Trial Outcomes & Findings for Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes (NCT NCT05644730)

NCT ID: NCT05644730

Last Updated: 2025-07-17

Results Overview

Percent of All Glucose Values Within Glucose Range \< 70 mg/dL

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time up to 24 hours
• Results posted on: 2025-07-17

Participant Flow

Participant milestones

Measure	FUSION Closed Loop Glucose Control System Safety Study All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes

Baseline characteristics by cohort

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	52.4 Years STANDARD_DEVIATION 7.7 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	2 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	6 Participants n=5 Participants
Race (NIH/OMB) White	0 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
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time up to 24 hours

Percent of All Glucose Values Within Glucose Range < 70 mg/dL

Outcome measures

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Primary Safety Outcome	1.4 Percentage of all glucose values Standard Deviation 2.7

PRIMARY outcome

Timeframe: From beginning of use of FUSION System to end of use of FUSION System, which will be a period of time of up to 24 hours

Percent of All Glucose Values Within Glucose Range 70-180 mg/dL

Outcome measures

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Primary Efficacy Outcome	79.0 Percentage of all glucose values Standard Deviation 21.3

SECONDARY outcome

Timeframe: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours

The percentage of all glucose values that less than 54 mg/dL

Outcome measures

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Percent of All Glucose Values Within Glucose Range < 54 mg/dL	0 Percentage of all glucose values Standard Deviation 0

SECONDARY outcome

Timeframe: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours

Percentage of all glucose values that are greater than 180 mg/dL

Outcome measures

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Percent of All Glucose Values Within Glucose Range > 180 mg/dL	19.6 Percentage of all glucose values Standard Deviation 22.0

SECONDARY outcome

Timeframe: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours

The percentage of all glucose values that are greater than 250 mg/dL

Outcome measures

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Percent of All Glucose Values Within Glucose Range > 250 mg/dL	2.9 Percentage of all glucose values Standard Deviation 4.4

SECONDARY outcome

Timeframe: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours

The average of all measured glucose values in mg/dL

Outcome measures

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Average Glucose Value in mg/dL	148.4 mg/dL Standard Deviation 25.1

SECONDARY outcome

Timeframe: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours

The percent coefficient of variation of glucose will be calculated by dividing the standard deviation of the average glucose value in mg/dL by the average glucose value in mg/dL, then multiplying this value by 100

Outcome measures

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Percent Coefficient of Variation of Glucose	21.3 Percentage of Coefficient of Variation Standard Deviation 5.3

SECONDARY outcome

Timeframe: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of time of up to 24 hours

Average weight in kilograms of the subjects

Outcome measures

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Weight in Kilograms	88.2 Kilograms Standard Deviation 14.7

SECONDARY outcome

Timeframe: As measured at the start of the closed loop glucose control session

The body mass index was calculated by dividing the subjects weight in kilograms by their height in meters squared

Outcome measures

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Body Mass Index	31.0 Kilograms/Height in meters squared Standard Deviation 6.1

SECONDARY outcome

Timeframe: As measured prior to the start of the closed loop glucose control session

The subjects total daily dose of insulin used prior to the start of the closed loop glucose control session was calculated by adding up all of the insulin doses used by the subjects (both short and long acting insulin) in units and dividing this value by the subjects weight in Kilograms

Outcome measures

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Total Daily Dose of Insulin in Units/Kilogram	0.9 Units Insulin/Kilogram per day Standard Deviation 0.4

SECONDARY outcome

Timeframe: As measured within 2 weeks of the start of the closed loop glucose control session

The subjects hemoglobin A1c measurement from a blood draw taken within 2 weeks of the start of the closed loop glucose control session

Outcome measures

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
Hemoglobin A1c Percentage Level	8.5 Percentage of glycated hemoglobin Standard Deviation 0.8

SECONDARY outcome

Timeframe: As measured from a blood draw taken within 2 weeks of the start of the closed loop glucose control session

C-Peptide level as measured from a blood draw

Outcome measures

Measure	FUSION Closed Loop Glucose Control System Safety Study n=7 Participants All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.
C-Peptide Level in ng/mL	1.5 ng/mL Standard Deviation 1.5

Adverse Events

FUSION Closed Loop Glucose Control System Safety Study

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

FUSION Closed Loop Glucose Control System Safety Study n=7 participants at risk All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours FUSION closed loop glucose control system: The FUSION system will be used to control the subjects glucose to a range of 100-140 mg/dL. Data will be collected for up to 24 hours, or upon early termination of the study session.

Endocrine disorders Sustained Glucose Value > 250 mg/dL

14.3% 1/7 • Number of events 1 • Adverse events were recorded during the closed loop glucose control session, which was a period of time of up to 24 hours for each subject The following guidelines were used to describe adverse event severity: * Mild - Events require minimal or no treatment and do not interfere with the participant's daily activities. * Moderate - Events result in a low level of inconvenience or concern with the therapeutic measures. Moderate events may cause some interference with functioning. * Severe - Events interrupt a participant's usual daily activity and may require systemic drug therapy or other treatment.

Additional Information

Dr. Leon DeJournett/Chief Medical Officer

Ideal Medical Technologies

Phone: 8283379960

Email: leondej@idealmedtech.com

Results disclosure agreements

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