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Effectiveness of continuous glucose monitoring in adults with Type 2 diabetes treated with basal insulin

Key Takeaway

In patients with T2D and poor glycemic control receiving BI without prandial insulin, CGM vs BGM monitoring showed:

  • Significantly greater improvement in -8month HbA 1c level
  • Increased time in target glucose range of 70–180mg/dL
  • Reduction in both time spent at >250 mg/dL and mean glucose level

Why This Matters

  • Glucose monitoring is critical for safe and effective management of individuals with T2D using insulin
  • As the role of CGM in T2D using less-intensive insulin regimens is not well defined; present study compared CGM vs BGM monitoring in this study population.

Study Design

This Multicenter, Randomized (N = 175 [CGM Or BGM Group: 2:1]), Open - Label, Parallel - Group Trial Was Conducted At 15 Centers In The United States*

Key inclusion criteria

  • Age ≥30 years
  • T2D treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin for ≤6 months
  • HbA 1c: 7.8%–11.5%
  • Self-reported BGM testing: ≥3 times per week
  • Smart phone compatible with CGM device

Study outcomes

  • Primary outcome: HbA1c level at 8 months (adjusted for BL value)
  • Key secondary outcomes:
    • Time in target glucose range of 70-180 mg/dL
    • Time at glucose level >250 mg/dL
    • Mean glucose level at 8 months (adjusted for BL value)

Key Result

A total of 175 participants were randomized (2:1) into CGM vs BGM group
(n = 116 vs 59; mean age = 57 years; mean BL HbA1c = 9.1%)

Primary outcome (cgm vs bgm group):

  • HbA1c level at 8 months 8.0% vs 8.4% (adjusted difference in mean change in HbA1c level from baseline:
    • -0.4% [%95 CI: %0.8− to %0.1−; P = 0.02])

Key secondary outcomes (cgm vs bgm group):

  • Time in target glucose range of 70-180 mg/dL (mean%): 59% vs 43% (adjusted mean difference: 15% [%95 CI: %8 to %23; P <0.001§])
  • Time at glucose level >250 mg/dL (mean%):11% vs 27% (adjusted mean difference: −16% [%95 CI: %21− to %11−; P <0.001¶])
  • Mean glucose levels at 8 months: 179 vs 206 mg/dL (adjusted difference: 26− mg/dL [%95 CI: 41− to 12−; P <0.001])
  • ADVERSE EVENTS: Severe hypoglycemic event (one in both, CGM and BGM group) and diabetic ketoacidosis (one in CGM group)
  • CGM satisfaction scale: Mean score (CGM group) = 4.1/5

Limitations

  • Follow-up duration was only 8 months
  • Due to virtual visits -8month HbA 1c or CGM data was not available for some participants
  • Limited generalizability of study findings to most routine clinical practice settings
  • In one-third of the CGM group HbA1c level still remained >%8 after 8 months highlighting the need for more aggressive pharmacological management

* Included participants not visiting an endocrinologist for diabetes and recruited participants from primary care practices.
 For data uploading.
Adjusted for BL values (mean BL HbA1c level [CGM vs BGM group] = %9.1 vs %9.0).
§ Equivalent to 3.6 hours more per day.
Equivalent to 3.8 hours less per day.
#The study participants had greater contact with the clinic staff vs typical usual care scenario

BL, baseline; BI, basal insulin; BGM, blood glucose meter; CGM, continuous glucose monitoring; CI, confidence interval; HbA1c, hemoglobin A1c; T2D, type 2 diabetes.

  1. Martens T, Beck RW, Bailey R, Ruedy KJ, Calhoun P, Peters AL, et al. Effect of continuous glucose monitoring on glycemic control in patients with type 2 diabetes treated with basal insulin: A randomized clinical trial. JAMA. 2272–2262:(22)325;2021. doi: 10.1001/jama.2021.7444. PMID: 34077499.
MAT-BH-2300652/v1/October 2023