Type 1 Diabetes MellitusSAFEDRIVENCT06382350
Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems
An observational study of Type 1 Diabetes Mellitus and Type 1 Diabetes Mellitus With Hypoglycemia, run by University Hospital, Motol at 1 site in Czechia.
Trial summary
The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes Mellitus, Type 1 Diabetes Mellitus With Hypoglycemia, Drive
- What is being tested?
- MiniMed 780 G
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 120 participants
- Where
- 1 siteCzechia
- Study dates
- 29 May 2024to May 2026
- Phase
- Observational
- 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
Study population: Type 1 diabetes patients
Who may be able to join
- Study group:
- type 1 diabetes
- patients aged ≥18 year
- diabetes duration ≥3 years
- regularly driving (non-professional drivers only)
- treated with insulin pump MiniMed 780 G for at least 6 months with closed-loop setting treatment
Show all 16Show fewer
- willing to fill in the study questionnaires
- signed patient's informed consent form
- Control group:
- type 1 diabetes
- patients aged ≥18 years
- diabetes duration ≥3 years
- regularly driving (non-professional drivers only)
- treatment with multiple daily injections (MDI) of insulin therapy and the use of CGM for at least 6 months
- willing to fill in the study questionnaires
- signed patient's informed consent form
Who cannot join
- professional drivers
- pregnancy
- inability to be present at the follow-up visit
- inability to complete the study questionnaires
- participation in another clinical study within the last 3 months
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
UH Motol
Prague, 150 00
Eva Al Jamal, Mgr., 224 431 017 ext. +420, eva.aljamal@fnmotol.cz
Veronika Šourková, 224 431 004 ext. +420, veronika.sourkova@fnmotol.cz
About this study
Official title: Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems (Insulin Pump and Continuous Glucose Monitor) Versus Conventional Treatment in Different Life Situations - an Observational Multicenter Study
The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy
Read the detailed description
This national multi-center prospective observational controlled study focuses on the safety of insulin pump closed-loop in patients over 18 with type 1 diabetes while driving. A total of 100 patients (treated with MiniMed 780 G + CGM) will be enrolled in the study group and 20 patients in the control group (treated by multiple daily injections (MDI) + CGM) at 10-20 study centers.
After the inclusion and exclusion criteria evaluation and informed consent signing, each patient receives the Patient Diary. The diary will be used to record the times of observed events during the study period lasting ten days: periods of driving (from-to), periods of night sleep, periods of occupation, periods of physical activity, periods of stress (self-defined), an extra dose of insulin not covered by carbohydrates, an extra dose of carbohydrates not covered by insulin (more variables are required to hide a little bit the primary target of the study).
CGM data obtained during the study period will also be downloaded at the end of the study period.
Finally, the data from the CGM and the patient diary will be compared and analyzed, especially regarding the course of glycemia during driving and the presence of hypoglycemia.
- Being tested
- MiniMed 780 G
- Keywords
- Type 1 diabetes mellitus, Driving, Closed-loop system
- 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.
MiniMed 780 GDevice
none, observational study
| Study group | Role | What they receive |
|---|---|---|
| Study group | Type 1 diabetes patients with insulin pump MiniMed 780 G +CGM (continuous glucose monitoring) Receives: Device: MiniMed 780 G | |
| Control group | Type 1 diabetes patients with patients treated by multiple daily injections (MDI) + CGM |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of hypoglycemia during the driving periods
This outcome evaluates the number of hypoglycemic events (drop of glycemia <3.9 mmol/l) during the driving periods.
Measured: 10 days of CGM measurement
Secondary outcomes (1)
Amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during the driving periods.
The outcome evaluates the amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during driving.
Measured: 10 days of CGM measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start29 May 2024
- Primary completionSep 2025 (estimated)
- Study completionMay 2026 (estimated)
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Motol
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jan Broz, University Hospital, Motol
- Investigators
- Jan Brož, MUDr., Ph.D., Principal investigator, Second Medical Faculty, Charles University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06382350
- Sponsor's protocol ID
- KHL-002-2024
- Acronym
- SAFEDRIVE
- Status last verified
- Jun 2024
- First submitted
- 19 Apr 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems (Insulin Pump and Continuous Glucose Monitor) Versus Conventional Treatment in Different Life Situations - an Observational Multicenter Study
- ClinicalTrials.gov ID
- NCT06382350
- Acronym / sponsor ID
- SAFEDRIVE / KHL-002-2024
- Keywords
- Type 1 diabetes mellitus, Driving, Closed-loop system
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, MotolUniversity, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 24 Apr 2024 (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 study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy
Detailed description
This national multi-center prospective observational controlled study focuses on the safety of insulin pump closed-loop in patients over 18 with type 1 diabetes while driving. A total of 100 patients (treated with MiniMed 780 G + CGM) will be enrolled in the study group and 20 patients in the control group (treated by multiple daily injections (MDI) + CGM) at 10-20 study centers.
After the inclusion and exclusion criteria evaluation and informed consent signing, each patient receives the Patient Diary. The diary will be used to record the times of observed events during the study period lasting ten days: periods of driving (from-to), periods of night sleep, periods of occupation, periods of physical activity, periods of stress (self-defined), an extra dose of insulin not covered by carbohydrates, an extra dose of carbohydrates not covered by insulin (more variables are required to hide a little bit the primary target of the study).
CGM data obtained during the study period will also be downloaded at the end of the study period.
Finally, the data from the CGM and the patient diary will be compared and analyzed, especially regarding the course of glycemia during driving and the presence of hypoglycemia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: MiniMed 780 GType 1 diabetes patients with insulin pump MiniMed 780 G +CGM (continuous glucose monitoring) |
| Control group | – | –Type 1 diabetes patients with patients treated by multiple daily injections (MDI) + CGM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 1 diabetes patients
Key inclusion criteria (16 listed)
- type 1 diabetes
- patients aged ≥18 year
- diabetes duration ≥3 years
- regularly driving (non-professional drivers only)
- treated with insulin pump MiniMed 780 G for at least 6 months with closed-loop setting treatment
Key exclusion criteria (5 listed)
- professional drivers
- pregnancy
- inability to be present at the follow-up visit
- inability to complete the study questionnaires
- participation in another clinical study within the last 3 months
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 |
|---|---|---|
| MiniMed 780 Gnone, observational study | Device | Study group |
Primary outcome
The frequency of hypoglycemia during the driving periods
Time frame: 10 days of CGM measurement
This outcome evaluates the number of hypoglycemic events (drop of glycemia <3.9 mmol/l) during the driving periods.
1 secondary outcome
Amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during the driving periods.
Time frame: 10 days of CGM measurement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- 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.
Jan Brož, MUDr., Ph.D. principal investigator
Second Medical Faculty, Charles University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes Mellitus and Type 1 Diabetes Mellitus With Hypoglycemia, run by University Hospital, Motol at 1 site in Czechia.
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 16 inclusion and 5 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 4 Jun 2024. 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 Czechia. 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 Eva Al Jamal, Mgr. (224 431 017 ext. +420, eva.aljamal@fnmotol.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of hypoglycemia during the driving periods (time frame: 10 days of CGM measurement). 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 4 Jun 2024.