Trial Outcomes & Findings for Overnight Closed Loop Study in U.S. (NCT NCT01857973)

Results Overview

time in euglycemic range (% of Senosr Glucose (SG) 70-180 mg/dL), Phase 3 (closed-loop using the Next Generation Pump (NGP) platform). The experiment was conducted in a monitored setting which lasted for 12 days with the following stressors: missed meal bolus, exercise, missed transmission, Umax (maximum insulin limit) challenges. The study was conducted in a clinic or hotel/house environment for 12 days/11 nights with no dietary or activity restrictions.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

78 participants

Primary outcome timeframe

12 days

Results posted on

2019-02-28

Participant Flow

A total of 8 phases: Exploratory A, Exploratory B, Phase 1, Phase 2, Phase 3, Phase 4, Phase 6 and Phase 7.

Participant milestones

Participant milestones
Measure	Hybrid Closed Loop In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Overall Study STARTED	78
Overall Study Exploratory A Phase	9
Overall Study Xploratory B Phase	9
Overall Study Phase 1	17
Overall Study Phase 2	14
Overall Study Phase 3	10
Overall Study Phase 4	10
Overall Study Phase 6	4
Overall Study Phase 7	4
Overall Study COMPLETED	73
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Hybrid Closed Loop In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Overall Study Subject did not meet required BG range	3
Overall Study drop out after 3 failed attempts	1
Overall Study Physician Decision	1

Baseline Characteristics

Overnight Closed Loop Study in U.S.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hybrid Closed Loop n=78 Participants In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Age, Continuous	38.5 years STANDARD_DEVIATION 16.04 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Region of Enrollment United States	78 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 days

Population: Eight type-1 diabetic subjects participated in this phase.

time in euglycemic range (% of Senosr Glucose (SG) 70-180 mg/dL), Phase 3 (closed-loop using the Next Generation Pump (NGP) platform). The experiment was conducted in a monitored setting which lasted for 12 days with the following stressors: missed meal bolus, exercise, missed transmission, Umax (maximum insulin limit) challenges. The study was conducted in a clinic or hotel/house environment for 12 days/11 nights with no dietary or activity restrictions.

Outcome measures

Outcome measures
Measure	Hybrid Closed Loop n=8 Participants In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Percentage of Time in Euglycemic Range - Phase 3 (Closed-loop Using the NGP Pump Platform)	69.3 percentage of time Standard Deviation 8.9

SECONDARY outcome

Timeframe: 1 day

Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Exploratory A phase. An overnight closed-loop experiment was performed using the Android Development Platform, software version 2.0 A system's closed-loop algorithm without implementing the upper-limit for insulin delivery.

Outcome measures

Outcome measures
Measure	Hybrid Closed Loop n=8 Participants In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Percentage of Time in Euglycemic Range - Exploratory A Phase	90.7 percentage of time Standard Deviation 13.3

SECONDARY outcome

Timeframe: 1 day

Population: Five out of the eight subjects with YSI dipped below 50mg/dL

The purpose of exploratory B study was to evaluate the efficacy and safety of the insulin upper-limit, Umax. The Umax is a patient-specific parameter which is calculated based on historical data from the pump that includes SG tracings, insulin delivery information, and the carbohydrate inputs from the user. The main objective of Umax is to prevent the user from being severely hypoglycemic (less than 50 mg/dL) by restricting the controller from over-delivery of insulin.

Outcome measures

Outcome measures
Measure	Hybrid Closed Loop n=8 Participants In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Number of Subject With YSI (Yellow Spring Instrument) Dipped Below 50mg/dL - Exploratory B Phase	5 number of subjects

SECONDARY outcome

Timeframe: 1 day

Population: 13 subjects with sensors under-calibrated to introduce a persistent under-reading sensor measurement bias

Number of subject under-calibrated to introduce a persistent under-reading sensor measurement bias- Phase 1

Outcome measures

Outcome measures
Measure	Hybrid Closed Loop n=16 Participants In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Number of Subject Under-calibrated to Introduce a Persistent Under-reading Sensor Measurement Bias- Phase 1	13 participants

SECONDARY outcome

Timeframe: 3 days

Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 2

Outcome measures

Outcome measures
Measure	Hybrid Closed Loop n=14 Participants In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Percentage of Time in Euglycemic Range - Phase 2	65.8 percentage of time Standard Deviation 16.2

SECONDARY outcome

Timeframe: 12 days

Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 4

Outcome measures

Outcome measures
Measure	Hybrid Closed Loop n=10 Participants In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Percentage of Time in Euglycemic Range - Phase 4	76.1 percentage of time Standard Deviation 8.6

SECONDARY outcome

Timeframe: 7 days

Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 6

Outcome measures

Outcome measures
Measure	Hybrid Closed Loop n=4 Participants In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Percentage of Time in Euglycemic Range - Phase 6	60 percentage of time Standard Deviation 8.0

SECONDARY outcome

Timeframe: 7 days

Percentage of time in euglycemic range (% of SG 70-180 mg/dL) - Phase 7

Outcome measures

Outcome measures
Measure	Hybrid Closed Loop n=4 Participants In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Percentage of Time in Euglycemic Range - Phase 7	60 percentage of time Standard Deviation 24.9

Adverse Events

Hybrid Closed Loop

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hybrid Closed Loop n=78 participants at risk In-clinic evaluation of the HCL System under various conditions. Hybrid Closed Loop: The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	1.3% 1/78 • Number of events 1 • 30 - 60 days
General disorders Left arm pain due to IV placement	1.3% 1/78 • Number of events 1 • 30 - 60 days
General disorders Right arm pain due to IV placement	1.3% 1/78 • Number of events 1 • 30 - 60 days
Respiratory, thoracic and mediastinal disorders Sore Throat	1.3% 1/78 • Number of events 1 • 30 - 60 days
Skin and subcutaneous tissue disorders Facial petechiae of the eyes	1.3% 1/78 • Number of events 1 • 30 - 60 days
Musculoskeletal and connective tissue disorders costochondritis	1.3% 1/78 • Number of events 1 • 30 - 60 days
Infections and infestations Common cold	1.3% 1/78 • Number of events 1 • 30 - 60 days
Metabolism and nutrition disorders Severe hyperglycemia	1.3% 1/78 • Number of events 4 • 30 - 60 days
Injury, poisoning and procedural complications Sunburn	1.3% 1/78 • Number of events 1 • 30 - 60 days

Additional Information

Suiying Huang, Statistician

Medtronic Minimed

Phone: 818-576-3319

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60