DIA:CONN P8(Smart Insulin Pen) Study in Diabetes Patients

NCT06406439 | Completed

• 1 other identifier: P8_S301
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

A Multicenter, Open label, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Electric Smart Insulin Pen DIA:CONN P8 in patients with Type 1, Type 2 or Pancreatogenic Diabetes Mellitus under Multiple Dose Insulin Therapy

Conditions

Diabetes (Insulin-requiring, Type 1 or Type 2); Pancreatogenic Diabetes Mellitus

Keywords

smart insulin pen; smart insulin pen with dose calculator; insulin dose calculator

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c(%) at 12 weeks compared to baseline

  Descriptive statistics (sample size, mean, standard deviation, median, minimum, and maximum) are provided for the change in HbA1c (%) from baseline to the 12-week time point, stratified by group.

  from baseline to the 12-week time point

Study Arms (2)

Treatment Group

EXPERIMENTAL

For the treatment group, education sessions will be conducted during the baseline visit on carb counting and bolus calculator methods, installation, and usage instructions for DIA:CONN P8 and DIA:CONN app, as well as CGM and CGM app. During the 12-week, for basal insulin, the treatment group will input and inject the dosage using the DIA:CONN P8, using only the insulin injection and injection recording functions, same as the blind CGM period. For bolus insulin, when the carbohydrate counting is entered or the type of meal is selected into the DIA:CONN P8 application, the insulin dosage is automatically calculated and set using the entered information and other indicators. Subjects inject the insulin at that calculated dosage using the DIA:CONN P8. Insulin injection dosage, time stamps, and other related details will be recorded into DIA:CONN P8 device and app.

Device: Smart Insulin Pen

Control Group

OTHER

The control group will receive education on insulin pen and CGM usage, maintaining their conventional multiple dose insulin therapy while implementing CGM. During the 12-week, the control group will use DIA:CONN P8 to manually input and inject the dosage of both basal and bolus insulin, only using the insulin injection and injection recording functions, same as the blind CGM period. Insulin injection dosage, time stamps, and other related details will be recorded into DIA:CONN P8 device and app.

Device: Injection of bolus insulin via conventional therapy using insulin pen

Interventions

Smart Insulin Pen DEVICE

During the 12-week, for basal insulin, the treatment group will input and inject the dosage using the DIA:CONN P8, using only the insulin injection and injection recording functions, same as the blind CGM period. For bolus insulin, when the carbohydrate counting is entered or the type of meal is selected into the DIA:CONN P8 application, the insulin dosage is automatically calculated and set using the entered information and other indicators. Subjects inject the insulin at that calculated dosage using the DIA:CONN P8.

Also known as: DIA:CONN P8

Treatment Group

Injection of bolus insulin via conventional therapy using insulin pen DEVICE

During the 12-week, the control group will use DIA:CONN P8 to manually input and inject the dosage of both basal and bolus insulin, only using the insulin injection and injection recording functions, same as the blind CGM period.

Control Group

Eligibility Criteria

• Age: 19 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 19 and 75 years old.
• Confirmed diagnosis of Type 1 or Type 2 diabetes or post-pancreatectomy(total or partial) diabetes at least 1 year prior to screening.
• Currently using multiple dose insulin therapy at least 3 months prior to screening, regardless of Continuous Glucose Monitoring(CGM) usage.
• HbA1c levels between 7.5% and 12.0% at screening.

You may not qualify if:

• Who have administered medications affecting glucose metabolism within 3 months before screening(e.g., corticosteroids, immunosuppressants) (Candidate with stable, ongoing dosage for over 6 months before screening are exempted from this criterion).
• Diagnosed with clinically significant cardiovascular disease within 6 months prior to screening.
• Exhibiting an estimated glomerular filtration rate(eGFR)\<15 mL/min at the screening.
• Unable to engage in study education due to severe systemic disorders(e.g., end-stage renal failure requiring dialysis, liver cirrhosis of Child-Pugh Class C or higher, etc)
• Participants with severe diabetic complications(e.g., diabetic foot, diabetic retinopathy, etc)
• Pregnant or lactating women

Sponsors & Collaborators

• G2e Co., Ltd: lead

Study Sites (1)

Samsung Medical Center

Seoul, Gangnam-gu, 135710, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• TAEMIN LEE

  G2e Co., Ltd

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2024
• First Posted: May 9, 2024
• Study Start: May 21, 2024
• Primary Completion: April 2, 2025
• Study Completion: April 2, 2025
• Last Updated: July 31, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)