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

NCT04155996 | Terminated DMC

• 1 other identifier: VTC-MLS-EC01
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (3)

• Data collection - Blood glucose levels

  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

  Patients wear an activity tracker that will record their number of steps over time.

  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.

  28 days

Secondary Outcomes (3)

• Data collection - Daily meals information

  28 days

• Data collection - Physical activity information

  28 days

• Data collection - Medical treatment information

  28 days

Study Arms (1)

data collection

20 patients

Device: data collection

Interventions

data collection DEVICE

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.

data collection

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Patient has Type 1 diabetes, diabetes secondary to pancreatic pathology, endocrinopathy or iatrogenic diabetes
• Patient is treated with a rapid-acting insulin
• 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

Sponsors & Collaborators

• ValoTec: lead
• APHP: collaborator

Study Sites (1)

GH Pitié Salpêtrière Charles Foix

Paris, Île-de-France Region, 75013, France

Location

MeSH Terms

Interventions

Data Collection

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Marine HALBRON, MD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2018
• First Posted: November 7, 2019
• Study Start: January 20, 2019
• Primary Completion: December 4, 2020
• Study Completion: December 4, 2020
• Last Updated: April 11, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)