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

NCT05683392 | Completed Results FDA Device

• 1 other identifier: TP-0011713
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Type 1 Diabetes

Keywords

Control-IQ technology; type 1 diabetes

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• Percent of Time <54 mg/dL

  2 weeks

• Percent of Time <70 mg/dL

  2 weeks

• Percent Time 70-140 mg/dL

  2 weeks

• Percent Time 70-180 mg/dL

  2 weeks

• Percent Time > 180 mg/dL

  2 weeks

Study Arms (2)

Control-IQ 2.0 Lower Range First, then Standard Range

EXPERIMENTAL

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

Control-IQ 2.0 Standard Range First, then Lower Range

EXPERIMENTAL

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

Interventions

t:slim X2 insulin pump with Control-IQ technology 2.0 DEVICE

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

Control-IQ 2.0 Lower Range First, then Standard Range; Control-IQ 2.0 Standard Range First, then Lower Range

Eligibility Criteria

• Age: 2 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• A negative pregnancy test will be required for all females of child-bearing potential
• 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

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead

Study Sites (4)

Barbara Davis Center (Pediatric Clinic)

Aurora, Colorado, 80045, United States

Location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• 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. 2025 Mar;27(3):187-193. doi: 10.1089/dia.2024.0501. Epub 2024 Nov 26.

  PMID: 39601043 RESULT

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

Results Point of Contact

• Title: Supervisor, Clinical Affairs
• Organization: Tandem Diabetes Care, Inc

clinicalaffairs@tandemdiabetes.com

(877) 801-6901

Study Officials

• Jordan Pinsker, MD

  Tandem Diabetes Care, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 13, 2023
• Study Start: February 1, 2023
• Primary Completion: December 13, 2023
• Study Completion: December 13, 2023
• Last Updated: December 20, 2024
• Results First Posted: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)