Effect of Continuous Glucose Monitoring System Alerts on Diabetes Management in the Hospital

Last updated: December 21, 2025
Sponsor: Shanghai 6th People's Hospital
Overall Status: Completed

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Treatment

CGM system with glucose alerts off

CGM system with only glucose threshold alerts on

CGM system with both glucose predictive alerts and threshold alerts on

Clinical Study ID

NCT05941286
2023061201
  • Ages > 18
  • All Genders

Study Summary

Current continuous glucose monitoring (CGM) devices provide features that alert for current and impending adverse glycemic events.This trial aims to examine whether these glucose alerts provided added benefit on glycemic outcomes in patients with type 1 or 2 diabetes who required intensive insulin therapy during hospitalization.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Males and females ≥ 18 years.

  2. Type 1 or type 2 diabetes with suboptimal glucose control requiring hospitalization,as determined by endocrinologists following clinical guidelines.

  3. Willingness and ability to comply with the clinical investigation plan.

Exclusion

Exclusion Criteria:

  1. significant hyperglycemia or diabetic ketoacidosis requiring continuous intravenousinsulin infusion.

  2. Female subjects who are pregnant or have a plan of pregnancy at time of enrollmentinto the study.

  3. Current users of real-time glucose monitoring sensors or flash-glucose monitoring.

  4. Participants were unable to tolerate tape adhesive around sensor placement area, orwith medically documented allergy towards the adhesive (glue) of plasters, or withserious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) aroundsensor placement area.

  5. Patients expected to require operation, admission to the ICU and MRI proceduresduring hospitalization.

  6. Mental condition rendering the subject unable to understand the nature, scope, andpossible consequences of the study.

Study Design

Total Participants: 533
Treatment Group(s): 4
Primary Treatment: CGM system with glucose alerts off
Phase:
Study Start date:
April 18, 2024
Estimated Completion Date:
December 16, 2024

Study Description

Glycemic management for patients with diabetes during hospitalization is highly challenging, especially for those requiring intensive insulin therapy. For those patients, hypoglycemia is a common adverse event, which is associated with adverse clinical outcomes. Bedside capillary point-of-care (POC) glucose monitoring is the standard of care to assess glycemic control in the hospital. However, POC glucose testing only provides glucose measurements at specific time points, leading to missed information important for glycemic control. Continuous glucose monitoring (CGM) measures interstitial glucose every 5 min, thus providing a more complete glycemic profile during a 24 h period compared with standard POC glucose testing.

The cloud-based real-time continuous glucose monitoring (RT-CGM) and management system was previously observed to be safe and effective in guiding intensive insulin therapy. Therefore, this CGM intergraded system holds promise for improving glucose control in patients with diabetes during hospitalization. However, it is currently unclear if alerts are the main reason for the better outcome in the RT-CGM groups, or rather the fact that sensor values are available in real-time. Moreover, the current system provided the feature of predictive threshold alerts that could alert before the onset of clinical hypoglycemia or hyperglycemia. Thus, this trial aims to examine whether these glucose alerts provided added benefit on glycemic outcomes in patients with type 1 or 2 diabetes who required intensive insulin therapy during hospitalization.

Connect with a study center

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai 200233
    China

    Site Not Available

  • Shanghai Sixth People's Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200233
    China

    Site Not Available

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