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

July 29, 2025 updated by: G2e Co., Ltd

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

[Blind CGM Period] All eligible participants who voluntarily provide informed consent to participate in this clinical trial and are determined suitable for trial inclusion/exclusion criteria undergo a blind CGM before the baseline visit (randomization). During this period, every subjects is provided with two DIA:CONN P8 devices for continuous glucose monitoring (CGM), basal insulin, and bolus insulin administration.

Throughout this period, subjects receive training on fundamental insulin pen usage and CGM operation. They use the DIA:CONN P8 specifically for insulin dosage entry and administration, functioning similarly to a conventional insulin pen, only utilizing the injection and injection recording function.

Insulin injection dosages and timing (time stamps) recorded on the DIA:CONN P8 and the participant's blood glucose data logged in the CGM app are collected.

[Application Period] The subject allocated to the intervention or control group through randomization will visit hospital maximun 5 times during the 12-week application period, including the baseline visit, in the following process.

  1. Treatment Group: 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.
  2. Control Group: The control group will receive education on insulin pen and CGM usage, maintaining their conventional multiple dose insulin therapy while implementing CGM.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Korea, Republic of
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 135710
        • Samsung Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. 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).
  2. Diagnosed with clinically significant cardiovascular disease within 6 months prior to screening.
  3. Exhibiting an estimated glomerular filtration rate(eGFR)<15 mL/min at the screening.
  4. 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)
  5. Participants with severe diabetic complications(e.g., diabetic foot, diabetic retinopathy, etc)
  6. Pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment Group
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
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.
Other Names:
  • DIA:CONN P8
Other: Control Group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in HbA1c(%) at 12 weeks compared to baseline
Time Frame: from baseline to the 12-week time point
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
G2e Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: TAEMIN LEE, G2e Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 2, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 2, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 6, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 29, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P8_S301

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Drug Interventions

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