Continuous Glucose Monitoring for In-hospital Management of Type 2 Diabetes
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.
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: POC-arm
|
|
|
Experimentell: CGM-arm
|
Participants in this arm are monitored with CGM and treated with support from a CGM-based algorithm for insulin titration.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of time spent in range (3.9-10.0 mmol/L)
Tidsram: 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.
|
From enrollment to end of hospitalization.
|
|
Inhospital complications
Tidsram: 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.
|
From enrollment to end of hospitalization.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Sjukdomar i det endokrina systemet
- Metaboliska sjukdomar
- Störningar i glukosmetabolism
- Närings- och metabola sjukdomar
- Diabetes mellitus
- Undersökningstekniker
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Blodkemisk analys
- Klinisk kemi -test
- Diagnostiska tekniker, endokrin
- Övervakning, fysiologisk
- Kontinuerlig glukosövervakning
Andra studie-ID-nummer
- 2500766
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