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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05683392
• Other study ID #: TP-0011713
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 13, 2023

Study information

• Verified date: July 2023
• Source: Tandem Diabetes Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 13, 2023
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado
United States	Barbara Davis Center (Pediatric Clinic)	Aurora	Colorado
United States	Joslin Diabetes Center	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Tandem Diabetes Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks
Primary	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	6 weeks
Primary	Number of unanticipated adverse device effects (UADEs)	Number of unanticipated adverse device effects during the study.	6 weeks
Primary	Number of other serious device-related adverse events	Number of serious device-related adverse events during the study.	6 weeks
Secondary	All device-related adverse events	Number of device-related adverse events	6 weeks
Secondary	Percent of time <54 mg/dL	CGM percent time <54 mg/dL during each study period.	6 weeks
Secondary	Percent of time <70 mg/dL	CGM percent time <70 mg/dL during each study period.	6 weeks
Secondary	Percent time 70-180 mg/dL	CGM percent time 70-180 mg/dL during each study period.	6 weeks
Secondary	Percent time > 180 mg/dL	CGM percent time >180 mg/dL during each study period.	6 weeks
Secondary	Percent time > 250 mg/dL	CGM percent time >250 mg/dL during each study period.	6 weeks
Secondary	Percent time 70-140 mg/dL	CGM percent time 70-140 mg/dL during each study period.	6 weeks
Secondary	Mean glucose	Mean CGM glucose mg/dL during each study period.	6 weeks
Secondary	Coefficient of variation	Coefficient of variation mg/dL during each study period.	6 weeks
Secondary	Standard deviation	Standard deviation mg/dL during each study period.	6 weeks
Secondary	CGM metrics for time in range by time of day	CGM metrics for time in range for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM) for each study period.	6 weeks
Secondary	Time to intervention for study meal challenges	Number of minutes until additional treatment given during study meal challenges for each study period.	6 weeks
Secondary	Number of interventions for study meal challenges	Number of additional treatments given during study meal challenges for each study period.	6 weeks