Clinical trial NCT01995539: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Type 2
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
Collaborators: name: Medtronic
First posted: 2013-11-26
Enrollment: 181
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in A1C at 3 Months
timeFrame: 3 months
Secondary outcomes:
measure: Number of Serious Adverse Device Effects (SADE).
timeFrame: 3 months
Other outcomes:
Locations:
city: Gopalapuram
country: India
facility: Madras Diabetes Research Foundation
state: Chennai
city: Ahmedabad
country: India
facility: DIA Care
state: Gujarat
city: Gurgaon
country: India
facility: Medanta
state: Haryana
city: Trivandrum
country: India
facility: Jothydev's Diabetes and Research Centre
state: Kerala
city: Indore
country: India
facility: TOTALL Diabetes Hormone Institute
state: Madhya Pradesh
city: Mumbai
country: India
facility: K.G.N Diabetes and Endocrine Centre
state: Maharashtra
city: Mumbai
country: India
facility: Lina Diabetes Care Centre
state: Maharashtra
city: Mumbai
country: India
facility: Dr.Kovil's Diabetes Care centre
state: Maharashtra
city: Mumbai
country: India
facility: Diab Care Center
state: Maharashtra
city: Pune
country: India
facility: Diabetes Care & Research Center
state: Maharashtra
city: Chennai
country: India
facility: M.V Hospital for Diabetes Research centre
state: Tamil Nadu
Study officials:
affiliation: Jothydev's Diabetes and Research Centre
name: Jothydev Kesavadev, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Madras Diabetes Research Foundation
name: Mohan V, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: M.V Hospital for Diabetes Research centre
name: Vijay Viswanathan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medanta Institute of Clinical Research
name: Ambrish Mithal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lina Diabetes Care Mumbai Diabetes Research Centre
name: Manoj Chawla, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dr.Kovil's Diabetes Care centre
name: Rajiv Kovil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DIA Care
name: Banshi Saboo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: TOTALL Diabetes Hormone Institute
name: Sunil Jain, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diabetes Care & Research Center
name: Abhay Mutha, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: K.G.N DIABETES AND ENDOCRINE CENTRE
name: Shehla Shaikh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Diab Care Centre
name: Dharmen Punatar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medtronic Diabetes
name: Scott Lee, MD
role: STUDY_DIRECTOR
References: