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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01995539
• Other study ID #: CEP274
• Status: Completed
• Phase: N/A
• Start date: December 2012
• Est. completion date: April 2014

Study information

• Verified date: November 2018
• Source: Medtronic Diabetes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 181
• Est. completion date: April 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion criteria:

1. Subject is > 18 years to = 70 years of age

2. 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

3. Subject's A1C > 8.0% to = 10% conducted in the last 4 weeks

4. Subject, or legal representative, has signed the study Patient Informed Consent Form (PIC)

5. Subject is willing to comply with the study procedures

Exclusion criteria:

1. Subject is unable to tolerate tape adhesive in the area of sensor placement

2. Subject is pregnant, or is expecting to become pregnant during the course of the trial per Investigator discretion.

3. Subject has no experience with SMBG and blood glucose meter use

4. Subject has undergone an iPro evaluation during the past 6 months

5. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, rash, Staphylococcus infection)

6. 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

7. 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

8. Subject has unresolved alcohol or drug addiction

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• therapy regimen
Subjects will be recommend changes in therapy regimens.

Locations

Country	Name	City	State
India	DIA Care	Ahmedabad	Gujarat
India	M.V Hospital for Diabetes Research centre	Chennai	Tamil Nadu
India	Madras Diabetes Research Foundation	Gopalapuram	Chennai
India	Medanta	Gurgaon	Haryana
India	TOTALL Diabetes Hormone Institute	Indore	Madhya Pradesh
India	Diab Care Center	Mumbai	Maharashtra
India	Dr.Kovil's Diabetes Care centre	Mumbai	Maharashtra
India	K.G.N Diabetes and Endocrine Centre	Mumbai	Maharashtra
India	Lina Diabetes Care Centre	Mumbai	Maharashtra
India	Diabetes Care & Research Center	Pune	Maharashtra
India	Jothydev's Diabetes and Research Centre	Trivandrum	Kerala

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Diabetes	Medtronic

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in A1C at 3 Months	Descriptive analysis of change in A1C from baseline to end of 3-month study period	3 months
Secondary	Number of Serious Adverse Device Effects (SADE).	Evaluation of incidence of SADE during the study.	3 months