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

26. august 2026 oppdatert av: Steno Diabetes Center Copenhagen

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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

314

Fase

  • Ikke aktuelt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: POC-arm
Eksperimentell: CGM-arm
Enhet: Continuous glucose monitoring
Participants in this arm are monitored with CGM and treated with support from a CGM-based algorithm for insulin titration.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Percentage of time spent in range (3.9-10.0 mmol/L)
Tidsramme: 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
Tidsramme: 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.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Steno Diabetes Center Copenhagen

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. mars 2027

Primær fullføring (Antatt)

1. mars 2028

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

1. mai 2025

Først innsendt som oppfylte QC-kriteriene

26. august 2026

Først lagt ut (Faktiske)

1. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

1. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

26. august 2026

Sist bekreftet

1. august 2025

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 2500766

Plan for individuelle deltakerdata (IPD)

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Ja

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Ja

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