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In a 13-week, randomized trial involving persons 6 to 79 years of age with type 1 diabetes, use of a bionic pancreas was associated with a greater reduction in the glycated hemoglobin level than standard care.

Despite the increasing adoption of insulin pumps and continuous glucose monitoring devices, most people with type 1 diabetes do not achieve their glycemic goals 1 . This could be related to a lack of expertise or inadequate time for clinicians to analyze complex sensor-augmented pump data. We tested whether frequent insulin dose adjustments guided by an automated artificial intelligence-based decision support system (AI-DSS) is as effective and safe as those guided by physicians in controlling glucose levels. ADVICE4U was a six-month, multicenter, multinational, parallel, randomized controlled, non-inferiority trial in 108 participants with type 1 diabetes, aged 10–21 years and using insulin pump therapy (ClinicalTrials.gov no. NCT03003806). Participants were randomized 1:1 to receive remote insulin dose adjustment every three weeks guided by either an AI-DSS, (AI-DSS arm, n  = 54) or by physicians (physician arm, n  = 54). The results for the primary efficacy measure—the percentage of time spent within the target glucose range (70–180 mg dl −1 (3.9–10.0 mmol l −1 ))—in the AI-DSS arm were statistically non-inferior to those in the physician arm (50.2 ± 11.1% versus 51.6 ± 11.3%, respectively, P  < 1 × 10 −7 ). The percentage of readings below 54 mg dl −1 (<3.0 mmol l −1 ) within the AI-DSS arm was statistically non-inferior to that in the physician arm (1.3 ± 1.4% versus 1.0 ± 0.9%, respectively, P  < 0.0001). Three severe adverse events related to diabetes (two severe hypoglycemia, one diabetic ketoacidosis) were reported in the physician arm and none in the AI-DSS arm. In conclusion, use of an automated decision support tool for optimizing insulin pump settings was non-inferior to intensive insulin titration provided by physicians from specialized academic diabetes centers. The randomized-controlled trial ADVICE4U demonstrates non-inferiority of an automated AI-based decision support system compared with advice from expert physicians for optimal insulin dosing in youths with type 1 diabetes.

Previous studies on telemedicine interventions have shown that older diabetic patients experience difficulty in using computers, which is a barrier to remote communication between medical teams and older diabetic patients. However, older people in China tend to find it easy to use mobile phones and personal messaging apps that have a user-friendly interface. Therefore, we designed a mobile health (mHealth) system for older people with diabetes that is based on mobile phones, has a streamlined operation interface, and incorporates maximum automation. The goal of the research was to investigate the use of mobile phone-based telemedicine apps for management of older Chinese patients with type 2 diabetes mellitus (T2DM). Variables of interest included efficacy and safety. A total of 91 older (aged over 65 years) patients with T2DM who presented to our department were randomly assigned to one of two groups. Patients in the intervention group (n=44) were provided glucometers capable of data transmission and received advice pertaining to medication, diet, and exercise via the mHealth telemedicine system. Patients assigned to the control group (n=47) received routine outpatient care with no additional intervention. Patients in both groups were followed up at regular 3-month intervals. After 3 months, patients in the intervention group showed significant (P<.05) improvement in postprandial plasma glucose level. After 6 months, patients in the intervention group exhibited a decreasing trend in postprandial plasma glucose and glycated hemoglobin levels compared with the baseline and those in the control group (P<.05). Mobile phone-based telemedicine apps help improve glycemic control in older Chinese patients with T2DM. China Clinical Trial Registration Center ChiCTR 1800015214; http://www.chictr.org.cn/showprojen.aspx?proj=25949 (Archived by WebCite at http://www.webcitation.org/73wKj1GMq).

Objective Artificial pancreas (AP) systems have been shown to improve glycemic control throughout the day and night in adults, adolescents, and children. However, AP testing remains limited during intense and prolonged exercise in adolescents and children. We present the performance of the Tandem Control‐IQ AP system in adolescents and children during a winter ski camp study, where high altitude, low temperature, prolonged intense activity, and stress challenged glycemic control. Methods In a randomized controlled trial, 24 adolescents (ages 13‐18 years) and 24 school‐aged children (6‐12 years) with Type 1 diabetes (T1D) participated in a 48 hours ski camp (∼5 hours skiing/day) at three sites: Wintergreen, VA; Kirkwood, and Breckenridge, CO. Study participants were randomized 1:1 at each site. The control group used remote monitored sensor‐augmented pump (RM‐SAP), and the experimental group used the t: slim X2 with Control‐IQ Technology AP system. All subjects were remotely monitored 24 hours per day by study staff. Results The Control‐IQ system improved percent time within range (70‐180 mg/dL) over the entire camp duration: 66.4 ± 16.4 vs 53.9 ± 24.8%; P = .01 in both children and adolescents. The AP system was associated with a significantly lower average glucose based on continuous glucose monitor data: 161 ± 29.9 vs 176.8 ± 36.5 mg/dL; P = .023. There were no differences between groups for hypoglycemia exposure or carbohydrate interventions. There were no adverse events. Conclusions The use of the Control‐IQ AP improved glycemic control and safely reduced exposure to hyperglycemia relative to RM‐SAP in pediatric patients with T1D during prolonged intensive winter sport activities.

In this randomized study, patients undergoing intensive therapy for type 1 diabetes mellitus who had glycated hemoglobin levels of 7.0 to 10.0% were stratified into three prespecified age groups and were assigned to receive continuous glucose monitoring or usual monitoring. The primary outcome was the change in glycated hemoglobin levels after 26 weeks. Continuous glucose monitoring was associated with improved glycemic control in adults but not in children and adolescents with type 1 diabetes. Continuous glucose monitoring was associated with improved glycemic control in adults but not in children and adolescents with type 1 diabetes. Despite the increased use of insulin pumps and multiple-injection regimens and the introduction of insulin analogues, intensive treatment of type 1 diabetes mellitus often does not achieve the target glycated hemoglobin levels recommended by the Diabetes Control and Complications Trial (DCCT) more than 15 years ago. 1 Although self-monitoring of blood glucose plays an important role in achieving target glycated hemoglobin levels, few patients with type 1 diabetes measure glucose levels after meals or overnight. Consequently, postprandial hyperglycemia and asymptomatic nocturnal hypoglycemia are commonly seen, even in patients with well-controlled type 1 diabetes who measure blood glucose several times daily with . . .

As the increasing prevalence of type 2 diabetes mellitus has put pressure on health systems to appropriately manage these patients, there have been a growing number of mobile apps designed to improve the self-management of diabetes. One such app, BlueStar, has been shown to significantly reduce hemoglobin A (HbA ) levels in small studies and is the first app in the United States to receive Food and Drug Administration approval as a mobile prescription therapy. However, the impact of the app across real-world population among different clinical sites and health systems remains unclear. The primary objective of this study was to conduct a pragmatic randomized controlled trial of the BlueStar mobile app to determine if app usage leads to improved HbA levels among diverse participants in real-life clinical contexts. We hypothesized that this mobile app would improve self-management and HbA levels compared with controls. The study consisted of a multicenter pragmatic randomized controlled trial. Overall, 110 participants randomized to the immediate treatment group (ITG) received the intervention for 6 months, and 113 participants randomized to the wait-list control (WLC) group received usual care for the first 3 months and then received the intervention for 3 months. The primary outcome was glucose control measured by HbA levels at 3 months. Secondary outcomes assessed intervention impact on patient self-management, experience of care, and self-reported health utilization using validated scales, including the Problem Areas in Diabetes, the Summary of Diabetes Self-Care Activities, and the EuroQol-5D. Intervention usage data were collected directly from the app. The results of an analysis of covariance controlling for baseline HbA levels did not show evidence of intervention impact on HbA levels at 3 months (mean difference [ITG-WLC] -0.42, 95% CI -1.05 to 0.21; P=.19). Similarly, there was no intervention effect on secondary outcomes measuring diabetes self-efficacy, quality of life, and health care utilization behaviors. An exploratory analysis of 57 ITG participants investigating the impact of app usage on HbA levels showed that each additional day of app use corresponded with a 0.016-point decrease in participants' 3-month HbA levels (95% CI -0.03 to -0.003). App usage varied significantly by site, as participants from 1 site logged in to the app a median of 36 days over 14 weeks (interquartile range [IQR] 10.5-124); those at another site used the app significantly less (median 9; IQR 6-51). The results showed no difference between intervention and control arms for the primary clinical outcome of glycemic control measured by HbA levels. Although there was low usage of the app among participants, results indicate contextual factors, particularly site, had a significant impact on overall usage. Future research into the patient and site-specific factors that increase app utilization are needed. Clinicaltrials.gov NCT02813343; https://clinicaltrials.gov/ct2/show/NCT02813343 (Archived by WebCite at https://clinicaltrials.gov/ct2/show/NCT02813343).

Objective. To evaluate patterns of continuous glucose monitor (CGM) use and perceptions of quality of life in adolescents/young adults with type 1 diabetes (T1D) after using CGM for up to 52 weeks in the CGM Intervention in Teens and Young (CITY) Adults randomized clinical trial (RCT). Subjects and Methods. Participants with T1D were initially randomized 1 : 1 to use of CGM or blood glucose meter (BGM) for 26 weeks. Following the RCT, participants in the BGM group initiated CGM (BGM–CGM cohort) and participants in the CGM group continued CGM (CGM–CGM cohort) for another 26 weeks. Problem Areas in Diabetes Survey-Pediatric Version (PAID-peds), Glucose Monitoring Satisfaction Survey (GMSS), Hypoglycemia Confidence Scale (HCS), Diabetes Technology Attitudes (DTA), Pittsburgh Sleep Quality Index (PSQI), Benefits of CGM, and Burdens of CGM were completed at baseline, 26 and 52 weeks. Results. In both cohorts, >70% of participants were wearing CGM > 5 days/week at 52 weeks; 5% discontinued CGM. The majority used the mobile app to receive glucose data. Adolescents (14 to <19 years) were more likely to use SHARE features than young adults (80% versus 41%). CGM–CGM participants had significantly higher scores on GMSS, DTA, and HCS at 52 weeks compared with baseline, and reported higher benefit and lower burden perceptions than at baseline. Similar results were observed for the BGM–CGM cohort. Conclusions. Improvements in self-reported measures were observed in adolescents and young adults using CGM. As CGM use is also associated with better glycemic control, utilizing CGM may contribute to improving both medical outcomes and emotional health.

ObjectiveTo determine accuracy, safety and acceptability of the FreeStyle Libre Flash Glucose Monitoring System in the paediatric population.Design, setting and patientsEighty-nine study participants, aged 4–17 years, with type 1 diabetes were enrolled across 9 diabetes centres in the UK. A factory calibrated sensor was inserted on the back of the upper arm and used for up to 14 days. Sensor glucose measurements were compared with capillary blood glucose (BG) measurements. Sensor results were masked to participants.ResultsClinical accuracy of sensor results versus BG results was demonstrated, with 83.8% of results in zone A and 99.4% of results in zones A and B of the consensus error grid. Overall mean absolute relative difference (MARD) was 13.9%. Sensor accuracy was unaffected by patient factors such as age, body weight, sex, method of insulin administration or time of use (day vs night). Participants were in the target glucose range (3.9–10.0 mmol/L) ∼50% of the time (mean 12.1 hours/day), with an average of 2.2 hours/day and 9.5 hours/day in hypoglycaemia and hyperglycaemia, respectively. Sensor application, wear/use of the device and comparison to self-monitoring of blood glucose were rated favourably by most participants/caregivers (84.3–100%). Five device related adverse events were reported across a range of participant ages.ConclusionsAccuracy, safety and user acceptability of the FreeStyle Libre System were demonstrated for the paediatric population. Accuracy of the system was unaffected by subject characteristics, making it suitable for a broad range of children and young people with diabetes.Trial registration numberNCT02388815.

Abstract Context Omnipod DASH Insulin Management System is a tubeless insulin pump that overcomes the physical inconveniences of conventional tubed insulin pump therapy (IPT). Objective We compared treatment satisfaction with Omnipod DASH System to usual care (multiple daily injections [MDIs] or tubed IPT) in adults with type 1 diabetes using self-monitoring blood glucose (SMBG). Methods Adults with type 1 diabetes on MDI (n = 40) or IPT (n = 25) from 4 diabetes centers in Australia were randomly assigned in a 1:1 nonblinded manner to Omnipod DASH System (Omnipod group) or continue usual care (Usual Care group) for 12 weeks, followed by a further 12-week extension during which all participants used the device. The primary outcome was treatment satisfaction assessed by change in Diabetes Technology Questionnaire “current” (ΔDTQ-current) score at 12 weeks (study end). Secondary outcomes included ΔDTQ-current following extension and other participant-reported outcomes (PROs) measuring quality of life, burden of disease treatment, and glycemic and device-related outcomes at 12 weeks (study end) and 24 weeks (end extension). Results Treatment satisfaction improved more in the Omnipod group vs the Usual Care group (ΔDTQ-current score of 16.4 [21.2] vs 0.0 [12.8]; P < .001) at study end. Significantly greater improvements in other PROs and glycated hemoglobin A1c were also observed. Improvements in DTQ-current and other PROs comparing study end and end extension were similar. While percentage in time in range change from baseline did not differ at study end (−2.0 [12.7] %), it was significantly greater at end extension (5.6 [10.9] %; P = .016). Conclusion The Omnipod DASH System resulted in greater treatment satisfaction at 12 weeks in adults with type 1 diabetes using SMBG that was sustained after 24 weeks of device use without compromising sleep quality and fear of hypoglycemia. Improvements in glycemia were also observed.

Aims/Introduction There is potential for mobile applications to deliver new self‐management interventions for chronic disease, especially in diabetes. The aim of the present study was to evaluate the effects of a mobile phone application (MPA) combined with or without self‐monitoring of blood glucose (SMBG) on glycemic control in patients with diabetes. Materials and Methods The study was a 24‐week period, four‐arm parallel group, non‐blinded, randomized trial. A total of 185 patients with mean age of 52 years were randomized to group A (no MPA and no SMBG), group B (SMBG only), group C (MPA only) and group D (both MPA and SMBG were used). Changes in glycated hemoglobin (HbA1c), fasting plasma glucose and 1,5‐anhydroglucitol from baseline to week 24 were analyzed. Results At 24 weeks, the HbA1c levels in patients of all groups decreased significantly from baseline. There were significant differences in the proportions of patients that achieved HbA1c <7% between groups, especially in group C and group D, compared with group A at week 24 (60.4%, 62.2% vs 25.5%, all P < 0.05). 1,5‐Anhydroglucitol changes were obvious in group A and group C at week 24 from baseline (all P < 0.05 within groups). Factorial analysis of anova showed that MPA intervention was the main effective factor for HbA1c change (F = 4.59, P = 0.034), and there was no effect on HbA1c change for SMBG intervention (P = 0.975). Conclusions Implementation of the MPA, Diabetes‐Carer, is effective in improving the proportion of HbA1c <7% in patients with type 2 diabetes. Mobile applications have the potential to deliver new self‐management interventions for diabetes. In this randomized controlled trial, we confirmed that the implementation of the mobile phone application, Diabetes‐Carer, is effective in improving the proportion of glycated hemoglobin (<7%) in type 2 diabetes patients.