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

• Sponsor: Medtronic Diabetes (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01995539
• Collaborator: Medtronic (Industry)
• Enrollment: 181
• Locations: 11
• Arm: 1
• Duration (Months): 16
• Patients Per Site: 16.5
• Patients Per Site Per Month: 1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Behavioral: therapy regimen	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 181 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Use of iPro™2 in Real Life Diabetes Management of Type 2 Patients in India
• Study Start Date: Dec 1, 2012
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: iPro2 Use All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests	Behavioral: therapy regimen; Subjects will be recommend changes in therapy regimens.

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in A1C at 3 Months [3 months]

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

Secondary Outcome Measures

1. Number of Serious Adverse Device Effects (SADE). [3 months]

   Evaluation of incidence of SADE during the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Madras Diabetes Research Foundation	Gopalapuram	Chennai	India	600086
2	DIA Care	Ahmedabad	Gujarat	India	380015
3	Medanta	Gurgaon	Haryana	India	122 001
4	Jothydev's Diabetes and Research Centre	Trivandrum	Kerala	India	695032
5	TOTALL Diabetes Hormone Institute	Indore	Madhya Pradesh	India	452010
6	K.G.N Diabetes and Endocrine Centre	Mumbai	Maharashtra	India	400008
7	Lina Diabetes Care Centre	Mumbai	Maharashtra	India	400053
8	Dr.Kovil's Diabetes Care centre	Mumbai	Maharashtra	India	400058
9	Diab Care Center	Mumbai	Maharashtra	India	400080
10	Diabetes Care & Research Center	Pune	Maharashtra	India	411011
11	M.V Hospital for Diabetes Research centre	Chennai	Tamil Nadu	India	600013

Sponsors and Collaborators

• Medtronic Diabetes
• Medtronic

Investigators

• Principal Investigator: 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
• Study Director: Scott Lee, MD, Medtronic Diabetes

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic Diabetes
• ClinicalTrials.gov Identifier: NCT01995539
• Other Study ID Numbers: CEP274
• First Posted: Nov 26, 2013
• Last Update Posted: Dec 4, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by Medtronic Diabetes: Type 2
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

Participant Flow

Arm/Group Title	iPro2 Use
Arm/Group Description	All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Period Title: Overall Study
STARTED	181
COMPLETED	148
NOT COMPLETED	33

Baseline Characteristics

Arm/Group Title	iPro2 Use
Arm/Group Description	All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Overall Participants	181
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	54.1 (10.06)
Sex: Female, Male (Count of Participants)
Female	70 38.7%
Male	111 61.3%
Region of Enrollment (participants) [Number]
India	181 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

181 subjects consented and screened; 1 subject screen failed; 148 subjects completed study; 32 subjects not completed study.

Arm/Group Title	iPro2 Use
Arm/Group Description	All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Measure Participants	148
Mean (Standard Deviation) [percent]	-0.6 (1.11)

2. Secondary Outcome

Title	Number of Serious Adverse Device Effects (SADE).
Description	Evaluation of incidence of SADE during the study.
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	iPro2 Use
Arm/Group Description	All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Measure Participants	181
Number [events]	0

Adverse Events

Time Frame	3 Month
Arm/Group Title	iPro2 Use
Arm/Group Description	All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
All Cause Mortality
	iPro2 Use
	Affected / at Risk (%)	# Events
Total	0/181 (0%)
Serious Adverse Events
	iPro2 Use
	Affected / at Risk (%)	# Events
Total	0/181 (0%)
Other (Not Including Serious) Adverse Events
	iPro2 Use
	Affected / at Risk (%)	# Events
Total	5/181 (2.8%)
General disorders
BLEEDING AT SENSOR INSERTION SITE	1/181 (0.6%)	1
Pain at insertion site area	2/181 (1.1%)	2
Skin and subcutaneous tissue disorders
Pricking sensation at insertion site	1/181 (0.6%)	1
itching at sensor insertion site	2/181 (1.1%)	2
Skin irritation at sensor insertion site	1/181 (0.6%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.