Michal Gillon-Keren

Background and Aims: Disordered eating behaviors (DEB) are more common among individuals with type 1 diabetes (T1D) compared to those without, and for insulin pump users may be associated with higher hemoglobin A1c (HbA1c). We investigated DEB risk factors among insulin pump-treated individuals with T1D and clinical characteristics of hybrid closed-loop (HCL) systems' users by DEB level. Methods: An observational, cross-sectional study of 167 insulin pump-treated individuals with T1D, 13–21 years of age. Data were obtained from patients' medical charts with additional self-reported questionnaires, including assessment of DEB. Results: DEB were found in 71 (42.5%) individuals, and positively associated with female sex (β = 2.98 [standard error (SE) = 1.31], P = 0.025), body mass index (BMI)-Z-score (β = 2.12 [SE = 0.64], P = 0.001), HbA1c (β = 1.40 [SE = 0.45], P = 0.02), and higher rate of pump discontinuation (β = 4.48 [SE = 1.99], P = 0.026). The use of HCL systems compared to insulin pumps was associated with higher BMI-Z-score (odds ratio [OR]: 3.46 [95% confidence interval, CI: 1.52–7.87], P = 0.003) and tendency to lower HbA1c level (OR: 0.44 [95% CI: 0.18–1.09], P = 0.078) among individuals without DEB, and with lower HbA1c level (OR: 0.29 [95% CI: 0.10–0.83], P = 0.022) and higher socioeconomic status (OR: 1.73 [95% CI: 1.09–2.74], P = 0.020) among individuals with DEB. Conclusions: DEB are common among individuals with T1D treated with insulin pumps and are associated with higher HbA1c levels. Among T1D individuals with DEB, HCL system use is associated with lower HbA1c compared to insulin pump treatment. Our findings highlight the importance of regular screening for DEB and its risk factors to improve pump treatment and diabetes management. Moreover, individuals with DEB using HCL systems may benefit from reduced HbA1c levels.

Background: The Medtronic MiniMed™ 670G system adjusts basal insulin delivery in response to continuous glucose monitoring levels and is already in use in clinical practice. We tested the home-based feasibility of the new MiniMed advanced hybrid closed-loop (AHCL) system, which includes several algorithm enhancements and an optional autocorrection bolus mode. Methods: Twelve adolescents and young adults (eight females) with type 1 diabetes [median (interquartile range)] aged 16.6 (15.9, 18.2) years and diabetes duration of 7.1 (4.7, 8.8) years] participated in this single-arm study. The first stage was a 6-day open-loop run-in period, with the predictive low-glucose suspend feature on. This was followed by 6 days/5 nights in a supervised hotel setting, using the AHCL system, including closed-loop challenges (missed meal bolus, late meal bolus, and physical activity); and finally, 3 weeks with unrestricted home use. Glycemic parameters were compared between the open-loop and closed-loop periods. Results: Participants spent 93.3% (4.7) of the time in SmartGuard™ Auto Mode. Hemoglobin A1C levels decreased from median (interquartile range) 7.1% (6.7, 7.9) at baseline to 6.8% (6.6, 7.4) at study end, after 4 weeks ( P = 0.0027). Time in range (TIR) (70–180 mg/dL) was 68.4% (10.6) and time below 70 mg/dL was 4% (3.5) during open-loop; and 74% (6.1) and 2.6% (1.9), respectively, during the closed-loop at home phase ( P = 0.06, P = 0.27). TIR increased during the nighttime, from 64.6% (17.4) to 80.7% (7.8), P = 0.007, without change in time below 70 mg/dL ( P = 0.15). No serious adverse events occurred. Conclusions: The new AHCL system demonstrated safety and effectiveness in controlling day and night glucose levels.

Efforts to shape the food environment are aimed at reducing diet-related co-morbidities. Front-of-package labeling (FOPL) may support the consumers to make an informed decision at the point of purchase and encourage industry to reformulate food products. The Israeli Ministry of Health (MOH) implemented a unique FOPL system, using two colors: A mandatory warning (red) label alongside a voluntary positive (green) label. An independent Scientific Committee, from academia, the healthcare system, and MOH was appointed to determine the core principles for the positive FOPL. The criteria were based on the Mediterranean diet principles, with adjustments to the Israeli dietary habits, focusing on the health advantages of the food and considering its processing level. The food products eligible for positive FOPL are foods in their natural form or with added spices or herbs, or those that underwent minimal processing, with no food additives. Based on population consumption data, 19.8% of food products were eligible for positive FOPL; of them, 54% were fruits and vegetables, 20% dairy, and 14% grains. An evaluation plan is needed to assess the degree of acceptance of the positive FOPL by the industry, retailers, and the public, and its impact on food consumption and on public health.

Background: Ethnic minority populations exhibit disproportionately high rates of type 2 diabetes mellitus (T2DM). Electronic health tools have the potential to facilitate the cultural adaptation and tailoring of T2DM education to improve the knowledge and management of diabetes mellitus (DM). Objective: This study aimed (1) to develop an adaptable Interactive Lifestyle Assessment, Counseling, and Education (I-ACE) software to support dietitian-delivered lifestyle counseling among low-socioeconomic status (SES) ethnic minority patients with T2DM and (2) to evaluate its effect on DM-related dietary knowledge and management compared with standard lifestyle advice (SLA) in a randomized controlled trial (RCT). Methods: The I-ACE software, developed in consultation with clinical dieticians, incorporates evidence-based dietary and physical activity (PA) recommendations and educational materials. The features and behavioral change techniques include quantitative lifestyle (dietary intake and PA) assessment and simulation, individually tailored education and recommendations, motivational interviewing, and goal setting. For the unblinded pilot RCT, 50 overweight or obese Arab adults (aged 40-62 years) with poorly controlled T2DM were recruited from primary care clinics and randomly assigned to receive 4 in-person, dietician-delivered counseling sessions over 6 months using either (1) the I-ACE tool (experimental arm) or (2) the SLA methods (comparison arm). All outcome assessments were face-to-face. DM-related dietary knowledge (primary outcome) was measured at baseline, 3, 6, and 12 months. Lifestyle and other parameters were measured before, during, and after the intervention. Multiple linear regression and repeated measures linear mixed models were used to compare the changes in study outcomes and explore time trends in between-group and within-group changes. Results: A total of 25 participants were enrolled in each arm, of whom 24 and 21 completed the final assessment of the primary outcome in the I-ACE and SLA arms, respectively. DM-related lifestyle knowledge increased more rapidly in the I-ACE arm than in the SLA arm (P value for study arm×time interaction=.02). Within the I-ACE arm, the mean (SE) differences in added sugar and dietary fiber intakes from baseline to 12 months were −2.6% (SE 1.0%) of total energy (P=.03) and 2.7 (SE 0.0) g/1000 kcal (P=.003), respectively. The odds of engaging in any leisure PA at 12 months tended to be higher in the I-ACE arm versus SLA arm, but did not reach statistical significance (odds ratio 2.8; 95% CI 0.7-11.6; P=.16). Both arms exhibited significant reductions in HbA1c (P value for change over time <.001). Conclusions: The use of the I-ACE software in a 6-month, 4-session dietician-delivered lifestyle counseling intervention improved the efficiency of lifestyle education, compared with SLA, among low-SES, ethnic minority patients with T2DM. This pilot trial provides justification for conducting a large-scale trial to evaluate its effectiveness and applicability in routine clinical care among ethnically diverse populations. Trial Registration: ClinicalTrials.gov NCT01858506; https://clinicaltrials.gov/ct2/show/NCT01858506.

BACKGROUND Ethnic minority populations exhibit disproportionately high rates of type 2 diabetes mellitus (T2DM). Electronic health tools have the potential to facilitate the cultural adaptation and tailoring of T2DM education to improve the knowledge and management of diabetes mellitus (DM). OBJECTIVE This study aimed (1) to develop an adaptable Interactive Lifestyle Assessment, Counseling, and Education (I-ACE) software to support dietitian-delivered lifestyle counseling among low-socioeconomic status (SES) ethnic minority patients with T2DM and (2) to evaluate its effect on DM-related dietary knowledge and management compared with standard lifestyle advice (SLA) in a randomized controlled trial (RCT). METHODS The I-ACE software, developed in consultation with clinical dieticians, incorporates evidence-based dietary and physical activity (PA) recommendations and educational materials. The features and behavioral change techniques include quantitative lifestyle (dietary intake and PA) assessment and simulation, individually tailored education and recommendations, motivational interviewing, and goal setting. For the unblinded pilot RCT, 50 overweight or obese Arab adults (aged 40-62 years) with poorly controlled T2DM were recruited from primary care clinics and randomly assigned to receive 4 in-person, dietician-delivered counseling sessions over 6 months using either (1) the I-ACE tool (experimental arm) or (2) the SLA methods (comparison arm). All outcome assessments were face-to-face. DM-related dietary knowledge (primary outcome) was measured at baseline, 3, 6, and 12 months. Lifestyle and other parameters were measured before, during, and after the intervention. Multiple linear regression and repeated measures linear mixed models were used to compare the changes in study outcomes and explore time trends in between-group and within-group changes. RESULTS A total of 25 participants were enrolled in each arm, of whom 24 and 21 completed the final assessment of the primary outcome in the I-ACE and SLA arms, respectively. DM-related lifestyle knowledge increased more rapidly in the I-ACE arm than in the SLA arm (P value for study arm×time interaction=.02). Within the I-ACE arm, the mean (SE) differences in added sugar and dietary fiber intakes from baseline to 12 months were −2.6% (SE 1.0%) of total energy (P=.03) and 2.7 (SE 0.0) g/1000 kcal (P=.003), respectively. The odds of engaging in any leisure PA at 12 months tended to be higher in the I-ACE arm versus SLA arm, but did not reach statistical significance (odds ratio 2.8; 95% CI 0.7-11.6; P=.16). Both arms exhibited significant reductions in HbA1c (P value for change over time <.001). CONCLUSIONS The use of the I-ACE software in a 6-month, 4-session dietician-delivered lifestyle counseling intervention improved the efficiency of lifestyle education, compared with SLA, among low-SES, ethnic minority patients with T2DM. This pilot trial provides justification for conducting a large-scale trial to evaluate its effectiveness and applicability in routine clinical care among ethnically diverse populations. CLINICALTRIAL ClinicalTrials.gov NCT01858506; https://clinicaltrials.gov/ct2/show/NCT01858506.