Aims
Regional variations in the adoption of diabetes technology may be reflected in population‐level metrics of glycaemic control. In this observational study, we aimed to assess the glycaemic ...impacts of transitioning from the Dexcom G5 Real‐Time Continuous Glucose Monitoring (RT‐CGM) System to the Dexcom G6 in three European countries.
Methods
Anonymised RT‐CGM data (uploaded to the Dexcom Clarity app) were from users in Germany, Sweden, and the United Kingdom (UK) who transitioned from G5 to G6 between 9‐12 months after G6 launched in 2018. Primary endpoints were percent time in hypoglycaemia, percent time in range (TIR), user retention rates, device utilisation, and urgent low soon (ULS) alert utilisation. Metrics were computed for 3‐month intervals in the 2‐year study window.
Results
In all three countries, the transition from G5 to G6 was associated with a clear decrease in hypoglycaemia. In months 0‐3 after transitioning, the median percent time 〈3 mmol/L (54 mg/dL) and 〈3.9 mmol/L (70 mg/dL) decreased by 0.12‐0.28 and 0.40‐0.43 percentage points, respectively, with another 0.11‐0.21 and 0.34‐0.65 percentage point decrease in months 3‐6 in the three countries analysed. TIR and CGM utilisation were sustained or improved slightly across all countries. At the end of the study window, the retention rate was 88.8‐94.8% and ULS utilization was 83.9‐86.9% in the three countries analysed.
Conclusions
Similar RT‐CGM trends were observed across Germany, Sweden, and the UK. Improvements in hypoglycaemia occurred in all countries. The high retention of users may lead to sustained glycaemic benefits associated with RT‐CGM use.
We aimed to describe patterns of continuous glucose monitoring (CGM) system use and glycemic outcomes from 2018 to 2020 in a large real-world cohort by analyzing anonymized data from US-based CGM ...users who transitioned from the G5 to the G6 System (Dexcom) in 2018. The main end points were persistent use, within-day and between-day utilization, hypoglycemia, time in range (TIR, 70-180 mg/dL 3.9-10 mmol/L), and use of the optional calibration feature in 2019 and 2020. In a cohort of 31,034 individuals, rates of persistent use were high, with 27,932 (90.0%) and 26,861 (86.6%) continuing to upload data in 2019 and 2020, respectively. Compared with G5 use, G6 use was associated with higher device utilization, less hypoglycemia, higher TIR (in 2020), and >80% fewer calibrations in both 2019 and 2020 (
s < 0.001). High persistence and utilization of the G6 system may contribute to sustainable glycemic outcomes and decreased user burden.
Accuracy and feature sets of continuous glucose monitoring (CGM) systems may influence device utilization and outcomes. We compared clinical trial accuracy and real-world utilization and ...effectiveness of two different CGM systems.
Separately conducted accuracy studies of a fifth-generation and a sixth-generation CGM system involved 50 and 159 adults, respectively. For between-system performance comparisons, propensity score methods were utilized to balance cohort characteristics. Real-world outcomes were assessed in 10,000 anonymized patients who had switched from the fifth-generation to the sixth-generation system and had used connected mobile devices to upload data from both systems, allowing pairwise comparisons of device utilization and glucose concentration distributions.
Propensity score-adjusted mean absolute relative differences for the fifth- and sixth-generation systems were 9.0% and 9.9%, and the percentages of values within ±20%/20 mg/dL were 93.1% and 92.5%, respectively. The sixth-generation system, but not the fifth-generation system, met accuracy criteria for interoperable CGM systems. Both systems had high real-world utilization rates (93.8% and 95.3% in the fifth- and sixth-generation systems, respectively). Use of the sixth-generation system was associated with fewer glucose values <55 mg/dL (<3.1 mmol/L) (0.7% vs. 1.1%, P < 0.001) and more values 70-180 mg/dL (3.9-10.0 mmol/L) (57.3% vs. 56.0%, P < 0.001) than the fifth-generation system.
CGM performance outcomes can be compared through the propensity score analysis of clinical trial data and pairwise comparisons of real-world data. The systems compared here had nearly equivalent accuracy and utilization rates. Longer term biochemical and psychosocial benefits observed with the fifth-generation system are also expected with the sixth-generation system.
Background: Glucose transport from blood to interstitial fluid impacts performance of interstitially-placed continuous glucose monitoring (CGM) sensors. We examined time series offsets (“lag times”) ...of the G7 CGM system (Dexcom) .
Methods: In a pivotal accuracy study conducted in the US, 316 adults with diabetes wearing 6sensors participated in clinic sessions that included glucose manipulations and frequent venous plasma glucose (YSI) determinations. G7 values were obtained every 5 min and interpolated to provide values at 1-min intervals. Each YSI value was associated with 21 G7 values obtained from min before to min after. The absolute relative difference (ARD) was calculated for each YSI:G7 pair and each sensor’s lag was estimated as the time with the lowest mean ARD.
Results: A lag time of 2 minutes provided the lowest mean ARD of 8.6% and the highest %20/20 agreement rate of 94.4%. The Figure shows summary statistics for the distribution of sensor-specific lag times. Lag times of ≤0 min (where interstitial glucose leads blood glucose) were observed for 2 (33.0%) of the sensors.
Conclusions: The distribution of G7 time series offsets suggests that CGM values may most accurately reflect previous or upcoming blood glucose values. This finding is likely due to technological innovations in G7’s hardware and algorithm. The minimal lag time observed should provide users with confidence in using CGM to manage their diabetes.
Disclosure
X.Zhang: Employee; Dexcom, Inc. J.L.Reid: Employee; Dexcom, Inc., GenMark Diagnostics. T.C.Walker: Employee; Dexcom, Inc., Stock/Shareholder; Dexcom, Inc. J.Welsh: Employee; Dexcom, Inc. A.Balo: Employee; Dexcom, Inc.
Funding
Dexcom, Inc.
Real-time continuous glucose monitoring (RT-CGM) is superior to blood glucose monitoring (BGM) for adults with insulin-treated type 2 diabetes (T2D); however, the utility of C-peptide levels for ...predicting the magnitude of the glycemic benefits is controversial. Data were from a subset of 147 participants in the MOBILE study who were treated with basal-only insulin and who had baseline C-peptide levels ≥0.5 ng/mL. Participants were randomized to treatment with either RT-CGM (
= 100) or BGM (
= 47). Between-group differences in hemoglobin A1c (HbA1c) and time in range (TIR) changes were assessed. The between-group difference in HbA1c favored the RT-CGM group (by 0.58 percentage points,
= 0.004 at 3 months and by 0.42 percentage points,
= 0.04 at 8 months). TIR was 16% higher, and time >180 mg/dL was 16% lower, in the RT-CGM group at 8 months (
= 0.002 for each). In T2D managed with basal insulin, RT-CGM benefits occur for those with residual insulin secretory capacity. Clinical Trial Identifier: NCT03566693.
Real-time continuous glucose monitoring (CGM) systems allow users to take immediate action based on current glucose and its trajectory; retrospective review of CGM data permits behavior modification ...according to historic trends. Dexcom CGM Systems allow for data to be uploaded automatically into Dexcom CLARITY for retrospective review. CLARITY mobile app users can also engage with their recent data by setting goals for time in range (TIR; 70-180 mg/dL) and opting to receive push notifications when TIR goals are met. We evaluated the associations between CLARITY engagement and glycemic metrics. Anonymized data uploaded in September 2020 by a convenience sample of 25,000 US-based users of the G6 CGM System (Dexcom, Inc., San Diego, CA) were assessed. Users were stratified by those who engaged with CLARITY never, at least once, or every day in September 2020. Utilization was calculated as the number of sensor glucose values over the number of total possible sensor glucose values for days with ≥1 glucose value. CGM-derived glycemic metrics are shown in the Table. Increased CLARITY engagement was associated with lower mean glucose and higher TIR, mainly attributable to less hyperglycemia. Hypoglycemia exposure was consistently low and did not depend on the extent of CLARITY engagement. Frequent retrospective CGM data review may motivate behaviors that result in improved glycemic control.
Background: Children and adolescents with diabetes may use data from continuous glucose monitoring (CGM) in management decisions and may share it in real time with others involved in their care. CGM ...systems from Dexcom (San Diego, CA) allow real-time sharing with up to 5 remote “Followers.” We explored associations between the presence of Follower(s), device utilization, and glycemic parameters.
Methods: We used estimated glucose values (EGVs) from a convenience sample of 25,000 CGM users of Dexcom's G5 or G6 system ages 2-24 that were uploaded between 5/1/2018 and 9/30/2018 by an app that allows for sharing. The number of Follower(s) was established on 8/10/2018. Each day with ≥1 valid EGV was counted as a day of device usage. Comparisons were made with two-sided Welch’s t-tests.
Results: Overall, 90.0% of the population used the sharing feature and had ≥1 Follower; the mean numbers of Followers for patients ages <8, 8-14, and 15-24 years were 2.73, 2.69, and 1.83, respectively. In all 3 age groups, having a Follower was associated with lower mean EGVs, more EGVs in the 70-180 mg/dL range, fewer EGVs in hypo- or hyperglycemia, and more device utilization (Table).
Conclusions: Real-time sharing and following of CGM data may encourage consistent device usage and facilitate timely interventions by parents of young children with diabetes or improve self-care behaviors among adolescents and young adults with diabetes.
Disclosure
A. Parker: Employee; Self; Dexcom, Inc. M. Derdzinski: Employee; Self; Dexcom, Inc. S. Puhr: None. J. Welsh: Employee; Self; Dexcom, Inc. T.C. Walker: Employee; Self; Dexcom, Inc. A. Jimenez: Employee; Self; Dexcom, Inc.
Background: The Dexcom G6 continuous glucose monitoring (CGM) system differs from Dexcom’s earlier G5 system in that G6 includes a predictive “Urgent Low Soon” (ULS) alert that notifies users when an ...estimated glucose value (EGV) ≤55 mg/dL is predicted in the next 20 minutes. The effect of the ULS alert on the distribution of EGVs was evaluated in the context of traditional threshold alerts.
Methods: We identified individuals who had used G5 and transitioned to G6 between 5/1/2018 and 10/31/2018. Evaluable data were from a subset of 4083 users who had maintained low threshold alerts at either 70 or 80 mg/dL, who used a smartphone to view and upload ≥30 days of data from each system, and who maintained the G6 ULS alert in its default (enabled) state.
Results: Use of the 80 mg/dL low threshold alert was associated with higher mean EGVs, less hypoglycemia, and more hyperglycemia than use of the 70 mg/dL low threshold alert (Table). Over 97% of the G6 systems were used with the ULS feature enabled, and the ULS alert was activated less than once daily. At either low threshold setting, the transition to G6 was associated with reductions in hypoglycemia (<55 and <70 mg/dL) and severe hyperglycemia (>250 mg/dL).
Conclusions: When used in the context of traditional low threshold alerts, the predictive ULS alert may enable timely and appropriate interventions that contribute to further reductions in hypoglycemia among CGM-experienced users.
Disclosure
M. Derdzinski: Employee; Self; Dexcom, Inc. J. Welsh: Employee; Self; Dexcom, Inc. S. Puhr: None. T.C. Walker: Employee; Self; Dexcom, Inc. A. Parker: Employee; Self; Dexcom, Inc. A. Jimenez: Employee; Self; Dexcom, Inc.
Remote monitoring of CGM data of children and youth attending diabetes camp has been shown to reduce overall and nocturnal hypoglycemia, compared to treatment decisions based on self-monitored blood ...glucose (SMBG) values. However, some diabetes camps still require regular SMBG testing. We compared at-home versus at-camp glucose control where CGM data were used as the basis for diabetes treatment decisions. Thirty-four campers with T1D (mean±SD age 12±3 years, A1C 7.5±1.2%) were eligible for inclusion if they were using Control-IQ technology (Tandem Diabetes Care) prior to and during their attendance at Camp Buck, a diabetes-focused facility near Lake Tahoe. At camp, their CGM data (Dexcom G6) were integrated with the CampViews EMR system (Nevada-California Diabetes Association). CGM data from at-home and at-camp intervals were compared. As shown in the Table, mean glucose and overall time in range (TIR, 70-180 mg/dL) improved at camp, with statistical significance in the overnight (10PM-6AM) interval. Although time in Level 1 hypoglycemia increased at camp, there were no significant changes between at-home and at-camp levels of Level 2 hypoglycemia. CGM data can be used nonadjunctively in the camp setting to maintain or improve glycemic control. Centralized remote monitoring of glucose data allows camp attendees and staff to safely reduce or eliminate SMBG testing.
Disclosure
S.E.Gleich: Research Support; Dexcom, Inc. H.R.Tecca: Employee; Dexcom, Inc. N.D.Gibson-north: None. S.B.Andrade: Employee; Dexcom, Inc. J.Welsh: Employee; Dexcom, Inc. E.Schuster: Employee; Dexcom, Inc. T.C.Walker: Employee; Dexcom, Inc., Stock/Shareholder; Dexcom, Inc.
Symptomatic hypoglycemia is an incentive for carbohydrate intake which, in excess, can lead to rebound hyperglycemia (RH) and contribute to high glycemic variability. We examined whether an optional ..."urgent low soon" (ULS) alert triggered by impending hypoglycemia could mitigate RH in the real world. Sensor glucose values (SGVs) were from the G5 and G6 continuous glucose monitoring (CGM) systems (Dexcom). G5 does not offer the ULS feature; all G6 usage was with the ULS alert enabled. An RH event was defined as any series of SGVs >180 mg/dL preceded within 2 hours by a low SGV (<70 or <55 mg/dL). Event severity was defined as the area under the curve (AUC) for consecutive SGVs >180 mg/dL. Data from a convenience sample of 24,518 anonymized G5 users who transitioned to G6 and uploaded ≥30 days of data from each system in 2018 were analyzed. RH events preceded by an SGV <70 mg/dL and those preceded by an SGV <55 mg/dL were analyzed separately. For both types of RH events, the transition from G5 to G6 and its predictive alert was associated with favorable and statistically significant reductions in the mean (SD) frequency, severity, and duration RH events (Table). The ULS alert in the G6 CGM system, intended to reduce hypoglycemia, mitigates RH events in users who transition from a system without predictive alerts and may contribute to other metrics of improved glycemic control.
Disclosure
G. Acciaroli: Employee; Self; Dexcom, Inc. A. Parker: Employee; Self; Dexcom, Inc. Stock/Shareholder; Self; Dexcom, Inc. J. Welsh: Employee; Self; CSL Behring. S. Puhr: Employee; Self; Dexcom, Inc. T.C. Walker: Employee; Self; Dexcom, Inc. H.K. Akturk: Advisory Panel; Self; Sanofi US. Research Support; Self; Eli Lilly and Company, REMD Biotherapeutics, Senseonics.
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