Continuous Glucose Monitoring System, Diabetes, Inpatient
Conditions
Brief summary
Title: Continuous glucose monitoring vs point of care glucose measurements for in-hospital type 2 diabetes management - STENO In-Hospital CGM Trial - a multisite, randomized controlled trial. Aim To investigate the effects and feasibility of continuous glucose monitoring (CGM) on in-hospital glycemic and clinical outcomes in hospitalized, non-intensive care unit (non-ICU) patients with type 2 diabetes compared to standard point-of-care (POC) glucose testing. Population: Non-ICU adults with type 2 diabetes at the participating departments at hospitals in the Capital Region of Denmark. Design: Investigator-initiated, multi-site, two-armed, prospective, randomized, open-labelled blinded endpoint (PROBE) trial. Participants are randomized 1:1 to either a POC-arm (control) or a CGM-arm (intervention): * POC-arm (control): Participants in this arm are monitored with standard of care POC-based glucose monitoring and treated with insulin according to national guidelines. Blinded CGM is applied. * CGM-arm (intervention): Participants in this arm are monitored with CGM and treated with support from a CGM-based algorithm for insulin titration. In the CGM-arm, a diabetes support team assists in insulin titration to ensure the execution of algorithmic decisions according to protocol. In the POC-arm the same diabetes support team will ensure that participants are treated with insulin according to national guidelines. Objectives: To compare in-hospital glycemic control and clinical outcomes between the POC- and CGM-arm participants. Outcomes: Time in range (3.9-10.0 mmol/L) and in-hospital complications are the primary outcomes. Additional secondary glycemic outcomes are reported in alignment with the newest consensus on CGM-metrics for in-hospital glucose management. Key secondary clinical outcomes are length of stay, 7-, 30-, 60-, and 90-days mortality and readmission rates after discharge. Tertiary outcomes are net costs of the two methods for handling in-hospital diabetes, and an assessment of potential heterogeneity of treatment effects from CGM compared to POC. Method: POC glucose measurements are transmitted to the Electronic Medical Record (Sundhedsplatformen). CGM data from the Dexcom G7 is transmitted to a separate web-based platform, Dexcom CLARITY, for retrospective review. Additionally, real-time glucose data from the Dexcom G7 is displayed on tablets/iPhones at diabetes support team stations for ongoing monitoring. Investigational device: Dexcom G7 CGM (Dexcom Inc., San Diego, USA). Time schedule: Inclusion Q2 2025 to Q4 2026.
Interventions
DEVICEContinuous glucose monitoring
Participants in this arm are monitored with CGM and treated with support from a CGM-based algorithm for insulin titration.
Sponsors
Steno Diabetes Center Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Type 2 diabetes defined as treatment with at least one glucose-lowering therapy prior to inclusion AND * age ≥ 18 years old AND * willingness and ability to comply with the trial protocol AND * ability to communicate (in Danish or English) with the trial personnel AND * an expected length of hospital stay for at least two days after enrolment.
Exclusion criteria
* Known hypersensitivity to the band-aid of the CGM Dexcom G7 sensor OR * Pregnancy OR * Patients admitted with diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS) OR * Concomitant treatment with hydroxyurea (CGM contraindication) OR * Treatment with enteral or parenteral nutrition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time spent in range (3.9-10.0 mmol/L) | From enrollment to end of hospitalization. | Primary outcome measures are collected from the day of inclusion (hospitalization) of a participant until the day the participant is discharged from the hospital. The duration of the hospitalization varies for each participant and will rarely exceed 30 days. |
| Inhospital complications | From enrollment to end of hospitalization. | Primary outcome measures are collected from the day of inclusion (hospitalization) of a participant until the day the participant is discharged from the hospital. The duration of the hospitalization varies for each participant and will rarely exceed 30 days. |
Outcome results
None listed