Benefits of Smart Pens in Type 1 Diabetes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Insulin Smart Pen

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Ana Palanca, MD, MPH, PhD; Phone Number: 96 197 35 17; Email: ana.palanca@gmail.com
• Study Contact Backup: Name: F. Javier Ampudia-Blasco, MD, PhD; Phone Number: 961 97 35 00; Email: ampudia_fra@gva.es

Study Locations

• Spain
  • Valencia, Spain, 46010
    • INCLIVA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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).

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Individuals with other types of diabetes
• Individuals utilizing continuous subcutaneous insulin infusion devices
• Individuals using automatic insulin delivery systems

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Type of smart pen prescribed	Type of smart pen prescribed (smart pen prescription)	up to 24 months
Type of basal insulin prescribed	Type of basal insulin prescribed (basal insulin prescription)	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)	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	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)	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)	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)	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	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)	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)	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	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)	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)	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	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.	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.	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.	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.	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.	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.	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	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).	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	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.	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)	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)	up to 12 months
Diabetic ketoacidosis	Diabetic ketoacidosis (DKA) in the year prior to the initiation of the smart pen (Yes/No)	up to 12 months
Severe hypoglycemia	Severe hypoglycemia in the year prior to the initiation of the smart pen (Yes/No)	up to 12 months
BMI	BMI (kg/m2): at month -3, 0, 6, 12, 18, 24	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)	up to 12 months

Collaborators and Investigators

• Sponsor: Fundación para la Investigación del Hospital Clínico de Valencia
• Investigators: Principal Investigator: F. Javier Ampudia-Blasco, MD, PhD, HCUV-INCLIVA

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: May 14, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 14, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: SMART PENS_RW

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No