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

Diabetes Mellitus Clinical Trial

— INDIGO  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04630925
• Other study ID #: 1-10-72-188-20, B
• Status: Terminated
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: November 16, 2022

Study information

• Verified date: November 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: November 16, 2022
• Est. primary completion date: November 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Other:
• isCGM
As previously described

Locations

Country	Name	City	State
Denmark	Aarhus university hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2-14 days
Secondary	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)	2-14 days
Secondary	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)	2-14 days
Secondary	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)	2-14 days
Secondary	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)	2-14 days
Secondary	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
Secondary	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)	2-14 days
Secondary	Time with active isCGM	Time with active isCGM (%) in intervention group	2-14 days