Control-IQ Technology 2.0 Adult and Adolescent Feasibility Study

NCT05014789 | Completed FDA Device

• 1 other identifier: G210146
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetes Mellitus, Type 1

Keywords

type 1 diabetes; Control-IQ Technology; automated insulin dosing; automated insulin delivery

Outcome Measures

Primary Outcomes (4)

• Significant Hypoglycemia

  CGM percent time \<54 mg/dL during each week of feature use, as well as during baseline and run-in periods

  8 weeks

• Severe hypoglycemia (needing assistance)

  Number of severe hypoglycemic events (per protocol) during each week of feature use, as well as during baseline and run-in periods

  8 weeks

• Diabetic Ketoacidosis

  Number of participants with Diabetic Ketoacidosis (per protocol) during each week of feature use, as well as during baseline and run-in periods

  8 weeks

• Serious Adverse Events

  Number of Serious Adverse Events during each week of feature use, as well as during baseline and run-in periods

  8 weeks

Secondary Outcomes (6)

• Percent of time <70 mg/dL

  8 weeks

• Percent of time > 250 mg/dL

  8 weeks

• Percent of time 70-180 mg/dL

  8 weeks

• Percent of time 70-140 mg/dL

  8 weeks

• Postprandial glycemic peak mg/dL

  8 weeks

Study Arms (1)

Control-IQ 2.0 technology 2.0 on the t:slim X2 insulin pump

EXPERIMENTAL

Each subject will use different combinations of new features of the system each week, in random order, over the next 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0. 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.

Device: Control-IQ technology 2.0

Interventions

Control-IQ technology 2.0 DEVICE

All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor

Control-IQ 2.0 technology 2.0 on the t:slim X2 insulin pump

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Share Dexcom G6 CGM data with study staff and Tandem
• Share t:connect data with Tandem
• Eat meals with known carbohydrate amounts
• Take meal boluses as directed (use of different options as scheduled and instructed)
• Follow study Glycemic Treatment Guidelines for hypo and hyperglycemia

You may not qualify if:

• 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

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jordan E Pinsker, MD

  Tandem Diabetes Care, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single arm, Single Center, Prospective Clinical Study

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: August 20, 2021
• Study Start: August 19, 2021
• Primary Completion: December 20, 2021
• Study Completion: December 20, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)