Type 1 Diabetes MellitusNCT04650945
In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part A
A study testing isCGM group in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Diabetes Mellitus
- What is being tested?
- isCGM group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jan 2021to 16 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Being tested
- isCGM group
- Keywords
- Continuous glucose monitoring, Hospitalization, Nutritional therapy
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
isCGM groupOther
As previously described
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2-14 days
Secondary outcomes (10)
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 2-14 days
Time with active isCGM
Time with active isCGM (%) in intervention group
Measured: 2-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start4 Jan 2021
- Primary completion16 Nov 2022
- Study completion16 Nov 2022
Why it stopped: Staff shortage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Julie Støy, University of Aarhus
- Investigators
- Julie Støy, MD, Principal investigator, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04650945
- Sponsor's protocol ID
- 1-10-72-188-20
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2020
- Last updated
- 21 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part A
- ClinicalTrials.gov ID
- NCT04650945
- Acronym / sponsor ID
- 1-10-72-188-20
- Keywords
- Continuous glucose monitoring, Hospitalization, Nutritional therapy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Staff shortage
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 16 Nov 2022 (actual)
- Study completion
- 16 Nov 2022 (actual)
- First posted
- 3 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| isCGM-arm | Active comparator | Other: isCGM groupisCGM (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-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| isCGM groupAs previously described | Other | isCGM-arm |
Primary outcome
Glucose time in range (3,9-10 mmol/l) (% pr day)
Time frame: 2-14 days
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)
10 secondary outcomes
Mean glucose (mmol/l) isCGM versus POC PG
Time frame: 2-14 days
Glycemic variability; coefficient of variation (CV) (in %)
Time frame: 2-14 days
Glycemic variability; standard deviation (SD)
Time frame: 2-14 days
Time in hypoglycemia (<3 mmol/L) (%)
Time frame: 2-14 days
Time in hypoglycemia (<3,9 mmol/l) (%)
Time frame: 2-14 days
Number of events with hypoglycemia (<3,9 mmol/l) (%)
Time frame: 2-14 days
Time in hyperglycemia (>10 mmol/l) (%)
Time frame: 2-14 days
Glucose out of range: Time in hypoglycemia and time in hyperglycemia (<3,9 and >10 mmol/l) (%)
Time frame: 2-14 days
Daily total insulin dosage (IE)
Time frame: 2-14 days
Time with active isCGM
Time frame: 2-14 days
Results and safety
The study was stopped early (reason given: Staff shortage). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Støy, MD principal investigator
Aarhus University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing isCGM group in people with Type 1 Diabetes Mellitus and Type 2 Diabetes Mellitus, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Staff shortage). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glucose time in range (3,9-10 mmol/l) (% pr day) (time frame: 2-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2022.