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Data Acquisition Study in Inadequately Balanced Patients With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT04155996
Recruitment Status : Recruiting
First Posted : November 7, 2019
Last Update Posted : November 13, 2019
Sponsor:
Collaborator:
APHP
Information provided by (Responsible Party):
ValoTec

Brief 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.

Condition or disease Intervention/treatment
Type2 Diabetes Device: data collection

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Data Acquisition Study in Patients With Type 2 Diabetes Mellitus Who Are Inadequately Balanced With Oral Antidiabetic Agents and Basal Insulin
Actual Study Start Date : January 20, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
data collection
20 patients
Device: 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.




Primary Outcome Measures :
  1. 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.

  2. Data collection - Number of steps [ Time Frame: 28 days ]
    Patients wear an activity tracker that will record their number of steps over time.

  3. 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.


Secondary Outcome Measures :
  1. Data collection - Daily meals information [ Time Frame: 28 days ]

    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.


  2. Data collection - Physical activity information [ Time Frame: 28 days ]

    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.


  3. Data collection - Medical treatment information [ Time Frame: 28 days ]

    Patients manually record information their medical treatment in a dedicated smartphone application.

    Treatment intake times are recorded in the smartphone application.




Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Type 2 Diabetic patients followed by french primary care or specialized centers.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04155996


Contacts
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Contact: Gary TENDON +33141659140 clinique@valotec.com
Contact: Jean-Christophe LOURME, Pr +33141654355 jc.lourme@valotec.com

Locations
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France
GH Pitié Salpêtrière Charles Foix Recruiting
Paris, Ile De France, France, 75013
Contact: Marine Halbron, PH    +33142178263    marine.halbron@aphp.fr   
Sponsors and Collaborators
ValoTec
APHP
Investigators
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Principal Investigator: Marine HALBRON, MD APHP

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Responsible Party: ValoTec
ClinicalTrials.gov Identifier: NCT04155996     History of Changes
Other Study ID Numbers: VTC-MLS-EC01
First Posted: November 7, 2019    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases