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

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

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Automated Insulin Delivery Settings Initialization and Adaptation Algorithm

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 Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control-IQ Technology with Algorithm Derived Initial Profile Settings and Regular Updates; 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.	Device: Automated Insulin Delivery Settings Initialization and Adaptation Algorithm; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Time < 54 mg/dL, Overall	CGM percent time < 54 mg/dL, Overall Study Participation	15 weeks
Percent Time < 54 mg/dL, Daytime Outcomes	CGM percent time < 54 mg/dL, Daytime Outcomes between 06:00-00:00	15 weeks
Percent Time < 54 mg/dL, Overnight Outcomes	CGM percent time < 54 mg/dL, Overnight Outcomes between 00:00-06:00	15 weeks
Percent Time < 70 mg/dL, Overall	CGM percent time < 70 mg/dL, Overall Study Participation	15 weeks
Percent Time < 70 mg/dL, Daytime Outcomes	CGM percent time < 70 mg/dL, Daytime Outcomes between 06:00-00:00	15 weeks
Percent Time < 70 mg/dL, Overnight Outcomes	CGM percent time < 70 mg/dL, Overnight Outcomes between 00:00-06:00	15 weeks
Percent of Time 70-140 mg/dL, Overall	CGM percent time 70-140 mg/dL, Overall Study Participation	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	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	15 weeks
Percent of Time 70-180 mg/dL, Overall	CGM percent time 70-180 mg/dL, Overall Study Participation	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	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	15 weeks
Percent Time > 180 mg/dL, Overall	CGM percent time > 180 mg/dL, Overall Study Participation	15 weeks
Percent Time > 180 mg/dL, Daytime Outcomes	CGM percent time > 180 mg/dL, Daytime Outcomes between 06:00-00:00	15 weeks
Percent Time > 180 mg/dL, Overnight Outcomes	CGM percent time > 180 mg/dL, Overnight Outcomes between 00:00-06:00	15 weeks
Percent Time > 250 mg/dL, Overall	CGM percent time > 250 mg/dL, Overall Study Participation	15 weeks
Percent Time > 250 mg/dL, Daytime Outcomes	CGM percent time > 250 mg/dL, Daytime Outcomes between 06:00-00:00	15 weeks
Percent Time > 250 mg/dL, Overnight Outcomes	CGM percent time > 250 mg/dL, Overnight Outcomes between 00:00-06:00	15 weeks
Median Sensor Glucose	CGM-measured median glucose (mg/dL)	15 weeks
Total Daily Insulin Use	Total Daily Insulin Use (Units/Day)	15 weeks
Total Daily Bolus Insulin Use	Total Daily Bolus Insulin Use (units/day)	15 weeks
Total Daily Basal Insulin Use	Total Daily Basal Insulin Use (units/day)	15 weeks
Physician Overrides/Physician Initiated Changes in Pump Settings	Number of physician overrides/physician initiated changes in pump settings during the entire study.	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	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	13 weeks

Collaborators and Investigators

• Sponsor: Tandem Diabetes Care, Inc.
• Investigators: Study Chair: Jordan E Pinsker, MD, Tandem Diabetes Care, Inc.

Publications and helpful links

General Publications

• 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 Feb 7:19322968241229074. doi: 10.1177/19322968241229074. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2022
• Primary Completion (Actual): September 9, 2022
• Study Completion (Actual): September 29, 2022

Study Registration Dates

• First Submitted: January 10, 2022
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (Actual): January 24, 2022

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: March 9, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: type 1 diabetes; automated insulin delivery; Control-IQ Technology; automated insulin dosing
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: TP-0009348

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes