Diabetes MellitusNCT07004153
A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 Diabetes
A study testing Smart Coaching Insulin Pen in people with Diabetes Mellitus, run by G2e Co., Ltd at 1 site in South Korea.
Trial summary
A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 Diabetes Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Smart Coaching Insulin Pen
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 19 and 75 years old.
- Diagnosis of type 1 or type 2 diabetes for at least 1 year prior to screening
- Continuous use of MDI therapy for at least 3 months prior to screening, defined as one of the following regimens:
- Long-acting insulin plus rapid-/short-acting insulin
- Mixed insulin (e.g., insulin aspart/insulin degludec) plus rapid-/short-acting insulin
- Mixed insulin ≥3 times per day
- HbA1c of 7.5% to 12.0% at screening.
Who cannot join
- Diabetes mellitus secondary to pancreatic resection.
- Use of corticosteroids exceeding a prednisolone-equivalent dose of 5 mg/day within 3 months prior to screening (Subjects on a stable dose for ≥3 months prior to screening may be eligible).
- eGFR <15 mL/min at screening or those receiving dialysis
- Pregnant or lactating women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samsung Medical Center
Seoul, Gangnam-gu, 06351
SANGMAN JIN, +82-10-3646-2705, sjin772@gmail.com
About this study
Official title: A Multicenter, Open Label, Randomized, Comparative Confirmatory Study to Evaluate the Efficacy and Safety of Electric Smart Insulin Pen (DIA:CONN P8) Including Setup Wizard, Advanced Insulin Injection Coaching and Bolus Calculator With Analysis Function Based on Continuous Glucose Monitoring Data in Patients With Type 1 or Type 2 Diabetes Mellitus Under Multiple Dose Insulin Therapy
A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 Diabetes
Read the detailed description
This study evaluates the efficacy and safety of the DIA:CONN P8, an electric smart insulin pen equipped with a Setup Wizard, CGM-based insulin injection coaching, and a bolus calculator. The device is designed to support patients with type 1 or type 2 diabetes who are on multiple daily insulin injections (MDI). The study compares the outcomes of patients using these advanced features to those using only the injection and recording functions of the device.
The rationale stems from previous research showing that structured education in combination with CGM improves glycemic control in patients with diabetes. The DIA:CONN P8 aims to replicate the benefits of such structured education through app-based coaching and algorithm-driven recommendations, potentially reducing the burden of complex insulin dose calculations in routine care.
Participants will undergo a run-in period using DIA:CONN P8 with injection-only functionality to assess compliance. Eligible subjects will then be randomized into either the investigational group (using all device functions) or the control group (injection and recording only). Over 12 weeks, the primary endpoint is the change in HbA1c. Secondary outcomes include CGM-based metrics such as Time in Range (TIR), Time Below Range (TBR), and insulin dosing behavior.
The study is designed as a multicenter, open-label, randomized, comparative confirmatory trial conducted at six sites. A total of 152 subjects will be enrolled.
- Conditions
- Diabetes Mellitus
- Being tested
- Smart Coaching Insulin Pen
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Coaching Insulin PenDevice
Subjects randomized to the intervention group will use the DIA:CONN P8 smart insulin pen with full functionality, including Setup Wizard, CGM-based insulin injection coaching, and a bolus calculator. During the 12-week application period, including the baseline visit, participants will visit the hospital up to 5 times. At the start of the period, initial basal and bolus doses will be determined using the Setup Wizard and reviewed by investigators. Throughout the study, subjects will receive real-time insulin dose recommendations and coaching via the DIA:CONN app based on CGM data, carbohydrate input, and insulin dosing history.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Group | Experimental | Basal and bolus insulin injection using an electric smart insulin pen (DIA:CONN P8); equipped with a Setup-wizard, CGM-based Advanced insulin injection Coaching and a Bolus calculator
- Providing education on Carb Counting(carbohydrate measurement) and Methods for adjusting insulin bolus calculator Receives: Device: Smart Coaching Insulin Pen |
| Control group | No intervention | Basal and bolus insulin injection using only the injection and recording functions of DIA:CONN P8 - Subjects manually enter and inject their insulin doses without using the bolus calculator or coaching functions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: from baseline to the 12-week time point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study startJun 2025 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G2e Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- TAEMIN LEE, Study director, G2e Co., Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004153
- Sponsor's protocol ID
- P8_S201
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim JY, Kim NH, Kwak SH, Jung CH, Kang ES, Moon JS, Moon SJ, Kwon SY, Yoo JH, Kim Y, Lee TM, Yang CI, Kim JH, Jin SM. Efficacy and Safety of Stage 5 Connected Insulin Pens in Type 1 or Type 2 Diabetes: Randomized Controlled Trial Protocol (SMART-5 Study). Endocrinol Metab (Seoul). 2026 Jun;41(3):393-404. doi: 10.3803/EnM.2025.2579. Epub 2025 Dec 12.
PubMed 41391451
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open Label, Randomized, Comparative Confirmatory Study to Evaluate the Efficacy and Safety of Electric Smart Insulin Pen (DIA:CONN P8) Including Setup Wizard, Advanced Insulin Injection Coaching and Bolus Calculator With Analysis Function Based on Continuous Glucose Monitoring Data in Patients With Type 1 or Type 2 Diabetes Mellitus Under Multiple Dose Insulin Therapy
- ClinicalTrials.gov ID
- NCT07004153
- Acronym / sponsor ID
- P8_S201
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- G2e Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Jun 2025 (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.
A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 Diabetes
Detailed description
This study evaluates the efficacy and safety of the DIA:CONN P8, an electric smart insulin pen equipped with a Setup Wizard, CGM-based insulin injection coaching, and a bolus calculator. The device is designed to support patients with type 1 or type 2 diabetes who are on multiple daily insulin injections (MDI). The study compares the outcomes of patients using these advanced features to those using only the injection and recording functions of the device.
The rationale stems from previous research showing that structured education in combination with CGM improves glycemic control in patients with diabetes. The DIA:CONN P8 aims to replicate the benefits of such structured education through app-based coaching and algorithm-driven recommendations, potentially reducing the burden of complex insulin dose calculations in routine care.
Participants will undergo a run-in period using DIA:CONN P8 with injection-only functionality to assess compliance. Eligible subjects will then be randomized into either the investigational group (using all device functions) or the control group (injection and recording only). Over 12 weeks, the primary endpoint is the change in HbA1c. Secondary outcomes include CGM-based metrics such as Time in Range (TIR), Time Below Range (TBR), and insulin dosing behavior.
The study is designed as a multicenter, open-label, randomized, comparative confirmatory trial conducted at six sites. A total of 152 subjects will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Group | Experimental | Device: Smart Coaching Insulin PenBasal and bolus insulin injection using an electric smart insulin pen (DIA:CONN P8); equipped with a Setup-wizard, CGM-based Advanced insulin injection Coaching and a Bolus calculator - Providing education on Carb Counting(carbohydrate measurement) and Methods for adjusting insulin bolus calculator |
| Control group | No intervention | –Basal and bolus insulin injection using only the injection and recording functions of DIA:CONN P8 - Subjects manually enter and inject their insulin doses without using the bolus calculator or coaching functions |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 19 and 75 years old.
- Diagnosis of type 1 or type 2 diabetes for at least 1 year prior to screening
- Continuous use of MDI therapy for at least 3 months prior to screening, defined as one of the following regimens:
- HbA1c of 7.5% to 12.0% at screening.
Key exclusion criteria (4 listed)
- Diabetes mellitus secondary to pancreatic resection.
- Use of corticosteroids exceeding a prednisolone-equivalent dose of 5 mg/day within 3 months prior to screening (Subjects on a stable dose for ≥3 months prior to screening may be eligible).
- eGFR <15 mL/min at screening or those receiving dialysis
- Pregnant or lactating women
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 |
|---|---|---|
| Smart Coaching Insulin PenSubjects randomized to the intervention group will use the DIA:CONN P8 smart insulin pen with full functionality, including Setup Wizard, CGM-based insulin injection coaching, and a bolus calculator. During the 12-week application period, including the baseline visit, participants will visit the hospital up to 5 times. At the start of the period, initial basal and bolus doses will be determined using the Setup Wizard and reviewed by investigators. Throughout the study, subjects will receive real-time insulin dose recommendations and coaching via the DIA:CONN app based on CGM data, carbohydrate input, and insulin dosing history. | Device | Investigational Group |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2025.
- Derived from this study: PubMed 41391451Kim JY, Kim NH, Kwak SH, Jung CH, Kang ES, Moon JS, Moon SJ, Kwon SY, Yoo JH, Kim Y, Lee TM, Yang CI, Kim JH, Jin SM. Efficacy and Safety of Stage 5 Connected Insulin Pens in Type 1 or Type 2 Diabetes: Randomized Controlled Trial Protocol (SMART-5 Study). Endocrinol Metab (Seoul). 2026 Jun;41(3):393-404. doi: 10.3803/EnM.2025.2579. Epub 2025 Dec 12.
- Individual participant dataSharing planned: No
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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.
TAEMIN LEE study director
G2e Co., Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart Coaching Insulin Pen in people with Diabetes Mellitus, run by G2e Co., Ltd at 1 site in South Korea.
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 7 inclusion and 4 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: opening soon, as of the sponsor's last update on 4 Jun 2025. 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 South Korea. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SOOHYUN YOON (+82-10-3352-4744, soohyun.yoon@g2e.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HbA1c(%) at 12 weeks compared to baseline (time frame: from baseline to the 12-week time point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07004153, which also lists 1 linked publication.
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 4 Jun 2025.