Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

Control-IQ 2.0 Feasibility Study #2: Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

The goal of this clinical trial is to assess safety of and explore glycemic outcomes with Control-IQ technology 2.0 in adults, children and preschoolers with type 1 diabetes.

Study Overview

• Status: Completed
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: t:slim X2 insulin pump with Control-IQ technology 2.0

Detailed Description

This feasibility study is a prospective, randomized, two-period crossover multi-center study of Control-IQ technology 2.0. After a two week run-in period, the automated insulin dosing (AID) system will be evaluated in multiple age groups over 4 weeks of use.

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center (Pediatric Clinic)
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 2 to ≤ 81 years
• Diagnosis of type 1 diabetes for at least 1 year, or at least 6 months for age 2-5 years at enrollment
• Prior Dexcom CGM user, with at least 11 of the prior 14 days of CGM use available for download at the screening visit to confirm eligibility
• Total Daily Insulin Dose (TDD) at least 2 units/day
• Weight ≥ 20 lbs
• HbA1c ≤ 10.5%
• For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia, present with the participant during and after the meal challenges, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study.
• For participants ≥18 years old, availability of a local contact who has access to the study participant, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. If the participant lives alone, the local contact must live within 30 minutes and have access to the subject overnight.
• Investigator has confidence that the participant and/or parent/guardian can successfully operate all study devices and is capable of adhering to the protocol.
• Willing to use only aspart (novolog) or lispro (humalog) insulin with the study devices, with no use of long-acting basal insulin injections, or inhaled insulin with the study devices.
• Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one)
• Willing and able to perform study meal challenges.

Exclusion Criteria:

• More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
• More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
• Inpatient psychiatric treatment in the past 6 months

• For Female: Currently pregnant or planning to become pregnant during the time period of study participation

  1. A negative pregnancy test will be required for all females of child-bearing potential
  2. Counseling on appropriate birth control options will be provided to all females of child-bearing potential
• Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
• Hemophilia or any other bleeding disorder
• Hemoglobinopathy
• History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
• History of allergic reaction to Humalog or Novolog
• Use of any medications determined by investigator to interfere with study
• Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
• Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea
• History of adrenal insufficiency
• History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
• History of gastroparesis
• A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
• Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
• Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Control-IQ 2.0 Lower Range First, then Standard Range; After a two week run in period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 with a lower range for two weeks, followed by use of t:slim X2 pump with Control-IQ technology 2.0 with a standard range for two weeks.	Device: t:slim X2 insulin pump with Control-IQ technology 2.0; t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor.
Experimental: Control-IQ 2.0 Standard Range First, then Lower Range; After a two week run in period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 with a standard range for two weeks, followed by use of t:slim X2 pump with Control-IQ technology 2.0 with a lower range for two weeks.	Device: t:slim X2 insulin pump with Control-IQ technology 2.0; 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
Number of Severe Hypoglycemic Events	Number of severe hypoglycemic events (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry over a 3-month time period	2 weeks
Number of Diabetic Ketoacidosis (DKA) Events	Number of diabetic ketoacidosis during study compared with data on DKA events, compared with data on DKA events reported by T1D Exchange clinic registry over a 3-month time period	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Time <54 mg/dL	CGM percent time <54 mg/dL during each study period.	2 weeks
Percent of Time <70 mg/dL	CGM percent time <70 mg/dL during each study period.	2 weeks
Percent Time 70-140 mg/dL	CGM percent time 70-140 mg/dL during each study period.	2 weeks
Percent Time 70-180 mg/dL	CGM percent time 70-180 mg/dL during each study period.	2 weeks
Percent Time > 180 mg/dL	CGM percent time >180 mg/dL during each study period.	2 weeks
Percent Time > 250 mg/dL	CGM percent time >250 mg/dL during each study period.	2 weeks
Mean Glucose	Mean CGM glucose mg/dL during each study period.	2 weeks
Glucose SD	Glucose SD mg/dL during each study period.	2 weeks
Glucose Coefficient of Variation	Glucose Coefficient of Variation (%) during each study period.	2 weeks

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Brown SA, Laffel LM, Akturk HK, Forlenza GP, Shah VN, Wadwa RP, Cobry EC, Isganaitis E, Schoelwer M, Lu VS, Rueda R, Sherer N, Corbett JP, Sasson-Katchalski R, Pinsker JE. Randomized, Crossover Trial of Control-IQ Technology with a Lower Treatment Range and a Modified Meal Bolus Module in Adults, Adolescents, Children, and Preschoolers with Varying Levels of Baseline Glycemic Control. Diabetes Technol Ther. 2024 Nov 26. doi: 10.1089/dia.2024.0501. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): December 13, 2023
• Study Completion (Actual): December 13, 2023

Study Registration Dates

• First Submitted: January 5, 2023
• First Submitted That Met QC Criteria: January 5, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: type 1 diabetes; Control-IQ technology
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1; Physiological Effects of Drugs; Hypoglycemic Agents; Insulin
• Other Study ID Numbers: TP-0011713

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