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

Not Applicable

Terminated

• Conditions: Type 2 Diabetes Mellitus; Type 1 Diabetes Mellitus; Diabetes Mellitus
• Interventions: Other: isCGM group

• Registration Number: NCT04650945
• Lead Sponsor: University of Aarhus

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 requiring nutritional therapy (tube feeding or parenteral feeding).

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.

Study Timeline

• Study First Submitted: 2020-11-13
• Study First Submitted QC: 2020-11-25
• Study First Posted: 2020-12-03
• Study Start: 2021-01-04
• Status Verified: 2022-11
• Primary Completion: 2022-11-16
• Study Completion: 2022-11-16
• Last Update Submitted: 2022-11-16
• Last Update Posted: 2022-11-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
isCGM-arm	isCGM group	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

Primary Outcome Measures

Name	Time	Method
Glucose time in range (3,9-10 mmol/l) (% pr day)	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 Outcome Measures

Name	Time	Method
Mean glucose (mmol/l) isCGM versus POC PG	2-14 days	Mean glucose (mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Glycemic variability; coefficient of variation (CV) (in %)	2-14 days	CV when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Glycemic variability; standard deviation (SD)	2-14 days	SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time in hypoglycemia (<3 mmol/L) (%)	2-14 days	Time in hypoglycemia (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time in hypoglycemia (<3,9 mmol/l) (%)	2-14 days	Time in hypoglycemia (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time with active isCGM	2-14 days	Time with active isCGM (%) in intervention group
Number of events with hypoglycemia (<3,9 mmol/l) (%)	2-14 days	Number of events with hypoglycemia per day (\<3,9 mmol/L for \>15 minutes) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Daily total insulin dosage (IE)	2-14 days	Daily total insulin dosage (IE) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time in hyperglycemia (>10 mmol/l) (%)	2-14 days	Time in hyperglycemia when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Glucose out of range: Time in hypoglycemia and time in hyperglycemia (<3,9 and >10 mmol/l) (%)	2-14 days	Glucose out of range: Time in hypoglycemia and time in hyperglycemia (\<3,9 and \>10 mmol/l) (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)

Trial Locations

Locations (1)

Aarhus university hospital; 🇩🇰 Aarhus, Denmark