Control-IQ Technology 2.0 Adult and Adolescent Feasibility Study

A Control-IQ Technology 2.0 Feasibility Study in Adult and Adolescent Subjects

The purpose of this study is to obtain preliminary safety and performance data on planned improvements to Control-IQ technology.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Control-IQ technology 2.0

Detailed Description

This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by a 48-hour supervised phase, followed by a 4-week at home study with sequential interventions (new feature use). Approximately 30 subjects, both male and female, aged 14 and up, will participate in the study, using new features each week with the t:slim X2 insulin pump with Control-IQ technology.

The first 5 subjects in the study will complete a 48 hour session with multiple challenges during use of Control-IQ technology 2.0, before moving on the outpatient portion of the trial.

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult and adolescent male and female subjects >age 14 years
• Clinical diagnosis of Type 1 diabetes for at least one year
• Experienced Control-IQ technology user for ≥3 months.
• Use of Control-IQ technology in closed-loop at least 80% of the 2-week time period before screening.
• Not pregnant or planning a pregnancy during the time period of the study
• Using only Humalog U-100 or Novolog U-100 insulin
• ICR and ISF optimized per investigator judgement
• CGM time in range (70-180 mg/dL) at least 50% on Control-IQ technology
• Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)

• Willing to:

  1. Share Dexcom G6 CGM data with study staff and Tandem
  2. Share t:connect data with Tandem
  3. Eat meals with known carbohydrate amounts
  4. Take meal boluses as directed (use of different options as scheduled and instructed)
  5. Follow study Glycemic Treatment Guidelines for hypo and hyperglycemia
  6. Keep food and exercise diary
  7. Set accurate sleep schedule on pump
  8. Exercise while using exercise activity in Control-IQ technology at least twice weekly
  9. Complete questionnaires before and after using investigational device
  10. Sign an informed consent form
• Willingness to use the Dexcom G6 app on their personal phone throughout the study, and share real time CGM information with a local contact and study staff
• Availability of a local contact who has access to the study participant, knows their whereabouts, and agrees to be promptly available if contacted by study staff. If the subject lives alone, the local contact must live within 30 minutes and have access to the subject overnight.

Exclusion Criteria:

• Diabetic ketoacidosis (DKA) in the past 6 months
• Severe hypoglycemia (needing assistance) 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 is unwilling to agree to abstain from illicit drugs throughout the study
• History of heart, lung or kidney disease determined by the investigator to interfere with the study
• Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with the study
• Use of long-acting insulin or any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than metformin
• Use of Afrezza during the study period
• Febrile illness within 3 days of the start of the study
• Subject is pregnant or lactating or intending to become pregnant before or during participation in this study
• For subjects >50 years old or with diabetes duration >20 years who will be exercising as part of the 48 hour study, abnormal electrocardiogram consistent with increased risk of arrhythmia, ischemia, or prolonged QTc interval (> 450 ms)
• Significant chronic kidney disease (eGFR < 60) or hemodialysis
• Significant liver disease
• History of adrenal insufficiency
• History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated

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 2.0 technology 2.0 on the t:slim X2 insulin pump; After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0. The first 5 subjects participated in a 48-hour supervised hotel phase before continuing in the outpatient setting.	Device: Control-IQ technology 2.0; All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Percent Time Less Than 54 mg/dL	CGM overall percent time less than 54 mg/dL, with different feature use of the pump each week.	Data collected over 1 week for each intervention, up to 5 weeks
Severe Hypoglycemia	Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment), with different feature use of the pump each week.	Data collected over 1 week for each intervention, up to 5 weeks
Diabetic Ketoacidosis	Number of Diabetic Ketoacidosis events with different feature use of the pump each week.	Data collected over 1 week for each intervention, up to 5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Time <70 mg/dL	CGM percent time <70 mg/dL, with different feature use of the pump each week.	Data collected over 1 week for each intervention, up to 5 weeks
Percent Time 70-140 mg/dL	CGM percent time 70-140 mg/dL, with different feature use of the pump each week.	Data collected over 1 week for each intervention, up to 5 weeks
Percent Time 70-180 mg/dL	CGM percent time 70-180 mg/dL, with different feature use of the pump each week.	Data collected over 1 week for each intervention, up to 5 weeks
Percent Time >180 mg/dL	CGM percent time >180 mg/dL, with different feature use of the pump each week.	Data collected over 1 week for each intervention, up to 5 weeks
Percent Time >250 mg/dL	CGM percent time >250 mg/dL, with different feature use of the pump each week.	Data collected over 1 week for each intervention, up to 5 weeks
Median of Mean Glucose (mg/dL)	Median of individual participants CGM Mean Glucose values (mg/dL), with different feature use of the pump each week.	Data collected over 1 week for each intervention, up to 5 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2021
• Primary Completion (Actual): December 20, 2021
• Study Completion (Actual): December 20, 2021

Study Registration Dates

• First Submitted: August 13, 2021
• First Submitted That Met QC Criteria: August 13, 2021
• First Posted (Actual): August 20, 2021

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: type 1 diabetes; automated insulin delivery; Control-IQ Technology; automated insulin dosing
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1
• Other Study ID Numbers: G210146

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