Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use

N/ACompletedNCT05204134

Tandem Diabetes Care, Inc.33 enrolled

Overview

Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes

Interventions

Automated Insulin Delivery Settings Initialization and Adaptation AlgorithmDEVICE

All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Barbara Davis Center

Aurora, Colorado, United States

Outcomes

Primary Outcomes

Severe Hypoglycemic Events

Number of Severe Hypoglycemic Events (with altered mental status)

Time frame: 15 weeks

Diabetic Ketoacidosis Events

Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT)

Time frame: 15 weeks

Secondary Outcomes

Percent Time < 54 mg/dL, Overall

CGM percent time \< 54 mg/dL, Overall Study Participation

Time frame: 15 weeks

Percent Time < 54 mg/dL, Daytime Outcomes

CGM percent time \< 54 mg/dL, Daytime Outcomes between 06:00-00:00

Time frame: 15 weeks

Percent Time < 54 mg/dL, Overnight Outcomes

CGM percent time \< 54 mg/dL, Overnight Outcomes between 00:00-06:00

Time frame: 15 weeks

Percent Time < 70 mg/dL, Overall

CGM percent time \< 70 mg/dL, Overall Study Participation

Time frame: 15 weeks

Percent Time < 70 mg/dL, Daytime Outcomes

CGM percent time \< 70 mg/dL, Daytime Outcomes between 06:00-00:00

Time frame: 15 weeks

Percent Time < 70 mg/dL, Overnight Outcomes

CGM percent time \< 70 mg/dL, Overnight Outcomes between 00:00-06:00

Time frame: 15 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Percent of Time 70-140 mg/dL, Overall

CGM percent time 70-140 mg/dL, Overall Study Participation

Time frame: 15 weeks

Percent of Time 70-140 mg/dL, Daytime Outcomes

CGM percent time 70-140 mg/dL, Daytime Outcomes between 06:00-00:00

Time frame: 15 weeks

Percent of Time 70-140 mg/dL, Overnight Outcomes

CGM percent time 70-140 mg/dL, Overnight Outcomes between 00:00-06:00

Time frame: 15 weeks

Percent of Time 70-180 mg/dL, Overall

CGM percent time 70-180 mg/dL, Overall Study Participation

Time frame: 15 weeks

Percent of Time 70-180 mg/dL, Daytime Outcomes

CGM percent time 70-180 mg/dL, Daytime Outcomes between 06:00-00:00

Time frame: 15 weeks

Percent of Time 70-180 mg/dL, Overnight Outcomes

CGM percent time 70-180 mg/dL, Overnight Outcomes between 00:00-06:00

Time frame: 15 weeks

Percent Time > 180 mg/dL, Overall

CGM percent time \> 180 mg/dL, Overall Study Participation

Time frame: 15 weeks

Percent Time > 180 mg/dL, Daytime Outcomes

CGM percent time \> 180 mg/dL, Daytime Outcomes between 06:00-00:00

Time frame: 15 weeks

Percent Time > 180 mg/dL, Overnight Outcomes

CGM percent time \> 180 mg/dL, Overnight Outcomes between 00:00-06:00

Time frame: 15 weeks

Percent Time > 250 mg/dL, Overall

CGM percent time \> 250 mg/dL, Overall Study Participation

Time frame: 15 weeks

Percent Time > 250 mg/dL, Daytime Outcomes

CGM percent time \> 250 mg/dL, Daytime Outcomes between 06:00-00:00

Time frame: 15 weeks

Percent Time > 250 mg/dL, Overnight Outcomes

CGM percent time \> 250 mg/dL, Overnight Outcomes between 00:00-06:00

Time frame: 15 weeks

Median Sensor Glucose

CGM-measured median glucose (mg/dL)

Time frame: 15 weeks

Total Daily Insulin Use

Total Daily Insulin Use (Units/Day)

Time frame: 15 weeks

Total Daily Bolus Insulin Use

Total Daily Bolus Insulin Use (units/day)

Time frame: 15 weeks

Total Daily Basal Insulin Use

Total Daily Basal Insulin Use (units/day)

Time frame: 15 weeks

Physician Overrides/Physician Initiated Changes in Pump Settings

Number of physician overrides/physician initiated changes in pump settings during the entire study.

Time frame: 13 weeks

Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion

The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The last 4 questions assess diabetes impact on a scale of 1-10 (1=Never, 10=always), with a lower score means a better outcome. Mean score for overall diabetes impact is reported after 13 weeks using the system with adaptive therapy settings

Time frame: 13 weeks

Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion

The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The first 7 questions assess device satisfaction on a scale of 1-10 (1=strongly disagree, 10=strongly agree), with a higher score means a better outcome. Mean score for overall device satisfaction is reported after 13 weeks using the system with adaptive therapy settings

Time frame: 13 weeks