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Reduction in hemoglobin A1C with real-time continuous glucose monitoring: results from a 12-week observational study
Timothy S Bailey1, Howard C Zisser, Satish K Garg
1North County Endocrine Medical Group, Escondido, California, USA.
Insights
Real-time continuous glucose monitoring (CGM) significantly lowered hemoglobin A1c (HbA1c) in adults with diabetes. Increased use of CGM devices correlated with greater HbA1c reductions, demonstrating its effectiveness in diabetes management.
Area of Science:
- Endocrinology
- Metabolic Diseases
- Medical Devices
Background:
- 140 adults with diabetes participated in a 12-week home-use study of real-time continuous glucose monitoring (CGM).
- Hemoglobin A1c (HbA1c) levels were measured at baseline, week 6, and week 12 to assess glycemic control.
Purpose of the Study:
- To evaluate the safety, tolerability, and efficacy of real-time CGM in adults with diabetes during home use.
- To determine the impact of CGM on Hemoglobin A1c (HbA1c) levels over a 12-week period.
Main Methods:
- Participants received CGM devices and training, with initial sensor insertion supervised by staff.
- The CGM system provided real-time glucose values, trend graphs, and alerts at 5-minute intervals.
- Follow-up visits every 3 weeks facilitated resupply, data download, and monitoring.
Main Results:
- A statistically significant reduction in HbA1c of 0.4% was observed overall (P < 0.0001).
- Significant HbA1c reductions were noted in both type 1 and type 2 diabetes subgroups, as well as those using insulin injections or pumps.
- Subjects with baseline HbA1c >9.0% experienced the largest reduction (1.4%), and increased CGM usage correlated with greater HbA1c decrease.
Conclusions:
- Home use of real-time CGM is safe, well-tolerated, and leads to clinically significant HbA1c reductions.
- The study supports the utility of CGM as a valuable tool for diabetes management.
- Further large-scale randomized controlled outcome studies are warranted to confirm CGM's long-term benefits.
Background:
Real-time continuous glucose monitoring (CGM) was studied in 140 adults with diabetes over a 12-week period of home use. Hemoglobin A(1c)(HbA1c) was measured on day 1 (baseline) and at weeks 6 and 12.
Methods:
On day 1, participants received the CGM device (STS(R) System, DexCom, Inc., San Diego, CA) and underwent training on proper use. Insertion of the first sensor was performed under staff supervision. Subjects inserted subsequent sensors on their own. After calibration, the device (a 3-day sensor, receiver, and transmitter) provided users with real-time glucose values updated at 5-min intervals, glucose trend graphs, configurable high/low alerts, and a hypoglycemia alarm (
Results:
Overall, a reduction in HbA1c of 0.4 +/- 0.05% (least squares mean +/- SE) was observed, P < 0.0001. Significant HbA1c reductions were observed across subgroups of subjects with both type 1 and 2 diabetes, and those delivering insulin by multiple daily injections and pumps. The largest HbA1c reduction (1.4 +/- 0.4%) was observed in subjects with baseline HbA1c >9.0%. Increased CGM use was associated with greater reductions in HbA1c.
Conclusions:
This observational study showed that home use of real-time GCM was safe and well tolerated and associated with a clinically and statistically significant reduction in HbA1c. Large-scale randomized, controlled outcome studies of CGM are indicated.
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