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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06192940
Acronym
BESTYLCO
Enrollment
30
Registered
2024-01-05
Start date
2024-03-28
Completion date
2025-12-31
Last updated
2025-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes

Keywords

insulin practice, Dependent patient, Smart connected insulin pen

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.

Interventions

BEHAVIORALCounseling home caregivers

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

Sponsors

Centre Hospitalier Sud Francilien
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Insulin Injectionat day 0Percentage of insulin injections not as prescribed

Secondary

MeasureTime frameDescription
number of missed injectionsat day 0Percentage of missed injections
number of injectionsat day 0Percentage of injections performed with a dose deviation of +-20% from the prescribed dose
Continuous glucose measurement parametersat day 0Time in range
Acute Diabetes Eventsat day 0severe hypoglycemia, hyperglycemia requiring hospitalization

Countries

France

Contacts

Primary ContactMarie BOULY, APN
marie.bouly@chsf.fr01 61 69 35 93
Backup ContactCaroline TOURTE
caroline.tourte@chsf.fr01 61 69 31 50

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026