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

NCT06192940 | Recruiting

• 1 other identifier: 2023/0052
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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?

Conditions

Diabetes

Keywords

insulin practice; Dependent patient; Smart connected insulin pen

Outcome Measures

Primary Outcomes (1)

• Insulin Injection

  Percentage of insulin injections not as prescribed

  at day 0

Secondary Outcomes (7)

• number of missed injections

  at day 0

• number of injections

  at day 0

• number of injections

  at day 0

• Continuous glucose measurement parameters

  at day 0

• Continuous glucose measurement parameters

  at day 30

Interventions

Counseling home caregivers BEHAVIORAL

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

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• \- Patient refusing study.

Sponsors & Collaborators

• Centre Hospitalier Sud Francilien: lead

Study Sites (1)

Centre Hospitalier Sud Francilien

Corbeil-Essonnes, France, 91106, France

RECRUITING

Related Publications (7)

• 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.

  PMID: 34324624 BACKGROUND

• 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.

  PMID: 36094418 BACKGROUND

• 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.

  PMID: 35604792 BACKGROUND

• 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.

  PMID: 24853809 BACKGROUND

• 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.

  PMID: 34738244 BACKGROUND

• 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.

  PMID: 35775735 BACKGROUND

• 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.

  PMID: 7591375 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Marie BOULY, APN

  Centre Hospitalier Sud Francilien

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: January 5, 2024
• Study Start: March 28, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)