DIA:CONN P8(Smart Insulin Pen) Study in Diabetes Patients (NCT06406439) | Clinical Trial Compass
CompletedNot Applicable
DIA:CONN P8(Smart Insulin Pen) Study in Diabetes Patients
South Korea120 participantsStarted 2024-05-21
Plain-language 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
Who can participate
Age range
19 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. 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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used a smart insulin pen in people with insulin-requiring diabetes — including Type 1, Type 2, and pancreatogenic diabetes — and measured changes in HbA1c over 12 weeks, so could you walk me through what the results actually showed and whether the HbA1c improvements were meaningful for someone in my situation?
2Since this study is already completed and didn't have a traditional phase number, what does that mean about how much we know regarding the safety and real-world benefit of using a smart insulin pen compared to my current insulin delivery method?
3The trial included people with pancreatogenic diabetes alongside Type 1 and Type 2 — given my specific diagnosis, do you think the findings from this study are relevant enough to my case to influence how we manage my insulin regimen?
4Smart insulin pens typically track dose timing and amounts to help with adherence — based on what this trial measured, do you think that kind of technology could help me better manage my HbA1c, and are there devices like this already available to me outside of a trial?
5Before considering any technology changes like a smart insulin pen, would you recommend we first focus on optimizing my current insulin routine, or do you think the data from this completed trial suggests it's worth exploring sooner?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in HbA1c(%) at 12 weeks compared to baseline
Timeframe: from baseline to the 12-week time point