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CTRI Number  CTRI/2013/12/004204 [Registered on: 10/12/2013] Trial Registered Prospectively
Last Modified On: 03/01/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   A Feasibility Trial to Evaluate the Senseonics Continuous Glucose Monitoring System 
Scientific Title of Study   A Feasibility Trial to Evaluate the Senseonics Continuous Glucose Monitoring System with Type - 2 Diabetes Patient. 
Trial Acronym  SEUSMD 
Secondary IDs if Any  
Secondary ID  Identifier 
CTP-0011 (04)  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vika G Pai 
Designation  Consultant Diabetologist 
Affiliation  Oyster and Pearls Hospital 
Address  Dr. Vikas Govind Pai Clinical Research Foundation,
778/B1, Abhinav Apartments, Next to Congress House, Shivaji Nagar
Pune
MAHARASHTRA
411005
India 
Phone  02025534404  
Fax  02030472453  
Email  drpaivikas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vika G Pai 
Designation  Consultant Diabetologist 
Affiliation  Oyster and Pearls Hospital 
Address  Dr. Vikas Govind Pai Clinical Research Foundation,
778/B1, Abhinav Apartments, Next to Congress House, Shivaji Nagar
Pune
MAHARASHTRA
411005
India 
Phone  02025534404  
Fax  02030472453  
Email  drpaivikas@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Vika G Pai 
Designation  Consultant Diabetologist 
Affiliation  Oyster and Pearls Hospital 
Address  Dr. Vikas Govind Pai Clinical Research Foundation,
778/B1, Abhinav Apartments, Next to Congress House, Shivaji Nagar
Pune
MAHARASHTRA
411005
India 
Phone  02025534404  
Fax  02030472453  
Email  drpaivikas@gmail.com  
 
Source of Monetary or Material Support  
Senseonics Inc, 20451 Seneca Meadows Parkway Germantown, MD 20876, USA 
 
Primary Sponsor  
Name  Senseonics Inc 
Address  20451 Seneca Meadows Parkway Germantown, MD 20876, USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Karmic Labs PVT LTD  Karmic Labs PVT LTD 802, Bldg 3, Raheja Mindspace, Plot 3, TTC Ind. Area, Thane Belapur Road, Airoli, Navi Mumbai – 400 708 INDIA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vikas G Pai  Dr. Vikas Govind Pai Clinical Research Foundation  Dr. Vikas Govind Pai Clinical Research Foundation, 778/B1, Abhinav Apartments, Shivaji Nagar
Pune
MAHARASHTRA 		 02025534404
02030472453
drpaivikas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
O&P Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Type 1 Diabetes Mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Senseonics Continuous Glucose Monitroing System  The device is continuous glucose monitoring system. It will be implanted in the body for 180 days. It does not need blood draws for glucose reading. 
Comparator Agent  YSI Glucose Analyzer 2300  The YSI 2300 stat plus glucose analyser will be used as a comparator. During site visit subject will stay at site for 11-12 hours. Sampling will be done every 15 minutes. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Age ≥ 18 to ≤ 65 years at screening
2. Clinically confirmed diagnosis of Type 1 diabetes mellitus (for at least I year of duration on multiple daily injections (>2 injections per day) or on insulin pump therapy.
3. Subject understands study procedures and risks, is willing to comply with protocol requirements, and has signed an informed consent document.
4. HbA1c ≤ 10% 
 
ExclusionCriteria 
Details  1. History of severe hypoglycemia in the 6 months immediately prior to study start.
2. Severe diabetic Ketoacidosis in the past 6 months.
3. Females who are lactating, pregnant or intending to become pregnant during the course of the investigation.
4. Any condition preventing or complicating the placement, operation or removal of the Sensor.
5. Any medical condition or illness that in the judgment of the investigator might interfere with the procedures, results or compliance during the course of this investigation, or increase the risk of induced hypoglycemia or repeated blood testing.
6. Known microvascular (diabetic) complications (other than non-proliferative retinopathy), including active proliferative diabetic retinopathy or macular edema, non-proliferative retinopathy stage 3, diabetic nephropathy (other than microalbuminuria with normal creatinine), gastroparesis or neuropathy requiring treatment.
7. Currently receiving any of the following therapies, or likely to need such treatment during the follow-up period of this study:
Immunosuppressant therapy
Chemotherapy for any form of cancer
Anti-coagulant therapy (e.g. Plavix, LMW heparin, coumadin)
8. Magnesium <1.6 mg/dL at screening.
9. Potassium <3.4 mmol/L at screening.
10. Hematocrit >50% or <30% at screening.
11. Topical or local anesthetic allergy.
12. Known current or recent alcohol or drug abuse by Subject history.
13. Participation in another clinical investigation within 30 days preceding screening, or intention to participate in any other clinical investigation during the period of this study.
14. The presence of any other active implanted device, whether turned on or off. Passive implants are allowed.
15. A condition requiring or likely to require the use of magnetic resonance imaging (MRI).
16. Positive drug screen results
17. Any condition that in the investigator’s opinion would make the Subject unable to complete the study. Investigator will supply rationale. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess accuracy and longevity of the Senseonics CGM System modifications and to assess safety of the Senseonics CGM System during up to 84 days of Sensor use in the clinic and during home use  Day 0, 14, 28, 42, 56, 70, 84 and 91 
 
Secondary Outcome  
Outcome  TimePoints 
To determine other relevant Senseonics CGM System performance measures.
To evaluate the incidence of procedure and device-related adverse events in clinic and home use.
To evaluate the incidence of all adverse events in clinic and home use. 		 Day 0, 14, 28, 42, 56, 70, 84 and 91 
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   11/12/2013 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  
The purpose of this clinical trial is to evaluate the effectiveness of modified Sensor designs on the longevity (up to 90 days) of the Senseonics CGM System. The trial will also evaluate the safety of the Senseonics CGM System during clinical use as well as during home use with a blinded display.
 
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