Type2 DiabetesNCT04155996
Data Acquisition Study in Inadequately Balanced Patients With Type 2 Diabetes Mellitus
An observational study of Type2 Diabetes, run by ValoTec at 1 site in France.
Trial summary
The aim of this study is to collect continuous glucose monitoring (CGM) data, coupled with physical activity and everyday day life data. The purpose of this data collection is to help diabetologists to make recommendations to optimize type 2 diabetic patient management. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- data collection
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2019to 4 Dec 2020
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Type 2 Diabetic patients followed by french primary care or specialized centers.
Who may be able to join
- Type 2 diabetic patient (T2D) with HbA1c ≥ 8% in the month prior to inclusion
- Patient is treated with oral anti-diabetics and / or analogous combined with basal insulin therapy (1 injection of slow-acting insulin in the evening)
- Age ≥ 35 years
- Diabetes diagnosis done over 1 year ago
- Patient accepting for 2 periods of 14 days spaced at most 3 days to wear a Freestyle glucose meter, a bracelet for measuring physical activity and to log daily life events in a dedicated smartphone application
- Patient is able to use a smartphone
- Patient is affiliated to the French health insurance system
Who cannot join
- Patient has Type 1 diabetes, diabetes secondary to pancreatic pathology, endocrinopathy or iatrogenic diabetes
- Patient is treated with a rapid-acting insulin
- Patient has had a severe hypoglycaemia in the year preceding inclusion
- Patent has a severe renal insufficiency (defined by a Glomerular Filtration Rate below 30 ml/min)
- Patient has had a myocardial infarction or other life-threatening medical condition in the last 6 months
- Patient has cognitive disorders or evolutionary psychiatric pathology
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- Pregnant woman or woman likely to be pregnant, breastfeeding woman
- Patient plans to travel outside europe during the study
- Patient is participating to another clinical study
Trial locations and contacts
1 site in 1 country.
France1 site
GH Pitié Salpêtrière Charles Foix
Paris, Île-de-France Region, 75013
About this study
Official title: Data Acquisition Study in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Balanced With Oral Antidiabetic Agents and Basal Insulin
The aim of this study is to collect continuous glucose monitoring (CGM) data, coupled with physical activity and everyday day life data. The purpose of this data collection is to help diabetologists to make recommendations to optimize type 2 diabetic patient management.
- Conditions
- Type2 Diabetes
- Being tested
- data collection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
data collectionDevice
Patients will receive a full data acquisition set with CGM sensors, an activity tracker and a smartphone application in which they can log daily events.
| Study group | Role | What they receive |
|---|---|---|
| data collection | 20 patients Receives: Device: data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Data collection - Blood glucose levels
Patients wear a continuous glucose monitoring patch and record blood glucose level measurements (in mg/dl) over time.
Measured: 28 days
Data collection - Number of steps
Patients wear an activity tracker that will record their number of steps over time.
Measured: 28 days
Data collection - Sleep hours
Patients wear an activity tracker that will record their sleep hours (sleep start time and sleep end time) during nighttime.
Measured: 28 days
Secondary outcomes (3)
Data collection - Daily meals information
Patients manually record information about meals in a dedicated smartphone application.
Each meal size (Small, Medium or Large) and glycemic index (Low, Medium or High) is evaluated by patients in the application.
Measured: 28 days
Data collection - Physical activity information
Patients manually record information about physical activities in a dedicated smartphone application.
Each physical activity duration (Short, Medium or Long) and intensity (Low, Medium or High) is evaluated by patients in the application.
Measured: 28 days
Data collection - Medical treatment information
Patients manually record information their medical treatment in a dedicated smartphone application.
Treatment intake times are recorded in the smartphone application.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2019
- Study start20 Jan 2019
- Primary completion4 Dec 2020
- Study completion4 Dec 2020
Why it stopped: Study terminated prematurely due to COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- ValoTec
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- APHP
- Responsible party
- Sponsor
- Investigators
- Marine HALBRON, MD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155996
- Sponsor's protocol ID
- VTC-MLS-EC01
- Status last verified
- Mar 2022
- First submitted
- 22 Jun 2018
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Acquisition Study in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Balanced With Oral Antidiabetic Agents and Basal Insulin
- ClinicalTrials.gov ID
- NCT04155996
- Acronym / sponsor ID
- VTC-MLS-EC01
- Conditions
- Type2 Diabetes
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study terminated prematurely due to COVID-19 pandemic
- Enrolment
- 10 participants (actual)
- Lead sponsor
- ValoTecIndustry (pharma, biotech, devices)
- Collaborators
- APHP
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 4 Dec 2020 (actual)
- Study completion
- 4 Dec 2020 (actual)
- First posted
- 7 Nov 2019 (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 this study is to collect continuous glucose monitoring (CGM) data, coupled with physical activity and everyday day life data. The purpose of this data collection is to help diabetologists to make recommendations to optimize type 2 diabetic patient management.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| data collection | – | Device: data collection20 patients |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type 2 Diabetic patients followed by french primary care or specialized centers.
Key inclusion criteria (7 listed)
- Type 2 diabetic patient (T2D) with HbA1c ≥ 8% in the month prior to inclusion
- Patient is treated with oral anti-diabetics and / or analogous combined with basal insulin therapy (1 injection of slow-acting insulin in the evening)
- Age ≥ 35 years
- Diabetes diagnosis done over 1 year ago
- Patient accepting for 2 periods of 14 days spaced at most 3 days to wear a Freestyle glucose meter, a bracelet for measuring physical activity and to log daily life events in a dedicated smartphone application
Key exclusion criteria (9 listed)
- Patient has Type 1 diabetes, diabetes secondary to pancreatic pathology, endocrinopathy or iatrogenic diabetes
- Patient is treated with a rapid-acting insulin
- Patient has had a severe hypoglycaemia in the year preceding inclusion
- Patent has a severe renal insufficiency (defined by a Glomerular Filtration Rate below 30 ml/min)
- Patient has had a myocardial infarction or other life-threatening medical condition in the last 6 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 |
|---|---|---|
| data collectionPatients will receive a full data acquisition set with CGM sensors, an activity tracker and a smartphone application in which they can log daily events. | Device | data collection |
Primary outcome
Data collection - Blood glucose levels
Time frame: 28 days
Patients wear a continuous glucose monitoring patch and record blood glucose level measurements (in mg/dl) over time.
Data collection - Number of steps
Time frame: 28 days
Patients wear an activity tracker that will record their number of steps over time.
Data collection - Sleep hours
Time frame: 28 days
Patients wear an activity tracker that will record their sleep hours (sleep start time and sleep end time) during nighttime.
3 secondary outcomes
Data collection - Daily meals information
Time frame: 28 days
Data collection - Physical activity information
Time frame: 28 days
Data collection - Medical treatment information
Time frame: 28 days
Results and safety
The study was stopped early (reason given: Study terminated prematurely due to COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 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.
Marine HALBRON, MD principal investigator
APHP
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 Type2 Diabetes, run by ValoTec 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 7 inclusion and 9 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 11 Apr 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 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: Study terminated prematurely due to COVID-19 pandemic). 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?
Data collection - Blood glucose levels (time frame: 28 days). The study lists 3 primary outcomes in all. 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 11 Apr 2022.