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BackgroundBlack adolescents with type 1 diabetes (T1D) are at increased risk for suboptimal diabetes health outcomes; however, evidence-based interventions for this population are lacking. Depression affects a high percentage of youth with T1D and increases the likelihood of health problems associated with diabetes. ObjectiveOur aim was to test whether baseline levels of depression moderate the effects of a brief eHealth parenting intervention delivered to caregivers of young Black adolescents with T1D on youths’ glycemic control. MethodsWe conducted a multicenter randomized controlled trial at 7 pediatric diabetes clinics located in 2 large US cities. Participants (N=149) were allocated to either the intervention group or a standard medical care control group. Up to 3 intervention sessions were delivered on a tablet computer during diabetes clinic visits over a 12-month period. ResultsIn a linear mixed effects regression model, planned contrasts did not show significant reductions in hemoglobin A1c (HbA1c) for intervention adolescents compared to controls. However, adolescents with higher baseline levels of depressive symptoms who received the intervention had significantly greater improvements in HbA1c levels at 6-month follow-up (0.94%; P=.01) and 18-month follow-up (1.42%; P=.002) than those with lower levels of depression. Within the intervention group, adolescents had a statistically significant reduction in HbA1c levels from baseline at 6-month and 18-month follow-up. ConclusionsA brief, culturally tailored eHealth parenting intervention improved health outcomes among Black adolescents with T1D and depressive symptoms. Trial RegistrationClinicalTrials.gov NCT03168867; https://clinicaltrials.gov/study/NCT03168867

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Abstract Background Urothelial bladder cancer (UBC) accounts for 10,000 new diagnoses and 5000 deaths annually in the UK (Cancer Research UK, http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/bladder-cancer, Cancer Research UK, Accessed 26 Mar 2018). Cisplatin-based chemotherapy is standard of care therapy for UBC for both palliative first-line treatment of advanced/metastatic disease and radical neoadjuvant treatment of localised muscle invasive bladder cancer. However, cisplatin resistance remains a critical cause of treatment failure and a barrier to therapeutic advance in UBC. Based on supportive pre-clinical data, we hypothesised that DNA methyltransferase inhibition would circumvent cisplatin resistance in UBC and potentially other cancers. Methods The addition of SGI-110 (guadecitabine, a DNA methyltransferase inhibitor) to conventional doublet therapy of gemcitabine and cisplatin (GC) is being tested within the phase Ib/IIa SPIRE clinical trial. SPIRE incorporates an initial, modified rolling six-dose escalation phase Ib design of up to 36 patients with advanced solid tumours followed by a 20-patient open-label randomised controlled dose expansion phase IIa component as neoadjuvant treatment for UBC. Patients are being recruited from UK secondary care sites. The dose escalation phase will determine a recommended phase II dose (RP2D, primary endpoint) of SGI-110, by subcutaneous injection, on days 1–5 for combination with GC at conventional doses (cisplatin 70 mg/m2, IV infusion, day 8; gemcitabine 1000 mg/m2, IV infusion, days 8 and 15) in every 21-day cycle. In the dose expansion phase, patients will be randomised 1:1 to GC with or without SGI-110 at the proposed RP2D. Secondary endpoints will include toxicity profiles, SGI-110 pharmacokinetics and pharmacodynamic biomarkers, and pathological complete response rates in the dose expansion phase. Analyses will not be powered for formal statistical comparisons and descriptive statistics will be used to describe rates of toxicity, efficacy and translational endpoints by treatment arm. Discussion SPIRE will provide evidence for whether SGI-110 in combination with GC chemotherapy is safe and biologically effective prior to future phase II/III trials as a neoadjuvant therapy for UBC and potentially in other cancers treated with GC. Trial Registration EudraCT Number: 2015–004062-29 (entered Dec 7, 2015) ISRCTN registry number: 16332228 (registered on Feb 3, 2016)

Objective: To describe sleep in adolescents and young adults with type 1 diabetes (T1D) and explore the association between sleep disturbances, diabetes management and glycemic control. Methods: Adolescents with T1D (n = 159, mean age = 16.4, 43% female, 69% white, mean hemoglobin A1c = 9.3%) completed the Pittsburgh Sleep Quality Index to assess sleep quantity and quality and sleep disturbances. Frequency of blood glucose monitoring (meter downloads) was used as a measure of diabetes management. Results: Average sleep duration was 7.4 hours, below the recommended duration for this age. Adolescents using insulin pumps reported fewer sleep disturbances and longer sleep duration than those on injections, and older adolescents reported less sleep than younger adolescents. Poorer sleep duration was related to poorer diabetes management, and better self-reported sleep quality was associated with better glycemic control for males but not for females. Conclusions: Assessing for and treating sleep disturbances in adolescents may improve diabetes management.

Older African American men are at increased risk of Type 2 Diabetes (T2D) but demonstrate high rates of poor illness management. They also participate in interventions targeting illness management at extremely low rates and are at high risk for dropout from clinical trials. One modifiable factor that has been identified in the literature that contributes to these disparities is health beliefs particular to men. Yet, despite the fact that illness management interventions have been developed to meet the needs of African Americans, none have followed recommendations to use gender-sensitive programming to meet the needs of men. The primary aim of this study was to advance our understanding of the intersection of age, race/ethnicity and gender on T2D self-management among older African American men, and to explore their preferences for a peer-led T2D self-management intervention. Two focus groups were conducted with older African American men (n = 16) over a 6-month period. Sessions lasted 90 min, were audiotaped, and analyzed using thematic content analysis techniques. The most prominent themes included: (a) the influence of gendered values and beliefs on health behavior; (b) quantity and quality of patient-provider communication; (c) social and structural barriers to T2D self-management; and (d) preferences for peer-led T2D self-management interventions. Results suggest that these themes may be particularly salient for T2D self-management in older African American men, and that this population may be receptive to a peer-led T2D self-management intervention.

Objective To compare New Zealand medical grade kanuka honey with topical aciclovir for the treatment of herpes simplex labialis.Design Prospective parallel randomised controlled open-label superiority trial.Setting 76 community pharmacies across New Zealand between 10 September 2015 and 13 December 2017.Participants 952 adults randomised within the first 72 hours of a herpes simplex labialis episode.Interventions Random assignment 1:1 to either 5% aciclovir cream or medical grade kanuka honey (90%)/glycerine (10%) cream, both applied five times daily.Outcome measures The primary outcome was time from randomisation to return to normal skin (stage 7). Secondary outcomes included time from randomisation to stage 4 (open wound), time from stage 4 to 7, maximal pain, time to pain resolution and treatment acceptability.Results Primary outcome variable: Kaplan-Meier-based estimates (95% CI) for the median time in days for return to normal skin were 8 (8 to 9) days for aciclovir and 9 (8 to 9) for honey; HR (95% CI) 1.06 (0.92 to 1.22), p=0.56. There were no statistically significant differences between treatments for all secondary outcome variables. No related serious adverse events were reported.Conclusion There was no evidence of a difference in efficacy between topical medical grade kanuka honey and 5% aciclovir in the pharmacy-based treatment of herpes simplex labialis.Trial registration number ACTRN12615000648527;Post-results