In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part B (INDIGO)

November 16, 2022 updated by: Julie Støy, University of Aarhus
The aim of the study is to investigate the applicability of a Flash glucose monitoring sensor (Freestyle Libre, isCGM) for in-hospital glucose monitoring in patients with diabetes and hypoglycemia (<3,9 mmol/l) during the hospitalization

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

All patients who meet study criteria will be invited to participate in the study. All patients included in the study will be followed by a trained clinical diabetes specialist and a trained study nurse (study personnel) for glucose management during their hospitalization. All patients included in the study will receive a Freestyle Libre isCGM. The patients will be randomized to control (blinded isCGM glucose values to patient and study personnel and POC (point-of-care) plasma glucose will be used for adjusting diabetes treatment) or intervention (isCGM blood glucose values will be used to aid with glucose management during the hospitalization). The study personnel will work with the patient's care team.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Expected length of hospital stay of at least 48 hours
  • Diagnosed with diabetes
  • Literate in Danish
  • In-hospital hypoglycemia with at least one POC glucose < 3,9 mmol/l (current hospitalization)
  • In-hospital treatment with insulin or sulfonylurea
  • Admission to Department of Gastrointestinal Surgery or Department of Heart-, Lung-, and Vascular surgery, both at Aarhus University Hospital, Denmark.

Exclusion Criteria:

  • Pregnancy
  • Patient unable to provide informed consent
  • Patient unable to use mobile phone for reading isCGM sensor
  • Known allergy to adhesives
  • Anticipated MRI during the hospital admission
  • Patients using CGM prior to hospital admission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: isCGM-arm
CGM data will be viewed real-time and used to adjust diabetes treatment
Other: isCGM
As previously described
No Intervention: POC-arm
POC glucose readings are used to adjust diabetes treatment. CGM data are blinded to all and only gathered for comparison purposes to intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose time in range (3,9-10 mmol/l) (% pr day)
Time Frame: 2-14 days
Glucose time in range (3,9-10 mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) (% pr day)
2-14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean glucose (mmol/l) isCGM versus POC PG
Time Frame: 2-14 days
Mean glucose (mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Daily total insulin dosage (IE)
Time Frame: 2-14 days
Daily total insulin dosage (IE) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Time with active isCGM
Time Frame: 2-14 days
Time with active isCGM (%) in intervention group
2-14 days
Glycemic variability; coefficient of variation (CV) and standard deviation (SD)
Time Frame: 2-14 days
CV and SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Number and duration of events with hypoglycemia (<3 mmol/L and <3,9 mmol/l) (time in hypoglycemia)
Time Frame: 2-14 days
Number and duration of events with hypoglycemia when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Time in hyperglycemia (>10 mmol/l)
Time Frame: 2-14 days
Time in hyperglycemia when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
2-14 days
Glucose out of range: Time in hypoglycemia and time in hyperglycemia (<3,9 and >10 mmol/l) undetected with POC PG (use of data from blinded CGM in control group)
Time Frame: 2-14 days
2-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

Aarhus University Hospital

Investigators

  • Principal Investigator: Julie Støy, MD, Aarhus University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2021

Primary Completion (Actual)

November 16, 2022

Study Completion (Actual)

November 16, 2022

Study Registration Dates

First Submitted

November 13, 2020

First Submitted That Met QC Criteria

November 13, 2020

First Posted (Actual)

November 16, 2020

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-188-20, B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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