DiabetesNCT07796802
Continuous Glucose Monitoring for In-hospital Management of Type 2 Diabetes
A study testing Continuous glucose monitoring in people with Diabetes and Continuous Glucose Monitoring System, run by Steno Diabetes Center Copenhagen.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Continuous Glucose Monitoring System, Inpatient
- What is being tested?
- Continuous glucose monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 314 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2027to 1 May 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official 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.
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.
Read more
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.
- Conditions
- Diabetes, Continuous Glucose Monitoring System, Inpatient
- Being tested
- Continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
Participants in this arm are monitored with CGM and treated with support from a CGM-based algorithm for insulin titration.
| Study group | Role | What they receive |
|---|---|---|
| POC-arm | No intervention | Not described |
| CGM-arm | Experimental | Not described Receives: Device: Continuous glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to end of hospitalization.
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.
Measured: From enrollment to end of hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start1 Mar 2027 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 314 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796802
- Sponsor's protocol ID
- 2500766
- Status last verified
- Aug 2025
- First submitted
- 1 May 2025
- Last updated
- 1 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided