Home Use of MD-Logic Automated Insulin Delivery System: Safety and Efficacy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- HealthPartners Institute
- Enrollment
- 126
- Locations
- 13
- Primary Endpoint
- Percentage of Time Glucose Levels Were > 180 mg/dL (10.0 mmol/L) From 6 AM to 11:59 PM
Study Overview
Brief Summary
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.
Detailed Description
Purpose of the study: A randomized crossover trial involving up to four clinical sites in the United States and three sites outside the US (Germany, Israel and Slovenia) will compare the efficacy and safety of an AID system with a PID algorithm versus an AID system with a PID algorithm enhanced with a fuzzy logic algorithm.
Study Objectives:
- EFFICACY: The co-primary outcomes are difference in continuous glucose monitoring (CGM)-measured metrics between periods:
- Superiority for percent of time >180 mg/dL (10.0 mmol/L) from 6 AM to 11:59 PM; and
- Non-inferiority of percent of time <54 mg/dL (3.0 mmol/L) during the entire 24-hour period.
- KEY SAFETY OUTCOMES:
- Percentage of sensor glucose readings <54 mg/dL (overall is a co-primary outcomes) and <70 mg/dL (3.0 and 3.9 mmol/L, respectively)
- Diabetic Ketoacidosis (DKA) events
- Severe hypoglycemia events
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Open label
Eligibility Criteria
- Ages
- 14 Years to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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).
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Percentage of Time Glucose Levels Were > 180 mg/dL (10.0 mmol/L) From 6 AM to 11:59 PM
Time Frame: 12 weeks for each arm of the crossover
Glucose levels based on sensor glucose data
Non-inferiority for Percent of Time <54 mg/dL (3.0 mmol/L) During the Entire 24-hour Period.
Time Frame: 12 weeks for each arm of the crossover
Glucose levels based on sensor glucose data
Secondary Outcomes
- Efficacy: CGM Derived Indices: Mean Glucose Only(12 weeks for each arm of the crossover)
- Key Safety Outcome 2) Number of DKA Events(12 weeks for each arm of the crossover)
- Efficacy: CGM Derived Indices(12 weeks for each arm of the crossover)
- Key Safety Outcome 3) Number of Severe Hypoglycemia Events(12 weeks for each arm of the crossover)
- Efficacy: Amount of Total, Basal and Bolus Daily Insulin Over the First 84 Days of Each Treatment Period(12 weeks for each arm of the crossover)
- Efficacy: BMI for Participants Age ≥18 Years(Time Frame: Screening visit, at initiation (Day 0); randomization (Week 2 through 8, depending); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending))
- Efficacy: BMI Percentile for Participants Age <18 Years(Time Frame: Screening visit, at initiation (Day 0); randomization (Week 2 through 8, depending); end of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending))
- Efficacy: HbA1c(Time Frame: End of crossover period 1 (Week 14 through 20, depending); and end of crossover period 2 (Week 26-32, depending))
- Key Safety Outcome 1) Percentage of Time Sensor Glucose Readings Were <54 mg/dL and <70 mg/dL (3.0 and 3.9 mmol/L, Respectively(12 weeks for each arm of the crossover)