Trial Outcomes & Findings for Inpatient Closed-loop Glucose Control (NCT NCT01819844)

NCT ID: NCT01819844

Last Updated: 2017-12-12

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 12 participants
• Primary outcome timeframe: 12 hours
• Results posted on: 2017-12-12

Participant Flow

Participant milestones

Measure	Closed-loop Blood Glucose Control Type 1 diabetes, Type 2 diabetes, total daily dose (TDD) of insulin that is \> 1 u/kg or \> 2 u/kg. Closed-loop blood glucose control: The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose \> 2 u/kg).
Overall Study STARTED	12
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Inpatient Closed-loop Glucose Control

Baseline characteristics by cohort

Measure	Closed-loop Blood Glucose Control n=12 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	55 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours

Outcome measures

Measure	Closed-loop Blood Glucose Control n=12 Participants
Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. Type 2 subjects average blood sugar	124.83 mg/dl Standard Deviation 21.85
Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. Overall average blood sugar	115.9 mg/dl Standard Deviation 19.7
Average Blood Glucose Over the Closed-loop Control Period, as Determined From GlucoScout Measurements. Type 1 subjects average blood sugar	107.0 mg/dl Standard Deviation 13.6

SECONDARY outcome

Timeframe: 12 hours

Outcome measures

Measure	Closed-loop Blood Glucose Control n=12 Participants
Number of Carbohydrate Interventions (15 g) Delivered According to Study Protocol	0 number of carbohydrate interventions

SECONDARY outcome

Timeframe: 12 hours

Outcome measures

Measure	Closed-loop Blood Glucose Control n=12 Participants
Number of BG Events < 70 mg/dl and Nadir BG for Each as Determined Form GlucoScout Measurements	4 Blood glucose values < 70 mg/dl

SECONDARY outcome

Timeframe: 12 hours

Outcome measures

Measure	Closed-loop Blood Glucose Control n=12 Participants
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl 70-180 mg/dl	95.5 percentage of time Standard Deviation 7.6
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl 70-120 mg/dl	67.5 percentage of time Standard Deviation 27.7
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl < 70 mg/dl	0.25 percentage of time Standard Deviation 0.45
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From GlucoScout Measurements: - < 70 mg/dl - 70-120 mg/dl - 70-180 mg/dl - >180 mg/dl > 180 mg/dl	4.3 percentage of time Standard Deviation 7.8

SECONDARY outcome

Timeframe: 12 hours

Outcome measures

Measure	Closed-loop Blood Glucose Control n=12 Participants
Average Blood Glucose Over the Closed-loop Control Period as Determined From the CGM Driving the Control Algorithm	115.8 mg/dl Standard Deviation 21.4

SECONDARY outcome

Timeframe: 12 hours

Outcome measures

Measure	Closed-loop Blood Glucose Control n=12 Participants
Number of BG Events < 70 mg/dl as Determined by the CGM	8 events

SECONDARY outcome

Timeframe: 12 hours

Outcome measures

Measure	Closed-loop Blood Glucose Control n=12 Participants
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl < 70 mg/dl	1.5 percentage of time Standard Deviation 3.0
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl 70-120 mg/dl	66.8 percentage of time Standard Deviation 26.4
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl 70-180 mg/dl	94.4 percentage of time Standard Deviation 6.9
Fraction of Time Spent Within Each of the Following Glucose Ranges as Determined From the CGM Driving the Control Algorithm: o < 70 mg/dl o 70-120 mg/dl o 70-180 mg/dl o >180 mg/dl > 180 mg/dl	4.0 percentage of time Standard Deviation 7.3

SECONDARY outcome

Timeframe: 12 hours

Outcome measures

Measure	Closed-loop Blood Glucose Control n=12 Participants
Insulin Dosing (u/kg)	0.42 units/kilogram Standard Deviation 0.28

SECONDARY outcome

Timeframe: 12 hours

Outcome measures

Measure	Closed-loop Blood Glucose Control n=12 Participants
Dextrose Dosing (g/kg)	0.48 grams/kilogram Standard Deviation 0.45

SECONDARY outcome

Timeframe: 12 hours

The Mean Absolute Relative Difference (MARD) between CGM and Glucoscout

Outcome measures

Measure	Closed-loop Blood Glucose Control n=12 Participants
Accuracy of the CGM Device Using the GlucoScout Measurements as the Standard.	8.29 percent absolute relative difference Standard Deviation 7.41

Adverse Events

Closed-loop Blood Glucose Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Steven J. Russell

Massachusetts General Hospital

Phone: 617-726-8722

Email: sjrussell@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place