Impact of Smart Connected Insulin Pens on Quality of Life in Dependent Patients with Diabetes Using Continuous Glucose Measurement
NCT ID: NCT06192940
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2024-03-28
2025-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Counseling 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
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Sud Francilien
OTHER
Responsible Party
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Principal Investigators
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Marie BOULY, APN
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Sud Francilien
Locations
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Centre Hospitalier Sud Francilien
Corbeil-Essonnes, France, France
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
Coleman BJ. European models of long-term care in the home and community. Int J Health Serv. 1995;25(3):455-74. doi: 10.2190/FYP6-DLWY-WKKT-6NNJ.
Other Identifiers
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2023/0052
Identifier Type: -
Identifier Source: org_study_id
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