Trial Outcomes & Findings for The Monitoring Study (NCT NCT02969863)

NCT ID: NCT02969863

Last Updated: 2018-07-30

Results Overview

A measure of hypoglycemia capturing amount of time the continuous glucose monitor is reading less than 60 mg/dl

Recruitment status

COMPLETED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

days 2-7

Results posted on

2018-07-30

Participant Flow

27 subjects were enrolled, but only 24 participated in the study. 2 subjects were ineligible, and 1 could not participate for scheduling reasons. 1 of the 24 was terminated by the investigator during the first arm of the study, so that 1 subject only started 1 arm. 23 subjects finished that arm, and 23 subjects started and finished the other arms

Participant milestones

Participant milestones
Measure	BBPM First, Then BBP, Then UCM, Then UC, Then IOBPM, Then IOBP UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm. BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm M-arm includes real-time remote monitoring for hypoglycemia	UCM First, Then UC, Then IOBPM, Then IOBP, Then BBPM, Then BBP UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm. BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm M-arm includes real-time remote monitoring for hypoglycemia	IOBPM First, Then IOBP, Then BBPM, Then BBP, Then UCM, Then UC UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm. BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm M-arm includes real-time remote monitoring for hypoglycemia	UC First, Then UCM, Then BBP, Then BBPM, Then IOBP, Then IOBPM UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm. BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm M-arm includes real-time remote monitoring for hypoglycemia	IOBP First, Then IOBPM, Then UC, Then UCM, Then BBP, Then BBPM UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm. BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm M-arm includes real-time remote monitoring for hypoglycemia	BBP First, Then BBPM, Then IOBP, Then IOBPM, Then UC, Then UCM UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm. BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm M-arm includes real-time remote monitoring for hypoglycemia
Overall Study STARTED	4	4	4	4	4	4
Overall Study COMPLETED	3	4	4	4	4	4
Overall Study NOT COMPLETED	1	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	BBPM First, Then BBP, Then UCM, Then UC, Then IOBPM, Then IOBP UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm. BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm M-arm includes real-time remote monitoring for hypoglycemia	UCM First, Then UC, Then IOBPM, Then IOBP, Then BBPM, Then BBP UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm. BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm M-arm includes real-time remote monitoring for hypoglycemia	IOBPM First, Then IOBP, Then BBPM, Then BBP, Then UCM, Then UC UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm. BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm M-arm includes real-time remote monitoring for hypoglycemia	UC First, Then UCM, Then BBP, Then BBPM, Then IOBP, Then IOBPM UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm. BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm M-arm includes real-time remote monitoring for hypoglycemia	IOBP First, Then IOBPM, Then UC, Then UCM, Then BBP, Then BBPM UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm. BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm M-arm includes real-time remote monitoring for hypoglycemia	BBP First, Then BBPM, Then IOBP, Then IOBPM, Then UC, Then UCM UC=usual care-Subjects will manage their own diabetes and wear a Dexcom CGM G5 to record their glucose data during the week IOBP-insulin only bionic pancreas. Subjects will wear the insulin only bionic pancreas consisting of a Dexcom G5 CGM, an insulin pump, and an iPhone running the study algorithm. BBP- bihormonal bionic pancreas- Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G5 CGM, and insulin and glucagon pump and an iPhone running the study algorithm M-arm includes real-time remote monitoring for hypoglycemia
Overall Study Physician Decision	1	0	0	0	0	0

Baseline Characteristics

The Monitoring Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=24 Participants All participants who began participating in the study
Age, Continuous	37.5 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Hemoglobin A1c	7.2 percent STANDARD_DEVIATION 1.0 • n=5 Participants

PRIMARY outcome

Timeframe: days 2-7

A measure of hypoglycemia capturing amount of time the continuous glucose monitor is reading less than 60 mg/dl

Outcome measures

Outcome measures
Measure	Usual Care Arm - Monitored n=23 Participants Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored for CGM connectivity and hypoglycemia. Monitored for hypoglycemia Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.	Usual Care Arm - Unmonitored n=23 Participants Subjects will manage their own diabetes and will wear a blinded Dexcom G4 CGM to record their glucose data during the week. They will be monitored only for CGM connectivity, not hypoglycemia. Not monitored for hypoglycemia Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.	Bihormonal Bionic Pancreas - Monitored n=23 Participants Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia. Monitored for hypoglycemia Bihormonal Bionic Pancreas: Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings. Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.	Bihormonal Bionic Pancreas - Unmonitored n=23 Participants Subjects will wear the bihormonal bionic pancreas, consisting of a Dexcom G4 CGM, an insulin and glucagon pump and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia. Not monitored for hypoglycemia Bihormonal Bionic Pancreas: Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings. Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.	Insulin Only Bionic Pancreas - Monitored n=23 Participants Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored for CGM connectivity and hypoglycemia. Monitored for hypoglycemia Insulin Only Bionic Pancreas: Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings. Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.	Insulin Only Bionic Pancreas - Unmonitored n=23 Participants Subjects will wear the insulin only bionic pancreas, consisting of a Dexcom G4 CGM, an insulin pump, and an iPhone running the study algorithm. They will be monitored only for CGM connectivity, not hypoglycemia. Not monitored for hypoglycemia Insulin Only Bionic Pancreas: Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings. Not Monitored for Hypoglycemia: During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.
Percentage of Time Spent With Dexcom CGMG < 60 mg/dl	1.32 percentage of time Standard Deviation 1.39	1.95 percentage of time Standard Deviation 2.11	1.05 percentage of time Standard Deviation 1.01	0.99 percentage of time Standard Deviation 0.93	1.55 percentage of time Standard Deviation 1.16	1.66 percentage of time Standard Deviation 1.33

Adverse Events

Usual Care Arm - Monitored

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths