Fuzzy Logic Automated Insulin Regulation

Completed · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

Adolescents and young adults with type 1 diabetes often have a difficult time achieving good glucose control, which is so important in reducing the risk for diabetes complications. Despite the use of multiple daily injections or insulin pumps and glucose sensors, there is still a need for many individuals to further improve glucose levels without causing low blood glucose levels (hypoglycemia) or adding to the daily burden of living with diabetes. Today an insulin pump can receive glucose readings from a continuous glucose monitor and adjust the insulin delivery in an attempt to keep glucose levels in a more optimal range. These systems are called hybrid closed loop (HCL). This means that much of the insulin delivery is automated, yet the patient still interacts regularly with the system, particularly to help determine the insulin dose to deliver to cover a meal. Results of early studies using HCL systems in adolescents and adults with type 1 diabetes are encouraging. The objective of this study is to compare the efficacy and safety of the automated insulin delivery (AID) system with proportional integral-derivative (PID) algorithm (Minimed 670G 3.0 HCL) to an AID system with combined PID and Fuzzy Logic Algorithm (Minimed 670G 4.0 Advanced Hybrid Closed-Loop (AHCL)). The trial will test the hypothesis that the Minimed AHCL can reduce daytime hyperglycemia, currently the biggest challenge for AID systems, without increasing hypoglycemia. Up to 124 adolescents and young adults (ages 14-\<30) will be recruited to test each system for three months in a randomized crossover trial. Investigators will compare how effective each hybrid closed loop system is at preventing high blood glucose readings during the day. The investigators will also evaluate the safety of each system and how participants adjust to the daily use of the technology.

Key facts

Study ID: NCT03040414
Run by: HealthPartners Institute
People needed: 126
Starts: 2019-06-03
Expected to finish: 2020-04-20
Last updated by the study team: 2021-04-20

Who can join

Age: 14 and older, up to 30. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Type 1 diabetes mellitus (as diagnosed clinically) for at least one year
Age 14-<30 years at enrollment
For females, not currently known to be pregnant, be breast-feeding or planning to become pregnant within the study duration.
Using an insulin pump or multiple daily injections of insulin
Participant must be able to obtain U-100 rapid acting insulin analogues, Aspart or Lispro, for use during the study (since these are the only insulins approved for the study pump and the study is not supplying insulin)
MDI users must be on a basal/bolus regimen
Participants must have a minimum total daily dose (TDD) of at least eight units
HbA1c from an approved HbA1c point of care analyzer with a value 7.0%-11.0%
Willingness or ability to do carbohydrate counting
In the investigator's judgment, able to understand and likely to be adherent to the protocol
For subjects <18 years old, living with one or more diabetes care partners (eg.g. parent/legal guardian), of whom at least one is committed to participating in study training for emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency.
Have adequate internet access and a computer system that meets requirements for uploading data.
For participants currently using CGM or insulin pump, willingness to discontinue personal CGM and pump when using the study CGM and pumps (note: including implantable CGMs).

You may not qualify if…

Individuals meeting any of the following exclusion criteria at screening will be excluded from study participation:
Concomitant disease that influences metabolic control or HbA1c interpretation (e.g. anemia, significantly impaired hepatic function, confirmed gastroparesis, renal failure, history of adrenal insufficiency, sickle cell disease, haemoglobinopathy, or has received red blood cell transfusion or erythropoietin within three months prior to time of screening) or other medical condition which, in the Investigator's opinion, may compromise patient safety, affect outcome assessments, or affect the participant's ability to follow the protocol
Oral or parenteral glucocorticoids taken within 1 month prior to enrollment, or plans to take oral or parenteral glucocorticoids within the planned study duration. Exceptions: Short term oral or parenteral glucocorticoids up to seven days
Use of antidiabetic agents other than insulin
Use of other medications, which in the judgment of the investigator would be a contraindication to participation in the study
One or more episodes of severe hypoglycemia (hypoglycemia requiring treatment by another person) within the previous six months
Known allergy to medical grade adhesives
Participation in another study of a medical device or drug that could affect glucose measurements or glucose management or receipt of any investigational medical product within 1 month prior to enrollment
Current eating disorder such as anorexia or bulimia
Currently abusing illicit drugs, marijuana, prescription drugs, or alcohol
Visual impairment or hearing loss, which may compromise the participant's ability to perform all study procedures safely, as determined by the investigator
One or more episodes of diabetic ketoacidosis (DKA) requiring hospitalization within six months prior to screening
Working night shifts
Untreated celiac disease, hyperthyroidism, or hypothyroidism
Clinically significant nephropathy (eGFR <45 mL/min) or on dialysis. Creatinine to determine eGFR must have been obtained as part of usual care within 12 months prior to enrollment (if not available, at time of enrollment, screening can proceed but it must be available prior to randomization)

Where it is running

Yale University — New Haven, Connecticut, United States
University of Florida — Gainesville, Florida, United States
Joslin Diabetes Center — Boston, Massachusetts, United States
International Diabetes Center — Saint Louis Park, Minnesota, United States
Kinderkrankenhaus Auf Der Bult — Hanover, Germany
Schneider Children's Medical Center of Israel — Petah Tikva, Israel
University of Ljubljana — Ljubljana, Slovenia

Full record on ClinicalTrials.gov

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