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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995539
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : October 18, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Diabetes

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Intervention Behavioral: therapy regimen
Enrollment 181
Recruitment Details  
Pre-assignment Details  
Arm/Group Title iPro2 Use
Hide 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
Reason Not Completed
Screening Failure             1
Withdrawal by Investigator             15
Withdrawal by Subject             11
Lost to Follow-up             5
Subject missed visit 3,4, came in for V5             1
Arm/Group Title iPro2 Use
Hide Arm/Group Description All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Overall Number of Baseline Participants 181
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 181 participants
54.1  (10.06)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 181 participants
Female
70
  38.7%
Male
111
  61.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
India Number Analyzed 181 participants
181
1.Primary Outcome
Title Change From Baseline in A1C at 3 Months
Hide Description Descriptive analysis of change in A1C from baseline to end of 3-month study period
Time Frame 3 months
Hide Outcome Measure Data
Hide 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
Hide Arm/Group Description:
All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Overall Number of Participants Analyzed 148
Mean (Standard Deviation)
Unit of Measure: percent
-0.6  (1.11)
2.Secondary Outcome
Title Number of Serious Adverse Device Effects (SADE).
Hide Description Evaluation of incidence of SADE during the study.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title iPro2 Use
Hide Arm/Group Description:
All subjects wearing iPro2, having therapy regimens, and having baseline and EOS A1C tests
Overall Number of Participants Analyzed 181
Measure Type: Number
Unit of Measure: events
0
Time Frame 3 Month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title iPro2 Use
Hide 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 (%)
Total   0/181 (0.00%)    
Hide Serious Adverse Events
iPro2 Use
Affected / at Risk (%) # Events
Total   0/181 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
iPro2 Use
Affected / at Risk (%) # Events
Total   5/181 (2.76%)    
General disorders   
BLEEDING AT SENSOR INSERTION SITE * 1  1/181 (0.55%)  1
Pain at insertion site area * 1  2/181 (1.10%)  2
Skin and subcutaneous tissue disorders   
Pricking sensation at insertion site * 1  1/181 (0.55%)  1
itching at sensor insertion site * 1  2/181 (1.10%)  2
Skin irritation at sensor insertion site * 1  1/181 (0.55%)  1
1
Term from vocabulary, MedDRA 15.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Suiying Huang, Statistician
Organization: Medtronic Minimed
Phone: 8184763319
EMail: suiying.huang@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT01995539    
Other Study ID Numbers: CEP274
First Submitted: November 8, 2013
First Posted: November 26, 2013
Results First Submitted: March 22, 2018
Results First Posted: October 18, 2018
Last Update Posted: December 4, 2018