N/A N=2 Device Feasibility

Closed Loop Glucose Control in Patients With Type 2 Diabetes

Diabetes Mellitus, Type 2

Bottom Line

View on ClinicalTrials.gov: NCT05386849 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Percent of All Glucose Values Within Glucose Range < 70 mg/dL — 0 Percentage of all glucose values

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: FUSION closed loop glucose control system (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Ideal Medical Technologies
Primary completion: Jul 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of All Glucose Values Within Glucose Range < 70 mg/dL	—	—
PRIMARY Percent of All Glucose Values Within Glucose Range 70-180 mg/dL	97.25	—
SECONDARY Percent of All Glucose Values Within Glucose Range < 54 mg/dL	—	—
SECONDARY Percent of All Glucose Values Within Glucose Range > 180 mg/dL	2.4	—
SECONDARY Percentage of Coefficient of Variation	19.65	—
SECONDARY Percent of All Glucose Values Within Glucose Range > 250 mg/dL	0.3	—

Summary

This is a proof of concept safety study of an artificial intelligence based closed loop glucose control system designed for use in the intensive care unit setting. The type 2 diabetic subjects in this study will have their glucose controlled to a range of 100-140 mg/dL by a novel artificial intelligence based closed loop glucose control system for a period of 24 hours. The subjects will consume three standardized meals during the 24 hour study period.

Eligibility Criteria

Inclusion Criteria

Are 18-70 years of age, inclusive.
Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.
Have had a diagnosis of type 2 diabetes for a period of at least 3 months.
Use insulin injections at home for glucose control.
Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.
Have a hemoglobin in the normal range for sex:
Females: 12-15.5 grams/dL.
Males: 13.5-17.5 grams/dl.
Have adequate venous access sites in upper extremities.
Body weight between 40 - 150 kg.

Exclusion Criteria

Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.
Have a known hypersensitivity to any of the components of study treatment.
Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.
Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being.
Have a clinically significant history or presence of any of the following conditions:
Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal.
Has an estimated GFR <30 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
Have congestive heart failure greater than class 1 on the NYHA classification system.
Have a history of seizures.
Have a history of cerebrovascular accident.
Have a history of ischemic heart disease.
For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:
Pregnant.
Refuse to agree to a pregnancy test at the time of enrollment.
Have a positive urine pregnancy test at the time of enrollment.
Have a positive COVID-19 test within 14 days of visit 3.
Have any COVID-19 related symptoms in the 14-day period prior to visit 3.
Have a known unprotected COVID-19 exposure in the 14-day period prior to visit 3.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05386849). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.