Clinical trial NCT05204134: Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Official title: Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: type 1 diabetes
Control-IQ Technology
automated insulin dosing
automated insulin delivery
Lead sponsor: Tandem Diabetes Care, Inc.
Sponsor class: INDUSTRY
First posted: 2022-01-24
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Severe Hypoglycemic Events
timeFrame: 15 weeks
measure: Diabetic Ketoacidosis Events
timeFrame: 15 weeks
Secondary outcomes:
measure: Percent Time < 54 mg/dL, Overall
timeFrame: 15 weeks
measure: Percent Time < 54 mg/dL, Daytime Outcomes
timeFrame: 15 weeks
measure: Percent Time < 54 mg/dL, Overnight Outcomes
timeFrame: 15 weeks
measure: Percent Time < 70 mg/dL, Overall
timeFrame: 15 weeks
measure: Percent Time < 70 mg/dL, Daytime Outcomes
timeFrame: 15 weeks
measure: Percent Time < 70 mg/dL, Overnight Outcomes
timeFrame: 15 weeks
measure: Percent of Time 70-140 mg/dL, Overall
timeFrame: 15 weeks
measure: Percent of Time 70-140 mg/dL, Daytime Outcomes
timeFrame: 15 weeks
measure: Percent of Time 70-140 mg/dL, Overnight Outcomes
timeFrame: 15 weeks
measure: Percent of Time 70-180 mg/dL, Overall
timeFrame: 15 weeks
measure: Percent of Time 70-180 mg/dL, Daytime Outcomes
timeFrame: 15 weeks
measure: Percent of Time 70-180 mg/dL, Overnight Outcomes
timeFrame: 15 weeks
measure: Percent Time > 180 mg/dL, Overall
timeFrame: 15 weeks
measure: Percent Time > 180 mg/dL, Daytime Outcomes
timeFrame: 15 weeks
measure: Percent Time > 180 mg/dL, Overnight Outcomes
timeFrame: 15 weeks
measure: Percent Time > 250 mg/dL, Overall
timeFrame: 15 weeks
measure: Percent Time > 250 mg/dL, Daytime Outcomes
timeFrame: 15 weeks
measure: Percent Time > 250 mg/dL, Overnight Outcomes
timeFrame: 15 weeks
measure: Median Sensor Glucose
timeFrame: 15 weeks
measure: Total Daily Insulin Use
timeFrame: 15 weeks
measure: Total Daily Bolus Insulin Use
timeFrame: 15 weeks
measure: Total Daily Basal Insulin Use
timeFrame: 15 weeks
measure: Physician Overrides/Physician Initiated Changes in Pump Settings
timeFrame: 13 weeks
measure: Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion
timeFrame: 13 weeks
measure: Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Barbara Davis Center
state: Colorado
Study officials:
affiliation: Tandem Diabetes Care, Inc.
name: Jordan E Pinsker, MD
role: STUDY_CHAIR
References:
citation: Shah VN, Akturk HK, Trahan A, Piquette N, Wheatcroft A, Schertz E, Carmello K, Mueller L, White K, Fu L, Sassan-Katchalski R, Messer LH, Habif S, Constantin A, Pinsker JE. Safety and Feasibility Evaluation of Automated User Profile Settings Initialization and Adaptation With Control-IQ Technology. J Diabetes Sci Technol. 2024 Nov;18(6):1281-1287. doi: 10.1177/19322968241229074. Epub 2024 Feb 7.