A Study of DIA:CONN P8 Smart Insulin Pen With CGM-Based Coaching in Patients With Type 1 or Type 2 Diabetes
NCT ID: NCT07004153
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
152 participants
INTERVENTIONAL
2025-06-30
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Investigational Group
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
Smart Coaching Insulin Pen
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.
Control group
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
No interventions assigned to this group
Interventions
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Smart Coaching Insulin Pen
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.
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of type 1 or type 2 diabetes for at least 1 year prior to screening
3. 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
4. HbA1c of 7.5% to 12.0% at screening.
Exclusion Criteria
2. 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).
3. eGFR \<15 mL/min at screening or those receiving dialysis
4. Pregnant or lactating women
19 Years
75 Years
ALL
No
Sponsors
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G2e Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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TAEMIN LEE
Role: STUDY_DIRECTOR
G2e Co., Ltd
Locations
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Samsung Medical Center
Seoul, Gangnam-gu, South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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P8_S201
Identifier Type: -
Identifier Source: org_study_id
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