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Regulation of Expression Occurs at Multiple Steps02:24

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Gene expression can be regulated at almost every step from gene to protein. Transcription is the step that is most commonly regulated. This involves the binding of proteins to short regulatory sequences on the DNA. This association can either promote or inhibit the transcription of a gene associated with the respective sequence.
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Self-regulation, also known as self-control, encompasses a range of cognitive and behavioral processes that allow individuals to adjust their internal states and outward actions to align with socially acceptable norms and long-term goals. It plays a fundamental role in adaptive functioning, from resisting impulsive behaviors to persisting through challenging tasks. While its benefits are widely recognized, self-regulation is not limitless. Muraven and Baumeister's theory posits that...
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Cellular needs and conditions vary from cell to cell and change within individual cells over time. For example, the required enzymes and energetic demands of stomach cells are different from those of fat storage cells, skin cells, blood cells, and nerve cells. Furthermore, a digestive cell works much harder to process and break down nutrients during the time that closely follows a meal compared with many hours after a meal. As these cellular demands and conditions vary, so do the amounts and...
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Updated: Mar 15, 2026

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Regulation Catches Up to Reality.

Steven V Edelman1

  • 11 University of California San Diego, San Diego, CA, USA.

Journal of Diabetes Science and Technology
|September 16, 2016
PubMed
Summary

The FDA is evaluating the Dexcom G5 Mobile continuous glucose monitoring (CGM) system for a nonadjunctive label claim. This would allow treatment decisions, like insulin dosing, directly from CGM data, improving diabetes care and hypoglycemia protection.

Area of Science:

  • Endocrinology
  • Medical Devices
  • Diabetes Technology

Background:

  • Continuous Glucose Monitoring (CGM) systems offer advantages over Self-Monitoring of Blood Glucose (SMBG) meters.
  • CGM provides frequent glucose readings, trend data, alerts, and remote monitoring capabilities.
  • Sporadic SMBG testing offers limited insights into glycemic variability.

Purpose of the Study:

  • To evaluate the safety, efficacy, and benefits of a nonadjunctive label claim for the Dexcom G5 Mobile CGM system.
  • To assess the potential for users to make treatment decisions, including insulin dosing, directly from CGM data.
  • To determine if this claim would improve diabetes management and reduce hypoglycemia.

Main Methods:

  • FDA Advisory Panel meeting convened to review data on the Dexcom G5 Mobile CGM system.
Keywords:
CGMFDA panel meetingSMBGnonadjunctive claim

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  • Evaluation of the system's performance for nonadjunctive use.
  • Assessment of benefits related to treatment decisions and hypoglycemia prevention.

    • Main Results:

    • The Advisory Panel meeting focused on the potential for the Dexcom G5 Mobile CGM to be used without confirmatory SMBG measurements.
    • The system's ability to provide real-time glucose values, rate of change arrows, alerts, and trending information was considered.
    • The potential for improved overall diabetes care and protection against hypoglycemia was discussed.

    Conclusions:

    • Approval of a nonadjunctive label claim for the Dexcom G5 Mobile CGM could significantly impact diabetes management.
    • This approval would empower users to make critical treatment decisions based solely on CGM data.
    • Widespread adoption of CGM for nonadjunctive use is anticipated to enhance patient care and safety, particularly in preventing hypoglycemia.