Insulin-Dependent DiabetesGLUCO FLASHNCT03411460
Satisfaction of Hospitalized Diabetic Patients Using a Continuous Glucose Monitoring System
A study testing FreeStyle Libre™ system and Finger prick in people with Insulin-Dependent Diabetes, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The aim of the study is to establish whether routine usage of the FreeStyle Libre™ system (Abbott) improves satisfaction and quality of sleep in patients hospitalized for poor glycemic control with an indication for external insulin pump treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Insulin-Dependent Diabetes
- What is being tested?
- FreeStyle Libre™ system and Finger prick
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2017to 23 Aug 2017
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient has given their free and informed consent
- The patient must be insured or the beneficiary of an insurance policy
- The patient is aged at least 18 years and less than 75 years old.
- Patients have a BMI between 18 and 40kg/m2
- Diabetic patient admitted for glycemic instability with indication for treatment using an external insulin pump but otherwise in a stable clinical state
Who cannot join
- The subject is participating in another study
- The subject is in an exclusion period determined by a previous study
- The patients is under judicial protection or state guardianship
- The subject refuses to sign the consent form
- It proves impossible to give the subject clear information.
- The patient is pregnant, parturient or breastfeeding
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- The patient is clinically unstable
- BMI less than 18 or over 40
- Existence of a severe rapidly progressive ischemic retinopathy or proliferative retinopathy.
- Serious psychiatric problems
- Chronic cutaneous infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Satisfaction of Using a Continuous Glucose Monitoring System to Monitor Interstitial Fluid Glucose Level in Hospitalized Insulin-dependent Diabetic Patients Treated Using a Portable Sub-cutaneous Pump
The aim of the study is to establish whether routine usage of the FreeStyle Libre™ system (Abbott) improves satisfaction and quality of sleep in patients hospitalized for poor glycemic control with an indication for external insulin pump treatment.
- Conditions
- Insulin-Dependent Diabetes
- Being tested
- FreeStyle Libre™ system, Finger prick
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FreeStyle Libre™ systemDevice
Measured non-invasively via scanner
Finger prickProcedure or surgery
Blood test
| Study group | Role | What they receive |
|---|---|---|
| Interstitial glucose | Experimental | Glucose level tested by continuous monitoring device Receives: Device: FreeStyle Libre™ system |
| Blood glucose | Active comparator | Glucose level tested on glucose monitor using standard finger prick Receives: Procedure: Finger prick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Satisfaction of patient-determined hospital care at discharge in the two groups
visual analogue scale 0-10
Measured: at discharge from hospital; maximum Day 5
Secondary outcomes (7)
Patient satisfaction concerning treatment for their diabetes
Diabetes Treatment Satisfaction Questionnaire
Measured: at discharge from hospital; maximum Day 5
Patient quality of sleep
Spiegel questionnaire
Measured: at each day of hospitalization and discharge; maximum Day 5
Satisfaction of nursing staff concerning care of patient
visual analogue scale response to 5 quesions
Measured: at end of study; maximum Day 5
Time taken by nurse to measure circulating glucose level
in minutes
Measured: Daily over length of hospitalization until maximum Day 5
Time necessary to achieve satisfactory equilibrium using insulin pump
average daily glucose level < 1.50 g/l
Measured: maximum Day 5
Number of glucose readings above 2g/l and below 0.80g/l over the hospital stay
Measured: maximum Day 5
Number of hypoglycmic events with the corresponding glucose level
Measured: maximum Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start19 Apr 2017
- Primary completion23 Aug 2017
- Study completion23 Aug 2017
Why it stopped: logistical difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin-Dependent DiabetesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411460
- Sponsor's protocol ID
- LOCAL/2016/MR-01
- Acronym
- GLUCO FLASH
- Status last verified
- Jan 2017
- First submitted
- 16 Jun 2017
- Last updated
- 26 Jan 2018
- 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 26 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction of Using a Continuous Glucose Monitoring System to Monitor Interstitial Fluid Glucose Level in Hospitalized Insulin-dependent Diabetic Patients Treated Using a Portable Sub-cutaneous Pump
- ClinicalTrials.gov ID
- NCT03411460
- Acronym / sponsor ID
- GLUCO FLASH / LOCAL/2016/MR-01
- Conditions
- Insulin-Dependent Diabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: logistical difficulties
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 19 Apr 2017 (actual)
- Primary completion
- 23 Aug 2017 (actual)
- Study completion
- 23 Aug 2017 (actual)
- First posted
- 26 Jan 2018 (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 establish whether routine usage of the FreeStyle Libre™ system (Abbott) improves satisfaction and quality of sleep in patients hospitalized for poor glycemic control with an indication for external insulin pump treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interstitial glucose | Experimental | Device: FreeStyle Libre™ systemGlucose level tested by continuous monitoring device |
| Blood glucose | Active comparator | Procedure: Finger prickGlucose level tested on glucose monitor using standard finger prick |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient has given their free and informed consent
- The patient must be insured or the beneficiary of an insurance policy
- The patient is aged at least 18 years and less than 75 years old.
- Patients have a BMI between 18 and 40kg/m2
- Diabetic patient admitted for glycemic instability with indication for treatment using an external insulin pump but otherwise in a stable clinical state
Key exclusion criteria (11 listed)
- The subject is participating in another study
- The subject is in an exclusion period determined by a previous study
- The patients is under judicial protection or state guardianship
- The subject refuses to sign the consent form
- It proves impossible to give the subject clear information.
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 |
|---|---|---|
| FreeStyle Libre™ systemMeasured non-invasively via scanner | Device | Interstitial glucose |
| Finger prickBlood test | Procedure or surgery | Blood glucose |
Primary outcome
Satisfaction of patient-determined hospital care at discharge in the two groups
Time frame: at discharge from hospital; maximum Day 5
visual analogue scale 0-10
7 secondary outcomes
Patient satisfaction concerning treatment for their diabetes
Time frame: at discharge from hospital; maximum Day 5
Patient quality of sleep
Time frame: at each day of hospitalization and discharge; maximum Day 5
Satisfaction of nursing staff concerning care of patient
Time frame: at end of study; maximum Day 5
Time taken by nurse to measure circulating glucose level
Time frame: Daily over length of hospitalization until maximum Day 5
Time necessary to achieve satisfactory equilibrium using insulin pump
Time frame: maximum Day 5
Number of glucose readings above 2g/l and below 0.80g/l over the hospital stay
Time frame: maximum Day 5
Number of hypoglycmic events with the corresponding glucose level
Time frame: maximum Day 5
Results and safety
The study was stopped early (reason given: logistical difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FreeStyle Libre™ system and Finger prick in people with Insulin-Dependent Diabetes, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 11 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 26 Jan 2018. 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 France. 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: logistical difficulties). 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?
Satisfaction of patient-determined hospital care at discharge in the two groups (time frame: at discharge from hospital; maximum Day 5). 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 26 Jan 2018.