Continuous Glucose Monitoring for In-hospital Management of Type 2 Diabetes

Sponsor
Steno Diabetes Center Copenhagen
Study ID
NCT07796802
Status
Not Yet Recruiting

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Conditions

  • Continuous Glucose Monitoring System
  • Diabetes
  • Inpatient

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Continuous glucose monitoring — DEVICE
    Participants in this arm are monitored with CGM and treated with support from a CGM-based algorithm for insulin titration.

Study Details

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.

Key Dates

First listed
Sep 1, 2026
Start date
Mar 1, 2027
Status verified
Aug 2025
Primary completion
Mar 1, 2028
Completion
May 1, 2028

Study Design

Enrollment
314 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: POC-arm
  • Experimental: CGM-arm

Primary Outcome Measure

Percentage of time spent in range (3.9-10.0 mmol/L) [ Time Frame: From enrollment to end of hospitalization. ]

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