Diabetes Mellitus, Type 1CLIONCT04503174

Control-IQ Observational (CLIO) Post-Approval Study

An observational study of Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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). Read more about this study

Who is it for?: Ages 6 years and older
Conditions the study is for: Diabetes Mellitus, Type 1
Type of treatment: Medical device
How many people: 3,157 participants
Where: 1 siteUnited States
Study dates: 4 Aug 2020to 26 Jun 2023
How long will I take part?: 1 Year
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

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.

Who may be able to join

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.

Show all 10Show fewer

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).

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Tandem Diabetes
San Diego, California, 92121

Other trials in United States

About this 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).

Read the detailed description

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.

Conditions: Diabetes Mellitus, Type 1
Being tested: t:slim X2 pump with Control-IQ technology
Medical subject headings: Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

t:slim X2 pump with Control-IQ technologyDevice
Real-world use

Study groups in NCT04503174
Study group	Role	What they receive
Pump Naive		New to insulin pump use Receives: Device: t:slim X2 pump with Control-IQ technology
6-13 YO		Subjects between the age of 6-13 years old. Receives: Device: t:slim X2 pump with Control-IQ technology
14-17 YO		Subjects between the age of 14-17 years old. Receives: Device: t:slim X2 pump with Control-IQ technology
Adults (18+)		Subjects are 18 years old and older. Receives: Device: t:slim X2 pump with Control-IQ technology
CGM Naive		Subjects have not used CGM in the 30 days prior to enrollment. Receives: 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. Receives: 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. Receives: Device: t:slim X2 pump with Control-IQ technology

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence Rates of Severe Hypoglycemia (SH)
Overall incidence rate of events per 100 patient years
Measured: 12 months
Incidence Rates of Diabetic Ketoacidosis (DKA)
Overall incidence rate of events per 100 patient years
Measured: 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.
Measured: 12 months

Secondary outcomes (7)

Percent Time in Range 70 - 180 mg/dL
CGM measured percent time in range 70 - 180 mg/dL during 12 months of Control-IQ use
Measured: 12 months
Percent Time Greater Than 180 mg/dL
CGM measured percent time greater than 180 mg/dL during 12 months of Control-IQ use
Measured: 12 months
Percent Time Greater Than 250 mg/dL
CGM measured percent time greater than 250 mg/dL during 12 months of Control-IQ use
Measured: 12 months
Percent Time Less Than 70 mg/dL
CGM measured percent time less than 70 mg/dL during 12 months of Control-IQ use
Measured: 12 months
Percent Time Less Than 54 mg/dL
CGM measured percent time less than 54 mg/dL during 12 months of Control-IQ use
Measured: 12 months
Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score
DIDS satisfaction score after 12 months of Control-IQ use. Score range from 0-10 with higher scores indicating better outcome.
Measured: 12 months
Diabetes Impact and Satisfaction Scale (DIDS), Impact Score
DIDS impact score after 12 months of Control-IQ use. Score range from 0 -10 with lower scores indicating better outcome.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

4 Aug 202026 Jun 2023

First posted7 Aug 2020
Study start4 Aug 2020
Primary completion2 Jun 2023
Study completion26 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 3,157 participants (actual)
Target duration: 1 Year

IDs, dates and publications

ClinicalTrials.gov ID: NCT04503174
Sponsor's protocol ID: CLIO Study
Acronym: CLIO
Status last verified: Dec 2023
First submitted: 3 Aug 2020
Last updated: 8 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 37782904

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Diabetes Mellitus, Type 1 trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Control-IQ Observational (CLIO) Post-Approval Study
ClinicalTrials.gov ID: NCT04503174
Acronym / sponsor ID: CLIO / CLIO Study
Conditions: Diabetes Mellitus, Type 1
Study type: Observational
Recruitment status: Completed
Enrolment: 3,157 participants (actual)
Lead sponsor: Tandem Diabetes Care, Inc.Industry (pharma, biotech, devices)
Collaborators: University of California, San Diego
Study start: 4 Aug 2020 (actual)
Primary completion: 2 Jun 2023 (actual)
Study completion: 26 Jun 2023 (actual)
First posted: 7 Aug 2020 (actual)
Results: Posted 8 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 1 Year
Number of arms: 7

Arm	Type	Receives
Pump Naive	–	Device: t:slim X2 pump with Control-IQ technologyNew to insulin pump use
6-13 YO	–	Device: t:slim X2 pump with Control-IQ technologySubjects between the age of 6-13 years old.
14-17 YO	–	Device: t:slim X2 pump with Control-IQ technologySubjects between the age of 14-17 years old.
Adults (18+)	–	Device: t:slim X2 pump with Control-IQ technologySubjects are 18 years old and older.
CGM Naive	–	Device: t:slim X2 pump with Control-IQ technologySubjects have not used CGM in the 30 days prior to enrollment.
HbA1c more than or equal to 8.5%	–	Device: t:slim X2 pump with Control-IQ technologySubjects have an HbA1c of more than or equal to 8.5% in the 3 months prior to enrollment.
HbA1c less than or equal to 8.5%	–	Device: t:slim X2 pump with Control-IQ technologySubjects have an HbA1c of less than or equal to 8.5% in the 3 months prior to enrollment.

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (6 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
t:slim X2 pump with Control-IQ technologyReal-world use	Device	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

Primary outcome

Incidence Rates of Severe Hypoglycemia (SH)
Time frame: 12 months
Overall incidence rate of events per 100 patient years
Incidence Rates of Diabetic Ketoacidosis (DKA)
Time frame: 12 months
Overall incidence rate of events per 100 patient years
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.

7 secondary outcomes

Percent Time in Range 70 - 180 mg/dL
Time frame: 12 months
Percent Time Greater Than 180 mg/dL
Time frame: 12 months
Percent Time Greater Than 250 mg/dL
Time frame: 12 months
Percent Time Less Than 70 mg/dL
Time frame: 12 months
Percent Time Less Than 54 mg/dL
Time frame: 12 months
Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score
Time frame: 12 months
Diabetes Impact and Satisfaction Scale (DIDS), Impact Score
Time frame: 12 months

Results and safety

Results posted to the registry on 8 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Enrolled Participants	3,061	2,998

Primary outcome: Incidence Rates of Severe Hypoglycemia (SH)

Time frame: 12 months. Mean (Standard Deviation). Unit: events per 100 patient years

Measure	Prior MDI User n = 915	6-17 YO n = 931	Adults (18+) n = 2130	No Prior CGM Experience n = 392	HbA1c Greater Than or Equal to 8% n = 1295	HbA1c Less Than 8% n = 1766	Prior Pump User n = 2146	Prior CGM Experience n = 2669
Value	9.65 (36.47)	9.31 (34.31)	9.77 (36.97)	7.99 (30.04)	9.58 (37.03)	9.66 (35.55)	9.61 (36.06)	9.87 (36.99)

Primary outcome: Incidence Rates of Diabetic Ketoacidosis (DKA)

Time frame: 12 months. Mean (Standard Deviation). Unit: events per 100 patient years

Measure	Prior MDI User n = 915	6-17 YO n = 931	Adults (18+) n = 2130	No Prior CGM Experience n = 392	HbA1c Greater Than or Equal to 8% n = 1295	HbA1c Less Than 8% n = 1766	Prior Pump User n = 2146	Prior CGM Experience n = 2669
Value	2.40 (16.69)	1.93 (13.78)	1.46 (13.10)	3.57 (19.91)	2.47 (16.50)	0.96 (10.33)	1.26 (11.56)	1.37 (12.02)

Primary outcome: 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. Number. Unit: percentage of boluses

Measure	All Enrolled Participants n = 3061
70 to 180 mg/dL Correction Bolus Results within 5 hours after bolus (with CGM auto population)	13.18
70 to 180 mg/dL Correction Bolus Results within 5 hours after bolus (no CGM auto population)	14.52
181 to 250 mg/dL Correction Bolus Results within 5 hours after bolus (with CGM auto population)	11.06
181 to 250 mg/dL Correction Bolus Results within 5 hours after bolus (no CGM auto population)	15.61
> 250 mg/dL Correction Bolus Results within 5 hours after bolus (with CGM auto population)	10.34
> 250 mg/dL Correction Bolus Results within 5 hours after bolus (no CGM auto population)	13.50
All (with CGM auto population)	12.22
All (no CGM auto population)	14.60

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Enrolled Participants	14 of 3,061 (0.5%)	0 of 3,061 (0%)	1 of 3,061

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 37782904Graham 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jordan Pinsker, MD principal investigator

Tandem Diabetes Care, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1, run by Tandem Diabetes Care, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rates of Severe Hypoglycemia (SH) (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04503174, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2023.