NCT05204134CompletedNot Applicable
Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Tandem Diabetes Care, Inc.2 sites in 1 country33 target enrollmentStarted: March 24, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tandem Diabetes Care, Inc.
- Enrollment
- 33
- Locations
- 2
- Primary Endpoint
- Severe Hypoglycemic Events
Study Overview
Brief Summary
Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.
Detailed Description
This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by 13 weeks of Control-IQ technology use. By using an algorithm to more accurately initialize insulin delivery settings and adapt them over time, faster than typical HCP visits, users onboarding from multiple daily injections (MDI) will reach optimal glycemic outcomes faster.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adult subjects ≥ age 18 years
- •Clinical diagnosis of type 1 diabetes for at least one year
- •Using a basal/bolus regimen by injection (MDI therapy)
- •Total daily dose ≥10 units/day
- •Willing to use only aspart (novolog) or lispro (humalog) U-100 insulin with the study pump.
- •A1c ≥ 7.5% and ≤ 11% at screening
- •Not pregnant or planning a pregnancy during the time period of the study.
- •Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
- •Willingness to follow study procedures and a signed informed consent form
Exclusion Criteria
- •Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months
- •Two or more episodes of diabetic ketoacidosis in the past 6 months
- •Inpatient psychiatric treatment in the past 6 months
- •History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study
- •Significant chronic kidney disease or hemodialysis
- •Significant liver disease
- •History of adrenal insufficiency
- •Hypothyroidism or hyperthyroidism that is not appropriately treated
- •Other chronic disease/condition determined by investigator to interfere with participation in the study
- •Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study
- •Use of long-acting insulin, inhaled insulin (Afrezza), or use of any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than Metformin with the study pump
- •Subject is pregnant or lactating or intending to become pregnant before or during participation in this study
- •Investigator judgement that subject would not be able to complete the trial
Outcomes
Primary Outcomes
Severe Hypoglycemic Events
Time Frame: 15 weeks
Number of Severe Hypoglycemic Events (with altered mental status)
Diabetic Ketoacidosis Events
Time Frame: 15 weeks
Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT)
Secondary Outcomes
- Percent of Time 70-140 mg/dL, Daytime Outcomes(15 weeks)
- Percent Time > 180 mg/dL, Overall(15 weeks)
- Percent Time < 54 mg/dL, Overnight Outcomes(15 weeks)
- Percent of Time 70-180 mg/dL, Overnight Outcomes(15 weeks)
- Percent Time < 54 mg/dL, Overall(15 weeks)
- Percent Time < 54 mg/dL, Daytime Outcomes(15 weeks)
- Percent Time < 70 mg/dL, Overnight Outcomes(15 weeks)
- Percent Time < 70 mg/dL, Overall(15 weeks)
- Percent Time < 70 mg/dL, Daytime Outcomes(15 weeks)
- Percent of Time 70-180 mg/dL, Daytime Outcomes(15 weeks)
- Percent Time > 180 mg/dL, Daytime Outcomes(15 weeks)
- Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion(13 weeks)
- Percent of Time 70-140 mg/dL, Overall(15 weeks)
- Percent Time > 180 mg/dL, Overnight Outcomes(15 weeks)
- Percent Time > 250 mg/dL, Overall(15 weeks)
- Percent Time > 250 mg/dL, Overnight Outcomes(15 weeks)
- Total Daily Insulin Use(15 weeks)
- Total Daily Bolus Insulin Use(15 weeks)
- Percent of Time 70-140 mg/dL, Overnight Outcomes(15 weeks)
- Percent of Time 70-180 mg/dL, Overall(15 weeks)
- Percent Time > 250 mg/dL, Daytime Outcomes(15 weeks)
- Physician Overrides/Physician Initiated Changes in Pump Settings(13 weeks)
- Median Sensor Glucose(15 weeks)
- Total Daily Basal Insulin Use(15 weeks)
- Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion(13 weeks)
Investigators
Study Sites (2)
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