monitoring (GMSS), a diabetes-specific assessment (DDS) and a generic measure (EQ-5D) was used. In a factor analysis, all three scales loaded on one factor. All questionnaire scores were z-transformed as well as the number of low glucose events. The figure shows the effect sizes of the combined PRO and the single scores as well as of the low glucose events. There was a significant positive impact of rtCGM use on the combined PRO. However, only GMSS but not DDS or EQ-5D showed a significant impact. The more device-specific the PRO, the higher was the effect size. Interestingly, the impact of rtCGM use on biochemical hypoglycemia had a remarkably larger effect size than the combined PRO. Since most other rtCGM studies are powered to detect a benefit in glycemic endpoints and not in PRO, the lower impact of rtCGM on PRO is a barrier to prove the efficacy of rtCGM on PRO like quality of life, diabetes distress or satisfaction with treatment.

Disclosure

D. Ehrmann: Speaker's Bureau; Self; Berlin-Chemie AG. L. Heinemann: Stock/Shareholder; Self; Profil Institute for Metabolic Research, ProSciento. Consultant; Self; Roche Diabetes Care Health and Digital Solutions. G. Freckmann: Speaker's Bureau; Self; Ascensia Diabetes Care. Research Support; Self; Ascensia Diabetes Care. Speaker's Bureau; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Roche Diabetes Care Health and Digital Solutions. Advisory Panel; Self; Abbott, Novo Nordisk Inc.. Consultant; Self; Sensile Medical AG. Speaker's Bureau; Self; Ypsomed AG. D. Waldenmaier: None. N. Hermanns: Speaker's Bureau; Self; Berlin-Chemie AG. Advisory Panel; Self; Abbott. Research Support; Self; Abbott. Speaker's Bureau; Self; Abbott. Research Support; Self; Berlin-Chemie AG. Advisory Panel; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Roche Diabetes Care Health and Digital Solutions. Research Support; Self; Ypsomed AG, Dexcom, Inc.. Speaker's Bureau; Self; Novo Nordisk Inc..
Impact of Diabetes-Related Distress on Predicted Cardiovascular Complications in Patients with Type 2 Diabetes
Authors: YOUNG CLIPPER , DUGAN JOY A. , RAY ANDREW J. , SHUBROOK JAY H.
Published: June 2018

Objective: To evaluate the impact of diabetes-related distress along with other cardiovascular risk factors on the predicted 10-year cardiovascular complication risks in patients with type 2 diabetes

Methods: This cross-sectional study involved Problem Areas in Diabetes (PAID) questionnaire and UK Prospective Diabetes Study (UKPDS) Risk Engine 2.0, surveying a population with lower socioeconomic status and type 2 diabetes. Statistical analyses incorporated multiple linear regression models, comprising of the predicted cardiovascular risks, PAID scores, tobacco use, gender, age, LDL levels, clinically documented depression status, BMI, and systolic blood pressure.

Results: Results are organized by statistical models (driven by risk factors for cardiovascular conditions) and the predicted, individual 10-year cardiovascular complication risks vs. PAID scores.

Conclusion: This study found an association between psychosocial status and cardiovascular disease risk management in lower socioeconomic patients with type 2 diabetes. Within all the multiple linear regression models, the levels of diabetes-related distress have been shown to impact the predicted fatal coronary heart disease risks, thus allowing this distress to predict such cardiovascular risk after including certain risk factors.

Coefficientp-value95% CIDepression Status, Tobacco Use, LDL Levels, Gender, AgePredicted Coronary Heart Disease Risks vs. PAID Scores0.0770.039(0.0039 – 0.15)Predicted Fatal Coronary Heart Disease Risks vs. PAID Scores0.0700.014(0.014 – 0.13)Predicted Stroke Risks vs. PAID Scores0.0160.38(-0.020 – 0.053)Predicted Fatal Stroke Risks vs. PAID Scores0.00170.62(-0.0050 – 0.0084)Systolic Blood Pressure, Tobacco Use, LDL Levels, Gender, AgePredicted Coronary Heart Disease Risks vs. PAID Scores0.0680.069(-0.0054 – 0.14)Predicted Fatal Coronary Heart Disease Risks vs. PAID Scores0.0630.029(0.0066 – 0.12)Predicted Stroke Risks vs. PAID Scores0.0150.388(-0.019 – 0.049)Predicted Fatal Stroke Risks vs. PAID Scores0.00190.495(-0.0036 – 0.0075)BMI, Tobacco Use, LDL Levels, Gender, AgePredicted Coronary Heart Disease Risks vs. PAID Scores0.0660.072(-0.0061 – 0.14)Predicted Fatal Coronary Heart Disease Risks vs. PAID Scores0.0610.032(0.0053 – 0.12)Predicted Stroke Risks vs. PAID Scores0.0110.52(-0.024 – 0.047)Predicted Fatal Stroke Risks vs. PAID Scores0.000880.79(-0.0056 – 0.0073)

Disclosure

C. Young: None. J.A. Dugan: None. A.J. Ray: None. J.H. Shubrook: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk Inc., Intarcia Therapeutics, Inc..
Increasing Daily Step Count Results in an Improvement in BMI and Aortic Blood Pressure in Patients with Type 2 Diabetes Mellitus
Authors: SEOW CHERNGJYE , XIA LIAN , TAN JANET S. , TANG XIN , SUN BING , DALAN RINKOO
Published: June 2018

Background: We investigated whether increasing daily steps by 3000 improves glycemic indices (HbA1c and glycemic variability), cardiometabolic risk factors (BMI, blood pressure (BP) and lipids) and aortic stiffness in middle-aged Chinese men with type 2 diabetes mellitus (T2DM).

Methods: In this 12 weeks, pre and post intervention, prospective study, 20 chinese men (40-70 years old; baseline HbA1c 7-10%) with T2DM were recruited. They were on stable therapeutic regime and had no preexisting macrovascular complications. Measurements included glycemic profile (HbA1c, CGMS (Medtronics iPro)), BMI, BP, fasting lipids, aortic BP and stiffness (SphygmoCor Xcel) and daily steps (pedometer). The intervention was to increase the daily step count by 3000/day. We compared group 1 who achieved an increase of >3000 steps/day (N=7) with group 2 who failed to achieve target (N=11). All comparisons were performed using Student’s independent t test.

Results: We found that compared to Group 2, Group 1 had a significant improvement in BMI (-1.14 vs. +0.11), aortic systolic (-1.38 vs. +6.58mmHg) and diastolic (-4.63 vs. +4.08mmHg) BP(p<0.05). Interaction analysis showed that in patients who had an improvement in BMI, there was a significant improvement in HbA1c (β=0.57, p=0.041). Changes in indices of glycemic variability were not significantly different between the two groups.

Conclusion: Increasing step counts by more than 3000 steps/day resulted in improvement in BMI and aortic BP with an interactive improvement in HbA1c in the long term. Further studies with a larger sample size and a longer follow-up are needed to confirm our findings.

Disclosure

C. Seow: None. L. Xia: None. J.S. Tan: None. X. Tang: None. B. Sun: None. R. Dalan: None.
From Research to Action—Impactful Intervention Arenas
Authors: DAVID NAPIER A. , LUND NIELS , BAGGER MALENE , JENSEN BJARNE B.
Published: June 2018

More than half the world’s population lives in cities and two thirds of 425 million people with diabetes live in cities. That makes cities a focal point for tackling diabetes. As part of Cities Changing Diabetes (CCD) five diverse cities (Copenhagen, Houston, Mexico City, Shanghai, Tianjin) have implemented actions based on 740 individual interviews with people with type 2 diabetes or at increased risk of developing it. Based on participants’ perspectives on socio-cultural barriers to live a healthy life action plans were created relevant to the local diabetes challenge and city context and tailor-made interventions were designed. CCD is a partnership between Novo Nordisk A/S, University College London, and Steno Diabetes Center Copenhagen aiming to map the diabetes challenge, understand risk and vulnerability to type 2 diabetes, and design interventions tailor-made to the respective city context. In the cities the program is driven by local partnerships in a collaborative working approach bringing together city governments, academics, businesses, city planners, patient organizations, faith-based organizations, and other non-governmental organizations. The research insights led to four arenas for impactful interventions: Health promoting policies by incorporating awareness and understanding of type 2 diabetes into local policies to address the diabetes challenge and improve overall health. Urban planning by integrating health-promoting aspects such as walkability and bikeability in urban planning to increase the ability to live a healthy life. Community involvement by strengthening communities around citizens vulnerable to diabetes to build resilience, improve diabetes care and quality of life. Health system strengthening by building capacity into the local healthcare system to help vulnerable citizens to access it.

In conclusion, insights from the research have directly guided development of city-specific tailor-made interventions within four arenas.

Disclosure

A. Napier: Consultant; Self; Novo Nordisk A/S. N. Lund: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. M. Bagger: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. B.B. Jensen: None.
Clinical Experience with the MiniMed 670G System in Children, Adolescents, and Young Adults with Type 1 Diabetes
Authors: HENSON CARLO J. , BARNES TIMOTHY L. , NICKEL AMANDA J. , JENNIFER ABUZZAHAB M. , KYLLO JENNIFER , GANDRUD LAURA M.
Published: June 2018

Objective: To compare measured HbA1c, estimated HbA1c, and percent time in range before and after the initiation of the Minimed 670G system in children and young adults with type 1 diabetes (T1D).

Methods: Data consisted of 67 T1D patients, aged 5-23 years, who started the MiniMed 670G system and were followed for at least 12 weeks. Data were analyzed at baseline and 2, 4, 8, and 12 weeks following Auto Mode start. Paired t tests and linear mixed regression models were used to evaluate the effect of time on percent of time in Auto Mode, percent of time in range (70-180 mg/L) and changes in most recently measured HbA1c and sensor estimated HbA1c.

Results: Fifteen percent of patients (n=10) were aged 5-9 years, 27% (n=18) were 10-13 years, 30% (n=20) were 14-17 years and 28% (n=19) were ≥ 18 years; average duration of T1D was 5.47 ± 4.26 years. Nearly 96% of patients were Caucasian; 54% were male. Estimated HbA1c levels decreased from 8.10% ± 1.26% at baseline to 7.51% ± 0.88% at 12 weeks (P<0.0001). Measured HbA1c decreased from 7.98% ± 1.03% to 7.73% ± 1.03% (P=0.0008) (Figure 1). Percent time in range increased from 50% at baseline to 61% at 12 weeks (P<0.0001), without significant change in time below range. Time in Auto Mode declined from 75.1% at start to 68.4% at 12 weeks (P=0.0015).

Conclusion: Initiation of the 670G system in a clinical setting led to improved glycemic control in children, adolescents, and young adults.

Disclosure

C.J. Henson: None. T.L. Barnes: None. A.J. Nickel: None. M. Abuzzahab: Research Support; Self; Ascendis, Genentech, Inc., Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc., Pfizer Inc.. Research Support; Self; Versartis, Inc., Medtronic. Advisory Panel; Self; Sandoz. J. Kyllo: None. L.M. Gandrud: Consultant; Self; UnitedHealth Group.
A Content Analysis of Text Messages in a Type 1 Diabetes Peer Mentoring Program—The Importance of Shared Interests
Authors: WALKER ASHBY F. , JOHNSON CATHRYN , ANEZ-ZABALA CLAUDIA , DORVIL SARAH R. , HALLER MICHAEL J. , GURKA MATTHEW J. , BRUGGEMAN BRITTANY S. , GUIFFRE DANIELLE , ATKINSON MARK A. , SCHATZ ILYSSA , SCHATZ DESMOND
Published: June 2018

A paucity of research exists regarding the feasibility of utilizing personalized, live-texting as outreach to improve health outcomes for low-income teenagers with type 1 diabetes (T1D). A peer mentoring program pairing college students with T1D with publicly insured teens ages 11-17 with T1D (gender matched) was piloted with the aim of improving outcomes for both groups (n=88; 44 control and 44 treatment). The program involved social events, clinic visits, automated daily texts for blood glucose monitoring (BGM), and weekly text exchanges. For consistency, mentors were trained in protocols for texts using a technique of reciprocal sharing and limited to one text exchange with their mentee a week at a time of day agreed on by parents. Mentors, mentees and parents were aware that all texts were monitored by study staff through IRB-approved processes. A content analysis of all texts for a 12-week period was conducted (47,475 words) using six coders with schemata that included presence/absence variables (e.g., did the mentor prompt for BGM), numeric variables (word counts), and categorical variables (major themes discussed). Texts included poignant examples of uninhibited sharing about daily life and excellent coaching by mentors. However, pairs that talked about a shared common interest outside of T1D used far more words about diabetes-specific and non-specific topics (both were athletes, both enjoyed drawing, shared an ethnic identity, etc.). Mean word use for pairs with a common interest was 2,902 compared to 1,537 with no common interest (p=.01; t-test). For mentors, as word use increased in texts there was a greater improvement in HbA1c (r = -.54, p=.03; Pearson’s correlation). This pilot study shows the feasibility of using texting in peer mentoring programs and reiterates the importance of finding common ground beyond T1D to facilitate rapport building. Additional efforts are needed to better explicate the role of shared interests in outcomes for peer mentoring programs.

Disclosure

A.F. Walker: None. C. Johnson: None. C. Anez-Zabala: None. S.R. Dorvil: None. M.J. Haller: None. M.J. Gurka: None. B.S. Bruggeman: None. D. Guiffre: None. M.A. Atkinson: Other Relationship; Self; Patent Issued. I. Schatz: None. D. Schatz: None.
Comparing Perceptions of Concerns Regarding Complications Including Reproductive Health (RH) in Male and Female Adolescents and Young Adults (AYA) with TID
Authors: FISCHL ANDREA F.R. , CHARRON-PROCHOWNIK DENISE , SEREIKA SUSAN M. , ROFEY DANA L. , BECKER DOROTHY J. , FINNEY JESSICA , DIAZ ANA M. , LIBMAN INGRID
Published: June 2018

Tight glycemic control decreases risks of complications. Male and female AYA with T1D are vulnerable to poor glycemic control resulting in retinopathy (RET), neuropathy, nephropathy, high blood pressure (HBP), and RH complications. About half of males with T1D report RH complications (e.g., erectile dysfunction) as early as 25 years and up to 10% of women with T1D have pregnancy-related complications; however, these topics are rarely discussed.

Purpose: To describe and compare concerns of diabetes-related complications, including adverse RH outcomes among male and female AYA with T1D.

Methods: A diabetes transition care program for AYA with T1D at an academic children’s hospital provides care and small group discussion-education sessions on relevant topics (e.g., RH with diabetes, complications/prevention, risk behavior, self-care). Participants were given a survey prior to the program to gauge perceptions on T1D complications. Both female (n=19) and male (n=23) participants (aged 17-22 years) ranked concerns for complications from 1 (most) to 5 (least). Mann-Whitney U-tests were used to compare genders on complication rankings.

Results: RET was the greatest concern for both females (n=7; 37%) and males (n=10; 44%). The second most frequently reported concern was RH for females (n=5; 26%) and HBP for males (n=5; 22%). The most frequently reported “least” concerning complication was RH for males (n=9; 39%) and HBP for females (n=11; 58%). A significant difference between genders was HBP (p=.02), where males tended to report greater concern.

Conclusion: Retinopathy was an overall major concern. Gender differences in concerns were found for only HBP. No males ranked RH complications as a major concern. It is imperative to raise awareness and discuss concerns during adolescence. Initiating discussions with health professionals can empower AYA with T1D to maintain healthy lifestyles and prevent complications including RH.

Disclosure

A.F.R. Fischl: None. D. Charron-Prochownik: None. S.M. Sereika: None. D.L. Rofey: None. D.J. Becker: None. J. Finney: None. A.M. Diaz: None. I. Libman: Consultant; Self; Novo Nordisk A/S.
Greater HbA1c Lowering with Tethered vs. Small Insulin Pumps in a Large UK Insulin Pump Service
Authors: DE SOYSA SHANI D. , GREY JOANNA , DAVENPORT KATY H. , GURNELL ELEANOR M. , HARTNELL SARA , EVANS MARK
Published: June 2018

Aim: To examine the impact of different types of insulin pumps (CSII) on HbA1c lowering control in a large UK type 1 diabetes practice.

Methods: Observational retrospective study of electronic database. We identified 597 adults (≥18 years) in our service who started on CSII between 2002 and 2017 with HbA1c data available at baseline and at 6 +/or 12 months after starting CSII. We classified by the starting pump model/manufacturer into traditional “tethered pumps” (Medtronic n=369; Roche n=79; Animas n=60) and “small pumps” (Omnipod n=79 and Cellnovo n=6). We examined change in HbA1c data (shown here in mmol/mol except where otherwise indicated) over the first year of CSII treatment.

Results: In general, CSII improved HbA1c during the first 12 months (72±0.7 to 64±0.6 and 65±0.6 mmol/mol at baseline, 6 and 12 months). Despite similar starting HbA1c, those using tethered pumps achieved a significantly lower HbA1c compared with small pump users after 6 and 12 months CSII therapy.

Conclusions: In real world data from a large pump service, we found significant differences in glycemic outcomes between different pumps. Those starting on tethered pumps had greater HbA1c lowering over first 12 months.HbA1c Outcomes for Tethered vs small PumpsPump typeInitial HbA1c range mol/mol (%)Baseline HbA1c6 months HbA1cp vs baseline12 months HbA1cp vs baselineTethered (n=509)All starting values71±0.763±0.6*<0.00165±0.7*<0.001Small (n=85)71±0.970±1.6NS69±1.6NSTethered (n=273)≥ 69 (85%)83±0.769±0.8**<0.00171±0.9*<0.001Small (n=43)83±2.377±2<0.0577±2.1<0.05Tethered (n=132)59-68 (7.5-8.4%)64±0.259±0.7**<0.00159±0.8*<0.001Small (n=28)64±0.566±1.4NS64±1.4NSData shown as mean±SEM. * p<0.05, ** p<0.001 for tethered vs small

Disclosure

S.D. De Soysa: None. J. Grey: None. K.H. Davenport: Advisory Panel; Self; Novo Nordisk Inc. E.M. Gurnell: Advisory Panel; Spouse/Partner; AstraZeneca, Pfizer Inc. S. Hartnell: Speaker's Bureau; Self; Medtronic, Roche Pharma. M. Evans: Advisory Panel; Self; Novo Nordisk A/S, Eli Lilly and Company, Cellnovo, Roche Pharma. Speaker's Bureau; Self; Abbott, Novo Nordisk A/S.
Evaluation of a Web-Based Tool for Parents of Teens with Type 1 Diabetes
Authors: WHITTEMORE ROBIN , COLEMAN JULIA L. , DELVY ROBERTA , KATO BERNET , AMBROSOLI JAMES A. , MAURAO MICHAEL P. , ZINCAVAGE REBEKAH , MARCEAU LISA
Published: June 2018

Parents of teens with type 1 diabetes (T1D) report challenges in maintaining involvement with diabetes care while supporting teen autonomy. We developed a web-based tool to support parents in this transition—Type 1 Teamwork—that provides interactive content and video vignettes of real families on challenges and strategies to transition T1D care from parent to teen. The purpose of this study was to determine the reach (demographic characteristics), participation (web usage and engagement) and short-term effects (parenting stress, perceived stress, parental support for teen autonomy, family conflict, teen A1C) of Type 1 Teamwork. Parents of teens with T1D (11-16 years) were randomized to Type 1 Teamwork (n=81) or a control group (n=81). Parents were 45.6 (±5.3) years of age, 98% female, 91% white, 91% married/partnered, 51% high income, 36% with elevated depressive symptoms, and 40% with elevated anxiety symptoms. Teens had a mean A1C of 7.9 (±1.2), T1D duration of 5.(±3.62) years, with 75% using a pump, 69% using a CGM, and 39% reporting 20 or more episodes of hypoglycemia in the previous 3 months. There were no significant differences between groups on baseline characteristics. Eighty-two percent (n=133) of participants completed 3-month data collection. Parents in the Type 1 Teamwork group who did not access the tool (n=6) were excluded from the comparative analyses. Type 1 Teamwork was accessed a total of 453 times and had 6,614 total pages viewed, with an average of 15 pages and 11 minutes per visit. There was less frequent parenting emotional distress (p=.04) and trends for less family conflict (p=.14) in the Type 1 Teamwork group, with no short-term effect on perceived stress, parental support for autonomy, or teen A1C in change scores over 3 months. Ongoing usage of Type 1 Teamwork may further enhance outcomes in parents of teens with T1D, which we will evaluate at 6 months. More research is needed to engage lower income families in the use of websites to support parent-teen teamwork in T1D.

Disclosure

R. Whittemore: None. J.L. Coleman: None. R. Delvy: None. B. Kato: None. J.A. Ambrosoli: None. M.P. Maurao: None. R. Zincavage: None. L. Marceau: None.
Glycemic Factors Related to Depression in Adults with Type 1 Diabetes
Authors: EGBUONU IFEOMA , TRIEF PAULA M. , ROE CHERYL A. , WEINSTOCK RUTH S.
Published: June 2018

Objective: To compare glycemic factors (home glucose monitoring, glucose variability, A1c) in adults with type 1 diabetes (T1D) with probable depression to those without depression in a real world setting.

Methods: Adults with T1D at our diabetes center are routinely screened for depression with the PHQ2. If the PHQ2 score is >3, PHQ9 is completed. Medical records were reviewed including device downloads for adults with PHQ9 scores =10 (“depressed”) and age-matched “not depressed” controls (PHQ2 scores =3). Patients with T1D duration <1 year, GFR =30 mL/min/1.73m2, hemoglobinopathy or dementia were excluded.

Results: Of 1292 adults screened, 83 (6.4%) were depressed, and compared to an age-selected group of 171 non-depressed T1D adults (age range 18-72 years, 86% white, 8% black, 99% non-Hispanic, 42% Medicaid). Depressed [mean (SD) PHQ9 score 16.8 (4.3)] did not differ from non-depressed on age [41.7 (15.6) vs. 41.8 (15.7) years], BMI [29.3 (8.8) vs. 28.9 (6.2) kg/m2], T1D duration [21.2 (13.4) vs. 22.0 (15.0) years], or % male [42.2 vs. 40.9]. Meter downloads were available for 215/254 patients (74% of depressed, 90% of non-depressed). The depressed group had higher A1c [9.6% (2.3) vs. 8.6% (1.8) p<0.001], and fewer glucose tests/day [2.8 (2.3) vs. 3.6 (2.5) p=0.048] based on meter downloads. Prior work found that depression did not relate to self-reported glucose monitoring in T1D adults. The groups did not differ on meter % coefficient of variation (CV; mean 42%) or % with hypoglycemia (glucose reading <54 mg/dL). Continuous glucose monitoring (CGM) was used by 38 patients; CGM % CV was also not different in those depressed [35.0 (6.2), n=5] vs. non-depressed [36.0 (6.0), n=33]. The depressed group using CGM had lower A1c, suggesting that CGM use should not be withheld in the presence of depression. The small number of patients using CGM is a limitation.

Conclusion: Adults with T1D and probable depression had higher A1c, less meter use, fewer glucose readings/day, but no difference in glucose variability (% CV) or hypoglycemia (<54 mg/dL).

Disclosure

I. Egbuonu: None. P.M. Trief: Research Support; Self; National Institute of Diabetes and Digestive and Kidney Diseases. C.A. Roe: None. R.S. Weinstock: Research Support; Self; Medtronic MiniMed, Inc., Mylan, Kowa Pharmaceuticals America, Inc., Diasome Pharmaceuticals, Inc., Calibra Medical, Dexcom, Inc., Ultradian Diagnostics LLC., JAEB Center For Health Research, JDRF, National Institute of Diabetes and Digestive and Kidney Diseases.
Affective Communication in Routine Diabetes Care for Adolescents and Young Adults
Authors: HOMMA KIRSTEN , COGEN FRAN R. , STREISAND RANDI , MONAGHAN MAUREEN
Published: June 2018

High quality communication between health care providers (HCPs) and adolescents and young adults (AYAs) with type 1 diabetes (T1D) may contribute to better diabetes self-care and health outcomes. Health communication reflects both informational content and how information is conveyed, including affect and tone. The aim of this study was to assess HCP affective communication and the relationship between HCP affective communication and glycemic control in AYAs with T1D. As part of a larger study of AYA-HCP health communication, routine clinic visits for 69 AYAs with T1D (M age 17.81 years; 56.5% female) and 8 HCPs (88% female) were audiorecorded. Clinic visits were coded using the Roter Interaction Analysis System (RIAS), a validated coding structure assessing verbal and non-verbal exchanges in a medical encounter. HCP global affective ratings were used to create two composite variables—positive HCP affect (e.g., attentiveness; respectfulness; Cronbach’s a = 0.82) and negative HCP affect (e.g., anger; dominance; Cronbach’s a = 0.75). Hemoglobin A1c (A1c) was taken from the medical chart. The mean A1c was 8.97% (±2.30). Descriptive analyses of positive and negative HCP affect indicated that HCPs expressed a high level of positive affect (M = 4.21) and a relatively low level of negative affect (M = 2.80). Negative affect was positively associated with HbA1c. After controlling for salient covariates (e.g., HCP, race, regimen), A1c accounted for a significant portion of the variance in negative affect during the clinic visit (Adj R2 = .36, ß = 0.57, p < 0.001). This sample of HCPs predominantly exhibited positive affect during routine T1D visits. Glycemic control was not associated with positive affect, but higher A1c was associated with more negative affect. This finding suggests elevated A1c levels may elicit more negative affect in routine diabetes care. Future research should examine these associations over time, including how AYA-HCP health communication quality predicts long-term glycemic control.

Disclosure

K. Homma: None. F.R. Cogen: None. R. Streisand: None. M. Monaghan: Research Support; Self; American Diabetes Association, National Institutes of Health.
Increased Perceived Effort during Low-Intensity Exercise Linked to Type 2 Diabetes
Authors: HUEBSCHMANN AMY G. , WAHL MATTHEW , SCALZO REBECCA L. , RAFFERTY DEIRDRE , REGENSTEINER JUDITH G.
Published: June 2018

Exercise is a cornerstone of type 2 diabetes (T2D) treatment, but most people with T2D are sedentary. We identified a novel behavioral barrier to exercise in women with T2D compared to nondiabetic women — greater effort during low intensity exercise. We hypothesized that the presence of T2D would confer greater effort for adults across a range of exercise intensities, even when controlling for fitness. As T2D decreases fitness more in women than men, we also hypothesized sex would modify this association. We analyzed secondary data from past sedentary, overweight research participants with and without T2D who were free of cardiopulmonary comorbidities. During graded exercise tests to assess fitness (VO2peak), we repeatedly measured objective effort (heart rate (HR)) and subjective effort (Borg Rating of Perceived Exertion (RPE)). We plotted the rise of RPE and HR, respectively, against increases in relative work rate (%VO2peak: VO2 at work rate divided by VO2peak) at lower intensities below anaerobic threshold (AT) and higher intensities above AT. Adults with T2D (n=57) had similar age and adiposity as those without T2D (n=55), but had lower VO2peak: 20.7± 4.5 vs. 24.5 ± 6.6 ml/kg/min (p<0.05). Below AT, people with T2D had a steeper rise in RPE for each unit increase in %VO2peak than those without T2D (p=0.0029), and this finding was more pronounced in men than women (p=0.004). T2D status did not influence the association of %VO2peak and RPE above AT, or the association of HR and %VO2peak either below or above AT. People with T2D have significantly greater RPE during lower intensity exercise below AT as compared to people without T2D. This finding was not explained by fitness differences and, counter to our hypothesis, was more significant in men. We found no group differences in RPE at higher intensity exercise where physiological inputs tend to dominate behavioral predictors of effort. Future work should further characterize sex-specific mechanisms of exercise effort for people with T2D.

Disclosure

A.G. Huebschmann: Research Support; Self; Merck & Co., Inc.. M. Wahl: None. R.L. Scalzo: None. D. Rafferty: None. J.G. Regensteiner: None.
A Nurse-Led Diabetes Navigation Program for Rural Appalachian Ohio
Authors: BEVERLY ELIZABETH A. , GUSEMAN EMILY H. , COOK KARIE A. , STANDLEY MELISSA
Published: June 2018

In the Appalachian region of rural southeastern Ohio, diabetes rates are more than double the national average (19.9% vs. 9.4%). Here, diabetes patients are more likely to have a delayed diagnosis, microvascular complications, depression, and lower empowerment. Further, nearly a third of residents are living below the poverty line and suffer from higher unemployment rates, lower educational achievement, poorer health, food insecurity, and lower access to care. Thus, strategies that complement standard diabetes care are critically important to alleviate the burden of complications, reduce health disparities, and improve quality of life. We designed the Diabetes Navigation Program to improve health outcomes and address social determinants of health by expanding access to care and enhancing care coordination via nurse navigators. To date, 47 adult patients with type 2 diabetes have completed the program (94% white, 66% female, 61±16 years old, A1C=9.0±2.7%, 12±8 years duration). At baseline, 24% of patients reported moderately severe to severe depression as measured via the PHQ-9, and 53% reported moderate to serious diabetes distress as measured via the PAID-5. Patients showed a significant improvement in A1C from baseline to 6-month follow-up (mean change: -1.2 points, t=2.23, p=0.017); however, no improvements were observed in depressive symptoms (t=1.37, p=0.199) or diabetes distress (t=1.82, p=0.098). The nurse navigator provided increased insurance coverage (59%), food stamps (50%) and emergency food boxes (16%), permanent or temporary housing (23%), diabetes education (21%), reduced hospital bills (14%), diabetes medication (14%), and emotional support (71%). These data are promising though more data are necessary to evaluate the clinical effectiveness. The next step is to design a randomized controlled trial to test the efficacy of navigation as compared to usual care. In the long term, this work has the potential to reduce health disparities and improve access to care for in Appalachian Ohio.

Disclosure

E.A. Beverly: None. E.H. Guseman: None. K.A. Cook: None. M. Standley: None.
The Relationship between Brain Volume Loss and Cognition in Subjects with T2DM
Authors: HUNT LEANNE , SELVARAJAH DINESH , TESFAYE SOLOMON , WILKINSON IAIN D.
Published: June 2018

Aim: Mild Cognitive Impairment (MCI) is thought to be a chronic sequelae of type 2 diabetes (T2DM). Cerebral atrophy is known to be associated with cognitive decline, particularly in dementia. Cerebral tissue volumes, in areas associated with cognitive function, were examined in matched patients with T2DM subjects and early cognitive decline. The aim of this study was to compare T2DM patients with and without MCI to identify regional brain volume changes that were specific to MCI.

Method: Seventy-six age and gender matched subjects [30, T2DM+normal cognition (T2DM); 17, T2DM+MCI (T2DM/MCI) and 29, healthy volunteers (HV)] were recruited. All subjects underwent clinical and questionnaire (Addenbrooke’s Cognitive Assessment [ACE-R]) assessments and high-resolution, 3D T1-weighted Magnetic Resonance Imaging (MRI, 3T Philips Ingenia). Cerebral volumes were analysed using voxel based morphometry (VBM, FSL, Oxford).

Results: Demographic data revealed aged-matched participants between all three groups (mean age 69.3-71.5 years, ANOVA, p = 0.164). Mean age of last education was significantly lower in the T2DM/MCI group (mean±SD;15.1 ±0.9 when compared to the other groups (HV 19.3±5.6, T2DM 17.1±2.9) Kruskal-Wallis, p = 0.003. T2DM/MCI ACE-R score (mean±SD; 83±4) was significantly lower compared to other groups (HV=96±2, T2DM=94±3; ANOVA, p<0.001). T2DM/MCI group had significantly lower regional cross-sectional grey matter volumes compared to HV in the left (p#x003C;0.0005) and right hippocampi (p<0.05), left putamen (p<0.05), caudate (p<0.05) and amygdala (p<0.05).

Conclusion: This study demonstrates significantly lower cortical differences in areas associated with cognition in patients with T2DM and early cognitive impairment. Further investigation of both anatomical and functional cerebral involvement is required to examine the pathological mechanisms underlying the increased cognitive impairment risk associated with T2DM.

Disclosure

L. Hunt: None. D. Selvarajah: None. S. Tesfaye: Speaker's Bureau; Self; Pfizer Inc.. Other Relationship; Self; Janssen Pharmaceuticals, Inc., Takeda Development Centre Europe Ltd.. Advisory Panel; Self; Wörwag Pharma GmbH & Co. KG. I.D. Wilkinson: None.
Real-World Effectiveness of a Digital Therapeutic in Improving Glycaemic Control in South Asians Living with Type 2 Diabetes
Authors: SOSALE ARAVIND R. , SHAIKH MAAZ , SHAH ABHISHEK , CHAWLA RAJEEV , MAKKAR BRIJ M. , KESAVADEV JOTHYDEV , JOSHI SHILPA , DESHPANDE NEETA , AGARWAL SANJAY , MAHESHWARI ANUJ , MADHU SV , SABOO BANSHI D.
Published: June 2018

Background: Insurers in South Asia are challenged by lack of a culturally relevant and clinically effective lifestyle intervention that can be delivered at scale. This study reports results from participants of a real-world pilot using Wellthy Diabetes™ (WD), a digital therapeutic for people living with type 2 diabetes, in collaboration with an insurance provider with the aim to validate WD as a diabetes management and risk reduction tool. WD was developed in scientific collaboration with the Research Society for Study of Diabetes in India (RSSDI).

Methods: A 16-week lifestyle modification program was delivered to persons with T2DM through an Artificial Intelligence (AI) powered smartphone app. The program included behavioral modification training based on structured DSME content, developed along AADE7™ guidelines. The WD app enables users to self-report data on blood glucose, weight, meals, and physical activity and encourages logging through personalized reminders and nudges using an AI-powered digital persuasion model. Participants received real-time feedback and coaching through an AI-powered chatbot and personalized coaching from an expert diabetes coach. A1c measures were conducted at the start and end of the program. This study presents results from 102 program completers who completed follow-up A1c.

Results: The mean pre and post-intervention A1c for 102 program completers (mean age: 50.8 years and 68% males) were 8.51% (95% CI:8.23-8.79) and 8.02% (95% CI: 7.72-8.32), respectively, showing a mean post-intervention reduction of -0.49% A1c (95% CI:-0.73 - -0.25, p=0.01). Sixty percent (n=61) of participants reduced their A1c by the end of the program with a mean reduction of -1.17% A1c (95% CI: 0.75-1.60).

Conclusion: This study demonstrates Wellthy Diabetes as a clinically effective intervention for Health and Life Insurers in South Asia to improve health outcomes and reduce risk for people with type 2 diabetes through improved glycemic control.

Disclosure

A.R. Sosale: None. M. Shaikh: Employee; Self; Wellthy Therapeutics Pvt Ltd. A. Shah: Stock/Shareholder; Self; Wellthy Therapeutics.R. Chawla: None.B.M. Makkar: None. J. Kesavadev: Advisory Panel; Self; Novo Nordisk India Private Limited. Speaker's Bureau; Self; Novo Nordisk India Private Limited. Advisory Panel; Self; Medtronic. Speaker's Bureau; Self; Medtronic. Advisory Panel; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Research Support; Self; MSD. Speaker's Bureau; Self; MSD. Advisory Panel; Self; AstraZeneca. Speaker's Bureau; Self; AstraZeneca.S. Joshi: None.N. Deshpande: None.S. Agarwal: None.A. Maheshwari: None.S. Madhu: None.B.D. Saboo: None.
Raising a Child with Type 1 Diabetes and Autism—Using Social Media to Identify Barriers and Facilitators
Authors: OSER TAMARA , OSER SEAN M. , BANGALORE KRISHNA KANTHI , HALE DANIEL E.
Published: June 2018

Children with both T1D and autism pose a distinct challenge, and there is exceedingly little research on T1D self-management in this special population and few resources to guide healthcare providers (HCPs) on how to best partner with families. This qualitative study used an exploratory inductive thematic approach to analyze a public Internet forum authored by caregivers to children with both T1D and autism. All 398 posts were imported into NVivo 11 (QSR International). After codebook development, the primary coders (TO, SO) coded 10% and then 20% of the dataset, with Cohen’s kappa .994 and .996, respectively. With high inter-rater reliability established, coding of all remaining posts was then completed. Inductive thematic analysis revealed the following themes: 1) Parents of children with T1D and autism yearned for support and did not feel understood by the autism community or the T1D community; social media provided much-needed peer support from families that understood the unique experience of raising a child with both conditions. 2) Numerous coping techniques were discussed, including focusing on T1D management first, as glucose levels could affect behavior; establishing concrete rules and routines; and advice on types of needles and technology that might be better tolerated in this unique population. 3) Descriptions of the healthcare experience, including the helpfulness of multidisciplinary teams with endocrinologists and autism specialists jointly developing treatment plans. 4) Challenges in school and camp settings, as well as challenges in finding caregivers. 5) Sensory issues precluding use of technology such as insulin pumps, and the utility of tubeless pumps in overcoming some of these challenges. This study provides valuable insight for HCPs into the challenges these families face and lays the groundwork for future studies to evaluate how HCPs can best care for and advise this unique population.

Disclosure

T. Oser: None. S.M. Oser: None. K. Bangalore Krishna: None. D.E. Hale: None.
Empowerment, Motivation, and Medical Adherence (EMMA)—Results of an RCT in Patients with Poorly Regulated Type 2 Diabetes
Authors: VARMING ANNEMARIE R. , OLESEN KASPER , WILLAING INGRID
Published: June 2018

Background: Many studies have shown that substantial improvement of glycemic control is difficult in patients with poor glycemic control. Knowledge, competences and motivation are critical requirements for optimal self-management and good glycemic control. The aim of this RCT was to test if a consultation program, EMMA could improve self-management and glycemic control in patients with T2D and poor glycemic control compared to a control group receiving usual care.

Methods: The study was a non-blinded parallel RCT targeting adults with T2D ≥ 1 year and HbA1c ≥ 64 mmol/mol in a Danish diabetes clinic. The intervention consisted of four consultations with nurses using EMMA, which provides a person-centered approach using dialogue tools designed to promote self-reflection, learning and goal-setting (3.5 months). Outcome measures were HbA1c and questionnaire scores investigating determinants of glycemic control according to Self-Determination Theory, such as autonomy support (Health Care Climate Questionnaire (HCCQ)). Consultation processes were evaluated by the level of nurse talk and the actual use of the tools.

Results: Nighty-seven participants completed the study (49 in the intervention group). The HCCQ score was significantly higher in the intervention group at end of the intervention. The increase in HCCQ score was not sustained at the end of follow-up (6 months). HbA1c was slightly reduced in both groups at the end of intervention and at follow-up. Average level of nurse talk in all recorded intervention consultations (n=57) was 37% of total talk-time. Records from the consultations showed that most of the reflection and goal-setting tools were used with >90% of the participants, whereas the learning tools were used with 61%.

Conclusion: The initial increase in autonomy support seemed attributed to the intervention. The non-significant decrease in HbA1c may be ascribed a short intervention period and less professional use of learning tools than intended.

Disclosure

A.R. Varming: None. K. Olesen: None. I. Willaing: None.
Improved Diabetes Medication Convenience in Persons with Type 2 Diabetes after Switching to Insulin Glargine 300 U/mL (U-300)—The Observational OPTIN-D Study
Authors: WIERINGA THOMAS H. , DE WIT MAARTJE , TWISK JOS , SNOEK FRANK J.
Published: June 2018

Insulin glargine-300 (U-300) provides a flatter and more prolonged profile than U-100, with less risk of hypoglycemia. Real-world evidence of the effect of U-300 on Patient Reported Outcomes (PROs) is lacking. Adults with type 2 diabetes (T2DM) using insulin for ≥6 months and initiating U-300 were included. Data were collected at baseline (start U-300; T0)), 3 (T1) and 6 months (T2). Intention-to-treat mixed model analyses examined change over time in HbA1c, self-reported hypoglycemia and PROs: emotional well-being (WHO-5), hypoglycemia worries (HFS-W), diabetes distress (PAID-SF), diabetes medication convenience (DMSRQ), sleep quality and duration (PSQI), and adherence (1 item SDSCA). Also, the extent to which U-300 fulfilled its expectations was measured at T2 both in physicians and patients. P-value threshold was set at .for the WHO-5 and .01 for other outcomes. In total, 162 persons with T2DM participated: 53.7% men, mean age 64.54 years (9.05), baseline mean HbA1c 62.48 mmol/mol (12.61). Hypoglycemia incidence decreased non-significantly: for symptomatic events from 31.5% (T0) to 24.8% (T2), nocturnal events from 6.8% (T0) to 4.1% (T2), severe events from 4.9% (T0) to 0.0% (T2). HbA1c trended towards a decrease to 60.32 mmol/mol (12.09) (T2). Mean WHO-5 scores trended towards improvement, from 61.73 (T0) to 63.93 (T2). Mean DMSRQ scores improved significantly from 32.70 (T0) to 35.80 (T1) (beta T0-T1 = 3.28; p<.001; 95% CI = 1.67 to 4.89) and 36.96 (T2) (beta T0-T2 = 4.40; p<.001; 95% CI = 2.77 to 6.02). U-300 fulfilled (or exceeded) its expectations in 89,0% of physicians and 92.4% of patients. Other PROs did not change significantly over time. U-300 fulfills physicians’ and patients’ expectations and improves diabetes medication convenience, possibly due to more flexible injection timing. Future research should further explore effects on quality of life in a more diverse population.

Disclosure

T.H. Wieringa: Other Relationship; Self; Sanofi. M. de Wit: Advisory Panel; Self; Sanofi.J. Twisk: None.F.J. Snoek: None.
Program ACTIVE II—Glycemic Improvements Are Sustained over 12 Months with Combination Therapy for MDD in Adults with T2DM
Authors: DE GROOT MARY , GUYTON W. HORNSBY , SAHA CHANDAN K. , YANG ZIYI , PILLAY YEGAN , FITZPATRICK KAREN M. , MATHER KIEREN J. , SHUBROOK JAY H.
Published: June 2018

Few studies have evaluated the long-term comparative effects of behavioral treatments for major depressive disorder (MDD) on glycemic and psychological outcomes. Program ACTIVE II was a multi-state randomized controlled comparative effectiveness trial of cognitive behavioral therapy (CBT), community-based exercise (EXER), combination treatment (CBT+EXER) or usual care (UC) for adults with MDD and type 2 diabetes (T2DM).

CBT+EXER had a lasting A1c benefit at 6-months (-1.27%; SE: 0.6; p=0.04) and 12 months (-1.42%; SE: 0.6; p=0.03) compared to UC in those with baseline A1c ≥ 7.0%, after controlling for baseline covariates.

At 6-month (N=74) and 12-month (N=64) follow-up assessments, all groups had high rates of MDD full remission (range: 63-93%; NS) and minimal depressive symptoms (BDI total score range: 10.7-15.6; NS).

At 6 months, CBT+EXER had significant improvements in diabetes-related distress regimen burden (p=0.05); and personal support for health (p=0.05) compared to UC. EXER had improvements in negative thoughts (p=0.005), community social support (p=0.005), diabetes-specific quality of life (DQoL; p=0.04) and satisfaction with T2DM (p=0.01) compared to UC. CBT had improvements over UC in personal support for health (p=0.04) and DQoL (p=0.047). At 12 months, all 3 treatment groups reported improved support from health care providers (p=0.03 CBT, EXER and CBT+EXER) compared to UC. CBT+EXER had improved SF-12 Physical Component Scores (p=0.04) compared to UC.

The Program ACTIVE II CBT+EXER intervention had a sustained benefit for A1c beyond the effect of MDD full remission. All 3 behavioral interventions sustained improvements in psychological well-being over 1 year. These findings highlight durable benefits of community-based depression interventions delivered by behavioral health and exercise professionals, which could allow expanded access to depression treatment for T2DM patients in rural and urban areas.

Disclosure

M. de Groot: Consultant; Self; Johnson &Johnson Diabetes Institute, LLC., Eli Lilly and Company.W. Hornsby: None.C.K. Saha: None.Z. Yang: None.Y. Pillay: None.K.M. Fitzpatrick: None. K.J. Mather: Research Support; Self; Merck &Co., Inc., Sanofi-Aventis, Novo Nordisk A/S, Abbott. Advisory Panel; Self; Merck & Co., Inc.J.H. Shubrook: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk Inc., Intarcia Therapeutics, Inc..