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

NCT04650945 | Terminated

• 1 other identifier: 1-10-72-188-20
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus; Diabetes Mellitus

Keywords

Continuous glucose monitoring; Hospitalization; Nutritional therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Mean glucose (mmol/l) isCGM versus POC PG

  2-14 days

• Glycemic variability; coefficient of variation (CV) (in %)

  2-14 days

• Glycemic variability; standard deviation (SD)

  2-14 days

• Time in hypoglycemia (<3 mmol/L) (%)

  2-14 days

• Time in hypoglycemia (<3,9 mmol/l) (%)

  2-14 days

Study Arms (2)

isCGM-arm

ACTIVE COMPARATOR

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

Other: isCGM group

POC-arm

NO INTERVENTION

POC glucose readings are used to adjust diabetes treatment. CGM data from the Freestyle Libre monitor are blinded to all and only gathered for comparison purposes to intervention group.

Interventions

isCGM group OTHER

As previously described

isCGM-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Aarhus university hospital

Aarhus, 8200, Denmark

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Julie Støy, MD

  Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 13, 2020
• First Posted: December 3, 2020
• Study Start: January 4, 2021
• Primary Completion: November 16, 2022
• Study Completion: November 16, 2022
• Last Updated: November 21, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)