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Open accessJournal ArticleDOI: 10.1089/DIA.2020.0654

Real-World Evidence and Glycemic Improvement Using Dexcom G6 Features

02 Mar 2021-Diabetes Technology & Therapeutics (Mary Ann Liebert, Inc., publishers 140 Huguenot Street, 3rd Floor New Rochelle, NY 10801 USA)-Vol. 23
Abstract: Background: Optional features of continuous glucose monitoring (CGM) systems empower patients and caregivers to understand and manage diabetes in new ways. We examined associations between use of optional features, demographics, and glycemic outcomes. Methods: Retrospective cohort studies were performed with data from US-based users of the G6 CGM System (Dexcom, Inc.). For all cohorts, data included sensor glucose values (SGVs). In separate cohorts, use of alert features (for hyperglycemia, existing hypoglycemia, and impending hypoglycemia), remote data sharing feature (Share), software for retrospective pattern analysis (CLARITY), "virtual assistant" feature that announces the current SGV and trend in response to a spoken request were assessed. Descriptive statistics were used to summarize feature set utilization patterns and relate them to glycemic outcomes. Results: Most individual features were consistently adopted by high proportions of G6 users. Threshold SGVs chosen for activating hyperglycemia and hypoglycemia alerts varied with age and were higher among the youngest and oldest patients. Use of the Share feature was more common among young patients and those with type 1 diabetes. Individuals who used more of the alert and notification features had more favorable glycemic outcomes, including time in range (TIR), than those who used fewer. More extensive engagement with CLARITY notifications was associated with higher TIR. Frequent use of the virtual assistant feature was associated with higher TIR and lower mean SGV. Conclusions: Optional features of the G6 CGM system are acceptable to and appear to benefit patients who use them. Different levels of engagement suggest that demographics and personal circumstances play a role in how patients and caregivers use CGM features to help manage diabetes.

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Topics: Glycemic (53%)
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7 results found


Open accessJournal ArticleDOI: 10.1089/DIA.2020.0666
Abstract: Background: Initiating continuous glucose monitoring (CGM) can affect hemoglobin A1c (HbA1c) levels and patients' relationship with their diabetes. We used real-world HbA1c data to quantify short-t...

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Topics: Diabetes mellitus (57%)

3 Citations


Open accessJournal ArticleDOI: 10.1111/DME.14739
10 Nov 2021-Diabetic Medicine
Abstract: Objective Prior to the Continuous Monitoring and Control of Hypoglycaemia (COACH) study described herein, no study had been powered to evaluate the impact of non-adjunctive RT-CGM use on the rate of debilitating moderate or severe hypoglycaemic events. Research design and methods In this 12-month observational study, adults with insulin-requiring diabetes who were new to RT-CGM participated in a 6-month control phase where insulin dosing decisions were based on self-monitored blood glucose (SMBG) values, followed by a 6-month phase where decisions were based on RT-CGM data (i.e., non-adjunctive RT-CGM use); recommendations for RT-CGM use were made according to sites' usual care. The primary outcome was change in debilitating moderate (requiring second-party assistance) and severe (resulting in seizures or loss of consciousness) hypoglycaemic event frequency. Secondary outcomes included changes in HbA1c and diabetic ketoacidosis (DKA) frequency. Results A total of 519 participants with mean (SD) age 50.3 (16.1) years and baseline HbA1c 8.0% (1.4%) completed the study, of whom 32.8% had impaired hypoglycaemia awareness and 33.5% had type 2 diabetes (T2D). The mean (SE) per-patient frequency of hypoglycaemic events decreased by 63% from 0.08 (0.016) during the SMBG phase to 0.03 (0.010) during the RT-CGM phase (p=0.005). HbA1c decreased during the RT-CGM phase both for participants with type 1 diabetes (T1D) and T2D and there was a trend toward larger reductions among individuals with higher baseline HbA1c. Conclusions Among adults with insulin-requiring diabetes, non-adjunctive use of RT-CGM data is safe, resulting in significantly fewer debilitating hypoglycaemic events than management using SMBG.

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Topics: Type 1 diabetes (53%), Diabetic ketoacidosis (51%), Type 2 diabetes (51%) ... read more

1 Citations


Open accessJournal ArticleDOI: 10.3390/BIOS11110457
Kyuhan Lee1, Shakthi Gunasinghe1, Alyson Chapman2, Lynne A Findlow2  +11 moreInstitutions (2)
15 Nov 2021-Biosensors
Abstract: Flash glucose monitoring (FGM) and real-time continuous glucose monitoring (RT-CGM) are increasingly used in clinical practice, with improvements in HbA1c and time in range (TIR) reported in clinical studies. We aimed to evaluate the impact of FGM and RT-CGM use on glycaemic outcomes in adults with type 1 diabetes (T1DM) under routine clinical care. We performed a retrospective data analysis from electronic outpatient records and proprietary web-based glucose monitoring platforms. We measured HbA1c (pre-sensor vs. on-sensor data) and sensor-based outcomes from the previous three months as per the international consensus on RT-CGM reporting guidelines. Amongst the 789 adults with T1DM, HbA1c level decreased from 61.0 (54.0, 71.0) mmol/mol to 57 (49, 65.8) mmol/mol in 561 people using FGM, and from 60.0 (50.0, 70.0) mmol/mol to 58.8 (50.3, 66.8) mmol/mol in 198 using RT-CGM (p 70%. For time-below-range (TBR) < 4 mmol/L, 70% of RT-CGM users and 58% of FGM users met international recommendations of <4%. Our data add to the growing body of evidence supporting the use of FGM and RT-CGM in T1DM.

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Open accessJournal ArticleDOI: 10.3390/NU13113697
Alaina P. Vidmar1, Alaina P. Vidmar2, Monica Naguib1, Monica Naguib2  +8 moreInstitutions (3)
21 Oct 2021-Nutrients
Abstract: Due to its simplicity, time-limited eating (TLE) may represent a more feasible approach for treating adolescents with obesity compared to other caloric restriction regimens. This pilot study examines the feasibility and safety of TLE combined with continuous glucose monitoring (CGM) in adolescents. Fifty adolescents with BMI ≥95th percentile were recruited to complete a 12-week study. All received standard nutritional counseling, wore a CGM daily, and were randomized to: (1) Prolonged eating window: 12 h eating/12 h fasting + blinded CGM; (2) TLE (8 h eating/16 h fasting, 5 days per week) + blinded CGM; (3) TLE + real-time CGM feedback. Recruitment, retention, and adherence were recorded as indicators of feasibility. Weight loss, dietary intake, physical activity, eating behaviors, and quality of life over the course of the intervention were explored as secondary outcomes. Forty-five participants completed the study (16.4 ± 1.3 years, 64% female, 49% Hispanic, 75% public insurance). There was high adherence to prescribed eating windows (TLE 5.2 d/wk [SD 1.1]; control 6.1 d/wk [SD 1.4]) and daily CGM wear (5.85 d/wk [SD 4.8]). Most of the adolescents (90%) assigned to TLE reported that limiting their eating window and wearing a CGM was feasible without negative impact on daily functioning or adverse events. There were no between-group difference in terms of weight loss, energy intake, quality of life, physical activity, or eating behaviors. TLE combined with CGM appears feasible and safe among adolescents with obesity. Further investigation in larger samples, with a longer intervention duration and follow-up assessments are needed.

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Journal ArticleDOI: 10.1016/J.DIABET.2021.101283
Abstract: After years of intensive investigation, the definition of glycaemic variability remains unclear and the term variability in glucose homoeostasis might be more appropriate covering both short and long-term glycaemic variability. For the latter, we remain in the search of an accurate definition and related targets. Recent work leads us to consider that the within-subject variability of HbA1c calculated from consecutive determinations of HbA1c at regular time-intervals could be the most relevant index for assessing the long-term variability with a threshold value of 5% (%CV = SD of HbA1c/mean HbA1c) to separate stability from lability of HbA1c. Presently, no one can deny that short- and long-term glucose variability should be maintained within their lower ranges to limit the incidence of hypoglycaemia. Usually, therapeutic strategies aimed at reducing post-meal glucose excursions, i.e. the major contributor to daily glucose fluctuations, exert a beneficial effect on the short-term glucose variability. This explains the effectiveness of adjunct therapies with either GLP- receptor agonists or SGLT inhibitors in type 2 diabetes. In type 1 diabetes, the application of a CGM device alone reduces the short-term glycaemic variability. In contrast, sophisticated insulin delivery does not necessarily lead to such reductions despite marked downward shifts of 24-hour glycaemic profiles. Such contrasting observations raise the question as to whether the prolonged wear of CGM devices is or not the major causative factor for improvement in glucose variability among intensively insulin-treated persons with type 1 diabetes.

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Open accessJournal ArticleDOI: 10.2337/DCI19-0028
01 Aug 2019-Diabetes Care
Abstract: Improvements in sensor accuracy, greater convenience and ease of use, and expanding reimbursement have led to growing adoption of continuous glucose monitoring (CGM). However, successful utilization of CGM technology in routine clinical practice remains relatively low. This may be due in part to the lack of clear and agreed-upon glycemic targets that both diabetes teams and people with diabetes can work toward. Although unified recommendations for use of key CGM metrics have been established in three separate peer-reviewed articles, formal adoption by diabetes professional organizations and guidance in the practical application of these metrics in clinical practice have been lacking. In February 2019, the Advanced Technologies & Treatments for Diabetes (ATTD) Congress convened an international panel of physicians, researchers, and individuals with diabetes who are expert in CGM technologies to address this issue. This article summarizes the ATTD consensus recommendations for relevant aspects of CGM data utilization and reporting among the various diabetes populations.

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851 Citations


Journal ArticleDOI: 10.1001/JAMA.2016.19975
24 Jan 2017-JAMA
Abstract: Importance Previous clinical trials showing the benefit of continuous glucose monitoring (CGM) in the management of type 1 diabetes predominantly have included adults using insulin pumps, even though the majority of adults with type 1 diabetes administer insulin by injection. Objective To determine the effectiveness of CGM in adults with type 1 diabetes treated with insulin injections. Design, Setting, and Participants Randomized clinical trial conducted between October 2014 and May 2016 at 24 endocrinology practices in the United States that included 158 adults with type 1 diabetes who were using multiple daily insulin injections and had hemoglobin A 1c (HbA 1c ) levels of 7.5% to 9.9%. Interventions Random assignment 2:1 to CGM (n = 105) or usual care (control group; n = 53). Main Outcomes and Measures Primary outcome measure was the difference in change in central-laboratory–measured HbA 1c level from baseline to 24 weeks. There were 18 secondary or exploratory end points, of which 15 are reported in this article, including duration of hypoglycemia at less than 70 mg/dL, measured with CGM for 7 days at 12 and 24 weeks. Results Among the 158 randomized participants (mean age, 48 years [SD, 13]; 44% women; mean baseline HbA 1c level, 8.6% [SD, 0.6%]; and median diabetes duration, 19 years [interquartile range, 10-31 years]), 155 (98%) completed the study. In the CGM group, 93% used CGM 6 d/wk or more in month 6. Mean HbA 1c reduction from baseline was 1.1% at 12 weeks and 1.0% at 24 weeks in the CGM group and 0.5% and 0.4%, respectively, in the control group (repeated-measures model P 1c level from baseline was –0.6% (95% CI, –0.8% to –0.3%; P P = .002). Severe hypoglycemia events occurred in 2 participants in each group. Conclusions and Relevance Among adults with type 1 diabetes who used multiple daily insulin injections, the use of CGM compared with usual care resulted in a greater decrease in HbA 1c level during 24 weeks. Further research is needed to assess longer-term effectiveness, as well as clinical outcomes and adverse effects. Trial Registration clinicaltrials.gov Identifier:NCT02282397

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519 Citations


Journal ArticleDOI: 10.1001/JAMA.2016.19976
Marcus Lind1, William H. Polonsky2, Irl B. Hirsch3, Tim Heise  +9 moreInstitutions (7)
24 Jan 2017-JAMA
Abstract: IMPORTANCE The majority of individuals with type 1 diabetes do not meet recommended glycemic targets. OBJECTIVE To evaluate the effects of continuous glucose monitoring in adults with type 1 diabetes treated with multiple daily insulin injections. DESIGN, SETTING, AND PARTICIPANTS Open-label crossover randomized clinical trial conducted in 15 diabetes outpatient clinics in Sweden between February 24, 2014, and June 1, 2016 that included 161 individuals with type 1 diabetes and hemoglobin A1c (HbA1c) of at least 7.5%(58 mmol/mol) treated with multiple daily insulin injections. INTERVENTIONS Participants were randomized to receive treatment using a continuous glucose monitoring system or conventional treatment for 26 weeks, separated by a washout period of 17 weeks. MAIN OUTCOMES AND MEASURES Difference in HbA1c between weeks 26 and 69 for the 2 treatments. Adverse events including severe hypoglycemia were also studied. RESULTS Among 161 randomized participants, mean age was 43.7 years, 45.3%were women, and mean HbA1c was 8.6%(70 mmol/mol). A total of 142 participants had follow-up data in both treatment periods. Mean HbA1c was 7.92%(63 mmol/mol) during continuous glucose monitoring use and 8.35%(68 mmol/mol) during conventional treatment (mean difference, -0.43%[95%CI, -0.57%to -0.29%] or -4.7 [-6.3 to -3.1 mmol/mol]; P < .001). Of 19 secondary end points comprising psychosocial and various glycemic measures, 6met the hierarchical testing criteria of statistical significance, favoring continuous glucose monitoring compared with conventional treatment. Five patients in the conventional treatment group and 1 patient in the continuous glucose monitoring group had severe hypoglycemia. During washout when patients used conventional therapy, 7 patients had severe hypoglycemia. CONCLUSIONS AND RELEVANCE Among patients with inadequately controlled type 1 diabetes treated with multiple daily insulin injections, the use of continuous glucose monitoring compared with conventional treatment for 26 weeks resulted in lower HbA1c. Furthe. (Less)

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Topics: Type 1 diabetes (56%), Glycemic (53%), Outpatient clinic (53%) ... read more

332 Citations


Journal ArticleDOI: 10.7326/M16-2855
Abstract: Background Continuous glucose monitoring (CGM), which studies have shown is beneficial for adults with type 1 diabetes, has not been well-evaluated in those with type 2 diabetes receiving insulin. Objective To determine the effectiveness of CGM in adults with type 2 diabetes receiving multiple daily injections of insulin. Design Randomized clinical trial. (The protocol also included a type 1 diabetes cohort in a parallel trial and subsequent second trial.) (ClinicalTrials.gov: NCT02282397). Setting 25 endocrinology practices in North America. Patients 158 adults who had had type 2 diabetes for a median of 17 years (interquartile range, 11 to 23 years). Participants were aged 35 to 79 years (mean, 60 years [SD, 10]), were receiving multiple daily injections of insulin, and had hemoglobin A1c (HbA1c) levels of 7.5% to 9.9% (mean, 8.5%). Intervention Random assignment to CGM (n = 79) or usual care (control group, n = 79). Measurements The primary outcome was HbA1c reduction at 24 weeks. Results Mean HbA1c levels decreased to 7.7% in the CGM group and 8.0% in the control group at 24 weeks (adjusted difference in mean change, -0.3% [95% CI, -0.5% to 0.0%]; P = 0.022). The groups did not differ meaningfully in CGM-measured hypoglycemia or quality-of-life outcomes. The CGM group averaged 6.7 days (SD, 0.9) of CGM use per week. Limitation 6-month follow-up. Conclusion A high percentage of adults who received multiple daily insulin injections for type 2 diabetes used CGM on a daily or near-daily basis for 24 weeks and had improved glycemic control. Because few insulin-treated patients with type 2 diabetes currently use CGM, these results support an additional management method that may benefit these patients. Primary funding source Dexcom.

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Topics: Type 1 diabetes (56%), Type 2 diabetes (54%), Randomized controlled trial (52%) ... read more

200 Citations


Open accessJournal ArticleDOI: 10.2337/DC16-1769
01 Jul 2017-Diabetes Care
Abstract: OBJECTIVE To define the threshold for excess glucose variability (GV), one of the main features of dysglycemia in diabetes. RESEARCH DESIGN AND METHODS A total of 376 persons with diabetes investigated at the University Hospital of Montpellier (Montpellier, France) underwent continuous glucose monitoring. Participants with type 2 diabetes were divided into several groups—groups 1, 2a, 2b, and 3 ( n = 82, 28, 65, and 79, respectively)—according to treatment: 1 ) diet and/or insulin sensitizers alone; 2 ) oral therapy including an insulinotropic agent, dipeptidyl peptidase 4 inhibitors (group 2a) or sulfonylureas (group 2b); or 3 ) insulin. Group 4 included 122 persons with type 1 diabetes. Percentage coefficient of variation for glucose (%CV = [(SD of glucose)/(mean glucose)] × 100) and frequencies of hypoglycemia (interstitial glucose RESULTS Percentages of CV (median [interquartile range]; %) increased significantly ( P P P 36% were compared with those with %CV ≤36%. CONCLUSIONS A %CV of 36% appears to be a suitable threshold to distinguish between stable and unstable glycemia in diabetes because beyond this limit, the frequency of hypoglycemia is significantly increased, especially in insulin-treated subjects.

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Topics: Type 2 diabetes (58%), Type 1 diabetes (57%), Hypoglycemia (54%) ... read more

179 Citations