An interventional study of FUSION closed loop glucose control system in Type 1 Diabetes, Type 2 Diabetes and Stress Induced Hyperglycemia, sponsored by Ideal Medical Technologies. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by Ideal Medical Technologies · Not applicable, Interventional, and Treatment
This is a proof of concept safety study of a rule-based closed loop glucose control system designed for use in the intensive care unit setting.
The persons with type 1 and type 2 diabetes in this study will have their glucose controlled to a range of 100-140 mg/dL by a fully autonomous novel rule-based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals and receive a continuous intravenous infusion of dextrose (D-glucose) during the 24 hour study period. Meals will not be announced to the glucose control system.
Tight glucose control in the intensive care unit (ICU) setting is difficult to achieve. The investigators hypothesize that a closed loop glucose control system that is rule-based will improve upon the glucose control currently achieved by the current open loop manual methods, and that this improved glucose control may improve the outcomes of critically ill patients.
This Earl Feasibility Study will test the ability of a prototype rule-based closed loop glucose control system named FUSION, to provide safe and effective glucose control in subjects with type 1 and type 2 diabetes in a clinical research center (CRC) setting. Subjects with type 1 diabetes have been chosen as safe and effective glucose control is difficult to achieve in these subjects during meal challenges. Subjects with type 2 diabetes have been chosen as they are insulin resistant, which makes their insulin resistance profile similar to that of ICU patients. As this is a safety study of a new medical device, the controlled environment of the CRC is preferable to the less controlled environment of an ICU setting.
The prototype FUSION system to be used in this study will consist to two Dexcom G6 continuous glucose monitors (CGM), the rule-based glucose control software run on an all-in-one medical computer, and two syringe pumps. The prototype system is housed on a medical cart. Based on the average glucose value of the two Dexcom G6 CGM's, and the algorithms of the FUSION systems rule-based glucose control software, the FUSION system will make rate adjustments every 5-10 minutes to the intravenous infusion rates of short acting insulin (NovoLog) and dextrose (D10NS) under its control, in an attempt to keep the subjects glucose in the range of 100-140 mg/dL. The FUSION system only requires entry of the subjects study identification number and weight in kilograms to initiate the system.
For safety reasons, the subjects will have their blood glucose independently measured every 10-60 minutes on the point of care Nova StatStrip system, throughout the 24 hour study period.
The study has halting criteria to avoid recurrent instances of severe hypoglycemia (\< 54 mg/dL).
The average of the two CGM's, that is used by the FUSION system for glucose control, will be used for statistical analysis.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
This study's planned enrollment of 6 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Ideal Medical Technologies is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants with type 1 and type 2 diabetes are eligible to be included in the study only if they meet all the following criteria:
Have a in the range for sex:
Exclusion Criteria:
Have a history or presence of any of the following conditions:
For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects will be treated with the FUSION closed loop glucose control system for up to 24 hours
Device: 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 Measure
The percentage of all glucose values \<70 mg/dL
Time frame: 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
Primary Efficacy Measure
The percentage of all glucose values within the glucose range of 70-180 mg/dL
Time frame: 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 <54 mg/dL
The percentage of all glucose values that are less than 54 mg/dL
Time frame: 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
Percent of All Glucose Values Within Glucose Range 54-69 mg/dL
The percentage of all glucose values that are within the glucose range of 54-69 mg/dL
Time frame: From beginning of use of the FUSION System to end of use of the FUSION System, which will be a period of up to 24 hours.
Number of Hypoglycemic Events (<70 mg/dL)
The total number of hypoglycemic events less than 70 mg/dL as measured by a continuous series of glucose values less than 70 mg/dL for at least 15 minutes duration.
Time frame: From beginning of use of the FUSION System until end of use of the FUSION System, which will be a period of time of up to 24 hours.
Percent of All Glucose Values Within Glucose Range 70-100 mg/dL
The percentage of all glucose values within the glucose range of 70-100 mg/dL
Time frame: 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 70-140 mg/dL
The percentage of all glucose values within the glucose range of 70-140 mg/dL
Time frame: 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 100-140 mg/dL
The percentage of all glucose values within the glucose range of 100-140 mg/dL
Time frame: 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 >140 mg/dL
The percentage of all glucose values greater than 140 mg/dL
Time frame: 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 >180 mg/dL
The percentage of all glucose values that are greater than 180 mg/dL
Time frame: 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
Percent of All Glucose Values Within Glucose Range >250 mg/dL
The percentage of all glucose values that are greater than 250 mg/dL
Time frame: 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 glucose value in mg/dL
The average of all measured glucose values in mg/dL
Time frame: 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
Measure of dispersion - Coefficient of Variation
The Coefficient of variation of glucose will be calculated by dividing the standard deviation of the average glucose value by the average glucose value, then multiplying this value by 100.
Time frame: 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
Clarke Error Grid Analysis of Continuous Glucose Monitor Data
The study data will be used to determine the percentage of the two Dexcom G6 CGM's glucose values in each zone using a Clarke error grid analysis. This same calculation will be performed on the average of the two Dexcom G6 CGM systems used by the FUSION system for purposes of glucose control.
Time frame: 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
FDA integrated Continuous Glucose Monitor Standards
The study data will be used to determine if each individual Dexcom G6 CGM system, and their average value meet FDA criteria for integrated Continuous Glucose Monitor (iCGM) accuracy for the glucose zones \<70 mg/dL, 70-180 mg/dL, and \>180 mg/dL.
Time frame: 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
Hemoglobin A1c Percentage Level
The subjects hemoglobin A1c measurement from a blood draw taken within 2 weeks of the start of the closed loop glucose control session
Time frame: As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
C-Peptide Level
The subjects C-peptide level will be measured prior to the start of the closed loop glucose control session.
Time frame: As measured from a blood draw within two weeks prior to the start of the 24-hour closed loop glucose control session
Total Daily Dose of Insulin in Units/Kilogram
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
Time frame: As documented within two weeks prior to the start of the 24-hour closed loop glucose control session
Weight in Kilograms
Average weight in kilograms of the subjects
Time frame: As measured just prior to the start of the 24-hour closed loop glucose control session
Body Mass Index
The body mass index will be calculated by dividing the subjects weight in kilograms by the square of their height in meters
Time frame: As measured just prior to the start of the 24-hour closed loop glucose control session
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jul 2026; primary completion for Dec 2026, 5 months later.
Of 105 industry-sponsored interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 18. This study's planned 5 months is below that.
Counting every sponsor, half of 949 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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