Benefits of Smart Pens in Type 1 Diabetes

NCT06415097 | Not Yet Recruiting

• 1 other identifier: SMART PENS_RW
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (30)

• 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

Study Arms (2)

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

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.

Interventions

Insulin Smart Pen DEVICE

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 Users

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

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).

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación para la Investigación del Hospital Clínico de Valencia: lead

Study Sites (1)

INCLIVA

Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• F. Javier Ampudia-Blasco, MD, PhD

  HCUV-INCLIVA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana Palanca, MD, MPH, PhD

CONTACT

96 197 35 17; ana.palanca@gmail.com

F. Javier Ampudia-Blasco, MD, PhD

CONTACT

961 97 35 00; ampudia_fra@gva.es

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: May 16, 2024
• Study Start: July 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

ES (1)