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Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

therapy regimen

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Type 2

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

Subject is > 18 years to ≤ 70 years of age
Subject has been diagnosed with type 2 diabetes mellitus for at least 1 year and is currently being treated with an oral anti-hyperglycemic medication and/or insulin
Subject's A1C > 8.0% to ≤ 10% conducted in the last 4 weeks
Subject, or legal representative, has signed the study Patient Informed Consent Form (PIC)
Subject is willing to comply with the study procedures

Exclusion criteria:

Subject is unable to tolerate tape adhesive in the area of sensor placement
Subject is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion.
Subject has no experience with SMBG and blood glucose meter use
Subject has undergone an iPro evaluation during the past 6 months
Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)
Subject is actively participating or planning to actively participate in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks
Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator
Subject has unresolved alcohol or drug addiction

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

iPro2 Use

Arm Description

All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests

Outcomes

Primary Outcome Measures

Change From Baseline in A1C at 3 Months

Descriptive analysis of change in A1C from baseline to end of 3-month study period

Secondary Outcome Measures

Number of Serious Adverse Device Effects (SADE).

Evaluation of incidence of SADE during the study.

Full Information

NCT ID

NCT01995539

First Posted

November 8, 2013

Last Updated

November 8, 2018

Sponsor

Medtronic Diabetes

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT01995539

Brief Title

Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India

Official Title

Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Diabetes

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the India iPro2 study is to demonstrate that iPro2 Continuous Glucose Monitoring System (CGMS) evaluation enables Health Care Professional (HCP)s treating patients in India with type 2 diabetes to get a better understanding of their patient's metabolic fluctuations, and support appropriate therapeutic intervention.

Detailed Description

The study will be designed to demonstrate the value of iPro2 in real-world diabetes management in type 2 patients in India. It will be an interventional post-market, prospective, multi-center study with a data review performed after 30 subjects have completed the trial. During the course of the study, patients will undergo two iPro2 evaluations: First iPro2 test (Visit 1 [application] & 2 [removal]) Second iPro2 test (Visit 3 [application] & 4 [removal]) Patient and HCP questionnaires will be administered at Visit 1, 2, 3, 4 and 5. These questionnaires aim to assess the impact of an iPro2 evaluation on the physicians understanding of their patient's metabolic fluctuations and its support of therapeutic interventions. They will also investigate the subjects understanding (both pre & post iPro2 evaluation) of the concept of glycemic variability and the importance of compliance to HCP recommendations.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

Keywords

Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

181 (Actual)

8. Arms, Groups, and Interventions

Arm Title

iPro2 Use

Arm Type

Experimental

Arm Description

All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests

Intervention Type

Behavioral

Intervention Name(s)

therapy regimen

Intervention Description

Subjects will be recommend changes in therapy regimens.

Primary Outcome Measure Information:

Title

Change From Baseline in A1C at 3 Months

Description

Descriptive analysis of change in A1C from baseline to end of 3-month study period

Time Frame

3 months

Secondary Outcome Measure Information:

Title

Number of Serious Adverse Device Effects (SADE).

Description

Evaluation of incidence of SADE during the study.

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion criteria: Subject is > 18 years to ≤ 70 years of age Subject has been diagnosed with type 2 diabetes mellitus for at least 1 year and is currently being treated with an oral anti-hyperglycemic medication and/or insulin Subject's A1C > 8.0% to ≤ 10% conducted in the last 4 weeks Subject, or legal representative, has signed the study Patient Informed Consent Form (PIC) Subject is willing to comply with the study procedures Exclusion criteria: Subject is unable to tolerate tape adhesive in the area of sensor placement Subject is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion. Subject has no experience with SMBG and blood glucose meter use Subject has undergone an iPro evaluation during the past 6 months Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection) Subject is actively participating or planning to actively participate in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator Subject has unresolved alcohol or drug addiction

Overall Study Officials: