Type 1 DiabetesNCT06415097
Benefits of Smart Pens in Type 1 Diabetes
An observational study of Type 1 Diabetes, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin Smart Pen
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2024to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population aged 18 years and older registered in the Population Information System of the Valencian Community (SIP), with an assigned doctor and belonging to the Valencia Clínico - Malvarrosa health department (approximately 320,000 citizens).
Who may be able to join
- Individuals aged 18 or above
- 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
Who cannot join
- Individuals with other types of diabetes
- Individuals utilizing continuous subcutaneous insulin infusion devices
- Individuals using automatic insulin delivery systems
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefits of Smart Pens in People With Type 1 Diabetes: a Real-word Retrospective Study.
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 (1:1). 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.
Read the 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 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
- Type 1 Diabetes
- Being tested
- Insulin Smart Pen
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insulin Smart PenDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Insulin Smart Pen | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type of smart pen prescribed
Type of smart pen prescribed (smart pen prescription)
Measured: up to 24 months
Type of basal insulin prescribed
Type of basal insulin prescribed (basal insulin prescription)
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Daily dose of basal insulin
Daily dose of basal insulin (UI/kg)
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Number of basal insulin injections
Number of basal insulin injections per day
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Omission of basal insulin
Omission of basal insulin doses (Yes/No)
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Type of prandial insulin prescribed
Type of insulin prescribed for prandial use (prandial insulin prescription)
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Daily dose of prandial insulin
Daily dose of prandial insulin (UI/kg)
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Number of prandial insulin injections
Number of prandial insulin injections per day
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Omission of prandial insulin
Omission of prandial insulin doses (Yes/No)
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Total daily insulin dose
Total daily insulin dose (UI/kg)
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Number of total insulin injections
Number of total insulin injections per day
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Self-monitoring of capillary glucose
Self-monitoring of capillary blood glucose (SMBG) (Y/N)
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Glucose monitoring device
Glucose monitoring in real-time or intermittently scanned (Yes/No)
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Time using the glucose monitoring device
Percentage of time using the glucose monitoring device
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
HbA1c concentration
HbA1c concentration: at month -3, 0, 3, 6, 12, 18, and 24.
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Time in Range (%TIR)
Time in Range (%TIR): at month -3, 0, 3, 6, 12, 18, and 24.
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Time Below Range (%TbR)
Time Below Range (%TbR): at month -3, 0, 3, 6, 12, 18, and 24.
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Time Above Range (%TaR)
Time Above Range (%TaR): at month -3, 0, 3, 6, 12, 18, and 24.
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Mean glucose (mg/dL)
Mean glucose (mg/dL): at month -3, 0, 3, 6, 12, 18, and 24.
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Coefficient of variation of continuous glucose sensor values (CV)
Coefficient of variation of continuous glucose sensor values (CV): at month -3, 0, 3, 6, 12, 18, and 24.
Measured: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Type of adverse event from the initiation of the prescription of smart insulin pens.
Type of adverse event from the initiation of the prescription of smart insulin pens (if any adverse event occurred): severe hypoglycemia, DKA (Diabetic Ketoacidosis), ketosis, other
Measured: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Months post smart pen prescription when the adverse event occurred.
Number of months post smart pen prescription when the adverse event occurred (nº).
Measured: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Adherence to smart insulin pen usage based on the number of days with data uploads
Adherence to data transfer in the mobile application when using the smart pen: at month 6, 12, 18, 24
Measured: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Smart pen persistence
Persistence in the use of smart insulin pens after prescription: at month 6, 12, 18, 24 Persistence defined as the percentage of patients continuing treatment since the first smart pen prescription until discontinuation.
Measured: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Exclusive use of smart pen
Exclusive use of smart insulin pens or mixed use with disposable pens (Yes/No)
Measured: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Duration of diabetes
Duration of diabetes at the time of the first smart pen prescription (years)
Measured: up to 12 months
Diabetic ketoacidosis
Diabetic ketoacidosis (DKA) in the year prior to the initiation of the smart pen (Yes/No)
Measured: up to 12 months
Severe hypoglycemia
Severe hypoglycemia in the year prior to the initiation of the smart pen (Yes/No)
Measured: up to 12 months
BMI
BMI (kg/m2): at month -3, 0, 6, 12, 18, 24
Measured: From three months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Age
Age at the time of the first smart pen prescription (years)
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study startJul 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier Ampudia Blasco, Fundación para la Investigación del Hospital Clínico de Valencia
- Investigators
- F. Javier Ampudia-Blasco, MD, PhD, Principal investigator, HCUV-INCLIVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415097
- Sponsor's protocol ID
- SMART PENS_RW
- Status last verified
- May 2024
- First submitted
- 23 Jan 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefits of Smart Pens in People With Type 1 Diabetes: a Real-word Retrospective Study.
- ClinicalTrials.gov ID
- NCT06415097
- Acronym / sponsor ID
- SMART PENS_RW
- Conditions
- Type 1 Diabetes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Fundación para la Investigación del Hospital Clínico de ValenciaUniversity, hospital or other
- Study start
- Jul 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (1:1). 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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 Diabetes MDI Smart Pen Users | – | Device: Insulin Smart PenIndividuals with type 1 diabetes receiving multiple daily doses of insulin (MDI), utilizing glucose monitoring devices, and using or having used 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population aged 18 years and older registered in the Population Information System of the Valencian Community (SIP), with an assigned doctor and belonging to the Valencia Clínico - Malvarrosa health department (approximately 320,000 citizens).
Key inclusion criteria (5 listed)
- Individuals aged 18 or above
- 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
Key exclusion criteria (3 listed)
- Individuals with other types of diabetes
- Individuals utilizing continuous subcutaneous insulin infusion devices
- Individuals using automatic insulin delivery systems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insulin Smart PenRetrospective 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. | Device | Type 1 Diabetes MDI Smart Pen Users |
Primary outcome
Type of smart pen prescribed
Time frame: up to 24 months
Type of smart pen prescribed (smart pen prescription)
Type of basal insulin prescribed
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Type of basal insulin prescribed (basal insulin prescription)
Daily dose of basal insulin
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Daily dose of basal insulin (UI/kg)
Number of basal insulin injections
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Number of basal insulin injections per day
Omission of basal insulin
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Omission of basal insulin doses (Yes/No)
Type of prandial insulin prescribed
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Type of insulin prescribed for prandial use (prandial insulin prescription)
Daily dose of prandial insulin
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Daily dose of prandial insulin (UI/kg)
Number of prandial insulin injections
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Number of prandial insulin injections per day
Omission of prandial insulin
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Omission of prandial insulin doses (Yes/No)
Total daily insulin dose
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Total daily insulin dose (UI/kg)
Number of total insulin injections
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Number of total insulin injections per day
Self-monitoring of capillary glucose
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Self-monitoring of capillary blood glucose (SMBG) (Y/N)
Glucose monitoring device
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Glucose monitoring in real-time or intermittently scanned (Yes/No)
Time using the glucose monitoring device
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Percentage of time using the glucose monitoring device
HbA1c concentration
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
HbA1c concentration: at month -3, 0, 3, 6, 12, 18, and 24.
Time in Range (%TIR)
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Time in Range (%TIR): at month -3, 0, 3, 6, 12, 18, and 24.
Time Below Range (%TbR)
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Time Below Range (%TbR): at month -3, 0, 3, 6, 12, 18, and 24.
Time Above Range (%TaR)
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Time Above Range (%TaR): at month -3, 0, 3, 6, 12, 18, and 24.
Mean glucose (mg/dL)
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Mean glucose (mg/dL): at month -3, 0, 3, 6, 12, 18, and 24.
Coefficient of variation of continuous glucose sensor values (CV)
Time frame: 3 months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
Coefficient of variation of continuous glucose sensor values (CV): at month -3, 0, 3, 6, 12, 18, and 24.
Type of adverse event from the initiation of the prescription of smart insulin pens.
Time frame: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Type of adverse event from the initiation of the prescription of smart insulin pens (if any adverse event occurred): severe hypoglycemia, DKA (Diabetic Ketoacidosis), ketosis, other
Months post smart pen prescription when the adverse event occurred.
Time frame: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Number of months post smart pen prescription when the adverse event occurred (nº).
Adherence to smart insulin pen usage based on the number of days with data uploads
Time frame: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Adherence to data transfer in the mobile application when using the smart pen: at month 6, 12, 18, 24
Smart pen persistence
Time frame: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Persistence in the use of smart insulin pens after prescription: at month 6, 12, 18, 24 Persistence defined as the percentage of patients continuing treatment since the first smart pen prescription until discontinuation.
Exclusive use of smart pen
Time frame: up to 24 months (from the time of the first prescription and throughout the study follow-up)
Exclusive use of smart insulin pens or mixed use with disposable pens (Yes/No)
Duration of diabetes
Time frame: up to 12 months
Duration of diabetes at the time of the first smart pen prescription (years)
Diabetic ketoacidosis
Time frame: up to 12 months
Diabetic ketoacidosis (DKA) in the year prior to the initiation of the smart pen (Yes/No)
Severe hypoglycemia
Time frame: up to 12 months
Severe hypoglycemia in the year prior to the initiation of the smart pen (Yes/No)
BMI
Time frame: From three months before the initiation of the first prescription and up to 24 months (throughout the study follow-up)
BMI (kg/m2): at month -3, 0, 6, 12, 18, 24
Age
Time frame: up to 12 months
Age at the time of the first smart pen prescription (years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
F. Javier Ampudia-Blasco, MD, PhD principal investigator
HCUV-INCLIVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Fundación para la Investigación del Hospital Clínico de Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ana Palanca, MD, MPH, PhD (96 197 35 17, ana.palanca@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type of smart pen prescribed (time frame: up to 24 months). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2024.