Effect of Continuous Glucose Monitoring on Hypoglycemia in Older Adults With Type 1 Diabetes

Abstract

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.

Glycemic Improvement Using Continuous Glucose Monitoring by Baseline Time in Range: Subgroup Analyses from the DIAMOND Type 1 Diabetes Study

“…S everal studies have shown use of continuous glucose monitors (CGMs) can improve glycemic control and reduce hypoglycemia for participants with type 1 diabetes (T1D). [1][2][3] The DIAMOND T1D trial found that participants randomized to receive a real-time continuous glucose monitor (rtCGM) had a 0.6% greater reduction in mean hemoglobin A1c (HbA1c) and spent an additional 77 min per day in range 70-180 mg/dL compared with participants in selfmonitoring of blood glucose (SMBG) group. 4 Beyond the finding of a clinically relevant overall benefit of rtCGMs, it is important to assess improvement at an individual level to identify individuals who can potentially benefit the most from rtCGM use.…”

Continuous Glucose Monitoring in Adolescent, Young Adult, and Older Patients With Type 1 Diabetes

“…In this issue of JAMA, 2 clinical trials provide important data on the efficacy of CGM in these high-risk populations with type 1 diabetes. 5,6 The periods of adolescence and young adulthood (13-24 y) are distinctive developmental stages marked by transition of disease self-management tasks from family to self in the midst of tumultuous change in an individual's social, geographic, financial, and health care situations. 7 As a result, adolescents and young adults exhibit the highest hemoglobin A 1c (HbA 1c ) levels and rates of hospitalization of all age groups with type 1 diabetes.…”

“…12,13 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. 14 To study whether CGM could reduce hypoglycemia incidence, Pratley and colleagues 6 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 <70 mg/dL) over 6 months.…”

Standardized Hybrid Closed-Loop System Reporting

“…1 Several decades were required to evolve from urine glucose monitoring to self-monitoring of blood glucose. 2 Despite ample evidence demonstrating the efficacy of a continuous glucose monitor (CGM) in improving glycemic control and safety in hypoglycemia reduction in patients with insulin-requiring diabetes, [3][4][5][6][7][8] it required nearly two decades to replace glucose meters (that too on a limited basis). 9 Usually it requires a decade to adopt new changes in the clinical practice, commonly known as the ''research to practice gap.''…”