Real-time Continuous Glucose Monitoring Research Articles

Use of Connected Pen as a Diagnostic Tool to Evaluate Missed Bolus Dosing Behavior in People with Type 1 and Type 2 Diabetes.

Objective: This study used connected pen to determine missed bolus dose (MBD) frequency during masked and unmasked continuous glucose monitoring (CGM) periods and examined its link with time-in-range (TIR), time-above-range (TAR), time-below-range (TBR), and key participant characteristics in people with diabetes.Methods: This was a 12-week, single-arm, exploratory, two-period study for people with type 1 diabetes (T1D) or type 2 diabetes (T2D). The primary objective was to estimate the average number of MBD during masked and real-time CGM use. The secondary objective was to estimate the average percent TIR and its relationship to MBD. An exploratory objective was to investigate the participant characteristics that were associated with MBD. Data were analyzed for differences in MBD by diabetes type and other participant characteristics, by CGM period, and by hypoglycemic fear scores.Results: Participants (n = 64; T1D, n = 38; T2D, n = 26) were 48 ± 11.9 years old and 44% were female. From the masked to the unmasked period, MBD, %TAR, %TBR, and glycated hemoglobin decreased significantly (0.74 MBD/day to 0.62 MBD/day, P = 0.008; 53.6%–48.1%, P = 0.004; 4.49%–2.93%, P < 0.001; mean 8.8%–8.4%, P < 0.001, respectively), while %TIR increased significantly (41.9%–49.0%, P < 0.001). MBD/day was negatively associated with TIR (P = 0.016) and positively associated with TAR (P = 0.015) for T1D and positively associated with TBR (P = 0.024) for T2D in the masked period only. MBD was significantly associated with fear of hypoglycemia for T2D, but not T1D.Conclusions: MBD is associated with reduced TIR when CGM is masked and tailored therapeutic approaches are needed for T1D and T2D populations.

Clustering of Hypoglycemia Events in Patients With Hyperinsulinism: Extension of the Digital Phenotype Through Retrospective Data Analysis.

BackgroundHyperinsulinism (HI) due to excess and dysregulated insulin secretion is the most common cause of severe and recurrent hypoglycemia in childhood. High cerebral glucose use in the early hours results in a high risk of hypoglycemia in people with diabetes and carries a significant risk of brain injury. Prevention of hypoglycemia is the cornerstone of the management of HI, but the risk of hypoglycemia at night or the timing of hypoglycemia in children with HI has not been studied; thus, the digital phenotype remains incomplete and management suboptimal.ObjectiveThis study aims to quantify the timing of hypoglycemia in patients with HI to describe glycemic variability and to extend the digital phenotype. This will facilitate future work using computational modeling to enable behavior change and reduce exposure of patients with HI to injurious hypoglycemic events.MethodsPatients underwent continuous glucose monitoring (CGM) with a Dexcom G4 or G6 CGM device as part of their clinical assessment for either HI (N=23) or idiopathic ketotic hypoglycemia (IKH; N=24). The CGM data were analyzed for temporal trends. Hypoglycemia was defined as glucose levels <3.5 mmol/L.ResultsA total of 449 hypoglycemic events totaling 15,610 minutes were captured over 237 days from 47 patients (29 males; mean age 70 months, SD 53). The mean length of hypoglycemic events was 35 minutes. There was a clear tendency for hypoglycemia in the early hours (3-7 AM), particularly for patients with HI older than 10 months who experienced hypoglycemia 7.6% (1480/19,370 minutes) of time in this period compared with 2.6% (2405/92,840 minutes) of time outside this period (P<.001). This tendency was less pronounced in patients with HI who were younger than 10 months, patients with a negative genetic test result, and patients with IKH. Despite real-time CGM, there were 42 hypoglycemic events from 13 separate patients with HI lasting >30 minutes.ConclusionsThis is the first study to have taken the first step in extending the digital phenotype of HI by describing the glycemic trends and identifying the timing of hypoglycemia measured by CGM. We have identified the early hours as a time of high hypoglycemia risk for patients with HI and demonstrated that simple provision of CGM data to patients is not sufficient to eliminate hypoglycemia. Future work in HI should concentrate on the early hours as a period of high risk for hypoglycemia and must target personalized hypoglycemia predictions. Focus must move to the human-computer interaction as an aspect of the digital phenotype that is susceptible to change rather than simple mathematical modeling to produce small improvements in hypoglycemia prediction accuracy.

Performance Evaluation of the Glunovo® Continuous Blood Glucose Monitoring System in Chinese Participants with Diabetes: A Multicenter, Self-Controlled Trial.

IntroductionThe present study was aimed to evaluate the performance and safety of the Glunovo® real-time continuous glucose monitoring system (CGMS) in monitoring interstitial fluid glucose in adult participants with diabetes (at least 18 years old) using venous blood glucose as control.MethodsThis was a multicenter, self-controlled clinical trial, conducted in participants with diabetes from China, between March 2019 to October 2019. The CGMS was used by all the participants for a 14-day wear-in period. The real-time glucose values measured by Glunovo® CGMS were compared with venous blood glucose values measured by the Entwicklung, Konstruktion und Fertigung (EKF) blood glucose detector. The primary outcomes were the consistency rate of CGMS readings and venous blood glucose values (20/20% standard).ResultsA total of 78 participants (41 men, 37 women) and 156 CGMS sensors were included in the study. Among the included participants, 25 and 53 participants had type 1 and type 2 diabetes, respectively, with median age of 52.50 years (range 32–62 years). The overall agreement rate (20/20%) was 89.71% (95% CI 89.18–90.24%). It was observed that 99.08% (95% CI 98.91–99.24%) and 99.82% (95% CI 99.74–99.89%) of the measuring points fell within the A + B zones of the Clarke error grid analysis and Parkes/consensus error grid analysis, respectively. The mean absolute relative difference was 10.30% ± 4.86%. The probability of a glucose measurement falling within a range, when stratified by venous glucose measurements, ranged from 7.14% for 19.44–22.22 mmol/L to 79.21% for 4.44–6.67 mmol/L. There were 73 (41.24%) and 27 (57.45%) successful CGMS alarms for hypoglycemic and hyperglycemic events, respectively.ConclusionFrom the results, Glunovo® CGMS had excellent accuracy and limited clinical risk compared with venous blood glucose in the range of 2.2–22.2 mmol/L over 14 days.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01171-2.

Time-Limited Eating and Continuous Glucose Monitoring in Adolescents with Obesity: A Pilot Study.

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.

Continuous glucose monitoring in extremely preterm infants in intensive care: the REACT RCT and pilot study of ‘closed-loop’ technology

BackgroundHyperglycaemia and hypoglycaemia are common in preterm infants and are associated with increased mortality and morbidity. Continuous glucose monitoring is widely used to target glucose control in adults and children, but not in neonates.ObjectiveTo evaluate the role of continuous glucose monitoring in the preterm infant.DesignThe REAl-time Continuous glucose moniToring in neonatal intensive care project combined (1) a feasibility study, (2) a multicentre randomised controlled trial and (3) a pilot of ‘closed-loop’ continuous glucose monitoring. The feasibility study comprised a single-centre study (n = 20). Eligibility criteria included a birthweight ≤ 1200 g and aged ≤ 48 hours. Continuous glucose monitoring was initiated to support glucose control. The efficacy and safety outcomes guided the design of the randomised controlled trial. The randomised controlled trial comprised a European multicentre trial (n = 182). Eligibility criteria included birthweight ≤ 1200 g and aged ≤ 24 hours. Exclusion criteria included any lethal congenital abnormality. Continuous glucose monitoring was initiated to support glucose control within 24 hours of birth. In the intervention group, the continuous glucose monitoring sensor provided real-time data on glucose levels, which guided clinical management. In control infants, the continuous glucose monitoring data were masked, and glucose level was managed in accordance with standard clinical practice and based on the blood glucose levels. The primary outcome measure was the percentage of time during which the sensor glucose level was within the target range of 2.6–10 mmol/l. Secondary outcome measures included mean sensor glucose level, the percentage of time during which the sensor glucose level was within the target range of 4–8 mmol/l, the percentage of time during which the sensor glucose level was in the hyperglycaemic range (i.e. &gt; 15 mmol/l) and sensor glucose level variability. Safety outcomes included hypoglycaemia exposure. Acceptability assessment and health economic analyses were carried out and further exploratory health outcomes were explored. The mean percentage of time in glucose target range of 2.6–10 mmol/l was 9% higher in infants in the continuous glucose monitoring group (95% confidence interval 3% to 14%;p = 0.002), and the mean time in the target range of 4–8 mmol/l was 12% higher in this group (95% confidence interval 4% to 19%;p = 0.004). There was no difference in the number of episodes of hypoglycaemia. Exploratory outcomes showed a reduced risk of necrotising enterocolitis in the intervention arm (odds ratio 0.33, 95% confidence interval 0.13 to 0.78;p = 0.01). Health economic analyses demonstrated that continuous glucose monitoring was cost-effective on the basis of the cost per additional case of adequate glucose control between 2.6 and 10 mmol/l. The ‘closed-loop’ study was a single-center pilot study, with eligibility criteria including a birthweight of ≤ 1200 g and aged ≤ 48 hours. Infants underwent continuous glucose monitoring for the first week of life (n = 21), with those in the intervention group receiving closed-loop insulin delivery between 48 and 72 hours of age. The primary outcome of percentage of time in the target range (i.e. sensor glucose 4–8 mmol/l) increased from a median of 26% (interquartile range 6–64%) to 91% (interquartile range 78–99%) during closed-loop insulin delivery (p &lt; 0.001).LimitationsThese studies have not defined the optimal targets for glucose control or the best strategies to achieve them in these infants.Future workStudies are needed to evaluate the longer-term impact of targeting glucose control on clinical outcomes.ConclusionsContinuous glucose monitoring in extremely preterm infants can improve glucose control, with closed-loop insulin delivery having further potential to target glucose levels. Staff and parents felt that the use of continuous glucose monitoring improved care and the results of the health economic evaluation favours the use of continuous glucose monitoring.Trial registrationCurrent Controlled Trials ISRCTN12793535.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a MRC and National Institute for Health Research (NIHR) partnership. This will be published in full inEfficacy and Mechanism Evaluation; Vol. 8, No. 16. See the NIHR Journals Library website for further project information. Medtronic plc provided some MiniMed™ 640G systems and Nova Biomedical (Waltham, MA, USA) provided point-of-care devices.

The Effect of Discontinuing Continuous Glucose Monitoring in Adults With Type 2 Diabetes Treated With Basal Insulin.

OBJECTIVETo explore the effect of discontinuing continuous glucose monitoring (CGM) after 8 months of CGM use in adults with type 2 diabetes treated with basal without bolus insulin.RESEARCH DESIGN AND METHODSThis multicenter trial had an initial randomization to either real-time CGM or blood glucose monitoring (BGM) for 8 months followed by 6 months in which the BGM group continued to use BGM (n = 57) and the CGM group was randomly reassigned either to continue CGM (n = 53) or discontinue CGM with resumption of BGM for glucose monitoring (n = 53).RESULTSIn the group that discontinued CGM, mean time in range (TIR) 70–180 mg/dL, which improved from 38% before initiating CGM to 62% after 8 months of CGM, decreased after discontinuing CGM to 50% at 14 months (mean change from 8 to 14 months −12% [95% CI −21% to −3%], P = 0.01). In the group that continued CGM use, little change was found in TIR from 8 to 14 months (baseline 44%, 8 months 56%, 14 months 57%, mean change from 8 to 14 months 1% [95% CI −11% to 12%], P = 0.89). Comparing the two groups at 14 months, the adjusted treatment group difference in mean TIR was −6% (95% CI −16% to 4%, P = 0.20).CONCLUSIONSIn adults with type 2 diabetes treated with basal insulin who had been using real-time CGM for 8 months, discontinuing CGM resulted in a loss of about one-half of the initial gain in TIR that had been achieved during CGM use.

Use of factory-calibrated real-time continuous glucose monitoring improves time in target and HbA1c in a multiethnic cohort of adolescents and young adults with type 1 diabetes: the MILLENNIALS study

OBJECTIVE International type 1 diabetes registries have shown that HbA1c levels are highest in young people with type 1 diabetes; however, improving their glycemic control remains a challenge. We propose that use of the factory-calibrated Dexcom G6 CGM system would improve glycemic control in this cohort. RESEARCH DESIGN AND METHODS We conducted a randomized crossover trial in young people with type 1 diabetes (16–24 years old) comparing the Dexcom G6 CGM system and self-monitoring of blood glucose (SMBG). Participants were assigned to the interventions in random order during two 8-week study periods. During SMBG, blinded continuous glucose monitoring (CGM) was worn by each participant for 10 days at the start, week 4, and week 7 of the control period. HbA1c measurements were drawn after enrollment and before and after each treatment period. The primary outcome was time in range 70–180 mg/dL. RESULTS Time in range was significantly higher during CGM compared with control (35.7 ± 13.5% vs. 24.6 ± 9.3%; mean difference 11.1% [95% CI 7.0–15.2]; P CONCLUSIONS CGM use in young people with type 1 diabetes improves time in target and HbA1c levels compared with SMBG.

Use of Real-Time Continuous Glucose Monitoring Improves Glycemic Control and Other Clinical Outcomes in Type 2 Diabetes Patients Treated with Less Intensive Therapy.

Objective: Use of real-time continuous glucose monitoring (rtCGM) has been shown to improve glycemic control in patients with type 2 diabetes (T2D) who are treated with intensive insulin therapy. However, most T2D patients are denied coverage for rtCGM due to failure to meet payer eligibility requirements: treatment with ≥3 insulin injections (or pump) and history of 4 × /day blood glucose testing. We investigated the relevance of these criteria to successful rtCGM use.Methods: This 6-month, prospective, interventional, single-arm study assessed the clinical effects of use rtCGM in patients with T2D treated with basal insulin only or noninsulin therapy. Primary outcomes were changes in HbA1c, average glucose, glycemic variability (% coefficient of variation), and percent of time in range (%TIR), below range (%TBR) and above range (%TAR).Results: Thirty-eight patients were included in the analysis (10.1% ± 1.8% HbA1c, 54.7 ± 10.2 years, 35.6 ± 6.4 body mass index). At 6 months, we observed reductions in HbA1c (−3.0% ± 1.3%, P < 0.001) and average glucose (−23.6 ± 38.8, P < 0.001). %TIR increased 15.2 ± 22.3, from 57.0 ± 29.9 to 72.2 ± 23.6, P < 0.001, with all patients maintaining %TBR targets (<4% at 70 mg/dL, <1% at <54 mg/dL). No changes in glycemic variability were observed. The greatest improvements in %TIR and %TAR were seen in patients treated with ≤1 medication.Conclusions: rtCGM use was associated with significant glycemic improvements in T2D patients treated with basal insulin only or noninsulin therapy. Given the growing body of evidence supporting rtCGM use in this population, insurance eligibility criteria should be modified to expand rtCGM use by T2D patients treated with less intensive therapies.

Benefits of a Switch from Intermittently Scanned Continuous Glucose Monitoring (isCGM) to Real-Time (rt) CGM in Diabetes Type 1 Suboptimal Controlled Patients in Real-Life: A One-Year Prospective Study §.

The switch from intermittently scanned continuous glucose monitoring (isCGM) to real-time (rt) CGM could improve glycemic management in suboptimal controlled type 1 diabetes patients, but long-term study is lacking. We evaluated retrospectively the ambulatory glucose profile (AGP) in such patients after switching from Free Style Libre 1 (FSL1) to Dexcom G4 (DG4) biosensors over 1 year. Patients (n = 21, 43 ± 15 years, BMI 25 ± 5, HbA1c 8.1 ± 1.0%) had severe hypoglycemia and/or HbA1c ≥ 8%. AGP metrics (time-in-range (TIR) 70–180 mg/dL, time-below-range (TBR) <70 mg/dL or <54 mg/dL, glucose coefficient of variation (%CV), time-above-range (TAR) >180 mg/dL or >250 mg/dL, glucose management indicator (GMI), average glucose) were collected the last 3 months of FSL1 use (M0) and of DG4 for 3, 6 (M6) and 12 (M12) months of use. Values were means ± standard deviation or medians [Q1;Q3]. At M12 versus M0, the higher TIR (50 ± 17 vs. 45 ± 16, p = 0.036), and lower TBR < 70 mg/dL (2.5 [1.6;5.5] vs. 7.0 [4.5;12.5], p = 0.0007), TBR < 54 mg/dL (0.7 [0.4;0.8] vs. 2.3 [0.8;7.0], p = 0.007) and %CV (39 ± 5 vs. 45 ± 8, p = 0.0009), evidenced a long-term effectiveness of the switch. Compared to M6, TBR < 70 mg/dL decreased, %CV remained stable, while the improvement on hyperglycemia exposure decreased (higher GMI, TAR and average glucose). This switch was a relevant therapeutic option, though a loss of benefit on hyperglycemia stressed the need for optimized management of threshold alarms. Nevertheless, few patients attained the recommended values for AGP metrics, and the reasons why some patients are “responders” vs. “non-responders” warrant to be investigated.

Glucose control using fast-acting insulin aspart in a real-world setting: A 1-year, two-centre study in people with type 1 diabetes using continuous glucose monitoring.

To evaluate the efficacy and safety of switching from traditional mealtime insulins to fast-acting insulin aspart (Fiasp) in a "real-world" clinical practice setting in adult people with type 1 diabetes (PWD1) who were using intermittently scanned or real-time continuous glucose monitoring (isCGM or rtCGM, respectively). Data from 438 adult PWD1 (60% men, age 44.6± 16.2 years, diabetes duration 21.5± 14.0 years, isCGM/rtCGM: 391/47, multiple daily injections/continuous subcutaneous insulin infusion: 409/29), who initiated Fiasp from January 2018 to May 2020, were analysed. The primary objective was the evolution of time in range (TIR; 70-180 mg/dL) at 6 and 12 months. Secondary objectives included change in HbA1c, body mass index (BMI), insulin doses, time below range (<70 and <54 mg/dL), and time above range (>180 and >250 mg/dL). TIR improved from 50.3% ± 15.6% to 54.3% ± 15.1% at 6months (n=425) and to 55.5% ± 15.2% at 12 months (n=385) (P< .001), corresponding to 57 min/d at 6months and 75 min/d at 12 months. Time spent below 54 mg/dL evolved from 3.1% ± 3.3% to 3.1% ± 3.7% and 2.5% ± 3.0% at 6 and 12 months, respectively (P= .011). Also, time spent above 180 mg/dL decreased from 42.3% ± 16.7% at start by 4.2% at 6months and by 4.6% at 12 months (P< .001). The proportion of people reaching TIR more than 70% increased from 11.0% to 14.8% (P= .002), and those spending less than 4% at time less than 70 mg/dL increased from 36.1% to 42.1% (P= .002). After 12 months, HbA1c, insulin doses, and BMI did not change significantly. In a Belgian real-world setting of adult PWD1, switching to Fiasp was associated with a 5% increased TIR after 12 months, corresponding to 75 min/d, in combination with less time spent below and above range.

Continuous Glucose Monitoring in the Management of Neonates With Persistent Hypoglycemia and Congenital Hyperinsulinism.

BackgroundPersistent hypoglycemia is common in the newborn and is associated with poor neurodevelopmental outcome. Adequate monitoring is critical in prevention, but is dependent on frequent, often hourly blood sampling. Continuous glucose monitoring (CGM) is increasingly being used in children with type 1 diabetes mellitus, but use in neonatology remains limited. We aimed to introduce real-time CGM to provide insights into patterns of dysglycemia and to support the management of persistent neonatal hypoglycemia.MethodsThis is a single-center retrospective study of real-time CGM use over a 4-year period in babies with persistent hypoglycemia.ResultsCGMs were inserted in 14 babies: 8 term and 6 preterm infants, 9 with evidence of congenital hyperinsulinism (CHI). A total of 224 days of data was collected demonstrating marked fluctuations in glucose levels in babies with CHI, with a higher sensor glucose SD (1.52 ± 0.79 mmol/L vs 0.77 ± 0.22 mmol/L) in infants with CHI compared with preterm infants. A total of 1254 paired glucose values (CGM and blood) were compared and gave a mean absolute relative difference of 11%.ConclusionCGM highlighted the challenges of preventing hypoglycemia in these babies when using intermittent blood glucose levels alone, and the potential application of CGM as an adjunct to clinical care.

Healthcare Utilization, Costs, and Adverse Events of Real-Time Continuous Glucose Monitoring versus Traditional Blood Glucose Monitoring Among US Adults with Type 1 Diabetes.

To compare healthcare utilization, costs, and incidence of diabetes-specific adverse events (ie, hyperglycemia, diabetic ketoacidosis, and hypoglycemia) in type 1 diabetes adult patients using real-time continuous glucose monitoring (rtCGM) versus traditional blood glucose monitoring (BG). Adult patients (≥18 years old) with type 1 diabetes in a large national administrative claims database between 2013 and 2015 were identified. rtCGM patients with 6-month continuous health plan enrollment and ≥1 pharmacy claim for insulin during pre-index and post-index periods were propensity-score matched with BG patients. Healthcare utilization associated with diabetic adverse events were examined. A difference-in-difference (DID) method was used to compare the change in costs between rtCGM and BG cohorts. Six-month medical costs for rtCGM patients (N = 153) increased from pre- to post-index period, while they decreased for matched BG patients (N = 153). DID analysis indicated a $2,807 (P = .062) higher post-index difference in total medical costs for rtCGM patients. Pharmacy costs for both cohorts increased. DID analysis indicated a $1,775 (P < .001) higher post-index difference in pharmacy costs for rtCGM patients. The incidence of hyperglycemia for both cohorts increased minimally from pre- to post-index period. The incidence of hypoglycemia for rtCGM patients decreased, while it increased marginally for BG patients. Inpatient hospitalizations for rtCGM and BG patients increased and decreased marginally, respectively. rtCGM users had non-significantly higher pre-post differences in medical costs but significantly higher pre-post differences in pharmacy costs (mostly due to the rtCGM costs themselves) compared to BG users. Changes in adverse events were minimal.

Evaluation of the Long-Term Cost-Effectiveness of the Dexcom G6 Continuous Glucose Monitor versus Self-Monitoring of Blood Glucose in People with Type 1 Diabetes in Canada.

BackgroundThe Dexcom G6 real-time continuous glucose monitoring (RT-CGM) system is one of the most sophisticated RT-CGM systems developed to date and became available in Canada in 2019. A health economic analysis was performed to determine the long-term cost-effectiveness of the Dexcom G6 RT-CGM system versus SMBG in adults with type 1 diabetes (T1D) in Canada.MethodsThe analysis was performed using the IQVIA Core Diabetes Model. Based on clinical trial data, patients with mean baseline HbA1c of 8.6% were assumed to have a HbA1c reduction of 1.0% with RT-CGM versus 0.4% reduction with SMBG. RT-CGM was also associated with a quality of life (QoL) benefit owing to reduced incidence of hypoglycemia, reduced fear of hypoglycemia (FoH) and elimination of fingerstick testing. Direct medical costs were sourced from published literature, and inflated to 2019 Canadian dollars (CAD).ResultsDexcom G6 RT-CGM was projected to improve mean quality-adjusted life expectancy by 2.09 quality-adjusted life years (QALYs) relative to SMBG (15.52 versus 13.43 QALYs) but mean total lifetime cots were CAD 35,353 higher with RT-CGM (CAD 227,357 versus CAD 192,004) resulting in an incremental cost-effectiveness ratio (ICER) of CAD 16,931 per QALY gained. Sensitivity analyses revealed that assumptions relating to the QoL benefit associated with reduced FoH and the elimination of fingerstick testing with RT-CGM as well as SMBG usage and change in HbA1c were the key drivers of cost-effectiveness.ConclusionFor adults with T1D in Canada, RT-CGM is associated with improved glycemic control and QoL benefits owing to a reduced FoH and elimination of the requirement for fingerstick testing and over a lifetime time horizon is cost-effective relative to SMBG.

The Importance of Time in Range (TIR) for Continuous Glucose Monitoring (CGM) in the Clinical Practice for Diabetes

As to the development of treatment for diabetes, Continuous Glucose Monitoring (CGM) has been recently prevalent rapidly. By the analysis of real-time CGM, Ambulatory Glucose Profile (AGP) has been used. It includes time in range (TIR, 70-180 mg/dL), time above range (TAR, &gt;181mg/dL), time below range (TBR, &lt;69 mg/dL), Glycemic Variability (GV), Glucose Management Indicator (GMI), Glycemic variability, Coefficient Of Variation (CV%) and so on. TIR value indicating approximately 70% seems to correlate closely with the HbA1c level of 6.77.0%. Marked discordance of HbA1c values has been found between laboratory HbA1c and estimated HbA1c (eA1c) using GMI from CGM.

Widening health inequalities related to type 1 diabetes care in children and young people in the UK: A time to act now.

In this recent 2019-2020 audit, 96% (168/173) of paediatric diabetes teams submitted data and included a total of 29,242 children and young people (CYP) up to the age of 24years, and type 1 diabetes consisted of 27,653 CYP. One of the key findings was that CYP with type 1 diabetes from minority ethnic communities have higher HbA1 compared to white ethnicity and that significantly lower use of insulin pumps or real-time continuous glucose monitoring systems was used among black children. There has been an increasing trend of widening health inequalities reported the past 6years. As chairs of Diabetes UK Diabetes Research Study Groups, the authors urge that research into barriers of access to technology for T1D in CYP in the UK specifically looking at provider bias, systemic issues within the health system, and individual and family factors are conducted with urgency.

Impact of continuous glucose monitoring on improving emotional well‑being among adults with type 1 diabetes mellitus: a systematic review and meta‑analysis.

Real-time continuous glucose monitoring (CGM) has changed the way people with type 1 diabetes mellitus (T1DM) and health care providers perceive diabetes management and glucose control. The purpose of this meta-analysis was to compare the emotional well-being of adults with T1DM who used CGM and those using conventional self-monitoring of blood glucose (SMBG). The MEDLINE/PubMed, Cochrane Library / Embase, CINAHL, Scopus, Web of Science, and ProQuest databases were searched for relevant publications. Primary outcome measures were health-related quality of life, glycemic control, and fear of hypoglycemia. Randomized controlled trials and survey studies focused on the quality of life and fear of hypoglycemia among adult patients using CGM and SMBG were included in the analysis. The meta-analysis included 11 studies involving a total of 1228 patients with T1DM. Analysis of the Worry subscale of the Hypoglycemia Fear Survey indicated a reduction of hypoglycemia fear in CGM users compared with SMBG users (Cohen d = –0.24; 95% CI, –0.41 to –0.07; mean difference, –3.15; 95% CI, –5.48 to –0.82). Outcome analysis of studies including the Diabetes Treatment Satisfaction Questionnaire showed Cohen d of 0.23 (95% CI, –0.18 to 0.63). The overall value of Cohen d equaled –0.24 (95% CI, –0.57 to 0.09), indicating a lack of effect of CGM use on improving HbA1c levels; however, after one of the studies was excluded from calculations, the reduction of HbA1c levels was significantly higher in CGM users (Cohen d = –0.33; 95% CI, –0.66 to 0.00; P = 0.047). This is the first quantitative meta-analysis of studies involving adult patients exclusively with T1DM, providing further evidence for the ability of CGM systems to reduce fear of hypoglycemia and improve quality of life. Continuous glucose monitoring systems have advantage over SMBG in adults with T1DM and improve HbA1c levels.

Real-Time Continuous Glucose Monitoring with Alerts Improves Glycemic Control in Type 1 Diabetes

Intermittently scanned continuous glucose monitors (isCGM) must be scanned manually with a receiver or smartphone, whereas more expensive real-time

Comparison of Glycemic Metrics Measured Simultaneously by Intermittently Scanned Continuous Glucose Monitoring and Real-Time Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes.

Background: We aimed to compare clinically important glycemic metrics with focus on mean sensor glucose and time-below-target range (TBR) during nighttime obtained with intermittently scanned continuous glucose monitoring (isCGM) and real-time CGM (rtCGM) in early pregnancy in women with type 1 diabetes. Materials and Methods: A prospective, observational study including 20 women with type 1 diabetes simultaneously monitored with isCGM (Freestyle Libre; Abbott) and rtCGM (Envision™ Pro; Medtronic) for 7 days in early pregnancy. Time-in-target range (TIR) was defined as 3.5-7.8 mmol/L. Results: Gestational age was median 66 (interquartile range 63-74) days and HbA1c was 48 mmol/mol (43-54). Median difference between isCGM and rtCGM was 0.1 mmol/L (-0.1 to 0.5) (P = 0.50) and -0.1 mmol/L (-0.4 to 0.2) (P = 0.35) for 24 h and during nighttime, respectively. For 24 h, TBR was 3.9% (1.6-7.0) versus 2.0% (0.6-3.7) (P = 0.06) and TIR was 57.2% (50.8-76.5) versus 69.6% (55.4-81.5) (P = 0.001) for isCGM and rtCGM, respectively. During nighttime TBR was 6.5% (0.4-16.7) versus 0% (0.0-0.8) (P = 0.003), TIR was 55.4 (41.1-81.0) versus 68.8 (52.4-80.3) (P = 0.005) and 75% versus 40% of the women had ≥1 glucose reading <3.5 mmol/L. Conclusions: In pregnant women with type 1 diabetes, mean sensor glucose was reported similar when measured by isCGM and rtCGM. However, during nighttime isCGM measured a clinically relevant higher percentage of TBR compared with rtCGM. Thus, the type of CGM device used may influence adjustments of insulin dose based on the concern for nocturnal hypoglycemia. ClinicalTrials.gov (NCT03770767).

Episodic Real-Time CGM Use in Adults with Type2 Diabetes: Results of a Pilot Randomized Controlled Trial.

IntroductionResistance to initiating insulin therapy is common for people with type 2 diabetes (T2D) using multiple oral agents, resulting in sustained poor glycemic control. We explored a non-pharmacologic option and examined whether adults with T2D and elevated hemoglobin A1c (HbA1c) who were using multiple, non-insulin antihyperglycemics could obtain glycemic benefit from limited, episodic use of real-time continuous glucose monitoring (rtCGM).MethodsA randomized, pilot trial enrolled patients with T2D who were using two or more non-insulin therapies and had HbA1c values of 7.8–10.5%. Following a baseline, 10-day, blinded CGM session, participants were randomized 2:1, rtCGM or self-monitoring of blood glucose (SMBG). Medication changes were not made during the 12-week study unless required for safety; benefits would result from lifestyle changes. The rtCGM group used unblinded rtCGM for three sessions at weeks 0, 4, and 8, and the control group managed diabetes with SMBG and wore blinded rtCGM at week 8. Glycemic endpoints were assessed.ResultsSeventy participants were enrolled from eight North American sites and data were available from 68 (n = 45 rtCGM; n = 23 SMBG). Median (IQR) baseline HbA1c was 8.4 (0.8)% and 8.3 (1.2)% and median (IQR) change in HbA1c at week 12 was − 0.5 (1.3)% and − 0.2 (1.1)% for the rtCGM and SMBG groups, respectively (between-group difference p = 0.74). More than one-third (34.1%) of the rtCGM group vs 17.4% of the SMBG group reached the HbA1c goal of less than 7.5% at week 12 (between-group difference p = 0.12). Compared to run-in, mean (SD) time in range (TIR 70–180 mg/dL) at week 8 increased for the rtCGM group (56.3 [24.5]% vs 63.1 [25.5]%) while it decreased for the SMBG group (68.4 [21.5]% vs 55.1 [30.3]%). HbA1c reductions were not sustained at month 9.ConclusionIn this pilot study, limited episodic rtCGM use in people failing multiple non-insulin therapies resulted in modest, short-term glycemic benefits.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01086-y.

Association of Real-time Continuous Glucose Monitoring With Glycemic Control and Acute Metabolic Events Among Patients With Insulin-Treated Diabetes

Continuous glucose monitoring (CGM) is recommended for patients with type 1 diabetes; observational evidence for CGM in patients with insulin-treated type 2 diabetes is lacking. To estimate clinical outcomes of real-time CGM initiation. Exploratory retrospective cohort study of changes in outcomes associated with real-time CGM initiation, estimated using a difference-in-differences analysis. A total of 41 753 participants with insulin-treated diabetes (5673 type 1; 36 080 type 2) receiving care from a Northern California integrated health care delivery system (2014-2019), being treated with insulin, self-monitoring their blood glucose levels, and having no prior CGM use were included. Initiation vs noninitiation of real-time CGM (reference group). Ten end points measured during the 12 months before and 12 months after baseline: hemoglobin A1c (HbA1c); hypoglycemia (emergency department or hospital utilization); hyperglycemia (emergency department or hospital utilization); HbA1c levels lower than 7%, lower than 8%, and higher than 9%; 1 emergency department encounter or more for any reason; 1 hospitalization or more for any reason; and number of outpatient visits and telephone visits. The real-time CGM initiators included 3806 patients (mean age, 42.4 years [SD, 19.9 years]; 51% female; 91% type 1, 9% type 2); the noninitiators included 37 947 patients (mean age, 63.4 years [SD, 13.4 years]; 49% female; 6% type 1, 94% type 2). The prebaseline mean HbA1c was lower among real-time CGM initiators than among noninitiators, but real-time CGM initiators had higher prebaseline rates of hypoglycemia and hyperglycemia. Mean HbA1c declined among real-time CGM initiators from 8.17% to 7.76% and from 8.28% to 8.19% among noninitiators (adjusted difference-in-differences estimate, -0.40%; 95% CI, -0.48% to -0.32%; P < .001). Hypoglycemia rates declined among real-time CGM initiators from 5.1% to 3.0% and increased among noninitiators from 1.9% to 2.3% (difference-in-differences estimate, -2.7%; 95% CI, -4.4% to -1.1%; P = .001). There were also statistically significant differences in the adjusted net changes in the proportion of patients with HbA1c lower than 7% (adjusted difference-in-differences estimate, 9.6%; 95% CI, 7.1% to 12.2%; P < .001), lower than 8% (adjusted difference-in-differences estimate, 13.1%; 95% CI, 10.2% to 16.1%; P < .001), and higher than 9% (adjusted difference-in-differences estimate, -7.1%; 95% CI, -9.5% to -4.6%; P < .001) and in the number of outpatient visits (adjusted difference-in-differences estimate, -0.4; 95% CI, -0.6 to -0.2; P < .001) and telephone visits (adjusted difference-in-differences estimate, 1.1; 95% CI, 0.8 to 1.4; P < .001). Initiation of real-time CGM was not associated with statistically significant changes in rates of hyperglycemia, emergency department visits for any reason, or hospitalizations for any reason. In this retrospective cohort study, insulin-treated patients with diabetes selected by physicians for real-time continuous glucose monitoring compared with noninitiators had significant improvements in hemoglobin A1c and reductions in emergency department visits and hospitalizations for hypoglycemia, but no significant change in emergency department visits or hospitalizations for hyperglycemia or for any reason. Because of the observational study design, findings may have been susceptible to selection bias.