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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NOT_YET_RECRUITING
100 participants
OBSERVATIONAL
2024-07-31
2024-12-31
Brief Summary
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Detailed Description
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Despite ongoing advancements in type 1 diabetes management, a significant number of patients continue to struggle in attaining recommended control goals, posing an elevated risk of complications and a diminished quality of life. Hence, there is a need for innovative interventions that genuinely improve diabetes management and associated clinical outcomes. Smart insulin pens, coupled with glucose monitoring devices, emerge as a promising treatment option for individuals on multiple daily insulin injections who may not be suitable candidates for continuous subcutaneous insulin infusion (CSII) therapy. These easy-to-use devices offer significant advantages, such as automated tracking of administered insulin doses along with information other relevant diabetes-related data, facilitating treatment optimization, and helping overcome barriers to achieve better glucose control where both patients and healthcare professionals can implement treatment plans with agility, adopting a more proactive and personalized approach to diabetes care.
While certain recent studies have shown positive outcomes in glycemic control and quality of life linked to the utilization of these devices, there is still a gap in understanding their impact under real-life conditions. Hence, conducting clinical studies within the framework of routine clinical practice becomes imperative to thoroughly assess their application and effects on individuals with type 1 diabetes undergoing multiple daily insulin injections.
The purpose of this study is to provide real-world evidence on the effectiveness of smart pens in enhancing glycemic control and identify specific patient subgroups for targeted interventions.
Hypothesis:
Our hypothesis suggests that the use of smart pens in patients with type 1 diabetes receiving multiple daily insulin doses and utilizing glucose monitoring devices is associated with improved glycemic control. It is expected that the use of these devices is linked to a significant increase in time in range, a reduction in time below the target range, and a decrease in glucose variability during the usage period, compared to a control group.
Primary objectives:
* To describe the clinical characteristics of individuals with type 1 diabetes using smart pens for multiple daily insulin doses in the Valencia Clínico-Malvarrosa Health Department, comparing it with a control group.
* To evaluate changes in glycemic control parameters (HbA1c and continuous glucose monitoring parameters) as well as the incidence of adverse events with the use of smart pens in patients with type 1 diabetes, comparing it with a control group in real-life conditions.
Sample size:
The sample will include all adults (≥ 18 years) with type 1 diabetes who attend or have attended the Diabetes Unit of the University Clinical Hospital of Valencia, using or having used smart insulin pens, along with a control group matched for age, sex, diabetes duration, and HbA1c value at the study's outset (1:1).
Data and study procedure:
Data for this study will be sourced from the electronic health records of adults (≥ 18 years) with type 1 diabetes who attend or have attended the Diabetes Unit of the University Clinical Hospital of Valencia.
The medical records of all participants using or having used smart insulin pens and glucose monitoring devices, as well as a control group (1:1), will be reviewed. Retrospective data will be collected on participant characteristics, the type of smart insulin pen used, and individual changes in glycemic control (HbA1c and glucose monitoring device parameters), as well as daily insulin doses, starting from the date of smart pen prescription. Additionally, all adverse events occurring during the use of smart pens will be documented, specifying their type and frequency for each individual. All data will be compiled in an anonymous Microsoft Excel database, which will be deleted upon completion of the study. Anonymization will be performed by an individual external to the clinical research team.
Ethical aspects:
The study database will not contain any information allowing the individual identification of study participants. The data will be used exclusively for the purposes described in this project. The information will be considered confidential and will be stored and processed in accordance with EU Regulation 2016/679 of the European Parliament and the Council of April 27, 2016, regarding personal data and the free movement of this data, as per Organic Law 3/2018 of December.
Although there are objectives related to medication use, being a retrospective study makes it impossible to alter the prescription habits of any physician in the unit under study.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Type 1 Diabetes MDI Smart Pen Users
Individuals with type 1 diabetes receiving multiple daily doses of insulin (MDI), utilizing glucose monitoring devices, and using or having used insulin smart pens.
Insulin Smart Pen
Retrospective analysis of electronic health records for individuals with type 1 diabetes receiving multiple daily doses of insulin, combined with glucose monitoring devices and who have used or are currently using insulin smart pens.
Type 1 Diabetes MDI Smart Pen Non-Users
Patients with type 1 diabetes receiving multiple daily doses of insulin (MDI) and using glucose monitoring devices.
No interventions assigned to this group
Interventions
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Insulin Smart Pen
Retrospective analysis of electronic health records for individuals with type 1 diabetes receiving multiple daily doses of insulin, combined with glucose monitoring devices and who have used or are currently using insulin smart pens.
Eligibility Criteria
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Inclusion Criteria
* Individuals diagnosed with type 1 diabetes
* Individuals receiving multiple daily doses of insulin
* Individuals using a glucose monitoring device
* Individuals who use or have used smart insulin pens since their introduction to the market
Exclusion Criteria
* Individuals utilizing continuous subcutaneous insulin infusion devices
* Individuals using automatic insulin delivery systems
18 Years
ALL
No
Sponsors
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Fundación para la Investigación del Hospital Clínico de Valencia
OTHER
Responsible Party
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Francisco Javier Ampudia Blasco
Principal Investigator
Principal Investigators
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F. Javier Ampudia-Blasco, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
HCUV-INCLIVA
Locations
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INCLIVA
Valencia, , Spain
Countries
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Central Contacts
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Other Identifiers
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SMART PENS_RW
Identifier Type: -
Identifier Source: org_study_id
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