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

NCT05941286 | Completed DMC FDA Device

• 1 other identifier: 2023061201
• Study Type: interventional
• Target: 533
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Time in range (3.9~10.0mmol/L, %)

  Percentage of time within glucose level of 3.9-10.0 mmol/L (70-180 mg/dL) measured by CGM.

  Through study completion (during hospitalization, 5-7 days)

Secondary Outcomes (9)

• Time above range (>10.0mmol/L, %)

  Through study completion (during hospitalization, 5-7 days)

• Time above range (>13.9mmol/L, %)

  Through study completion (during hospitalization, 5-7 days)

• Time below range (<3.9mmol/L, %)

  Through study completion (during hospitalization, 5-7 days)

• Time below range (<3.0mmol/L, %)

  Through study completion (during hospitalization, 5-7 days)

• Time in range (3.9~7.8mmol/L, %)

  Through study completion (during hospitalization, 5-7 days)

Other Outcomes (5)

• Time taken to achieve target glucose (days)

  Through study completion (during hospitalization, 5-7 days)

• Length of hospital stay (days)

  Through study completion (during hospitalization, 5-7 days)

• Total daily insulin dose (units/kg/day)

  Through study completion (during hospitalization, 5-7 days)

Study Arms (3)

CGM system with both glucose predictive alerts and threshold alerts on

EXPERIMENTAL

Patients will wear a real-time CGM (The Guardian Connect CGM System with Guardian sensor 3, Medtronic), which provide glucose readings every 5 minutes for up to 7 days. High/low predictive/threshold alerts will be enabled in this group, with low glucose alert set at 3.9 mmol/L and high glucose alert set at 16.7 mmol/L. Notably, predictive threshold alerts are triggered when a high/low glucose value is predicted within the next 15 min. In addition, patients will undergo POC testing at least 4 times per day (usually before meals and bedtime).

Device: CGM system with both glucose predictive alerts and threshold alerts on

CGM system with only glucose threshold alerts on

EXPERIMENTAL

Patients will wear a real-time CGM (The Guardian Connect CGM System with Guardian sensor 3, Medtronic), which provide glucose readings every 5 minutes for up to 7 days. Only high/low threshold alerts will be enabled in this group, with the same high/low glucose alert set, which is 3.9 mmol/L and 16.7 mmol/L respectively. In addition, patients will undergo POC testing at least 4 times per day (usually before meals and bedtime).

Device: CGM system with only glucose threshold alerts on

CGM system with glucose alerts off

ACTIVE COMPARATOR

Patients will wear a real-time CGM (The Guardian Connect CGM System with Guardian sensor 3, Medtronic), which provide glucose readings every 5 minutes for up to 7 days. High/low predictive/threshold alerts will be off in this group. In addition, patients will undergo POC testing at least 4 times per day (usually before meals and bedtime).

Device: CGM system with glucose alerts off

Interventions

CGM system with only glucose threshold alerts on DEVICE

the cloud-based real-time continuous glucose monitoring and management system with only glucose threshold alerts on

CGM system with only glucose threshold alerts on

CGM system with glucose alerts off DEVICE

the cloud-based real-time continuous glucose monitoring and management system with glucose predictive/threshold alerts off

CGM system with glucose alerts off

CGM system with both glucose predictive alerts and threshold alerts on DEVICE

the cloud-based real-time continuous glucose monitoring and management system with both glucose predictive alerts and threshold alerts on

CGM system with both glucose predictive alerts and threshold alerts on

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females ≥ 18 years.
• Type 1 or type 2 diabetes with suboptimal glucose control requiring hospitalization, as determined by endocrinologists following clinical guidelines.
• Willingness and ability to comply with the clinical investigation plan.

You may not qualify if:

• significant hyperglycemia or diabetic ketoacidosis requiring continuous intravenous insulin infusion.
• Female subjects who are pregnant or have a plan of pregnancy at time of enrollment into the study.
• Current users of real-time glucose monitoring sensors or flash-glucose monitoring.
• Participants were unable to tolerate tape adhesive around sensor placement area, or with medically documented allergy towards the adhesive (glue) of plasters, or with serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) around sensor placement area.
• Patients expected to require operation, admission to the ICU and MRI procedures during hospitalization.
• Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

Sponsors & Collaborators

• Shanghai 6th People's Hospital: lead

Study Sites (1)

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200233, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Jian Zhou

  Shanghai 6th People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Professor, Chief Physician, Deputy Director

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 12, 2023
• Study Start: April 18, 2024
• Primary Completion: December 16, 2024
• Study Completion: December 16, 2024
• Last Updated: December 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)