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

NCT ID: NCT04650945

Last Updated: 2022-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2022-11-16

Brief Summary

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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 requiring nutritional therapy (tube feeding or parenteral feeding).

Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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isCGM-arm

isCGM (intermittently scanned continuous glucose monitor) data obtained from a FreeStyle Libre Flash continuous glucose monitoring system will be viewed real-time and used to adjust diabetes treatment

Group Type ACTIVE_COMPARATOR

isCGM group

Intervention Type OTHER

As previously described

POC-arm

POC glucose readings are used to adjust diabetes treatment. CGM data from the Freestyle Libre monitor are blinded to all and only gathered for comparison purposes to intervention group.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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isCGM group

As previously described

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Expected length of hospital stay of at least 48 hours
* Diagnosed with diabetes
* Literate in Danish
* Nutritional therapy using tube feeding or parenteral nutritional therapy
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Julie Støy

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Julie Støy, MD

Role: PRINCIPAL_INVESTIGATOR

Aarhus University Hospital

Locations

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Aarhus university hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1-10-72-188-20

Identifier Type: -

Identifier Source: org_study_id

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