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Abstract
Background: The I HART CGM study showed that real-time continuous glucose monitoring (RT-CGM) has greater beneficial impact on hypoglycemia than intermittent flash glucose monitoring (flash) in adults with type 1 diabetes (T1D) at high risk. The impact of continuing RT-CGM or switching from flash to RT-CGM for another 8 weeks was then evaluated.Methods: Prospective randomized parallel group study with an extension phase. After a 2-week run-in with blinded CGM, participants were randomized to either RT-CGM or flash for 8 weeks. All participants were then given the option to continue with RT-CGM for another 8 weeks. Glycemic outcomes at 8 weeks are compared with the 16-week endpoint.Results: Forty adults with T1D on intensified multiple daily insulin injections and with impaired awareness of hypoglycemia or a recent episode of severe hypoglycemia were included (40% female, median [IQR] age 49.5 [37.5–63.5] years, diabetes duration 30.0 [21.0–36.5] years, HbA1c 56 [48–63] mmol/mol, and Gold Score 5 [4–5]), of whom 36 completed the final 16-week extension. There was a significant reduction in percentage time in hypoglycemia (<3.0 mmol/L) in the group switching from flash to RT-CGM (from 5.0 [3.7–8.6]% to 0.8 [0.4–1.9]%, P = 0.0001), whereas no change was observed in the RT-CGM group continuing with the additional 8 weeks of RT-CGM (1.3 [0.4–2.8] vs. 1.3 [0.8–2.5], P = 0.82). Time in target (3.9–10 mmol/L) increased in the flash group after switching to RT-CGM (60.0 [54.5–67.8] vs. 67.4 [56.3–72.4], P = 0.02) and remained the same in the RT-CGM group that continued with RT-CGM (65.9 [54.1–74.8] vs. 64.9 [49.2–73.9], P = 0.64).Conclusions: Our data suggest that switching from flash to RT-CGM has a significant beneficial impact on hypoglycemia outcomes and that continued use of RT-CGM maintains hypoglycemia risk benefit in this high-risk population.
Highlights
Hypoglycemia is a serious acute metabolic complication of type 1 diabetes (T1D).[1]
There was a significant reduction in percentage time in hypoglycemia (
Of the initial 40 participants included in the I HART CGM study, four participants in the RT-CGM group did not complete the second 8-week treatment period with RT-CGM (one participant decided not to partake in the second treatment period, one participant lost the transmitter during the treatment period and did not inform the study team, one participant could not commit to the study due to work, and one participant did not comply with the study protocol and was excluded from the study)
Summary
Hypoglycemia is a serious acute metabolic complication of type 1 diabetes (T1D).[1]. Recurrent hypoglycemia may lead to impaired awareness of hypoglycemia (inability to recognize symptoms of hypoglycemia) and severe hypoglycemia (requiring third-party assistance to treat), both of which are associated with increased morbidity and mortality.[2,3,4,5] Hypoglycemia, especially severe hypoglycemia, adds a significant burden to the health cost worldwide.[6]Capillary finger-prick blood glucose testing remains the mainstay of self-monitoring of blood glucose (SMBG)Division of Diabetes, Endocrinology and Metabolism, Imperial College, London, United Kingdom. The I HART CGM study showed that real-time continuous glucose monitoring (RT-CGM) has greater beneficial impact on hypoglycemia than intermittent flash glucose monitoring (flash) in adults with type 1 diabetes (T1D) at high risk. There was a significant reduction in percentage time in hypoglycemia (
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