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Clinical Trial NCT04650945 for Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Diabetes Mellitus is terminated. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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University of AarhusIn-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part A 13
Clinical Trial NCT04650945 is an interventional study for Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Diabetes Mellitus that is terminated. It started on 4 January 2021 with plans to enroll 13 participants. Led by University of Aarhus, it is expected to complete by 16 November 2022. The latest data from ClinicalTrials.gov was last updated on 21 November 2022.
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 t...Show More
Official Title
In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part A
Conditions
Type 1 Diabetes MellitusType 2 Diabetes MellitusDiabetes MellitusOther Study IDs
- 1-10-72-188-20
NCT ID Number
Start Date (Actual)
2021-01-04
Last Update Posted
2022-11-21
Completion Date (Estimated)
2022-11-16
Enrollment (Estimated)
13
Study Type
Interventional
PHASE
N/A
Status
Terminated
Keywords
Continuous glucose monitoring
Hospitalization
Nutritional therapy
Hospitalization
Nutritional therapy
Primary Purpose
Other
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Active ComparatorisCGM-arm 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 | isCGM group As previously described |
No InterventionPOC-arm 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. | N/A |
Primary Outcome Measures
Secondary 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 |
| 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 |
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) | 2-14 days |
Glycemic variability; standard deviation (SD) | SD when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) | 2-14 days |
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) | 2-14 days |
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) | 2-14 days |
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) | 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) (%) | 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) | 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 |
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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
University of Aarhus305 active studies to exploreAarhus University HospitalStudy Responsible Party
Julie Støy, Principal Investigator, Principal investigator, University of Aarhus
No contact data.
1 Study Locations in 1 Countries
Aarhus university hospital, Aarhus, 8200, Denmark