Clinical trial NCT06406439: DIA:CONN P8(Smart Insulin Pen) Study in Diabetes Patients
Official title: 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 type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: G2e Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-05-09
Enrollment: 120
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in HbA1c(%) at 12 weeks compared to baseline
timeFrame: from baseline to the 12-week time point
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
state: Gangnam-gu
Study officials:
affiliation: G2e Co., Ltd
name: TAEMIN LEE
role: STUDY_DIRECTOR
References: