Clinical trial NCT05941286: Effect of Continuous Glucose Monitoring System Alerts on Diabetes Management in the Hospital
Official title: Effect of Continuous Glucose Monitoring System Alerts on Diabetes Management in the Hospital: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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 Criteria:

1. significant hyperglycemia or diabetic ketoacidosis requiring continuous intravenous insulin infusion.
2. Female subjects who are pregnant or have a plan of pregnancy at time of enrollment into 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, 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.
5. Patients expected to require operation, admission to the ICU and MRI procedures during hospitalization.
6. Mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.

Primary outcomes:
measure: Time in range (3.9~10.0mmol/L, %)
timeFrame: Through study completion (during hospitalization, 5-7 days)
Secondary outcomes:
measure: Time above range (>10.0mmol/L, %)
timeFrame: Through study completion (during hospitalization, 5-7 days)
measure: Time above range (>13.9mmol/L, %)
timeFrame: Through study completion (during hospitalization, 5-7 days)
measure: Time below range (<3.9mmol/L, %)
timeFrame: Through study completion (during hospitalization, 5-7 days)
measure: Time below range (<3.0mmol/L, %)
timeFrame: Through study completion (during hospitalization, 5-7 days)
measure: Time in range (3.9~7.8mmol/L, %)
timeFrame: Through study completion (during hospitalization, 5-7 days)
measure: Glycemia risk index (GRI)
timeFrame: Through study completion (during hospitalization, 5-7 days)
measure: Mean sensor glucose (MSG)
timeFrame: Through study completion (during hospitalization, 5-7 days)
measure: Coefficient of variation (CV)
timeFrame: Through study completion (during hospitalization, 5-7 days)
measure: Standard deviation (SD)
timeFrame: Through study completion (during hospitalization, 5-7 days)
Other outcomes:
measure: Time taken to achieve target glucose (days)
timeFrame: Through study completion (during hospitalization, 5-7 days)
measure: Length of hospital stay (days)
timeFrame: Through study completion (during hospitalization, 5-7 days)
measure: Total daily insulin dose (units/kg/day)
timeFrame: Through study completion (during hospitalization, 5-7 days)
measure: Total daily basal insulin dose (units/kg/day)
timeFrame: Through study completion (during hospitalization, 5-7 days)
measure: Total prandial insulin dose (units/kg/day)
timeFrame: Through study completion (during hospitalization, 5-7 days)
Locations:
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Jian Zhou
role: PRINCIPAL_INVESTIGATOR
References: