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

Recruiting

• Conditions: Diabetes

• Registration Number: NCT06192940
• Lead Sponsor: Centre Hospitalier Sud Francilien

Brief Summary

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?

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 Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-20
• Study First Posted: 2024-01-05
• Study Start: 2024-03-28
• Last Update Submitted: 2024-04-05
• Last Update Posted: 2024-04-08
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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.

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Exclusion Criteria

• Patient refusing study.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Insulin Injection	at day 0	Percentage of insulin injections not as prescribed

Secondary Outcome Measures

Name	Time	Method
number of injections	at day 0	Percentage of injections performed outside the meal time : more than 15 minutes before or more than an hour after the meal.
Acute Diabetes Events	at day 30	severe hypoglycemia, hyperglycemia requiring hospitalization
number of missed injections	at day 0	Percentage of missed injections
Continuous glucose measurement parameters	at day 30	Time in range

Trial Locations

Locations (1)

Centre Hospitalier Sud Francilien; 🇫🇷 Corbeil-essonnes Cedex, France