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

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
isCGM
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Type 1 Diabetes Mellitus focused on measuring Hypoglycemia, Continuous glucose monitoring, Hospitalization

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

CGM data will be viewed real-time and used to adjust diabetes treatment

POC glucose readings are used to adjust diabetes treatment. CGM data 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) and standard deviation (SD)
CV and SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
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)
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) undetected with POC PG (use of data from blinded CGM in control group)
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

First Posted
November 13, 2020
Last Updated
November 16, 2022
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04630925
Brief Title
In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part B
Acronym
INDIGO
Official Title
In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part B
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
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 and hypoglycemia (<3,9 mmol/l) during the hospitalization
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
Hypoglycemia, Continuous glucose monitoring, Hospitalization

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
isCGM-arm
Arm Type
Active Comparator
Arm Description
CGM data 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 are blinded to all and only gathered for comparison purposes to intervention group.
Intervention Type
Other
Intervention Name(s)
isCGM
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) and standard deviation (SD)
Description
CV and SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG)
Time Frame
2-14 days
Title
Number and duration of events with hypoglycemia (<3 mmol/L and <3,9 mmol/l) (time in hypoglycemia)
Description
Number and duration of events with 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 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) undetected with POC PG (use of data from blinded CGM in control group)
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 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
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

Learn more about this trial

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

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