Insulin Treated Type 2 Diabetes With High Risk of HypoglycemiaNCT03570138
Efficacy of Flash Glucose-Sensing Technology on the Occurrence of Cardiac Arrhythmias Associated With Hypoglycemia
A study testing FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System and Usual self monitoring Blood Glucose device in people with Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia, run by Poitiers University Hospital at 7 sites in France.
Trial summary
Hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia
- What is being tested?
- FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System and Usual self monitoring Blood Glucose device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 7 sitesFrance
- Study dates
- 29 Jun 2018to 30 Sep 2021
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes (diagnosis based on the World Health Organization criteria)
- Treatment with insulin therapy (continuous subcutaneous insulin Infusion or more than 1 daily injection)
- Resting heart beat ≥ 60bpm
- High risk of hypoglycemia defined as :
- Estimated glomerular filtration rate 15-59 ml/min/1.73 m² (according to CKD-EPI formula)
- Or history of stable proliferative diabetic retinopathy
Show all 9Show fewer
- Or body mass index ≤ 30 kg/m²
- Or history of severe hypoglycemia in the previous 6 months
- Or history of non-severe ≤70mg/dL hypoglycemia in the previous 4 weeks
Who cannot join
- Type 1 diabetes mellitus or diabetes due to other cause
- History of atrial fibrillation
- Pacemaker
- Estimated glomerular filtration rate <15 ml/min/1.73 m² (according to CKD-EPI formula)
- Currently using a flash continuous Glucose Monitoring device
- In the investigator's opinion, acute or chronic medical condition considered as unsuitable for inclusion in the study .
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites, 7 recruiting
- Recruiting
University Hospital, Bordeaux
Bordeaux, 33000
MOHAMMEDI Kamel, Prof.
- Recruiting
University Hospital, Limoges
Limoges, 87000
TEISSIER Marie-Pierre, Prof.
- Recruiting
University Hospital, Nantes
Nantes, 44000
CARIOU Bertrand, Prof.
- Not yet recruiting
Hospital, Niort
Niort, 79000
TEYNIE Julie, Dr.
- Recruiting
Hospital, Pau
Pau, 64000
TEYNIE Julie, Dr.
- Recruiting
University Hospital, Poitiers
Poitiers, 86000
SAULNIER Pierre-Jean, Prof.
- Recruiting
University Hospital, Toulouse
Toulouse, 31000
GOURDY Pierre, Prof.
About this study
Official title: Efficacy of Flash Continuous Glucose Monitoring (FREESTYLE LIBRE) on the Occurrence of Cardiac Arrhythmias Associated With Hypoglycemia in Patients With Type 2 Diabetes, High Risk of Hypoglycemia and Insulin Therapy : Open-label Randomized Controlled Trial
Hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with type 2 diabetes (T2D). The study hypothesize is that the hypoglycemia reduction, achieved with the FREESTYLE LIBRE device, a Glucose Continuous Monitoring system, may decrease cardiac arrythmias associated with hypoglycemia. So the main objective is to evaluate the efficacy of the FREESTYLE LIBRE system, associated with a specific therapeutic education on the cardiac arrythmias reduction, compared to a capillary ASG system with standard therapeutic education, in patient with T2D with high risk of hypoglycemia.
This is a open, multicenter, controlled, randomized study in parallel group.
- Being tested
- FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System, Usual self monitoring Blood Glucose device
- Keywords
- Freestyle libre, Type 2 diabetes, Hypoglycemia-induced cardiac arrhythmias, Flash Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring SystemDevice
Specific therapeutic education for diabetes self management
Usual self monitoring Blood Glucose deviceDevice
Standard therapeutic education for diabetes self management
| Study group | Role | What they receive |
|---|---|---|
| Flash continuous glucose monitoring system | Experimental | Participants will wear the FREESTYLE LIBRE device and receive a specific therapeutic education for its use. Receives: Device: FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System |
| Standard self monitoring blood glucose system | Active comparator | Participants will use their own usual self monitoring blood glucose system and receive a C They will wear a masked FREESTYLE LIBRE Pro system. Receives: Device: Usual self monitoring Blood Glucose device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring
Cardiac arrythmic events :
- Bradycardia < 45 bpm for ≥ 10 seconds
- or Asystole ≥ 3 seconds
- or Atrial Fibrillation ≥ 30 seconds
- or Non-sustained ventricular tachycardia defined as runs of beats arising from the ventricles with duration between 3 beats and 30 s with QRS ≥ 120ms and with RR intervall ≤ 600 ms (>100 bpm)
Measured: 14 days
Secondary outcomes (4)
Prevalence of each component of the primary outcome
Measured: 14 days
Prevalence of ≥ 5 minutes Atrial Fibrillation episodes
Measured: 14 days
Mean QT interval
Measured: First 24 hours
Prevalence of ventricular extrasystoles
Measured: First 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start29 Jun 2018
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin Treated Type 2 Diabetes With High Risk of HypoglycemiaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03570138
- Sponsor's protocol ID
- SPIDER-STYLE
- Status last verified
- Oct 2020
- First submitted
- 15 Jun 2018
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Flash Continuous Glucose Monitoring (FREESTYLE LIBRE) on the Occurrence of Cardiac Arrhythmias Associated With Hypoglycemia in Patients With Type 2 Diabetes, High Risk of Hypoglycemia and Insulin Therapy : Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03570138
- Acronym / sponsor ID
- SPIDER-STYLE
- Keywords
- Freestyle libre, Type 2 diabetes, Hypoglycemia-induced cardiac arrhythmias, Flash Continuous Glucose Monitoring
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 29 Jun 2018 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 26 Jun 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.
Hypoglycemia, frequently asymptomatic, may lead to cardiac arrythmias and induce an increased risk of cardiovascular morbidity and mortality in patients with type 2 diabetes (T2D). The study hypothesize is that the hypoglycemia reduction, achieved with the FREESTYLE LIBRE device, a Glucose Continuous Monitoring system, may decrease cardiac arrythmias associated with hypoglycemia. So the main objective is to evaluate the efficacy of the FREESTYLE LIBRE system, associated with a specific therapeutic education on the cardiac arrythmias reduction, compared to a capillary ASG system with standard therapeutic education, in patient with T2D with high risk of hypoglycemia.
This is a open, multicenter, controlled, randomized study in parallel group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flash continuous glucose monitoring system | Experimental | Device: FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring SystemParticipants will wear the FREESTYLE LIBRE device and receive a specific therapeutic education for its use. |
| Standard self monitoring blood glucose system | Active comparator | Device: Usual self monitoring Blood Glucose deviceParticipants will use their own usual self monitoring blood glucose system and receive a C They will wear a masked FREESTYLE LIBRE Pro system. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Type 2 diabetes (diagnosis based on the World Health Organization criteria)
- Treatment with insulin therapy (continuous subcutaneous insulin Infusion or more than 1 daily injection)
- Resting heart beat ≥ 60bpm
- High risk of hypoglycemia defined as :
Key exclusion criteria (6 listed)
- Type 1 diabetes mellitus or diabetes due to other cause
- History of atrial fibrillation
- Pacemaker
- Estimated glomerular filtration rate <15 ml/min/1.73 m² (according to CKD-EPI formula)
- Currently using a flash continuous Glucose Monitoring device
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 device, a Flash Continuous Glucose Monitoring SystemSpecific therapeutic education for diabetes self management | Device | Flash continuous glucose monitoring system |
| Usual self monitoring Blood Glucose deviceStandard therapeutic education for diabetes self management | Device | Standard self monitoring blood glucose system |
Primary outcome
Prevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring
Time frame: 14 days
Cardiac arrythmic events : * Bradycardia < 45 bpm for ≥ 10 seconds * or Asystole ≥ 3 seconds * or Atrial Fibrillation ≥ 30 seconds * or Non-sustained ventricular tachycardia defined as runs of beats arising from the ventricles with duration between 3 beats and 30 s with QRS ≥ 120ms and with RR intervall ≤ 600 ms (>100 bpm)
4 secondary outcomes
Prevalence of each component of the primary outcome
Time frame: 14 days
Prevalence of ≥ 5 minutes Atrial Fibrillation episodes
Time frame: 14 days
Mean QT interval
Time frame: First 24 hours
Prevalence of ventricular extrasystoles
Time frame: First 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia
Active, not recruiting
Continuous Glucose Monitoring Devices in Hospitalized Veterans With Diabetes
Diabetes Mellitus, Type 2, Hypoglycemia
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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System and Usual self monitoring Blood Glucose device in people with Insulin Treated Type 2 Diabetes With High Risk of Hypoglycemia, run by Poitiers University Hospital at 7 sites 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 9 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SAULNIER Pierre-Jean, Prof. (+33 549444689, pierre-jean.saulnier@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of cardiac arrythmic events during a 14 days Continuous ECG Monitoring (time frame: 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 22 Oct 2020.