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

Not Applicable

Completed

Conditions: Type 1 Diabetes

Interventions: Device: Automated Insulin Delivery Settings Initialization and Adaptation Algorithm

Registration Number: NCT05204134

Lead Sponsor: Tandem Diabetes Care, Inc.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 33

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Control-IQ Technology with Algorithm Derived Initial Profile Settings and Regular Updates	Automated Insulin Delivery Settings Initialization and Adaptation Algorithm	After CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use.

Primary Outcome Measures

Name	Time	Method
Severe Hypoglycemic Events	15 weeks	Number of Severe Hypoglycemic Events (with altered mental status)
Diabetic Ketoacidosis Events	15 weeks	Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT)

Secondary Outcome Measures

Name	Time	Method
Percent Time > 250 mg/dL, Daytime Outcomes	15 weeks	CGM percent time \> 250 mg/dL, Daytime Outcomes between 06:00-00:00
Physician Overrides/Physician Initiated Changes in Pump Settings	13 weeks	Number of physician overrides/physician initiated changes in pump settings during the entire study.
Percent of Time 70-140 mg/dL, Daytime Outcomes	15 weeks	CGM percent time 70-140 mg/dL, Daytime Outcomes between 06:00-00:00
Percent Time < 54 mg/dL, Overnight Outcomes	15 weeks	CGM percent time \< 54 mg/dL, Overnight Outcomes between 00:00-06:00
Percent of Time 70-180 mg/dL, Overnight Outcomes	15 weeks	CGM percent time 70-180 mg/dL, Overnight Outcomes between 00:00-06:00
Percent Time > 180 mg/dL, Overall	15 weeks	CGM percent time \> 180 mg/dL, Overall Study Participation
Percent Time < 54 mg/dL, Overall	15 weeks	CGM percent time \< 54 mg/dL, Overall Study Participation
Percent Time < 54 mg/dL, Daytime Outcomes	15 weeks	CGM percent time \< 54 mg/dL, Daytime Outcomes between 06:00-00:00
Percent Time < 70 mg/dL, Overnight Outcomes	15 weeks	CGM percent time \< 70 mg/dL, Overnight Outcomes between 00:00-06:00
Percent Time < 70 mg/dL, Overall	15 weeks	CGM percent time \< 70 mg/dL, Overall Study Participation
Percent Time > 250 mg/dL, Overnight Outcomes	15 weeks	CGM percent time \> 250 mg/dL, Overnight Outcomes between 00:00-06:00
Percent Time < 70 mg/dL, Daytime Outcomes	15 weeks	CGM percent time \< 70 mg/dL, Daytime Outcomes between 06:00-00:00
Percent of Time 70-180 mg/dL, Daytime Outcomes	15 weeks	CGM percent time 70-180 mg/dL, Daytime Outcomes between 06:00-00:00
Percent Time > 180 mg/dL, Daytime Outcomes	15 weeks	CGM percent time \> 180 mg/dL, Daytime Outcomes between 06:00-00:00
Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion	13 weeks	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
Percent of Time 70-140 mg/dL, Overall	15 weeks	CGM percent time 70-140 mg/dL, Overall Study Participation
Percent Time > 180 mg/dL, Overnight Outcomes	15 weeks	CGM percent time \> 180 mg/dL, Overnight Outcomes between 00:00-06:00
Percent Time > 250 mg/dL, Overall	15 weeks	CGM percent time \> 250 mg/dL, Overall Study Participation
Total Daily Insulin Use	15 weeks	Total Daily Insulin Use (Units/Day)
Total Daily Bolus Insulin Use	15 weeks	Total Daily Bolus Insulin Use (units/day)
Percent of Time 70-140 mg/dL, Overnight Outcomes	15 weeks	CGM percent time 70-140 mg/dL, Overnight Outcomes between 00:00-06:00
Percent of Time 70-180 mg/dL, Overall	15 weeks	CGM percent time 70-180 mg/dL, Overall Study Participation
Median Sensor Glucose	15 weeks	CGM-measured median glucose (mg/dL)
Total Daily Basal Insulin Use	15 weeks	Total Daily Basal Insulin Use (units/day)
Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion	13 weeks	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