Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06192940

Impact of Smart Connected Insulin Pens on Quality of Life in Dependent Patients with Diabetes Using Continuous Glucose Measurement

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?

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106

Location status: Recruiting

Location contact

Marie BOULY

CONTACT

[email protected]

01 61 69 35 93

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Counseling home caregivers

Behavioral

Advice on the proper use of insulin therapy will be given, if necessary, to caregivers. Patients are reviewed at 1 month of this first visit with a collection of the same data

Primary outcomes

  1. Insulin Injection

    Time frame: at day 0

    Percentage of insulin injections not as prescribed

Secondary outcomes

  1. number of missed injections

    Time frame: at day 0

    Percentage of missed injections

  2. number of injections

    Time frame: at day 0

    Percentage of injections performed with a dose deviation of +-20% from the prescribed dose

  3. 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.

  4. Continuous glucose measurement parameters

    Time frame: at day 0

    Time in range

  5. Continuous glucose measurement parameters

    Time frame: at day 30

    Time in range

  6. Acute Diabetes Events

    Time frame: at day 0

    severe hypoglycemia, hyperglycemia requiring hospitalization

  7. Acute Diabetes Events

    Time frame: at day 30

    severe hypoglycemia, hyperglycemia requiring hospitalization

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline TOURTE

CONTACT

[email protected]

01 61 69 31 50

Marie BOULY, APN

CONTACT

[email protected]

01 61 69 35 93

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Sud Francilien

Other

Registry information

Acronym: BESTYLCO

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 5, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.