Diabetes Mellitus, Type 1
Conditions
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).
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.
Interventions
DEVICEt:slim X2 pump with Control-IQ technology
Real-world use
Sponsors
University of California, San Diego
Tandem Diabetes Care, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence Rates of Severe Hypoglycemia (SH) | 12 months | Overall incidence rate of events per 100 patient years |
| Incidence Rates of Diabetic Ketoacidosis (DKA) | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Percent Time Less Than 70 mg/dL | 12 months | CGM measured percent time less than 70 mg/dL during 12 months of Control-IQ use |
| Percent Time Less Than 54 mg/dL | 12 months | CGM measured percent time less than 54 mg/dL during 12 months of Control-IQ use |
| Percent Time in Range 70 - 180 mg/dL | 12 months | CGM measured percent time in range 70 - 180 mg/dL during 12 months of Control-IQ use |
| Diabetes Impact and Satisfaction Scale (DIDS), Impact Score | 12 months | DIDS impact score after 12 months of Control-IQ use. Score range from 0 -10 with lower scores indicating better outcome. |
| Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score | 12 months | DIDS satisfaction score after 12 months of Control-IQ use. Score range from 0-10 with higher scores indicating better outcome. |
| Percent Time Greater Than 180 mg/dL | 12 months | CGM measured percent time greater than 180 mg/dL during 12 months of Control-IQ use |
| Percent Time Greater Than 250 mg/dL | 12 months | CGM measured percent time greater than 250 mg/dL during 12 months of Control-IQ use |
Countries
United States
Participant flow
Pre-assignment details
3157 participants completed the baseline survey and were enrolled, but only 3061 had started closed-loop and had adequate data available for analysis.
Participants by arm
| Arm | Count |
|---|---|
| All Enrolled Participants All participants who started the monthly surveys.
t:slim X2 pump with Control-IQ technology: Real-world use | 3,157 |
| Total | 3,157 |
Baseline characteristics
| Characteristic | All Enrolled Participants |
|---|---|
| Age, Continuous | 29.0 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 271 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2819 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 67 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 60 Participants |
| Race (NIH/OMB) Asian | 78 Participants |
| Race (NIH/OMB) Black or African American | 184 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 14 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 67 Participants |
| Race (NIH/OMB) White | 2628 Participants |
| Region of Enrollment United States | 3157 Participants |
| Sex: Female, Male Female | 1759 Participants |
| Sex: Female, Male Male | 1398 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 3,061 |
| other Total, other adverse events | 0 / 3,061 |
| serious Total, serious adverse events | 14 / 3,061 |
Outcome results
Primary
Incidence Rates of Diabetic Ketoacidosis (DKA)
Overall incidence rate of events per 100 patient years
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prior MDI User | Incidence Rates of Diabetic Ketoacidosis (DKA) | 2.40 events per 100 patient years | Standard Deviation 16.69 |
| 6-17 YO | Incidence Rates of Diabetic Ketoacidosis (DKA) | 1.93 events per 100 patient years | Standard Deviation 13.78 |
| Adults (18+) | Incidence Rates of Diabetic Ketoacidosis (DKA) | 1.46 events per 100 patient years | Standard Deviation 13.1 |
| No Prior CGM Experience | Incidence Rates of Diabetic Ketoacidosis (DKA) | 3.57 events per 100 patient years | Standard Deviation 19.91 |
| HbA1c Greater Than or Equal to 8% | Incidence Rates of Diabetic Ketoacidosis (DKA) | 2.47 events per 100 patient years | Standard Deviation 16.5 |
| HbA1c Less Than 8% | Incidence Rates of Diabetic Ketoacidosis (DKA) | 0.96 events per 100 patient years | Standard Deviation 10.33 |
| Prior Pump User | Incidence Rates of Diabetic Ketoacidosis (DKA) | 1.26 events per 100 patient years | Standard Deviation 11.56 |
| Prior CGM Experience | Incidence Rates of Diabetic Ketoacidosis (DKA) | 1.37 events per 100 patient years | Standard Deviation 12.02 |
Primary
Incidence Rates of Severe Hypoglycemia (SH)
Overall incidence rate of events per 100 patient years
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Prior MDI User | Incidence Rates of Severe Hypoglycemia (SH) | 9.65 events per 100 patient years | Standard Deviation 36.47 |
| 6-17 YO | Incidence Rates of Severe Hypoglycemia (SH) | 9.31 events per 100 patient years | Standard Deviation 34.31 |
| Adults (18+) | Incidence Rates of Severe Hypoglycemia (SH) | 9.77 events per 100 patient years | Standard Deviation 36.97 |
| No Prior CGM Experience | Incidence Rates of Severe Hypoglycemia (SH) | 7.99 events per 100 patient years | Standard Deviation 30.04 |
| HbA1c Greater Than or Equal to 8% | Incidence Rates of Severe Hypoglycemia (SH) | 9.58 events per 100 patient years | Standard Deviation 37.03 |
| HbA1c Less Than 8% | Incidence Rates of Severe Hypoglycemia (SH) | 9.66 events per 100 patient years | Standard Deviation 35.55 |
| Prior Pump User | Incidence Rates of Severe Hypoglycemia (SH) | 9.61 events per 100 patient years | Standard Deviation 36.06 |
| Prior CGM Experience | Incidence Rates of Severe Hypoglycemia (SH) | 9.87 events per 100 patient years | Standard Deviation 36.99 |
Primary
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.
Time frame: 12 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Prior MDI User | Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature | 70 to 180 mg/dL Correction Bolus Results within 5 hours after bolus (with CGM auto population) | 13.18 percentage of boluses |
| Prior MDI User | Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature | 70 to 180 mg/dL Correction Bolus Results within 5 hours after bolus (no CGM auto population) | 14.52 percentage of boluses |
| Prior MDI User | Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature | 181 to 250 mg/dL Correction Bolus Results within 5 hours after bolus (with CGM auto population) | 11.06 percentage of boluses |
| Prior MDI User | Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature | 181 to 250 mg/dL Correction Bolus Results within 5 hours after bolus (no CGM auto population) | 15.61 percentage of boluses |
| Prior MDI User | Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature | > 250 mg/dL Correction Bolus Results within 5 hours after bolus (with CGM auto population) | 10.34 percentage of boluses |
| Prior MDI User | Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature | > 250 mg/dL Correction Bolus Results within 5 hours after bolus (no CGM auto population) | 13.50 percentage of boluses |
| Prior MDI User | Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature | All (with CGM auto population) | 12.22 percentage of boluses |
| Prior MDI User | Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature | All (no CGM auto population) | 14.60 percentage of boluses |
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prior MDI User | Diabetes Impact and Satisfaction Scale (DIDS), Impact Score | 2.75 score on a scale |
Secondary
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.
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prior MDI User | Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score | 9.14 score on a scale |
Secondary
Percent Time Greater Than 180 mg/dL
CGM measured percent time greater than 180 mg/dL during 12 months of Control-IQ use
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prior MDI User | Percent Time Greater Than 180 mg/dL | 28.6 percentage of time |
| 6-17 YO | Percent Time Greater Than 180 mg/dL | 37.0 percentage of time |
| Adults (18+) | Percent Time Greater Than 180 mg/dL | 37.2 percentage of time |
| No Prior CGM Experience | Percent Time Greater Than 180 mg/dL | 31.4 percentage of time |
Secondary
Percent Time Greater Than 250 mg/dL
CGM measured percent time greater than 250 mg/dL during 12 months of Control-IQ use
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prior MDI User | Percent Time Greater Than 250 mg/dL | 6.3 percentage of time |
| 6-17 YO | Percent Time Greater Than 250 mg/dL | 12.8 percentage of time |
| Adults (18+) | Percent Time Greater Than 250 mg/dL | 12.7 percentage of time |
| No Prior CGM Experience | Percent Time Greater Than 250 mg/dL | 8.0 percentage of time |
Secondary
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
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prior MDI User | Percent Time in Range 70 - 180 mg/dL | 70.1 percentage of time |
| 6-17 YO | Percent Time in Range 70 - 180 mg/dL | 60.9 percentage of time |
| Adults (18+) | Percent Time in Range 70 - 180 mg/dL | 61.2 percentage of time |
| No Prior CGM Experience | Percent Time in Range 70 - 180 mg/dL | 67.3 percentage of time |
Secondary
Percent Time Less Than 54 mg/dL
CGM measured percent time less than 54 mg/dL during 12 months of Control-IQ use
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prior MDI User | Percent Time Less Than 54 mg/dL | 0.2 percentage of time |
| 6-17 YO | Percent Time Less Than 54 mg/dL | 0.2 percentage of time |
| Adults (18+) | Percent Time Less Than 54 mg/dL | 0.2 percentage of time |
| No Prior CGM Experience | Percent Time Less Than 54 mg/dL | 0.2 percentage of time |
Secondary
Percent Time Less Than 70 mg/dL
CGM measured percent time less than 70 mg/dL during 12 months of Control-IQ use
Time frame: 12 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Prior MDI User | Percent Time Less Than 70 mg/dL | 1.1 percentage of time |
| 6-17 YO | Percent Time Less Than 70 mg/dL | 1.0 percentage of time |
| Adults (18+) | Percent Time Less Than 70 mg/dL | 1.1 percentage of time |
| No Prior CGM Experience | Percent Time Less Than 70 mg/dL | 1.1 percentage of time |