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

University of Aarhus

Status: Terminated

Conditions: Type 1 Diabetes Mellitus; Diabetes Mellitus; Type 2 Diabetes Mellitus

Treatments: Other: isCGM group

Study type: Interventional

Funder types: Other

Identifiers

NCT04650945

1-10-72-188-20

Details and patient eligibility

About

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).

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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13 participants in 2 patient groups

isCGM-arm

Active Comparator group

Description:

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

Treatment:

Other: isCGM group

POC-arm

No Intervention group

Description:

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.