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

Diabetes Clinical Trial

— BESTYLCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192940
• Other study ID #: 2023/0052
• Status: Recruiting
• Start date: March 28, 2024
• Est. completion date: November 30, 2024

Study information

• Verified date: December 2023
• Source: Centre Hospitalier Sud Francilien
• Contact: Marie BOULY, APN
• Phone: 01 61 69 35 93
• Email: marie.bouly[@]chsf.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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 institutionalized patients?

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2024
• Est. primary completion date: November 30, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
France	Centre Hospitalier Sud Francilien	Corbeil-essonnes Cedex

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Sud Francilien

Country where clinical trial is conducted

France, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin Injection	Percentage of insulin injections not as prescribed	at day 0
Secondary	number of missed injections	Percentage of missed injections	at day 0
Secondary	number of injections	Percentage of injections performed with a dose deviation of +-20% from the prescribed dose	at day 0
Secondary	number of injections	Percentage of injections performed outside the meal time : more than 15 minutes before or more than an hour after the meal.	at day 0
Secondary	Continuous glucose measurement parameters	Time in range	at day 0
Secondary	Continuous glucose measurement parameters	Time in range	at day 30
Secondary	Acute Diabetes Events	severe hypoglycemia, hyperglycemia requiring hospitalization	at day 0
Secondary	Acute Diabetes Events	severe hypoglycemia, hyperglycemia requiring hospitalization	at day 30