Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ)

  • STATUS
    Recruiting
  • days left to enroll
    18
  • participants needed
    60
  • sponsor
    Tandem Diabetes Care, Inc.
Updated on 7 October 2022
Investigator
Stephanie Zimmerman, RD,LD, CDCES
Primary Contact
International Diabetes Center (4.1 mi away) Contact
+3 other location
diabetes
insulin
hyperglycemia
glucagon
hemoglobin a1c
hypoglycemia

Summary

A prospective, single-arm study of 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ technology in individuals with type 1 diabetes who will plan to use at least one basal rate > 3 units/hr.

Description

The objectives of the study are to assess safety and explore glycemic outcomes with use of an automated insulin dosing (AID) system (t:slim X2 insulin pump with Control-IQ technology v1.5) in adults with type 1 diabetes who will plan to use at least one basal rate > 3 units/hr. Up to 60 participants may be recruited.

Details
Condition Type 1 Diabetes
Treatment t:slim X2 insulin pump with Control-IQ technology 1.5
Clinical Study IdentifierNCT05422053
SponsorTandem Diabetes Care, Inc.
Last Modified on7 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years
Diagnosis of type 1 diabetes for at least 1 year
Currently using an insulin pump (of any brand) for at least 3 months, and will plan to use at least one basal rate above 3 units/hr with the study pump
HbA1c < 10.5%
Weight ≤ 200 kg
Residing full-time in the United States, with no anticipated travel outside the United States during the period of study participation
Participant has agreed to participate in the study; and has read, understood and signed the informed consent form (ICF); and has agreed to follow all study procedures, including suspending use of any personal CGM for the duration of the clinical trial once the study CGM is in use
Willing to use only aspart (novolog) or lispro (humalog) insulin with the study pump, with no use of concentrated insulin above U-100, long-acting basal insulin injections, or inhaled insulin with the study pump
Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
Willing and able to perform the study exercise and meal challenges
Have a care partner, trained in hypoglycemia and hyperglycemia treatment guidelines, present during the challenges and until the next day
Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including ability to respond to alerts and alarms, and to provide basic diabetes self-management

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
History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study
For Female: Currently pregnant or planning to become pregnant during the time period of study participation
Use of sulfonylureas, meglitinides or other medications specifically listed in protocol or determined by investigator to interfere with the study
Unstable dose of SGLT-2 inhibitor, GLP-1 receptor agonist, or DPP-4 inhibitor as listed in the protocol, or starting a new non-insulin glucose lowering or weight loss agent during the trial
Hemophilia or any other bleeding disorder
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 glucocorticoids or other medications determined by investigator to interfere with study
Abnormal screening electrocardiogram consistent with increased risk during study exercise activities, such as arrhythmia, ischemia, or prolonged QTc interval. Investigator will review all electrocardiograms
Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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