A Multi-center Observational Study During Pregnancy for Women With T1DM Treated With the Paradigm Insulin Pumps Donated by the 'Wielka Orkiestra Świątecznej Pomocy' Foundation in Poland
Conditions: Type 1 Diabetes Mellitus, Pregnancy
Sponsor: Medtronic MiniMed, Inc.

 
Study Title 
A multi-center observational study during pregnancy for women with T1DM 
treated with the Paradigm insulin pumps donated by the ‘Wielka Orkiestra 
Świątecznej Pomocy’ Foundation in Poland  
NCT Number 
NCT01779141 
Document Description 
Study Protocol, Version 4.0 
Document Date 
18-MAR-2015 
 

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REFERENCES ...............................................51 
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APPENDICES ...............................................53 

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Daily basal insulin doses 
Bolus insulin brand 
Daily bolus insulin frequency 
Daily bolus insulin doses 
Total daily doses 
Pump model 
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Insulin brand 
MiniLink serial number (if applicable) 
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Weight 
Height 
BMI – to be generated by the algorithm 
Blood pressure 
Systolic 
Diastolic 
Hypoglycaemia history 
Number of severe hypoglycaemia over last the 12 
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DKA history 
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Folic acid 
Diabetes complications 
Retinopathy 
Laser therapy 
Nephropathy 
Neuropathy 
Macroangiopathy 
Pregnancy history 
Number of  successful pregnancies 
Number of pregnancies before 
Other medical conditions 
Other medications 
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Medtronic 
----------------- 
Cllnlcal lnveatlgatlon Pion 
 
Change History record 
 
 
CIP Change History 
Version 
Summary of Changes 
Author 
 
 
 
f 
 rso
i n  1.0 
Initial release 
 
 
ers,on 2.0 
A, D. f - lnclusioncriteria: "Subject having a male 
1  
 
partner" deleted 
8. 2 - Use of prelerred / accepted BGmeters 
explained 
E. 5 - lnfonnallon on current reimbursement status of 
CStl and CGMin Poland added 
F. 2 - Patient questionnaires: DTSQ added, HFS 
t,melin es adjusted 
G. 1. 3 - Pnorily of source data review adjusted 
G. 2 - Medtronic monitors' responsibility specified 
Wording and text adjustments 
A, Treatment - sensor use 
 
A, 8 .2 - devicecertificate references removed 
A., D.1, D. 2 lnctus on/Exclusion criteria - wording 
adjustmenst, "Use of contraception during insulin 
pump therapy" deleted; Adjustment of endpo10ts 
A. Planmng phase extended from 6 to 12 months 
C. 7 - Adjustment of study t,mehnes 
F. 2, F. 3 - Extension of planningphase from 6 to 12 
months 
F. 3 - 'Mlcroalbumni /creaitnin' replaced by 
'Album1n/ creat1nin e' 
F. 4- 'Role of sponsor representatives' added 
H. 1 - Detailed'Analysis of clinicaldata' added 
H. 2 - 'Publication policy' adjusted 
I. 2 - 'Advisory committees'adjusted 
L. 1 -  Namesand addresses updated 
Wording adjustmentsbased on new CIP template 
Version 4.0 
Author"=""ne-w Study Manager 
A. "CSII and SAP: replacedby "CSll lnduding SAP",
----1 
duration of enrolment period, "Sensorcompilance· 
deleted 
C. "CSIIand/or SAP:  replaced by "CSIIindudmg 
S AP" 
 
C. 3 New wording 
C.7 Updaled l imelines 
  
  H. 1 Adj!-!_s te d wording 
 
 
 
 
 
 
 
 
Version 4.0 
PL01 
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18Mar2015 
Orchestra Pregnancy 
BAC_T431 V4.0 
Observational Studyin Poland 
MedtronicConlldentlal 
Version 3.0 
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