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

Not Applicable

Completed

Conditions: Type 1 Diabetes

Registration Number: NCT05683392

Lead Sponsor: Tandem Diabetes Care, Inc.

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 72

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Number of Severe Hypoglycemic Events	2 weeks	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
Number of Diabetic Ketoacidosis (DKA) Events	2 weeks	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

Secondary Outcome Measures

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

Trial Locations

Locations (4): Barbara Davis Center
🇺🇸
Aurora, Colorado, United States
Barbara Davis Center (Pediatric Clinic)
🇺🇸
Aurora, Colorado, United States
University of Virginia
🇺🇸
Charlottesville, Virginia, United States
Joslin Diabetes Center
🇺🇸
Boston, Massachusetts, United States