Control-IQ Observational (CLIO) Post-Approval Study

NCT04503174 | Completed Results FDA Device

• 1 other identifier: CLIO Study
• Study Type: observational
• Target: 3,157
• Locations: 1 country
• Sites: 1

Brief Summary

Post-approval 522 study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system).

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (3)

• Incidence Rates of Severe Hypoglycemia (SH)

  Overall incidence rate of events per 100 patient years

  12 months

• Incidence Rates of Diabetic Ketoacidosis (DKA)

  Overall incidence rate of events per 100 patient years

  12 months

• Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature

  Percent of boluses using the auto population feature resulting in at least one reading less than 70 mg/dL than those not using the feature, in every pre-bolus glucose range examined.

  12 months

Secondary Outcomes (7)

• Percent Time in Range 70 - 180 mg/dL

  12 months

• Percent Time Greater Than 180 mg/dL

  12 months

• Percent Time Greater Than 250 mg/dL

  12 months

• Percent Time Less Than 70 mg/dL

  12 months

• Percent Time Less Than 54 mg/dL

  12 months

Study Arms (7)

Pump Naive

New to insulin pump use

Device: t:slim X2 pump with Control-IQ technology

6-13 YO

Subjects between the age of 6-13 years old.

Device: t:slim X2 pump with Control-IQ technology

14-17 YO

Subjects between the age of 14-17 years old.

Device: t:slim X2 pump with Control-IQ technology

Adults (18+)

Subjects are 18 years old and older.

Device: t:slim X2 pump with Control-IQ technology

CGM Naive

Subjects have not used CGM in the 30 days prior to enrollment.

Device: t:slim X2 pump with Control-IQ technology

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.

Device: t:slim X2 pump with Control-IQ technology

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.

Device: t:slim X2 pump with Control-IQ technology

Interventions

t:slim X2 pump with Control-IQ technology DEVICE

Real-world use

14-17 YO; 6-13 YO; Adults (18+); CGM Naive; HbA1c less than or equal to 8.5%; HbA1c more than or equal to 8.5%; Pump Naive

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects who start therapy with the Control-IQ System once the study is approved to start, that meet the indications for use and the study eligibility criteria.

You may qualify if:

• Patients with self-reported type 1 diabetes who have been prescribed the Control-IQ system.
• 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).

You may not qualify if:

• Self-reported type 2 diabetes
• \< 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.

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead
• University of California, San Diego: collaborator

Study Sites (1)

Tandem Diabetes

San Diego, California, 92121, United States

Location

Related Publications (1)

• 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.

  PMID: 37782904 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: Clinical Affairs
• Organization: Tandem Diabetes Care

clinicalaffairs@tandemdiabetes.com

877-801-6901

Study Officials

• Jordan Pinsker, MD

  Tandem Diabetes Care, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Post-Marketing Study: Yes

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 7, 2020
• Study Start: August 4, 2020
• Primary Completion: June 2, 2023
• Study Completion: June 26, 2023
• Last Updated: December 8, 2023
• Results First Posted: December 8, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)