In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part A
Primary Purpose
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Diabetes Mellitus
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
isCGM group
Sponsored by
About this trial
This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring Continuous glucose monitoring, Hospitalization, Nutritional therapy
Eligibility Criteria
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
Sites / Locations
- Aarhus university hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
isCGM-arm
POC-arm
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Glycemic variability; coefficient of variation (CV) (in %)
CV when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Glycemic variability; standard deviation (SD)
SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time in hypoglycemia (<3 mmol/L) (%)
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) (%)
Time in hypoglycemia (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Number of events with hypoglycemia (<3,9 mmol/l) (%)
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)
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)
Glucose out of range: Time in hypoglycemia and time in hyperglycemia (<3,9 and >10 mmol/l) (%)
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)
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)
Time with active isCGM
Time with active isCGM (%) in intervention group
Full Information
NCT ID
NCT04650945
First Posted
November 13, 2020
Last Updated
November 16, 2022
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04650945
Brief Title
In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part A
Official Title
In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part A
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Staff shortage
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
November 16, 2022 (Actual)
Study Completion Date
November 16, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Diabetes Mellitus
Keywords
Continuous glucose monitoring, Hospitalization, Nutritional therapy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
isCGM-arm
Arm Type
Active Comparator
Arm Description
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
Arm Title
POC-arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
isCGM group
Intervention Description
As previously described
Primary Outcome Measure Information:
Title
Glucose time in range (3,9-10 mmol/l) (% pr day)
Description
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)
Time Frame
2-14 days
Secondary Outcome Measure Information:
Title
Mean glucose (mmol/l) isCGM versus POC PG
Description
Mean glucose (mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time Frame
2-14 days
Title
Glycemic variability; coefficient of variation (CV) (in %)
Description
CV when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time Frame
2-14 days
Title
Glycemic variability; standard deviation (SD)
Description
SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time Frame
2-14 days
Title
Time in hypoglycemia (<3 mmol/L) (%)
Description
Time in hypoglycemia (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time Frame
2-14 days
Title
Time in hypoglycemia (<3,9 mmol/l) (%)
Description
Time in hypoglycemia (%) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time Frame
2-14 days
Title
Number of events with hypoglycemia (<3,9 mmol/l) (%)
Description
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)
Time Frame
2-14 days
Title
Time in hyperglycemia (>10 mmol/l) (%)
Description
Time in hyperglycemia when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time Frame
2-14 days
Title
Glucose out of range: Time in hypoglycemia and time in hyperglycemia (<3,9 and >10 mmol/l) (%)
Description
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)
Time Frame
2-14 days
Title
Daily total insulin dosage (IE)
Description
Daily total insulin dosage (IE) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time Frame
2-14 days
Title
Time with active isCGM
Description
Time with active isCGM (%) in intervention group
Time Frame
2-14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Støy, MD
Organizational Affiliation
Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus university hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
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In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part A
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