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Could a smart pen take the guesswork out of insulin dosing?

NCT ID NCT06406439

Disease control Sponsor: G2e Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 30, 2026 · Last updated Aug 06, 2026 · Updated 3 times

Summary

This trial tests whether a smart insulin pen called DIA:CONN P8 can help people with type 1, type 2, or pancreatogenic diabetes better control their blood sugar. Participants use the pen for 12 weeks, and the pen automatically calculates bolus insulin doses based on meal information and other factors. The study compares changes in HbA1c levels between those using the smart pen and those using standard insulin injections.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a smart insulin pen called DIA:CONN P8 that automatically calculates and sets bolus insulin doses based on meal information and other indicators
What this could lead to
If it works, this could make daily insulin management easier and more accurate, potentially improving blood sugar control and reducing the mental burden of dose calculations.
What could go wrong
This is a relatively small, early-stage trial, and the device may not prove superior to standard insulin pens. Technical failures or user errors could also limit its effectiveness.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

120 people

The number who actually took part.

Started

May 2024

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus type 1 diabetes mellitus type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes (insulin-requiring, type 1 or type 2) Pancreatogenic diabetes mellitus

Contacts and locations

Locations

  • Chung-Ang University Gwangmyeong Hospital

    Gwangmyeong, Deokan-ro, 14353, South Korea

  • Kangbuk Samsung Hospital

    Seoul, Jongno-gu, 03181, South Korea

  • Kyung Hee University Hospital

    Seoul, Dongdaemun-gu, 02447, South Korea

  • Kyung Hee University Hospital at Gangdong

    Seoul, Gangdong-gu, 05278, South Korea

  • National Health Insurance Service Ilsan Hospital

    Goyang-si, Ilsandong-gu, 10444, South Korea

  • Samsung Changwon Hospital

    Changwon, Masanhoewon-gu, 51353, South Korea

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351, South Korea

  • Seoul St. Mary's Hospital

    Seoul, Seocho-gu, 06591, South Korea

  • Severance Hospital

    Seoul, Seodaemun-gu, 03722, South Korea

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