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

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

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus; Type 2 Diabetes Mellitus; Type 1 Diabetes Mellitus
• Intervention / Treatment: Other: isCGM

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: isCGM-arm; CGM data will be viewed real-time and used to adjust diabetes treatment	Other: isCGM; As previously described
No Intervention: POC-arm; POC glucose readings are used to adjust diabetes treatment. CGM data are blinded to all and only gathered for comparison purposes to intervention group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Time with active isCGM	Time with active isCGM (%) in intervention group	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)	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)	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)	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

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: Aarhus University Hospital
• Investigators: Principal Investigator: Julie Støy, MD, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2021
• Primary Completion (Actual): November 16, 2022
• Study Completion (Actual): November 16, 2022

Study Registration Dates

• First Submitted: November 13, 2020
• First Submitted That Met QC Criteria: November 13, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Hypoglycemia; Continuous glucose monitoring; Hospitalization
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 1-10-72-188-20, B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No