Clinical trial NCT04630925: In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part B
Official title: In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part B
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Diabetes Mellitus
Keywords: Hypoglycemia
Continuous glucose monitoring
Hospitalization
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2020-11-16
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Glucose time in range (3,9-10 mmol/l) (% pr day)
timeFrame: 2-14 days
Secondary outcomes:
measure: Mean glucose (mmol/l) isCGM versus POC PG
timeFrame: 2-14 days
measure: Glycemic variability; coefficient of variation (CV) and standard deviation (SD)
timeFrame: 2-14 days
measure: Number and duration of events with hypoglycemia (<3 mmol/L and <3,9 mmol/l) (time in hypoglycemia)
timeFrame: 2-14 days
measure: Time in hyperglycemia (>10 mmol/l)
timeFrame: 2-14 days
measure: 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)
timeFrame: 2-14 days
measure: Daily total insulin dosage (IE)
timeFrame: 2-14 days
measure: Time with active isCGM
timeFrame: 2-14 days
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus university hospital
Study officials:
affiliation: Aarhus University Hospital
name: Julie Støy, MD
role: PRINCIPAL_INVESTIGATOR
References: