Data Acquisition Study in Inadequately Balanced Patients With Type 2 Diabetes Mellitus
NCT ID: NCT04155996
Last Updated: 2022-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
10 participants
OBSERVATIONAL
2019-01-20
2020-12-04
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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data collection
20 patients
data collection
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.
Interventions
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data collection
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* 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
35 Years
ALL
No
Sponsors
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APHP
OTHER
ValoTec
INDUSTRY
Responsible Party
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Principal Investigators
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Marine HALBRON, MD
Role: PRINCIPAL_INVESTIGATOR
APHP
Locations
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GH Pitié Salpêtrière Charles Foix
Paris, Île-de-France Region, France
Countries
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Other Identifiers
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VTC-MLS-EC01
Identifier Type: -
Identifier Source: org_study_id
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