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Study Title Safety Evaluation of the Hybrid Closed Loop (HCL) system in pediatric subjects with Type 1 Diabetes NCT Number NCT02660827 Document Description Study Protocol (Version G) Document Date 14-SEP-2018

Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

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Page 1: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

Study Title Safety Evaluation of the Hybrid Closed Loop (HCL) system in pediatric

subjects with Type 1 Diabetes

NCT Number NCT02660827

Document Description Study Protocol (Version G)

Document Date 14-SEP-2018

Page 2: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 1 of 102

Page 3: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 2 of 102

Page 4: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 3 of 102

Page 5: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 4 of 102

Page 6: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 5 of 102

Page 7: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 6 of 102

Page 8: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 7 of 102

Page 9: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 8 of 102

Page 10: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 9 of 102

Page 11: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 10 of 102

Page 12: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 11 of 102

Page 13: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 12 of 102

Page 14: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 13 of 102

Page 15: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 14 of 102

Page 16: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 15 of 102

Page 17: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 16 of 102

Page 18: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 17 of 102

Page 19: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 18 of 102

Page 20: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 19 of 102

Page 21: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 20 of 102

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CEP302DOC Revision G Page 21 of 102

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CEP302DOC Revision G Page 22 of 102

Page 24: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 23 of 102

Page 25: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 24 of 102

Page 26: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 25 of 102

Page 27: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 26 of 102

Page 28: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 27 of 102

Page 29: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 28 of 102

Page 30: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 29 of 102

Page 31: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 30 of 102

Page 32: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 31 of 102

Page 33: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 32 of 102

Page 34: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 33 of 102

Page 35: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 34 of 102

Page 36: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 35 of 102

Page 37: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 36 of 102

Page 38: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 37 of 102

Page 39: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 38 of 102

Page 40: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 39 of 102

Page 41: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 40 of 102

Page 42: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 41 of 102

Page 43: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 42 of 102

Page 44: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 43 of 102

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CEP302DOC Revision G Page 44 of 102

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CEP302DOC Revision G Page 45 of 102

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CEP302DOC Revision G Page 46 of 102

Page 48: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 47 of 102

Page 49: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 48 of 102

Page 50: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 49 of 102

Page 51: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 50 of 102

Page 52: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 51 of 102

Page 53: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 52 of 102

Page 54: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 53 of 102

Page 55: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 54 of 102

Page 56: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 55 of 102

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CEP302DOC Revision G Page 56 of 102

Page 58: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 57 of 102

Page 59: Safety Evaluation of the Hybrid Closed Loop (HCL) system ...7klv vwxg\ lv d vlqjoh dup pxowl fhqwhu +rph dqg +rwho &olqlfdo ,qyhvwljdwlrq lq shgldwulf ... /rz 6hwxs /lplw pd\ qrw eh

CEP302DOC Revision G Page 58 of 102

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CEP302DOC Revision G Page 60 of 102

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CEP302DOC Revision G Page 61 of 102

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CEP302DOC Revision G Page 65 of 102

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CEP302DOC Revision G Page 66 of 102

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CEP302DOC Revision G Page 76 of 102

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