Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
3157 participants
OBSERVATIONAL
2020-08-04
2023-06-26
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Pump Naive
New to insulin pump use
t:slim X2 pump with Control-IQ technology
Real-world use
6-13 YO
Subjects between the age of 6-13 years old.
t:slim X2 pump with Control-IQ technology
Real-world use
14-17 YO
Subjects between the age of 14-17 years old.
t:slim X2 pump with Control-IQ technology
Real-world use
Adults (18+)
Subjects are 18 years old and older.
t:slim X2 pump with Control-IQ technology
Real-world use
CGM Naive
Subjects have not used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology
Real-world use
HbA1c more than or equal to 8.5%
Subjects have an HbA1c of more than or equal to 8.5% in the 3 months prior to enrollment.
t:slim X2 pump with Control-IQ technology
Real-world use
HbA1c less than or equal to 8.5%
Subjects have an HbA1c of less than or equal to 8.5% in the 3 months prior to enrollment.
t:slim X2 pump with Control-IQ technology
Real-world use
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
t:slim X2 pump with Control-IQ technology
Real-world use
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* At least 6 years of age
* Using Humalog or Novolog insulin
* For females, not pregnant or planning pregnancy in the next 12 months.
* Agreement to use the t:slim X2 with Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.
* Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment.
* Ability to respond to alerts and alarms, and to provide basic diabetes self-management.
* Patients who reside full-time in the United States.
* Willingness to download the t:connect Mobile application to their Smartphone and keep it active throughout the study. Patients unable to use t:connect Mobile application must be willing to manually upload their insulin pump data to t:connect every three months and at the completion of the study.
* Subject has read, understood and agreed to participate in the study, and has electronically signed the Informed Consent Form (ICF).
Exclusion Criteria
* \< 6 years of age
* Use of any glucose-lowering therapy other than Humalog or Novolog insulin
* Inability to respond to alerts and alarms, or to provide basic diabetes self-management.
* Pregnancy
* Subjects who have not signed the ICF.
6 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of California, San Diego
OTHER
Tandem Diabetes Care, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jordan Pinsker, MD
Role: PRINCIPAL_INVESTIGATOR
Tandem Diabetes Care, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tandem Diabetes
San Diego, California, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Graham R, Mueller L, Manning M, Habif S, Messer LH, Pinsker JE, Aronoff-Spencer E. Real-World Use of Control-IQ Technology Is Associated with a Lower Rate of Severe Hypoglycemia and Diabetic Ketoacidosis Than Historical Data: Results of the Control-IQ Observational (CLIO) Prospective Study. Diabetes Technol Ther. 2024 Jan;26(1):24-32. doi: 10.1089/dia.2023.0341. Epub 2023 Oct 26.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CLIO Study
Identifier Type: -
Identifier Source: org_study_id