In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part B
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Type 1 Diabetes Mellitus
- Sponsor
- University of Aarhus
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Glucose time in range (3,9-10 mmol/l) (% pr day)
- Status
- Terminated
- Last Updated
- 3 years ago
Overview
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.
Investigators
Julie Støy
Clinical diabetes specialist
University of Aarhus
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Mean glucose (mmol/l) isCGM versus POC PG(2-14 days)
- Time with active isCGM(2-14 days)
- Number and duration of events with hypoglycemia (<3 mmol/L and <3,9 mmol/l) (time in hypoglycemia)(2-14 days)
- Glycemic variability; coefficient of variation (CV) and standard deviation (SD)(2-14 days)
- Time in hyperglycemia (>10 mmol/l)(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)(2-14 days)
- Daily total insulin dosage (IE)(2-14 days)