Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06406439
Status:
RECRUITING
Last Update Posted:
2024-05-13
First Post:
2024-05-06
Brief Title:
DIACONN P8Smart Insulin Pen Study in Diabetes Patients
Sponsor:
G2e Co Ltd
Organization:
G2e Co Ltd
Study Overview
Official Title:
A Multicenter Open Label Randomized Comparative Study to Evaluate the Efficacy and Safety of Electric Smart Insulin Pen DIACONN P8 in Patients With Type 1 Type 2 or Pancreatogenic Diabetes Mellitus Under Multiple Dose Insulin Therapy
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Multicenter Open label Randomized Comparative Study to Evaluate the Efficacy and Safety of Electric Smart Insulin Pen DIACONN 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 inclusionexclusion criteria undergo a blind CGM before the baseline visit randomization During this period every subjects is provided with two DIACONN 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 DIACONN 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 DIACONN P8 and the participants 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 DIACONN P8 and DIACONN 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
Throughout this period subjects receive training on fundamental insulin pen usage and CGM operation They use the DIACONN 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 DIACONN P8 and the participants 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 DIACONN P8 and DIACONN 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None