Clinical Outcomes
Source: National Institute for Health and Care Excellence (NICE) Guideline – Diabetes in Pregnancy: Management from Preconception to the Postnatal Period (2020)
Key Takeaway: In December 2020, NICE reviewed the evidence and changed the recommendations on intermittently scanned CGM (isCGM, also commonly referred to as flash) and continuous glucose monitoring during pregnancy for women with type 1 diabetes.
Recommendations for Managing Diabetes During Pregnancy-Intermittently scanned CGM and continuous glucose monitoring
| 1.3.17 | Offer continuous glucose monitoring (CGM) to all pregnant women with type 1 diabetes to help them meet their pregnancy blood glucose targets and improve neonatal outcomes. |
| 1.3.18 | Offer intermittently scanned CGM (isCGM, commonly referred to as flash) to pregnant women with type 1 diabetes who are unable to use continuous glucose monitoring or express a clear preference for it. |
| 1.3.19 | Consider continuous glucose monitoring for pregnant women who are on insulin therapy but do not have type 1 diabetes, if they have problematic severe hypoglycaemia (with or without impaired awareness of hypoglycaemia) or they have unstable blood glucose levels that are causing concern despite efforts to optimise glycaemic control. |
| 1.3.20 | For pregnant women who are using isCGM or continuous glucose monitoring, a member of the joint diabetes and antenatal care team with expertise in these systems should provide education and support (including advising women about sources of out-of-hours support). |
For a short explanation of why the committee made the 2020 recommendations and how they might affect practice, see the rationale and impact section on flash and continuous glucose monitoring on pages 35-36 in the Guideline. Full details of the evidence and the committee’s discussion are in evidence review A: continuous glucose monitoring.
LEARN MORESource: AMCP Science and Innovation Theater Webinar – November 17, 2020
Key Takeaway: Advances in the Dexcom G6 technology are an important CGM differentiator that allows for improved safety, glycemic management and telehealth opportunities for persons 2 years and older through the use of real-time CGM data with features such as a predictive Urgent Low Soon alert, customizable high/low glycemic threshold alerts, remote monitoring and the CLARITY diabetes management application.
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Key Takeaway: Real-world data from the German/Austrian Prospective Diabetes Follow-Up Registry showed real-time continuous glucose monitoring was associated with a higher percentage of Time-in-Range and improved metabolic stability as compared to intermittent scanning continuous glucose monitoring.
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Key Takeaway: A recent systematic review and meta-analysis of 15 randomized controlled trials involving 2,461 patients showed greater improvement in mean hemoglobin A1c, time in target range, and time above range with use of real-time continuous glucose monitoring as compared to intermittently scanned continuous glucose monitoring.
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Key Takeaway: In a Medicaid population of youth with Type 1 Diabetes, uninterrupted continuous glucose monitoring (CGM) use was associated with improvements in hemoglobin A1c. Interruptions in use—primarily due to gaps in insurance coverage of CGM—were associated with increased hemoglobin A1c, supporting initial and ongoing CGM coverage in high-risk, publicly insured demographics.
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Key Takeaway: Recent data from a prospective, randomized study conducted by Intermountain Health suggests that real-time CGM can reduce healthcare utilization and decrease the overall cost of care compared to SMBG. Participants reported that real-time CGM data were helpful in modifying their nutrition, physical activity, stress, and medication adherence.
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Key Takeaway: In a 16-week trial funded by the NIDDK and Tandem Diabetes Care, 101 children ages 6-13 with type 1 diabetes were randomized to a closed-loop system of insulin delivery (n=78) or the control group (n=23) where patients used a sensor-augmented insulin pump. Children using the closed-loop system, consisting of a t:slim X2 insulin pump with Control-IQ technology and a Dexcom G6 CGM, saw a significant time in range (TIR) improvement (target 70-180 mg/dL) from 53% at baseline to 67% (equivalent to 3.4 more hours per day; p<0.001) at the end of the study. The control group saw a smaller TIR increase from 51% at baseline to 55% at the end of the study. Notably, TIR increased most significantly overnight with children reaching 80% overnight TIR compared to 54% in the control group. The treatment effect was evident in the first month and appeared consistent over 4 months. Control-IQ technology demonstrated benefits across a broad range of baseline characteristics and proved easy to use for children and their parents.
Learn MoreSource: Journal of the American Medical Association
Key Takeaway: Six-month, multicenter, randomized controlled trial using the Dexcom G5. The baseline population had diverse racial/ethnic backgrounds (38% Hispanic or non-white), high baseline HbA1c levels, and 41% had public health insurance. The trial showed a 0.4% A1c advantage in favor of CGM over BGM (p=0.01; baseline: 8.9%). Moreover, more than twice as many in the CGM group as compared to the BGM group achieved an A1c reduction ≥0.5% (44% vs. 21%, p=0.005) and over four-times as many participants in the CGM group vs. the BGM group saw an A1c reduction of ≥1% (25% vs. 6%, p=0.003). The CGM group also saw a 1.7 hour/day advantage vs. BGM on time-in-range (70-180 mg/dl) (p<0.001). Over two-thirds of the CGM group were using CGM at least five days/week by the end of the six-month study – the highest CGM use observed for adolescents in a study to date. Moreover, the CGM group reported significantly higher glucose monitoring satisfaction, measured via the Glucose Monitoring Satisfaction Survey score, at 26 weeks than the BGM group . Newer models of CGM devices that eliminate fingerstick calibration should lead to improved wearability and glycemic control even beyond the measured benefits observed in this trial. Improved glycemic control early in diabetes duration may prevent diabetes complications later in adulthood, making CGM an attractive option for this population.
Source: Journal of the American Medical Association
Key Takeaway: Older populations are more prone than younger populations to severe hypoglycemic episodes, which in turn contribute to dementia, risk of falls, glycemic variability, and mortality. To study whether CGM could reduce hypoglycemia incidence, Pratley and colleagues performed a randomized clinical trial that compared the effect of CGM (n = 103) with BGM (n = 100) in older adults (median age, 68 years) with type 1 diabetes in 22 diabetes centers across the US. The primary outcome was reduction in hypoglycemia (glucose <70mg/dL) over 6 months. Results showed that the median time in hypoglycemia was reduced from 73 minutes to 39 minutes per day in the CGM group compared with no change (from 68 minutes to 70 minutes per day) in the BGM group, an adjusted between group reduction of 27 minutes per day (95% CI, −40 to −16 min/d). Additionally, the median percentage of time with blood glucose levels below the range for severe hypoglycemia (glucose <54mg/dL) reached the goal per international guidelines (<14min/d in older adults). Moreover, only 1 severe hypoglycemic event (glucose <54mg/dL) occurred in the CGM group vs 10 in the BGM group, with 5 of those events involving seizure or loss of consciousness. 83% of participants in the CGM group used CGM at least 6 days per week during month 6 and the results did not differ by level of cognitive impairment, education level, or age. In summary, CGM reduced the time spent in the severe hypoglycemic range, which has health care use, mortality, morbidity, and economic benefits.
Source: Diabetes Technology & Therapeutics
Key Takeaway: CGM initiated within the first year of T1D diagnosis was effective in lowering and maintaining A1C for 2.5 years and reduced the frequency of ED visits related to hypoglycemia and hyperglycemia irrespective of insulin delivery method.
