Background: As the use of continuous glucose monitoring (CGM) increases, there is a need to better understand key metrics of time in range 70-180 mg/dL (TIR70-180) and hyperglycemia and how they relate to hemoglobin A1c (A1C). Methods: Analyses were conducted utilizing datasets from four randomized trials encompassing 545 adults with type 1 diabetes (T1D) who had central-laboratory measurements of A1C. CGM metrics were calculated and compared with each other and A1C cross-sectionally and longitudinally. Results: Correlations among CGM metrics (TIR70-180, time >180 mg/dL, time >250 mg/dL, mean glucose, area under the curve above 180 mg/dL, high blood glucose index, and time in range 70-140 mg/dL) were typically 0.90 or greater. Correlations of each metric with A1C were lower (absolute values 0.66-0.71 at baseline and 0.73-0.78 at month 6). For a given TIR70-180 percentage, there was a wide range of possible A1C levels that could be associated with that TIR70-180 level. On average, a TIR70-180 of 70% and 50% corresponded with an A1C of approximately 7% and 8%, respectively. There also was considerable spread of change in A1C for a given change in TIR70-180, and vice versa. An increase in TIR70-180 of 10% (2.4 hours per day) corresponded to a decrease in A1C of 0.6%, on average. Conclusions: In T1D, CGM measures reflecting hyperglycemia (including TIR and mean glucose) are highly correlated with each other but only moderately correlated with A1C. For a given TIR or change in TIR there is a wide range of possible corresponding A1C values.

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for the Wireless Innovation for Seniors With Diabetes Mellitus (WISDM) Study Group IMPORTANCE Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes. OBJECTIVE To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes. DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes. INTERVENTIONS Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100). MAIN OUTCOMES AND MEASURESThe primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A 1c (HbA 1c ); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate. RESULTSOf the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, years; 52% female; 53% insulin pump use; mean HbA 1c , 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, −1.9% (−27 minutes per day); 95% CI, −2.8% to −1.1% [−40 to −16 minutes per day]; P <.001). Of the 31 prespecified secondary end points, there were statistically significant differences for all 9 CGM metrics, 6 of 7 HbA 1c outcomes, and none of the 15 cognitive and patient-reported outcomes. Mean HbA 1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, −0.3%; 95% CI, −0.4% to −0.1%; P <.001). The most commonly reported adverse events using CGM and standard BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits (6 and 8).CONCLUSIONS AND RELEVANCE Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit.

AimTo evaluate the efficacy and safety of mealtime or post‐meal fast‐acting insulin aspart (faster aspart) vs mealtime insulin aspart (IAsp), both in combination with insulin degludec, in participants with type 1 diabetes (T1D).MethodsThis multicentre, treat‐to‐target trial (Clinical trial registry: NCT02500706, http://clinicaltrials.gov) randomized participants to double‐blind mealtime faster aspart (n = 342) or IAsp (n = 342) or open‐label post‐meal faster aspart (n = 341). The primary endpoint was change from baseline in HbA1c 26 weeks post randomization. All available information, regardless of treatment discontinuation, was used for evaluation of the effect.ResultsNon‐inferiority for the change from baseline in HbA1c was confirmed for mealtime and post‐meal faster aspart vs IAsp (estimated treatment difference [ETD]: 95%CI, −0.02% [−0.11; 0.07] and 0.10% [0.004; 0.19], respectively). Mealtime faster aspart was superior to IAsp for 1‐hour PPG increment using a meal test (ETD, −0.90 mmol/L [−1.36; –0.45]; P < 0.001). Self‐monitored 1‐hour PPG increment favoured faster aspart at breakfast (ETD, −0.58 mmol/L [−0.99; −0.17]; P = 0.006) and across all meals (−0.48 mmol/L [−0.74; −0.21]; P < 0.001). Safety profiles and overall rate of severe or blood glucose‐confirmed hypoglycaemia were similar between treatments, but significantly less hypoglycaemia was seen 3 to 4 hours after meals with mealtime faster aspart.ConclusionMealtime and post‐meal faster aspart in conjunction with insulin degludec provided effective glycaemic control compared with IAsp, with no increased safety risk. Mealtime faster aspart provided PPG control superior to that of IAsp.

Background: Hemoglobin A1c is an excellent population health measure for the risk of vascular complications in diabetes, while continuous glucose monitoring (CGM) is a tool to help personalize a diabetes treatment plan. The value of CGM in individuals with type 1 diabetes (T1D) has been well demonstrated when compared with utilizing self-monitoring of blood glucose (SMBG) to guide treatment decisions.CGM is a tool for patients and clinicians to visualize the important role that diet, exercise, stress management, and the appropriate selection of diabetes medications can have in managing type 2 diabetes (T2D). Several diabetes organizations have recently reviewed the literature on the appropriate use of CGM in diabetes management and concluded CGM may be a useful educational and management tool particularly for patients on insulin therapy. The indications for using CGM either as a clinic-based loaner distribution model for intermittent use (professional CGM) or a CGM system owned by the patient and used at home with real-time glucose reading (personal CGM) are only beginning to be addressed in T2D. Most summaries of CGM studies conclude that having a standardized glucose pattern report, such as the ambulatory glucose profile (AGP) report, should help facilitate effective shared decision-making sessions.The future of CGM indications for the use of CGM is evolving rapidly. In some instances, CGM is now approved for making medication adjustments without SMBG confirmation and it appears that some forms of CGM will be approved for use in the Medicare population in the United States in the near future. Many individuals with T1D and T2D and their care teams will come to depend on CGM as a key tool for diabetes management.

Use of continuous glucose monitoring (CGM) is recognized as a valuable component of diabetes selfmanagement and is increasingly considered a standard of care for individuals with diabetes who are treated with intensive insulin therapy. As the clinical use of CGM technology expands, consistent and standardized glycemic metrics and glucose profile visualization have become increasingly important. A common set of CGM metrics has been proposed by an international expert panel in 2017, including standard definitions of time in ranges, glucose variability, and adequacy of data collection. We describe the core CGM metrics, as well as the standardized glucose profile format consolidating 2 weeks of CGM measurements, referred to as the ambulatory glucose profile (AGP), which was also recommended by the CGM expert panel. We present an updated AGP report featuring the core CGM metrics and a visualization of glucose patterns that need clinical attention. New tools for use by clinicians and patients to interpret AGP data are reviewed. Strategies based on the authors' experience in implementing CGM technology across the clinical care spectrum are highlighted.

Introduction: This trial assessed safety and effectiveness of an advanced hybrid closedloop (AHCL) system with automated basal (Auto Basal) and automated bolus correction (Auto Correction) in adolescents and adults with type 1 diabetes (T1D). Materials and Methods:This multi-center, single-arm study involved an intent to treat population of 157 individuals (39 adolescents aged 14-21 years and 118 adults aged ≥22-75 years) with T1D. Study participants used the MiniMed™ AHCL system during a baseline run-in period in which sensor-augmented pump +/-predictive low glucose management or Auto Basal was enabled for ~14 days. Thereafter, Auto Basal and Auto Correction were enabled for a study phase (~90 days), with glucose target set to 100mg/dL or 120mg/dL for ~45 days, followed by the other target for ~45 days. Study endpoints included safety events and change in mean A1C, time in range (TIR, 70-180mg/dL) and time below range (TBR, <70mg/dL). Run-in and study phase values were compared using Wilcoxon signedrank test a or paired t-test.Results: Overall group time spent in closed loop averaged 94.9±5.4% and involved only 1.2±0.8 exits/week. Compared to run-in, AHCL reduced A1C from 7.5±0.8% to 7.0±0.5% (<0.001 a , N=155), TIR increased from 68.8±10.5% to 74.5±6.9% (<0.001 a ) and TBR reduced from 3.3±2.9% to 2.3±1.7% (<0.001 a ). Similar benefits to glycemia were observed for each age group, and were more pronounced for the nighttime (12AM-6AM). The 100mg/dL target increased TIR to 75.4% (N=155), that was further optimized at a lower active insulin time setting (i.e. 2 hours), without increasing TBR. There were no severe hypoglycemia or diabetic ketoacidosis events during the study phase.Conclusions: These findings show that the MiniMed™ AHCL system is safe and allows for achievement of recommended glycemic targets in adolescents and adults with T1D.Adjustments in target and active insulin time settings may further optimize glycemia and improve user experience. a Wilcoxon signed-rank test.

The significant and growing global prevalence of diabetes continues to challenge people with diabetes (PwD), healthcare providers and payers. While maintaining near-normal glucose levels has been shown to prevent or delay the progression of the long-term complications of diabetes, a significant proportion of PwD are not attaining their glycemic goals. During the past six years, we have seen tremendous advances in automated insulin delivery (AID) technologies. Numerous randomized controlled trials and real-world studies have shown that the use of AID systems is safe and effective in helping PwD achieve their long-term glycemic goals while reducing hypoglycemia risk. Thus, AID systems have recently become an integral part of diabetes management. However, recommendations for using AID systems in clinical settings have been lacking. Such guided recommendations are critical for AID success and acceptance. All clinicians working with PwD need to become familiar with the available systems in order to eliminate disparities in diabetes quality of care. This report provides much-needed guidance for clinicians who are interested in utilizing AIDs and presents a comprehensive listing of the evidence payers should consider when determining eligibility criteria for AID insurance coverage.