Continuous Glucose Monitoring for In-hospital Management of Type 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSteno Diabetes Center Copenhagen
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Continuous glucose monitoring
DeviceParticipants in this arm are monitored with CGM and treated with support from a CGM-based algorithm for insulin titration.
Treatment groups
314 Participants
are divided into 2 treatment groupsGroup A: POC-armNo intervention 0 interventions
Group B: CGM-armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of time spent in range (3.9-10.0 mmol/L)
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.
Time frame
From enrollment to end of hospitalization.2
Inhospital complications
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.
Time frame
From enrollment to end of hospitalization.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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