Clinical trial NCT06192940: Impact of Smart Connected Insulin Pens on Quality of Life in Dependent Patients with Diabetes Using Continuous Glucose Measurement
Official title: Impact of Smart Connected Insulin Pens on Quality of Life in Dependent Patients with Diabetes Using Continuous Glucose Measurement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Diabetes
Keywords: insulin practice
Dependent patient
Smart connected insulin pen
Lead sponsor: Centre Hospitalier Sud Francilien
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient managed by a caregivers for the management of insulin therapy at home or in nursing home or in healthcare facility.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insulin Injection
timeFrame: at day 0
Secondary outcomes:
measure: number of missed injections
timeFrame: at day 0
measure: number of injections
timeFrame: at day 0
measure: number of injections
timeFrame: at day 0
measure: Continuous glucose measurement parameters
timeFrame: at day 0
measure: Continuous glucose measurement parameters
timeFrame: at day 30
measure: Acute Diabetes Events
timeFrame: at day 0
measure: Acute Diabetes Events
timeFrame: at day 30
Other outcomes:
Locations:
city: Corbeil-essonnes Cedex
country: France
facility: Centre Hospitalier Sud Francilien
Study officials:
affiliation: Centre Hospitalier Sud Francilien
name: Marie BOULY, APN
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.