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

March 31, 2022 updated by: ValoTec

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ile De France
      • Paris, Ile De France, France, 75013
        • GH Pitié Salpêtrière Charles Foix

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Type 2 Diabetic patients followed by french primary care or specialized centers.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
data collection
20 patients
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

28 days
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.

28 days
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.

28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Marine HALBRON, MD, APHP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2019

Primary Completion (Actual)

December 4, 2020

Study Completion (Actual)

December 4, 2020

Study Registration Dates

First Submitted

June 22, 2018

First Submitted That Met QC Criteria

November 6, 2019

First Posted (Actual)

November 7, 2019

Study Record Updates

Last Update Posted (Actual)

April 11, 2022

Last Update Submitted That Met QC Criteria

March 31, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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