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DiabetesBESTYLCONCT06192940

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

An observational study of Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes
What is being tested?
Counseling home caregivers
How many people
30 participants
Where
1 siteFrance
Study dates
28 Mar 2024to 31 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • Patient refusing study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marie BOULY, APN contact

01 61 69 35 93

marie.bouly@chsf.fr

Caroline TOURTE contact

01 61 69 31 50

caroline.tourte@chsf.fr

France1 site, 1 recruiting

  • Centre Hospitalier Sud Francilien

    Corbeil-Essonnes, France, 91106

    Marie BOULY, 01 61 69 35 93, marie.bouly@chsf.fr

    Recruiting

Other trials in France

About this study

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?

Read the 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.

Conditions
Diabetes
Being tested
Counseling home caregivers
Keywords
insulin practice, Dependent patient, Smart connected insulin pen
Medical subject headings
Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Counseling home caregiversBehavioural

    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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Insulin Injection

    Percentage of insulin injections not as prescribed

    Measured: at day 0

Secondary outcomes (7)

  1. number of missed injections

    Percentage of missed injections

    Measured: at day 0

  2. number of injections

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

    Measured: at day 0

  3. number of injections

    Percentage of injections performed outside the meal time : more than 15 minutes before or more than an hour after the meal.

    Measured: at day 0

  4. Continuous glucose measurement parameters

    Time in range

    Measured: at day 0

  5. Continuous glucose measurement parameters

    Time in range

    Measured: at day 30

  6. Acute Diabetes Events

    severe hypoglycemia, hyperglycemia requiring hospitalization

    Measured: at day 0

  7. Acute Diabetes Events

    severe hypoglycemia, hyperglycemia requiring hospitalization

    Measured: at day 30

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2024
  2. Study start28 Mar 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06192940
Sponsor's protocol ID
2023/0052
Acronym
BESTYLCO
Status last verified
Mar 2025
First submitted
7 Dec 2023
Last updated
14 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bouillet B, Tscherter P, Vaillard L, Nonciaux C, Hourdain P, Ravier A, Rouland A, Petit JM, Verges B, Quilot E. Frequent and severe hypoglycaemia detected with continuous glucose monitoring in older institutionalised patients with diabetes. Age Ageing. 2021 Nov 10;50(6):2088-2093. doi: 10.1093/ageing/afab128.

    PubMed 34324624

  • Guerci B, Roussel R, Levrat-Guillen F, Detournay B, Vicaut E, De Pouvourville G, Emery C, Riveline JP. Important Decrease in Hospitalizations for Acute Diabetes Events Following FreeStyle Libre System Initiation in People with Type 2 Diabetes on Basal Insulin Therapy in France. Diabetes Technol Ther. 2023 Jan;25(1):20-30. doi: 10.1089/dia.2022.0271. Epub 2022 Nov 24.

    PubMed 36094418

  • Riveline JP, Roussel R, Vicaut E, de Pouvourville G, Detournay B, Emery C, Levrat-Guillen F, Guerci B. Reduced Rate of Acute Diabetes Events with Flash Glucose Monitoring Is Sustained for 2 Years After Initiation: Extended Outcomes from the RELIEF Study. Diabetes Technol Ther. 2022 Sep;24(9):611-618. doi: 10.1089/dia.2022.0085. Epub 2022 Jul 11.

    PubMed 35604792

  • Andreassen LM, Sandberg S, Kristensen GB, Solvik UO, Kjome RL. Nursing home patients with diabetes: prevalence, drug treatment and glycemic control. Diabetes Res Clin Pract. 2014 Jul;105(1):102-9. doi: 10.1016/j.diabres.2014.04.012. Epub 2014 Apr 28.

    PubMed 24853809

  • Poret F, Nacher M, Pujo J, Cauvin JM, Demar M, Massicard M, Sabbah N. Risk factors for hypoglycaemia in people with diabetes admitted to the Emergency Department of a Hospital in French Guiana. Diabet Med. 2022 Feb;39(2):e14736. doi: 10.1111/dme.14736. Epub 2021 Nov 23.

    PubMed 34738244

  • Ekberg NR, Hartvig NV, Kaas A, Moller JB, Adolfsson P. Smart Pen Exposes Missed Basal Insulin Injections and Reveals the Impact on Glycemic Control in Adults With Type 1 Diabetes. J Diabetes Sci Technol. 2024 Jan;18(1):66-73. doi: 10.1177/19322968221104142. Epub 2022 Jul 1.

    PubMed 35775735

  • Adolfsson P, Hartvig NV, Kaas A, Moller JB, Hellman J. Increased Time in Range and Fewer Missed Bolus Injections After Introduction of a Smart Connected Insulin Pen. Diabetes Technol Ther. 2020 Oct;22(10):709-718. doi: 10.1089/dia.2019.0411. Epub 2020 Mar 11.

    PubMed 32003590

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marie BOULY, APN (01 61 69 35 93, marie.bouly@chsf.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insulin Injection (time frame: at day 0). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06192940, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.

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