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

NCT01995539 | Completed Results

• 1 other identifier: CEP274
• Study Type: interventional
• Target: 181
• Locations: 1 country
• Sites: 11

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Serious Adverse Device Effects (SADE).

  3 months

Study Arms (1)

iPro2 Use

EXPERIMENTAL

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

Behavioral: therapy regimen

Interventions

therapy regimen BEHAVIORAL

Subjects will be recommend changes in therapy regimens.

iPro2 Use

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Diabetes: lead
• Medtronic: collaborator

Study Sites (11)

Madras Diabetes Research Foundation

Gopālapuram, Chennai, 600086, India

Location

DIA Care

Ahmedabad, Gujarat, 380015, India

Location

Medanta

Gurgaon, Haryana, 122 001, India

Location

Jothydev's Diabetes and Research Centre

Trivandrum, Kerala, 695032, India

Location

TOTALL Diabetes Hormone Institute

Indore, Madhya Pradesh, 452010, India

Location

K.G.N Diabetes and Endocrine Centre

Mumbai, Maharashtra, 400008, India

Location

Lina Diabetes Care Centre

Mumbai, Maharashtra, 400053, India

Location

Dr.Kovil's Diabetes Care centre

Mumbai, Maharashtra, 400058, India

Location

Diab Care Center

Mumbai, Maharashtra, 400080, India

Location

Diabetes Care & Research Center

Pune, Maharashtra, 411011, India

Location

M.V Hospital for Diabetes Research centre

Chennai, Tamil Nadu, 600013, India

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Suiying Huang, Statistician
• Organization: Medtronic Minimed

suiying.huang@medtronic.com

8184763319

Study Officials

• Jothydev Kesavadev, MD

  Jothydev's Diabetes and Research Centre

  PRINCIPAL INVESTIGATOR

• Mohan V, MD

  Madras Diabetes Research Foundation

  PRINCIPAL INVESTIGATOR

• Vijay Viswanathan, MD

  M.V Hospital for Diabetes Research centre

  PRINCIPAL INVESTIGATOR

• Ambrish Mithal, MD

  Medanta Institute of Clinical Research

  PRINCIPAL INVESTIGATOR

• Manoj Chawla, MD

  Lina Diabetes Care Mumbai Diabetes Research Centre

  PRINCIPAL INVESTIGATOR

• Rajiv Kovil, MD

  Dr.Kovil's Diabetes Care centre

  PRINCIPAL INVESTIGATOR

• Banshi Saboo, MD

  DIA Care

  PRINCIPAL INVESTIGATOR

• Sunil Jain, MD

  TOTALL Diabetes Hormone Institute

  PRINCIPAL INVESTIGATOR

• Abhay Mutha, MD

  Diabetes Care & Research Center

  PRINCIPAL INVESTIGATOR

• Shehla Shaikh, MD

  K.G.N DIABETES AND ENDOCRINE CENTRE

  PRINCIPAL INVESTIGATOR

• Dharmen Punatar, MD

  Diab Care Centre

  PRINCIPAL INVESTIGATOR

• Scott Lee, MD

  Medtronic Diabetes

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2013
• First Posted: November 26, 2013
• Study Start: December 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 4, 2018
• Results First Posted: October 18, 2018

Record last verified: 2018-11

Locations

IN (11)