Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2025-12-24 @ 6:35 PM
Study NCT ID:
NCT03775057
Status:
UNKNOWN
Last Update Posted:
2018-12-17
First Post:
2018-09-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of the MyDose Coach Digital Tool for Self-titration of Insulin in Patients With Type 2 Diabetes
Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Organization:
Study Overview
Official Title:
Use of the MyDose Coach Digital Tool for Self-titration of Insulin in Patients With Type 2 Diabetes
Status:
UNKNOWN
Status Verified Date:
2018-12
Last Known Status:
RECRUITING
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:
Scientific studies show that the introduction of digital tools led to: Significant improvement in glycemic control, greater patient satisfaction, reduction of emotional burden, reduction of fear of hypoglycaemia, reduction of anxiety of the regimen, significantly fewer of additional visits to the doctor in addition to those scheduled and a reduction of resources.
Primary Objective:
To evaluate the efficacy and safety of the MyDose Coach digital tool in patients with T2D with basal insulin or candidates for the use of basal insulin.
Secondary Objectives:
Evaluate demographic variables and control variables (HbA1c, SMPG, FPG). Measure the units of insulin used before and after the intervention
Primary Objective:
To evaluate the efficacy and safety of the MyDose Coach digital tool in patients with T2D with basal insulin or candidates for the use of basal insulin.
Secondary Objectives:
Evaluate demographic variables and control variables (HbA1c, SMPG, FPG). Measure the units of insulin used before and after the intervention
Detailed Description:
The maximum study duration will be 29 weeks per patient that will consist of a 12-week screening period, a 16-week treatment period, and 1-week follow-up period.
Study Oversight
Has Oversight DMC:
True
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?: