Impact of Smart Connected Insulin Pens on Quality of Life in Dependent Patients With Diabetes Using Continuous Glucose Measurement (BESTYLCO)

April 5, 2024 updated by: Centre Hospitalier Sud Francilien
Insulin-treated diabetes in dependent or institutionalized patients is often poorly balanced and continuous glucose measurement is underused. The purpose of this tudy is to know how smart connected insulin pens and continuous glucose measurement can improve insulin therapy practice in dependent and/or institutionalized patients?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Insulin-treated diabetes in dependent or institutionalized patients is often poorly balanced and continuous glucose measurement is underused. Current practice and my experience in diabetes show a misuse of insulin therapy by caregivers at home and in institutions. Studies on the elderly insulin-treated person living in institutions show, through continuous glucose measurement, frequent nocturnal hypoglycemia at 79%. The continuous measurement of glucose has also shown its interest in reducing hospitalizations for acute event and, permanently.

A norwegian study shows that hypoglycemic treatments are too frequently prescribed in nursing homes. Hospitalizations for severe hypoglycemia are often due to dose errors or unsupervised recommendations in people over 65 years.

Smart connected insulin pens have shown a benefit in the management of insulin therapy in patients living with type 1 diabetes, improving glycemic balance.

Study focuses on the identification of misuses of insulin therapy in dependent and/or institutionalized patients. A study of everyday life, we expect a decrease in dysfunctions in patients equipped with a continuous glucose measurement system and connected pens after advice given to their caregivers.

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • France
      • Corbeil-essonnes Cedex, France, 91106
        • Recruiting
        • Centre Hospitalier Sud Francilien
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

patient managed by a caregivers for the management of insulin therapy at home or in nursing home or in healthcare facility.

Description

Inclusion Criteria:

  • Older than 18 years patient with type 1 or 2 diabetes
  • Treated with multiple insulin injections
  • Equipped with a continuous glucose measurement system and smart connected insulin pens at least one month before
  • Dependent on a health professional for treatment management.
  • Subject informed of the study and not objecting to data collection.

Exclusion Criteria:

- Patient refusing 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin Injection
Time Frame: at day 0
Percentage of insulin injections not as prescribed
at day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of missed injections
Time Frame: at day 0
Percentage of missed injections
at day 0
number of injections
Time Frame: at day 0
Percentage of injections performed with a dose deviation of +-20% from the prescribed dose
at day 0
number of injections
Time Frame: at day 0
Percentage of injections performed outside the meal time : more than 15 minutes before or more than an hour after the meal.
at day 0
Continuous glucose measurement parameters
Time Frame: at day 0
Time in range
at day 0
Continuous glucose measurement parameters
Time Frame: at day 30
Time in range
at day 30
Acute Diabetes Events
Time Frame: at day 0
severe hypoglycemia, hyperglycemia requiring hospitalization
at day 0
Acute Diabetes Events
Time Frame: at day 30
severe hypoglycemia, hyperglycemia requiring hospitalization
at day 30

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Sud Francilien

Investigators

  • Principal Investigator: Marie BOULY, APN, Centre Hospitalier Sud Francilien

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 28, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

November 30, 2024

Study Registration Dates

First Submitted

December 7, 2023

First Submitted That Met QC Criteria

December 20, 2023

First Posted (Actual)

January 5, 2024

Study Record Updates

Last Update Posted (Actual)

April 8, 2024

Last Update Submitted That Met QC Criteria

April 5, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/0052

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

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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