Trial Outcomes & Findings for Closed Loop Glucose Control in Patients With Type 2 Diabetes (NCT NCT05386849)

NCT ID: NCT05386849

Last Updated: 2026-03-27

Results Overview

Calculated by dividing the number of glucose values \< 70 mg/dl by the total number of all glucose values and then multiplying times 100

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

3 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 of up to 24 hours

Results posted on

2026-03-27

Participant Flow

Subjects recruited from the adult diabetes clinics of Emory Healthcare

3 subjects signed consents to be screened for eligibility. * 1 subject signed a consent but did not meet the eligibility criteria to start the study (screen failure) * 2 subjects were assigned to the treatment group in this single arm study

Participant milestones

Participant milestones
Measure	FUSION Closed Loop Glucose Control System 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	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Closed Loop Glucose Control in Patients With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FUSION Closed Loop Glucose Control System n=2 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, Continuous	38.5 Years STANDARD_DEVIATION 1.5 • n=56 Participants
Sex: Female, Male Female	2 Participants n=56 Participants
Sex: Female, Male Male	0 Participants n=56 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=56 Participants
Race (NIH/OMB) Asian	0 Participants n=56 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=56 Participants
Race (NIH/OMB) Black or African American	1 Participants n=56 Participants
Race (NIH/OMB) White	1 Participants n=56 Participants
Race (NIH/OMB) More than one race	0 Participants n=56 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=56 Participants
Region of Enrollment United States	2 participants n=56 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 of up to 24 hours

Calculated by dividing the number of glucose values \< 70 mg/dl by the total number of all glucose values and then multiplying times 100

Outcome measures

Outcome measures
Measure	FUSION Closed Loop Glucose Control System n=2 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 < 70 mg/dL	0 Percentage of all glucose values Standard Deviation 0

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 of up to 24 hours

Calculated by dividing the number of glucose values in the 70-180 mg/dl range by the total number of all glucose values and then multiplying times 100

Outcome measures

Outcome measures
Measure	FUSION Closed Loop Glucose Control System n=2 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 70-180 mg/dL	97.25 Percentage of all glucose values Standard Deviation 2.75

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

Calculated by dividing the number of glucose values \< 54 mg/dl by the total number of all glucose values and then multiplying times 100

Outcome measures

Outcome measures
Measure	FUSION Closed Loop Glucose Control System n=2 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

Calculated by dividing the number of glucose values \> 180 mg/dl by the total number of all glucose values and then multiplying times 100

Outcome measures

Outcome measures
Measure	FUSION Closed Loop Glucose Control System n=2 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	2.4 Percentage of all glucose values Standard Deviation 2.4

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 glucose percentage of coefficient of variation is calculated by dividing the average glucose values standard deviation in mg/dL by the average glucose value in mg/dL, then multiplying times 100 to achieve a unitless percent value

Outcome measures

Outcome measures
Measure	FUSION Closed Loop Glucose Control System n=2 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.
Percentage of Coefficient of Variation	19.65 Percentage of coefficient of variation Standard Error 6.65

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

Calculated by dividing the number of glucose values \> 250 mg/dl by the total number of all glucose values and then multiplying times 100

Outcome measures

Outcome measures
Measure	FUSION Closed Loop Glucose Control System n=2 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	0.3 Percentage of all glucose values Standard Deviation 0.3

OTHER_PRE_SPECIFIED 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

Calculate the average glucose value by adding up all glucose values and then dividing by the total number of glucose values that were added up

Outcome measures

Outcome measures
Measure	FUSION Closed Loop Glucose Control System n=2 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	123 mg/dL Standard Deviation 2

Adverse Events

FUSION Closed Loop Glucose Control System

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

Dr. Leon DeJournett/Chief Medical Officer

Ideal Medical Technologies

Phone: 8283379960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place