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

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Other: isCGM group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: isCGM-arm<br>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<br>* As previously described<br>|
| No Intervention: POC-arm<br>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. | |

What is the study measuring?
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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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Continuous glucose monitoring, Hospitalization, Nutritional therapy