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Completed

NCT Number: NCT04503174

Control-IQ Observational (CLIO) Post-Approval Study

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).

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tandem Diabetes

San Diego, California, 92121, United States

About this study

Post-approval 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), by assessing the rate of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) during the first 12 months of use. Secondary endpoints assessing the effectiveness of this product in real-world use by assessing the impact on patients' glycemic outcomes and user experience will also be collected. The Control-IQ system will be used as intended and in accordance with FDA-approved labeling.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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.

Treatment and study plan

t:slim X2 pump with Control-IQ technology

Device

Real-world use

Primary outcomes

  1. Incidence Rates of Severe Hypoglycemia (SH)

    Time frame: 12 months

    Overall incidence rate of events per 100 patient years

  2. Incidence Rates of Diabetic Ketoacidosis (DKA)

    Time frame: 12 months

    Overall incidence rate of events per 100 patient years

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

    Time frame: 12 months

    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.

Secondary outcomes

  1. Percent Time in Range 70 - 180 mg/dL

    Time frame: 12 months

    CGM measured percent time in range 70 - 180 mg/dL during 12 months of Control-IQ use

  2. Percent Time Greater Than 180 mg/dL

    Time frame: 12 months

    CGM measured percent time greater than 180 mg/dL during 12 months of Control-IQ use

  3. Percent Time Greater Than 250 mg/dL

    Time frame: 12 months

    CGM measured percent time greater than 250 mg/dL during 12 months of Control-IQ use

  4. Percent Time Less Than 70 mg/dL

    Time frame: 12 months

    CGM measured percent time less than 70 mg/dL during 12 months of Control-IQ use

  5. Percent Time Less Than 54 mg/dL

    Time frame: 12 months

    CGM measured percent time less than 54 mg/dL during 12 months of Control-IQ use

  6. Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score

    Time frame: 12 months

    DIDS satisfaction score after 12 months of Control-IQ use. Score range from 0-10 with higher scores indicating better outcome.

  7. Diabetes Impact and Satisfaction Scale (DIDS), Impact Score

    Time frame: 12 months

    DIDS impact score after 12 months of Control-IQ use. Score range from 0 -10 with lower scores indicating better outcome.

Sponsors and collaborators

Lead sponsor

Tandem Diabetes Care, Inc.

Industry

Collaborators

  • University of California, San Diego

Registry information

Acronym: CLIO

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 7, 2020
Registry last updated
Dec 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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