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

Abstract

International type 1 diabetes registries have shown that HbA 1c 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 METHODSWe 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. HbA 1c measurements were drawn after enrollment and before and after each treatment period. The primary outcome was time in range 70-180 mg/dL. RESULTSTime in range was significantly higher during CGM compared with control (35.7 6 13.5% vs. 24.6 6 9.3%; mean difference 11.1% [95% CI 7.0-15.2]; P < 0.001). CGM use reduced mean sensor glucose (219.7 6 37.6 mg/dL vs. 251.9 6 36.3 mg/dL; mean difference 232.2 mg/dL [95% CI 244.5 to 220.0]; P < 0.001) and time above range (61.7 6 15.1% vs. 73.6 6 10.4%; mean difference 11.9% [95% CI 216.4 to 27.4]; P < 0.001). HbA 1c level was reduced by 0.76% (95% CI 21.1 to 20.4) (28.5 mmol/mol [95% CI 212.4 to 24.6]; P < 0.001). Times spent below range (<70 mg/dL and <54 mg/dL) were low and comparable during both study periods. Sensor wear was 84% during the CGM period. CONCLUSIONSCGM use in young people with type 1 diabetes improves time in target and HbA 1c levels compared with SMBG.

Effectiveness of continuous glucose monitoring in maintaining glycaemic control among people with type 1 diabetes mellitus: a systematic review of randomised controlled trials and meta-analysis

“…The characteristics of the 22 included studies involving 2188 participants are summarised in Table 1. Seven studies were crossover designs [39][40][41][42][43][44][45]. The remaining 15 studies were parallelgroup designs.…”

“…Participants' mean baseline HbA 1c was either ≤64 mmol/ mol (≤8%) (n = 8) [39,40,47,[55][56][57][58]60] or >64 mmol/mol (>8%) (n = 11) [41,42,44,46,[48][49][50][51][52][53]59]. Three studies did not report participant's baseline HbA 1c [43,45,54]. Insulin delivery was via MDI alone (n = 8) [41,42,48,49,51,[55][56][57], CSII alone (n = 3) [46,54,58] and MDI/CSII (n = 11) [39, 40, 43-45, 47, 50, 52, 53, 59, 60].…”

“…The various CGM systems were P-CGM (n = 2) [51,57], isCGM (n = 2) [47,50] and RT-CGM (n = 18). Study duration was <8 weeks (n = 3) [40, 51, 57], 14-16 weeks (n = 5) [39,43,45,46,48] and >24 weeks (n = 13). Duration of diabetes was <10 years (n = 6) [46, 50-52, 56, 57], 10 years to <20 years (n = 4) [39,40,48,59], 20 years to <30 years (n = 5) [41,47,49,55,58] and ≥30 years (n = 2) [53,60].…”

Current treatment options and challenges in patients with Type 1 diabetes: Pharmacological, technical advances and future perspectives

“…Over the last years, their accuracy has been improved, and some of them have been approved for non-adjunctive use, allowing patients with T1D to adopt decisions regarding their insulin therapy without the need for capillary glucose control [63]. Some devices need calibration vs. capillary glucose to ensure adequate accuracy, but now devices factory-calibrated are available [64]. An implantable subcutaneous sensor of 180 days duration has been recently introduced: this approach avoids the need for weekly sensor replacement with similar efficacy in terms of metabolic control [65,66].…”

Technological Ecological Momentary Assessment Tools to Study Type 1 Diabetes in Youth: Viewpoint of Methodologies

“…Thus far, there is substantial evidence to suggest that CGM use is associated with improved glycemic control, including lower or improved HbA 1c , reaching target HbA 1c , decreased hyper-or hypoglycemic events or time in a hyper-or hypoglycemic state [137,138,[145][146][147][148], reduced SD or mean glucose [134,146], reduced glucose variability [134,137,148], and increased time in the target glucose range [127,137,146]. CGM use has also been shown to be related to improved treatment and outcomes, including more advanced and optimized treatment recommendations by physicians to improve glycemic outcomes [149,150], increased satisfaction with diabetes treatment [123,151], improved perceived awareness of or hormonal responses to hypoglycemia [123,152], reduced fear of hypoglycemia [153,154], reduced patient distress [139], and altered amount of insulin used per day (eg, both decreased and increased insulin use per day) [140,154].…”