Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06415097
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-01-23
Brief Title:
Benefits of Smart Pens in Type 1 Diabetes
Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Organization:
Fundación para la Investigación del Hospital Clínico de Valencia
Study Overview
Official Title:
Benefits of Smart Pens in People With Type 1 Diabetes a Real-word Retrospective Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to address persistent challenges in achieving recommended control goals for patients with type 1 diabetes through innovative interventions Specifically the research focuses on assessing the effectiveness of smart insulin pens combined with glucose monitoring devices as a promising treatment option for individuals on multiple daily insulin injections The study will analyze electronic health records from adults 18 years attending the Diabetes Unit of the University Clinical Hospital of Valencia Participants who are or have used smart insulin pens will be compared with a control group matched for age sex duration of diabetes and HbA1c value at baseline 11 Data will be collected on participant characteristics smart pen usage glycemic control parameters and daily insulin doses The study also aims to identify adverse events associated with the use of smart pens Ethical considerations include ensuring the anonymity of participant data and the study is designed to comply with European EU data protection regulations The retrospective nature ensures no interference with physicians prescription habits
Detailed Description:
Rationale
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 studys outset 11
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 11 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 2016679 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 32018 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
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 studys outset 11
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 11 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 2016679 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 32018 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None