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

University of Aarhus1 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

Type 1 Diabetes Mellitus Type 2 Diabetes Mellitus Diabetes Mellitus

Interventions

isCGMOTHER

As previously described

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Aarhus university hospital

Aarhus, Denmark

Outcomes

Primary Outcomes

Glucose time in range (3,9-10 mmol/l) (% pr day)

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)

Time frame: 2-14 days

Secondary Outcomes

Mean glucose (mmol/l) isCGM versus POC PG

Mean glucose (mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)

Time frame: 2-14 days

Glycemic variability; coefficient of variation (CV) and standard deviation (SD)

CV and SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)

Time frame: 2-14 days

Number and duration of events with hypoglycemia (<3 mmol/L and <3,9 mmol/l) (time in hypoglycemia)

Number and duration of events with hypoglycemia when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)

Time frame: 2-14 days

Time in hyperglycemia (>10 mmol/l)

Time in hyperglycemia when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)

Time frame: 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

Daily total insulin dosage (IE)

Daily total insulin dosage (IE) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)

Data from ClinicalTrials.gov

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