G6 continuous glucose monitoring system feature use and its associations with glycaemia in Europe.

AIMS: Current continuous glucose monitoring (CGM) devices provide features that alert individuals with diabetes about their current and impending adverse glycaemic events. The use of these features has been associated with glycaemic improvements. However, how these features are utilised under real-world conditions has not been well studied. We queried a large database to quantify utilisation of the Dexcom G6 system features and how utilisation impacted glycaemic outcomes within a cohort of European users. METHODS: This 6-month retrospective, observational, large database analysis utilised anonymised data from a sample of 47,784 Europe-based G6 users. Primary outcome measures were associations between utilisation and customisation of High/Low threshold alerts, 'urgent low soon' (ULS) alert, and established CGM metrics. RESULTS: Users in the Germany, Austria, Switzerland region (n = 20,257), the Nordic countries (n = 10,314), United Kingdom (n = 9006), Italy (n = 4747), France (n = 2130) and Spain (1330) were included. All alert features were utilised by >75% of the cohort across all regions/countries and age groups. Enabling the Low alert and ULS alert was associated with lower percentage of time below range compared to disabling the Low alert (p < 0.001). Enabling the High alert was associated with higher percentage of time in range (%TIR) and lower percentage of time above range (%TAR) %TAR compared to disabling the High alert (p < 0.001). Paediatric patients and older adults tended to set a higher threshold for High/Low alerts, while younger adults tended to use lower threshold values for High/Low alerts. CONCLUSIONS: Individuals who utilised the Dexcom G6 features showed better glycaemic control, particularly among those who utilised more sensitive High alert and Low alert settings, than users who did not utilise the system features.

Improved Glycemic Control Following Transition to Tubeless Insulin Pump Therapy in Adults With Type 1 Diabetes.

Continuous subcutaneous insulin infusion (CSII) treatment may improve long-term glycemic outcomes and enhance quality of life compared with a multiple daily injection (MDI) insulin regimen for people with type 1 diabetes. As the number of people treated with CSII via a tubeless insulin pump is increasing, there is growing interest in the long-term glycemic outcomes of this treatment option across diverse populations. This multicenter, retrospective study evaluated glycemic control in 156 adults with type 1 diabetes initiating tubeless insulin pump therapy following transition from either MDI or CSII with a tubed insulin pump. In this study, use of the tubeless insulin pump over 12 months was associated with significant improvement in A1C in adults with type 1 diabetes, most notably in those with an A1C ≥9.0% and those previously treated with MDI.

Glycemic Outcomes in Adults With Type 2 Diabetes Participating in a Continuous Glucose Monitor-Driven Virtual Diabetes Clinic: Prospective Trial.

BACKGROUND: The Onduo virtual diabetes clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote personalized lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices for intermittent use. OBJECTIVE: This prospective single-arm study evaluated glycemic outcomes associated with participation in the Onduo VDC for 4 months. METHODS: Adults aged ≥18 years with T2D and a baseline glycated hemoglobin (HbA1c) of ≥8% to ≤12% were enrolled from 2 primary care centers from February 2019 to October 2019. Participants were asked to engage at ≥1 time per week with their care team and to participate in a telemedicine consultation with a clinic endocrinologist for diabetes medication review. Participants were asked to use a RT-CGM device and wear six 10-day sensors (total 60 days of sensor wear) intermittently over the course of 4 months. The primary outcome was change in HbA1c at 4 months from baseline. Other endpoints included change in weight and in RT-CGM glycemic metrics, including percent time <70, 70-180, 181-250, and >250 mg/dL. Changes in blood pressure and serum lipids at 4 months were also evaluated. RESULTS: Participants (n=55) were 57.3 (SD 11.6) years of age, body mass index 33.7 (SD 7.2), and 40% (22/55) female. HbA1c decreased significantly by 1.6% (SD 1%; P<.001). When stratified by baseline HbA1c of 8.0% to 9.0% (n=36) and >9.0% (n=19), HbA1c decreased by 1.2% (SD 0.6%; P<.001) and 2.4% (SD 1.3%; P<.001), respectively. Continuous glucose monitoring-measured (n=43) percent time in range (TIR) 70-180 mg/dL increased by 10.2% (SD 20.5%; P=.002), from 65.4% (SD 23.2%) to 75.5% (SD 22.7%), which was equivalent to a mean increase of 2.4 hours TIR per day. Percent time 181-250 mg/dL and >250 mg/dL decreased by 7.2% (SD 15.4; P=.005) and 3.0% (SD 9.4; P=.01), respectively. There was no change in percent time <70 mg/dL. Mean weight decreased by 9.0 lb (SD 10.4; P<.001). Significant improvements were also observed in systolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and triglycerides (P=.04 to P=<.001). CONCLUSIONS: Participants in the Onduo VDC experienced significant improvement in HbA1c, increased TIR, decreased time in hyperglycemia, and no increase in hypoglycemia at 4 months. Improvements in other metabolic health parameters including weight and blood pressure were also observed. In conclusion, the Onduo VDC has potential to support people with T2D and their clinicians between office visits by increasing access to specialty care and advanced diabetes technology including RT-CGM. TRIAL REGISTRATION: ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381.

Impact of Participation in a Virtual Diabetes Clinic on Diabetes-Related Distress in Individuals With Type 2 Diabetes.

The Onduo Virtual Diabetes Clinic is a telehealth program for people with type 2 diabetes that combines mobile app technology, remote personalized lifestyle coaching, connected blood glucose meters, real-time continuous glucose monitoring (rtCGM) devices, and clinical support from board-certified endocrinologists. This analysis evaluated change in diabetes distress among 228 program participants who reported moderate distress (score 2.0-2.9) or high distress (score ≥3.0) on the 17-item Diabetes Distress Scale (DDS17) at enrollment. Participants reported significant reductions in overall distress from 3.0 ± 0.8 at baseline to 2.5 ± 0.9 (P <0.001) at an average of 6 months of follow-up. Significant reductions in all DDS17 subscale scores were observed; most notable were reductions in the regimen-related and emotional distress subscales (-0.9 and -0.4, respectively; both P <0.001). Significantly greater reductions in overall distress (P = 0.012) and regimen-related distress (P <0.001) were reported by participants who were prescribed and used intermittent rtCGM (n = 77) versus nonusers (n = 151). Although the generalizability of these findings may be limited by the study's small sample size and potential for self-selection bias, these results do suggest that telemedicine programs such as the Onduo VDC could be a valuable tool for addressing the problem of diabetes-related distress.

Long-Term Improvements in Glycemic Control with Dexcom CGM Use in Adults with Noninsulin-Treated Type 2 Diabetes.

Aims: The objective of this real-world, observational study was to evaluate change in continuing glucose monitoring (CGM) metrics for 1 year after CGM initiation in adults with noninsulin-treated type 2 diabetes (T2D). Methods: Data were analyzed from Dexcom G6 and G7 users who self-reported: T2D, ≥18 years, gender, no insulin use, and had a baseline percent time in range (TIR) 70-180 mg/dL of ≤70%. Outcomes were change in CGM metrics from baseline to 6 and 12 months overall and for younger (<65 years) and older (≥65 years) cohorts. Additional analyses explored the relationship between use of the high alert feature and change in TIR and time in tight range (TITR) 70-140 mg/dL. Results: CGM users (n = 3,840) were mean (SD) 52.5 (11.2) years, 47.9% female, mean TIR was 41.7% (21.4%), and 12.4% of participants were ≥65 years. Significant improvement in all CGM metrics not meeting target values at baseline was observed at 6 months, with continued improvement at 12 months. Mean baseline TIR increased by 17.3% (32.1%) from 41.7% (21.4%) to 59.0% (28.9%), and mean glucose management indicator decreased by 0.5% (1.2%) from 8.1% (0.9%) to 7.6% (1.1%) (both P < 0.001). Participants who maintained or customized the high alert default setting of 250 mg/dL had a greater increase in TIR and TITR compared with participants who disabled the alert. Days of CGM use over 12 months were high in 84.7% (15.9%). Conclusion: In this large, real-world study of adults with suboptimally controlled T2D not using insulin, Dexcom CGM use was associated with meaningful improvements in glycemic control over 12 months. Use of the high alert system feature was positively associated with glycemic outcomes. High use of CGM over 12 months suggests benefits related to consistent CGM use in this population.

Impact of a Combined Continuous Glucose Monitoring-Digital Health Solution on Glucose Metrics and Self-Management Behavior for Adults With Type 2 Diabetes: Real-World, Observational Study.

BACKGROUND: The BlueStar (Welldoc) digital health solution for people with diabetes incorporates data from multiple devices and generates coaching messages using artificial intelligence. The BlueStar app syncs glucose data from the G6 (Dexcom) real-time continuous glucose monitoring (RT-CGM) system, which provides a glucose measurement every 5 minutes. OBJECTIVE: The objective of this real-world study of people with type 2 diabetes (T2D) using the digital health solution and RT-CGM was to evaluate change in glycemic control and engagement with the program over 3 months. METHODS: Participants were current or former enrollees in an employer-sponsored health plan, were aged 18 years or older, had a T2D diagnosis, and were not using prandial insulin. Outcomes included CGM-based glycemic metrics and engagement with the BlueStar app, including logging medications taken, exercise, food details, blood pressure, weight, and hours of sleep. RESULTS: Participants in the program that met our analysis criteria (n=52) were aged a mean of 53 (SD 9) years; 37% (19/52) were female and approximately 50% (25/52) were taking diabetes medications. The RT-CGM system was worn 90% (SD 8%) of the time over 3 months. Among individuals with suboptimal glycemic control at baseline, defined as mean glucose >180 mg/dL, clinically meaningful improvements in glycemic control were observed, including reductions in a glucose management indicator (-0.8 percentage points), time above range 181-250 mg/dL (-4.4 percentage points) and time above range >250 mg/dL (-14 percentage points; all P<.05). Time in range 70-180 mg/dL also increased by 15 percentage points (P=.016) in this population, which corresponds to an increase of approximately 3.5 hours per day in the target range. Over the 3-month study, 29% (15/52) of participants completed at least one engagement activity per week. Medication logging was completed most often by participants (23/52, 44%) at a rate of 12.1 (SD 0.8) events/week, and this was closely followed by exercise and food logging. CONCLUSIONS: The combination of an artificial intelligence-powered digital health solution and RT-CGM helped people with T2D improve their glycemic outcomes and diabetes self-management behaviors.

Medication Optimization Among People With Type 2 Diabetes Participating in a Continuous Glucose Monitoring-Driven Virtual Care Program: Prospective Study.

BACKGROUND: The Onduo virtual care program for people with type 2 diabetes (T2D) includes a mobile app, remote lifestyle coaching, connected devices, and telemedicine consultations with endocrinologists for medication management and prescription of real-time continuous glucose monitoring (RT-CGM) devices. In a previously described 4-month prospective study of this program, adults with T2D and baseline glycated hemoglobin (HbA1c) ≥8.0% to ≤12.0% experienced a mean HbA1c decrease of 1.6% with no significant increase in hypoglycemia. OBJECTIVE: The objective of this analysis was to evaluate medication optimization and management in the 4-month prospective T2D study. METHODS: Study participants received at least 1 telemedicine consultation with an Onduo endocrinologist for diabetes medication management and used RT-CGM intermittently to guide therapy and dosing. Medication changes were analyzed. RESULTS: Of 55 participants, 48 (87%) had a medication change consisting of a dose change, addition, or discontinuation. Of these, 15 (31%) participants had a net increase in number of diabetes medication classes from baseline. Mean time to first medication change for these participants was 36 days. The percentage of participants taking a glucagon-like peptide-1 receptor agonist increased from 25% (12/48) to 56% (n=27), while the percentages of participants taking a sulfonylurea or dipeptidyl peptidase 4 inhibitor decreased from 56% (n=27) to 33% (n=16) and 17% (n=8) to 6% (n=3), respectively. Prescriptions of other antidiabetic medication classes including insulin did not change significantly. CONCLUSIONS: The Onduo virtual care program can play an important role in providing timely access to guideline-based diabetes management medications and technologies for people with T2D. TRIAL REGISTRATION: ClinicalTrials.gov NCT03865381; https://clinicaltrials.gov/ct2/show/NCT03865381.

Remote Application and Use of Real-Time Continuous Glucose Monitoring by Adults with Type 2 Diabetes in a Virtual Diabetes Clinic.

The Onduo Virtual Diabetes Clinic (VDC) for people with type 2 diabetes (T2D) combines a mobile app, remote lifestyle coaching, connected devices, and live video consultations with board-certified endocrinologists. Adults with T2D (n = 594) who were evaluated by a VDC endocrinologist, remotely prescribed and mailed a real-time continuous glucose monitoring (rtCGM) device and used ≥1 sensor completed a CGM satisfaction questionnaire. The CGM satisfaction score was 4.5 ± 0.8 out of 5. Most respondents (94.7%) agreed/strongly agreed that they were comfortable inserting the sensor remotely and that rtCGM use improved understanding of the impact of eating (97.0%), increased diabetes knowledge (95.7%), and helped improve diabetes control when not wearing the sensor (79.4%). HbA1c (n = 372) decreased from 7.7% ± 1.6% to 7.1% ± 1.2% (P < 0.001; 10.2 months). These data suggest that it is feasible to provide rtCGM directly to individuals with T2D through a VDC without in-office training. Intermittent use of rtCGM was well-received by adults with T2D and was associated with improvement in HbA1c.

A Virtual Type 2 Diabetes Clinic Using Continuous Glucose Monitoring and Endocrinology Visits.

The Onduo Virtual Diabetes Clinic (VDC) telehealth technology/care model for adults with type 2 diabetes (T2D) combines connected devices, remote lifestyle coaching, and clinical support with a mobile App. Key differentiating program features are the availability of live video consultations with board-certified endocrinologists for medication management and real-time continuous glucose monitor use for higher-risk participants. Preliminary data (n = 740) suggest that participation was associated with a significant improvement in HbA1c with up to 6 months follow-up in those not meeting treatment targets. HbA1c decreased by 2.3% ± 1.9%, 0.7% ± 1.0%, and 0.2% ± 0.8% across baseline categories of >9.0%, 8.0%-9.0% and 7.0% to <8.0%, respectively (all P < .001). These findings suggest that the VDC has potential to support individuals with T2D and their clinicians in diabetes management between office visits.

Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions.

Background: The objective of this study was to assess the safety and performance of the Omnipod® personalized model predictive control (MPC) algorithm in adults, adolescents, and children aged ≥6 years with type 1 diabetes (T1D) under free-living conditions using an investigational device. Materials and Methods: A 96-h hybrid closed-loop (HCL) study was conducted in a supervised hotel/rental home setting following a 7-day outpatient standard therapy (ST) phase. Eligible participants were aged 6-65 years with A1C <10.0% using insulin pump therapy or multiple daily injections. Meals during HCL were unrestricted, with boluses administered per usual routine. There was daily physical activity. The primary endpoints were percentage of time with sensor glucose <70 and ≥250 mg/dL. Results: Participants were 11 adults, 10 adolescents, and 15 children aged (mean ± standard deviation) 28.8 ± 7.9, 14.3 ± 1.3, and 9.9 ± 1.0 years, respectively. Percentage time ≥250 mg/dL during HCL was 4.5% ± 4.2%, 3.5% ± 5.0%, and 8.6% ± 8.8% per respective age group, a 1.6-, 3.4-, and 2.0-fold reduction compared to ST (P = 0.1, P = 0.02, and P = 0.03). Percentage time <70 mg/dL during HCL was 1.9% ± 1.3%, 2.5% ± 2.0%, and 2.2% ± 1.9%, a statistically significant decrease in adults when compared to ST (P = 0.005, P = 0.3, and P = 0.3). Percentage time 70-180 mg/dL increased during HCL compared to ST, reaching significance for adolescents and children: HCL 73.7% ± 7.5% vs. ST 68.0% ± 15.6% for adults (P = 0.08), HCL 79.0% ± 12.6% vs. ST 60.6% ± 13.4% for adolescents (P = 0.01), and HCL 69.2% ± 13.5% vs. ST 54.9% ± 12.9% for children (P = 0.003). Conclusions: The Omnipod personalized MPC algorithm was safe and performed well over 5 days and 4 nights of use by a cohort of participants ranging from youth aged ≥6 years to adults with T1D under supervised free-living conditions with challenges, including daily physical activity and unrestricted meals.

Novel Bluetooth-Enabled Tubeless Insulin Pump: Innovating Pump Therapy for Patients in the Digital Age.

The Omnipod DASH™ Insulin Management System (Insulet Corp, Billerica, MA) is a discreet, tubeless, wearable insulin pump that holds up to 200 units of U-100 insulin and delivers therapy through customizable basal rates and bolus amounts. This recently FDA-cleared system consists of the insulin pump ("Pod"), which is worn on body and delivers insulin, and the Personal Diabetes Manager (PDM), which is a handheld device used to wirelessly control and monitor the Pod functionality. The PDM can also be paired with the CONTOUR® NEXT ONE blood glucose (BG) meter (Ascensia Diabetes Care, Basel, Switzerland) to wirelessly receive BG readings. This review provides a detailed description of the Pod and PDM. Key features of the Pod are described, including the novel pump delivery mechanism, waterproof (IP28) housing design, and automated cannula insertion. The technology introduced in the new system, such as touchscreen PDM interface, Bluetooth® wireless technology, and wireless internet connectivity, is also presented. Last, Omnipod® Insulin Management System clinical data are reviewed, including early feasibility results for the Omnipod Horizon™ Automated Glucose Control hybrid closed-loop system.

Performance of Omnipod Personalized Model Predictive Control Algorithm with Moderate Intensity Exercise in Adults with Type 1 Diabetes.

Background: The objective of this study was to assess the safety and performance of the Omnipod® personalized model predictive control (MPC) algorithm with variable glucose setpoints and moderate intensity exercise using an investigational device in adults with type 1 diabetes (T1D). Materials and Methods: A supervised 54-h hybrid closed-loop (HCL) study was conducted in a hotel setting after a 7-day outpatient standard treatment phase. Adults aged 18-65 years with T1D and HbA1c between 6.0% and 10.0% were eligible. Subjects completed two moderate intensity exercise sessions of >30 min duration on consecutive days: the first with the glucose set point increased from 130 to 150 mg/dL and the second with a temporary basal rate of 50%, both started 90 min pre-exercise. Primary endpoints were percentage time in hypoglycemia <70 mg/dL and hyperglycemia ≥250 mg/dL. Results: Twelve subjects participated in the study, with (mean ± standard deviation) age 36.5 ± 14.4 years, diabetes duration 21.7 ± 15.7 years, HbA1c 7.6% ± 1.1%, and total daily dose 0.60 ± 0.22 U/kg. Outcomes for the 54-h HCL period were mean glucose: 136 ± 14 mg/dL, percentage time <70 mg/dL: 1.4% ± 1.3%, 70-180 mg/dL: 85.1% ± 9.3%, and ≥250 mg/dL: 1.8% ± 2.4%. In the 12-h period after exercise start, percentage time <70 mg/dL was 1.4% ± 2.7% with the raised glucose set point and 1.6% ± 3.0% with reduced basal rate. The percentage time <70 mg/dL overnight was 0% ± 0% on both study nights. Conclusions: The Omnipod personalized MPC algorithm performed well and was safe during day and night use in response to variable glucose set points and with temporarily raised glucose set point or reduced basal rate 90 min in advance of moderate intensity exercise in adults with T1D.

Resistance training and timed essential amino acids protect against the loss of muscle mass and strength during 28 days of bed rest and energy deficit.

Spaceflight and bed rest (BR) result in losses of muscle mass and strength. Resistance training (RT) and amino acid (AA) supplementation are potential countermeasures to minimize these losses. However, it is unknown if timing of supplementation with exercise can optimize benefits, particularly with energy deficit. We examined the effect of these countermeasures on body composition, strength, and insulin levels in 31 men (ages 31-55 yr) during BR (28 days) followed by active recovery (14 days). Subjects were randomly assigned to essential AA supplementation (AA group, n = 7); RT with AA given 3 h after training (RT group, n = 12); or RT with AA given 5 min before training (AART group, n = 12). Energy intake was reduced by 8 +/- 6%. Midthigh muscle area declined with BR for the AA > RT > AART groups: -11%, -3%, -4% (P = 0.05). Similarly, greatest losses in lower body muscle strength were seen in the AA group (-22%). These were attenuated in the exercising groups [RT (-8%) and AART (-6%; P < 0.05)]. Fat mass and midthigh intramuscular fat increased after BR in the AA group (+3% and +14%, respectively), and decreased in the RT (-5% and -4%) and AART groups (-1 and -5%; P = 0.05). Muscle mass and strength returned toward baseline after recovery, but the AA group showed the lowest regains. Combined resistance training with AA supplementation pre- or postexercise attenuated the losses in muscle mass and strength by approximately two-thirds compared with AA supplement alone during BR and energy deficit. These data support the efficacy of combined AA and RT as a countermeasure against muscle wasting due to low gravity.

In Silico Modeling of Minimal Effective Insulin Doses Using the UVA/PADOVA Type 1 Diabetes Simulator.

BACKGROUND: The objective of this study was to identify the minimum basal insulin infusion rates and bolus insulin doses that would result in clinically relevant changes in blood glucose levels in the most insulin sensitive subjects with type 1 diabetes. METHODS: The UVA/PADOVA Type 1 Diabetes Simulator in silico population of children, adolescents, and adults was administered a basal insulin infusion rate to maintain blood glucose concentrations at 120 mg/dL (6.7 mmol/L). Two scenarios were modeled independently after 1 hour of simulated time: (1) basal insulin infusion rates in increments of 0.01 U/h were administered and (2) bolus doses in increments of 0.01 U were injected. Subjects were observed for 4 hours to determine insulin delivery required to change blood glucose by 12.5 mg/dL (0.7 mmol/L) and 25 mg/dL (1.4 mmol/L) in only 5% of the in silico population. RESULTS: The basal insulin infusion rates required to change blood glucose by 12.5 mg/dL and 25 mg/dL in 5% of children, adolescents, and adults were 0.03, 0.11, and 0.10 U/h and 0.06, 0.21, and 0.19 U/h, respectively. The bolus insulin doses required to change blood glucose by the target amounts in the respective populations were 0.10, 0.28, and 0.30 U and 0.19, 0.55, and 0.60 U. CONCLUSIONS: In silico modeling suggests that only a very small percentage of individuals with type 1 diabetes, corresponding to children with high insulin sensitivity and low body weight, will exhibit a clinically relevant change in blood glucose with very low basal insulin rate changes or bolus doses.

Safety and Feasibility of the OmniPod Hybrid Closed-Loop System in Adult, Adolescent, and Pediatric Patients with Type 1 Diabetes Using a Personalized Model Predictive Control Algorithm.

BACKGROUND: The safety and feasibility of the OmniPod personalized model predictive control (MPC) algorithm in adult, adolescent, and pediatric patients with type 1 diabetes were investigated. METHODS: This multicenter, observational trial included a 1-week outpatient sensor-augmented pump open-loop phase and a 36-h inpatient hybrid closed-loop (HCL) phase with announced meals ranging from 30 to 90 g of carbohydrates and limited physical activity. Patients aged 6-65 years with HbA1c between 6.0% and 10.0% were eligible. The investigational system included a modified version of OmniPod, the Dexcom G4 505 Share® AP System, and the personalized MPC algorithm running on a tablet computer. Primary endpoints included sensor glucose percentage of time in hypoglycemia <70 mg/dL and hyperglycemia >250 mg/dL. Additional glycemic targets were assessed. RESULTS: The percentage of time <70 mg/dL during the 36-h HCL phase was mean (standard deviation): 0.7 (1.7) in adults receiving 80% meal bolus (n = 24), and 0.7 (1.2) in adults (n = 10), 2.0 (2.4) in adolescents (n = 12), and 2.0 (2.6) in pediatrics (n = 12) receiving 100% meal bolus. The overall hypoglycemia rate was 0.49 events/24 h. The percentage of time >250 mg/dL was 8.0 (7.5), 3.6 (3.7), 4.9 (6.3), and 6.7 (5.6) in the study groups, respectively. Percentage of time in the target range of 70-180 mg/dL was 69.5 (14.4), 73.0 (15.0), 72.6 (15.5), and 70.1 (12.3), respectively. CONCLUSIONS: The OmniPod personalized MPC algorithm performed well and was safe during day and night use in adult, adolescent, and pediatric patients with type 1 diabetes. Longer term studies will assess the safety and performance of the algorithm under free living conditions with extended use.

Performance of the Omnipod Personalized Model Predictive Control Algorithm with Meal Bolus Challenges in Adults with Type 1 Diabetes.

BACKGROUND: This study assessed the safety and performance of the Omnipod® personalized model predictive control (MPC) algorithm using an investigational device in adults with type 1 diabetes in response to overestimated and missed meal boluses and extended boluses for high-fat meals. MATERIALS AND METHODS: A supervised 54-h hybrid closed-loop (HCL) study was conducted in a hotel setting after a 7-day outpatient open-loop run-in phase. Adults aged 18-65 years with type 1 diabetes and HbA1c 6.0%-10.0% were eligible. Primary endpoints were percentage time in hypoglycemia <70 mg/dL and hyperglycemia ≥250 mg/dL. Glycemic responses for 4 h to a 130% overestimated bolus and a missed meal bolus were compared with a 100% bolus for identical meals, respectively. The 12-h postprandial responses to a high-fat meal were compared using either a standard or extended bolus. RESULTS: Twelve subjects participated in the study, with (mean ± standard deviation): age 35.4 ± 14.1 years, diabetes duration 16.5 ± 9.3 years, HbA1c 7.7 ± 0.9%, and total daily dose 0.58 ± 0.19 U/kg. Outcomes for the 54-h HCL period were mean glucose 153 ± 15 mg/dL, percentage time <70 mg/dL [median (interquartile range)]: 0.0% (0.0-1.2%), 70-180 mg/dL: 76.1% ± 8.0%, and ≥250 mg/dL: 4.5% ± 3.6%. After both the 100% and 130% boluses, postprandial percentage time <70 mg/dL was 0.0% (0.0-0.0%) (P = 0.50). After the 100% and missed boluses, postprandial percentage time ≥250 mg/dL was 0.2% ± 0.6% and 10.3% ± 16.5%, respectively (P = 0.06). Postprandial percentages time ≥250 mg/dL and <70 mg/dL were similar with standard or extended boluses for a high-fat meal. CONCLUSIONS: The Omnipod personalized MPC algorithm performed well and was safe during day and night use in response to overestimated, missed, and extended meal boluses in adults with type 1 diabetes.

Skeletal muscle sodium glucose co-transporters in older adults with type 2 diabetes undergoing resistance training.

We examined the expression of the sodium-dependent glucose co-transporter system (hSGLT3) in skeletal muscle of Hispanic older adults with type 2 diabetes. Subjects (65+/-8 yr) were randomized to resistance training (3x/wk, n=13) or standard of care (controls, n=5) for 16 weeks. Skeletal muscle hSGLT3 and GLUT4 mRNA transcript levels were determined by real time RT-PCR. hSGLT3 transcripts increased by a factor of ten following resistance training compared to control subjects (0.10, P=0.03). There were no differences in GLUT4 mRNA expression levels between groups. Protein expression levels of these transporters were confirmed by immunohistochemistry and Western blotting. hSGLT3 after resistance exercise was found not to be co-localized with the nicotinic acetylcholine receptor. The change in hSGLT3 transcript levels in the vastus lateralis muscle was positively correlated with glucose uptake, as measured by the change in muscle glycogen stores (r=0.53, P=0.02); and with exercise intensity, as measured by the change in muscle strength (r=0.73, P=0.001). Group assignment was be the only independent predictor of hSGLT3 transcript levels, explaining 68% of its variability (P=0.01). Our data show that hSGLT3, but not GLTU4, expression was enhanced in skeletal muscle after 16 weeks of resistance training. This finding suggests that hSGLT3, an insulin-independent glucose transporter, is activated with exercise and it may play a significant role in glycemic control with muscle contraction. The hSGLT3 exact mechanism is not well understood and requires further investigation. However its functional significance regarding a reduction of glucose toxicity and improvement of insulin resistance is the subject of ongoing research.

Strength training improves muscle quality and insulin sensitivity in Hispanic older adults with type 2 diabetes.

Hispanics are at increased risk of morbidity and mortality due to their high prevalence of diabetes and poor glycemic control. Strength training is the most effective lifestyle intervention to increase muscle mass but limited data is available in older adults with diabetes. We determined the influence of strength training on muscle quality (strength per unit of muscle mass), skeletal muscle fiber hypertrophy, and metabolic control including insulin resistance (Homeostasis Model Assessment -HOMA-IR), C-Reactive Protein (CRP), adiponectin and Free Fatty Acid (FFA) levels in Hispanic older adults. Sixty-two community-dwelling Hispanics (>55 y) with type 2 diabetes were randomized to 16 weeks of strength training plus standard care (ST group) or standard care alone (CON group). Skeletal muscle biopsies and biochemical measures were taken at baseline and 16 weeks. The ST group show improved muscle quality (mean+/-SE: 28+/-3) vs CON (-4+/-2, p<0.001) and increased type I (860+/-252 microm(2)) and type II fiber cross-sectional area (720+/-285 microm(2)) compared to CON (type I: -164+/-290 microm(2), p=0.04; and type II: -130+/-336 microm(2), p=0.04). This was accompanied by reduced insulin resistance [ST: median (interquartile range) -0.7(3.6) vs CON: 0.8(3.8), p=0.05]; FFA (ST: -84+/-30 micromol/L vs CON: 149+/-48 micromol/L, p=0.02); and CRP [ST: -1.3(2.9) mg/L vs CON: 0.4(2.3) mg/L, p=0.05]. Serum adiponectin increased with ST [1.0(1.8) microg/mL] compared to CON [-1.2(2.2) microg/mL, p<0.001]. Strength training improved muscle quality and whole-body insulin sensitivity. Decreased inflammation and increased adiponectin levels were related with improved metabolic control. Further studies are needed to understand the mechanisms associated with these findings. However, these data show that strength training is an exercise modality to consider as an adjunct of standard of care in high risk populations with type 2 diabetes.

Efficacy of the Omnipod Insulin Management System on Glycemic Control in Patients With Type 1 Diabetes Previously Treated With Multiple Daily Injections or Continuous Subcutaneous Insulin Infusion.

BACKGROUND: Continuous subcutaneous insulin infusion (CSII) treatment with a tubeless patch pump has not been previously evaluated in a large cohort of patients. METHODS: This multisite, retrospective study evaluated glycemic control in patients with type 1 diabetes (n = 873) after 3 months treatment the Omnipod(®) insulin management system (Insulet Corporation, Billerica, MA) compared to prior treatment with multiple daily injections (MDI) (78.1%) or CSII (21.9%). The primary outcome was change in HbA1c from baseline at 3 months post-Omnipod treatment initiation. Secondary outcomes included shifts in HbA1c to target levels, change in total daily dose (TDD) of insulin and in the frequency and severity of hypoglycemic episodes. RESULTS: HbA1c was significantly improved at 3 months post-Omnipod treatment for the total population (mean ± SD): -0.6% ± 1.3 (P < .001). HbA1c was also significantly lower compared to MDI: -0.3% ± 1.3, -0.4% ± 1.4, -0.8% ± 1.3 and -0.6% ± 1.3 (P = .002 to P < .001) and CSII: -0.3% ± 0.8, -1.1% ± 1.6 (P < .01), -0.4% ± 1.1 (P < .001), and -0.5% ± 1.1 (P < .001) for pediatric, adolescent, adult, and total populations, respectively. There was a 37.9% change increase in the proportion of patients ≥18 years and a 39.3% change increase in those <18 years achieving ADA treatment targets (P = .004 to P < .001). There was a 16.4% change decrease in TDD of insulin at 3 months for the total population (P < .001). The frequency of self-reported hypoglycemia decreased significantly (P < .001) by 1.0 ± 2.4 episodes per week. CONCLUSIONS: Treatment with the Omnipod insulin management system was associated with clinically meaningful and statistically significant improvement in glycemic control, reduction in daily insulin requirement and reduction in the frequency and severity of hypoglycemic episodes.

Impact of the Omnipod® Insulin Management System on Quality of Life: A Survey of Current Users.

BACKGROUND: Few recent studies have examined the impact of continuous subcutaneous insulin infusion systems on patient-reported quality of life (QOL). We explored QOL changes resulting from treatment with the Omnipod® Insulin Management System (Insulet Corp., Billerica, MA). METHODS: One thousand two hundred forty-five adults (>18 years) with type 1 diabetes and current Omnipod users completed an online questionnaire examining perceived changes in QOL and glycemic control since Omnipod initiation. The QOL dimensions included overall well-being (World Health Organization-5, modified to examine changes retrospectively), diabetes distress (Type 1 Diabetes Distress Scale, current distress and a modified retrospective version), and psychosocial impact (two subscales from the Diabetes Technology Impact Measure, perceived control over diabetes, and hypoglycemic safety). Regression analyses examined associations between demographics, key psychological factors, and perceived change in glycemic control with the QOL dimensions. RESULTS: Broad QOL and clinical benefits associated with Omnipod use were common. The majority reported positive changes in the following: overall well-being (53.5%), perceived control over diabetes (72.5%), hypoglycemic safety (50.6%), and diabetes distress (69.6%). Worsening in any of these areas was uncommon. In addition, 64.2% of patients reported glycemic improvement post-Omnipod initiation, while 35.2% reported a decrease in severe hypoglycemic episodes. Trust in one's Omnipod, perceived improvement in glycemic control, and reductions in severe hypoglycemia independently predicted benefits in all QOL measures (all P < 0.001). CONCLUSIONS: These findings suggest that Omnipod users perceived substantial QOL benefits from the device; benefits are more apparent in those who trust the device and have noted positive changes in glycemic control.