Type 2 Diabetes Treated With Insulin
Conditions
Keywords
type 2 diabetes, Control-IQ technology, automated insulin dosing, automated insulin delivery
Brief summary
A prospective, multicenter study of 6 weeks of home use of Control-IQ technology in individuals with type 2 diabetes age 18 and older.
Detailed description
The objective of this prospective, multicenter study is to assess safety and explore glycemic outcomes associated with use of Control-IQ technology in adults with type 2 diabetes who require insulin. After an initial run-in period, all participants will use the study system (pump and CGM) for 6 weeks. Participants will perform exercise challenges once each week during the study.
Interventions
DEVICEControl-IQ technology 1.5
All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor. Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level.
Sponsors
Jaeb Center for Health Research
Tandem Diabetes Care, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Multicenter, prospective clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years old and residing in the US * Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least one year * Using a stable insulin dose for at least 3 months, to include A) basal insulin only, or B) MDI, to include CSII (including use of AID systems other than Tandem Control-IQ technology) * Total daily insulin dose ≤200 units/day * Willing to use only aspart (novolog) or lispro (humalog) insulin with the study pump, with no use of concentrated insulin above U-100, long-acting basal insulin injections, or inhaled insulin * For females, not currently known to be pregnant * If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued. * HbA1c ≥ 7.5% and ≤ 12% at screening * Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one) * Be willing to exercise for 30 minutes or more at least once per week during the main phase of the study * Has the ability to read and understand written English * Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study.
Exclusion criteria
* Prior use of Tandem t:slim X2 insulin pump with Control-IQ technology * Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months * History of inpatient psychiatric treatment in the past 6 months * History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study. * History of significant heart disease, lung disease, liver disease, chronic kidney disease, or other systemic disease determined by investigator to interfere with the study, or make required exercise unsafe * History of significant vision, hearing, or dexterity problems that will impair use of the closed loop system * Use of glucocorticoids, beta blockers, sulfonylureas, meglitinides or other medications specifically listed in the protocol or determined by investigator to interfere with the study * Unstable dose of SGLT-2 inhibitor, GLP-1 receptor agonist, or other adjuvant medication specifically listed in the protocol, or starting a new glucose lowering agent during the trial. * Unstable dose of any medication used for weight loss, as listed in the protocol, or starting a new medication for weight loss during the trial. * Abnormal screening electrocardiogram consistent with increased risk during exercise, such as arrhythmia, ischemia, or prolonged QTc interval (\>450 ms) * History of hemodialysis * History of adrenal insufficiency * Uncontrolled hypo- or hyperthyroidism * Significant diabetes related complications, based on investigator assessment * Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care, Inc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CGM Time Below 54 mg/dL | 14 weeks | CGM-measured percentage below 54 mg/dl, compared to baseline |
| CGM Time Above 180 mg/dL | 14 weeks | CGM-measured percentage above 180 mg/dl, compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CGM Time Below 70 mg/dL | 14 weeks | CGM-measured percentage below 70 mg/dl, compared to baseline |
| CGM Time In Range 70-180 mg/dL | 14 weeks | CGM-measured percentage in range 70-180 mg/dl, compared to baseline |
| CGM Time Above 250 mg/dL | 14 weeks | CGM-measured percentage above 250 mg/dl, compared to baseline |
| CGM Time In Range 70-140 mg/dL | 14 weeks | CGM-measured percentage in range 70-140 mg/dl, compared to baseline |
| CGM Mean Glucose mg/dL | 14 weeks | CGM measured mean glucose mg/dL, compared to baseline |
| Coefficient of Variation (CV) | 14 weeks | CGM measured glucose variability measured with the coefficient of variation (CV), compared to baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| All Serious Adverse Events | 14 weeks | The number of Serious Adverse Events |
| Unanticipated Adverse Device Effects | 14 weeks | The number of Unanticipated Adverse Device Effects |
| DKA | 14 weeks | The number of DKA events |
| Severe Hypoglycemia (Needing Assistance) | 14 weeks | The number of severe hypoglycemic events (needing assistance) |
| Hyperosmolar Hyperglycemic Syndrome | 14 weeks | The number of Hyperosmolar Hyperglycemic Syndrome events |
Countries
United States
Participant flow
Recruitment details
Study participants were recruited from 3 clinical centers in the United States. All eligible participants were included without regard to gender, race, or ethnicity. Each site was asked to contribute \ 10 participants (5 basal only / 5 MDI) toward the overall recruitment goal.
Participants by arm
| Arm | Count |
|---|---|
| Basal Insulin Only (Group A) * 2 to 4 week CGM run-in
* 2 to 4 week pump run-in
* 6 weeks Control-IQ technology use
Control-IQ technology 1.5: All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level. | 13 |
| Multiple Daily Injections (Group B) * 2 to 4 week CGM run-in
* 2 to 4 week pump run-in
* 6 weeks Control-IQ technology use
Control-IQ technology 1.5: All subjects wearing the t-slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor.
Outcomes will be analyzed overall and subgroup analysis will be performed by Group, and by baseline A1c level. | 17 |
| Total | 30 |
Baseline characteristics
| Characteristic | Basal Insulin Only (Group A) | Multiple Daily Injections (Group B) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 15 Participants | 26 Participants |
| Age, Continuous | 54 years STANDARD_DEVIATION 12 | 54 years STANDARD_DEVIATION 12 | 54 years STANDARD_DEVIATION 12 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 12 Participants | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Hemoglobin A1c | 8.2 Percent of glycated hemoglobin STANDARD_DEVIATION 0.9 | 8.9 Percent of glycated hemoglobin STANDARD_DEVIATION 1.3 | 8.6 Percent of glycated hemoglobin STANDARD_DEVIATION 1.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 9 Participants | 14 Participants | 23 Participants |
| Sex: Female, Male Female | 10 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 3 Participants | 9 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 17 |
| other Total, other adverse events | 1 / 13 | 5 / 17 |
| serious Total, serious adverse events | 0 / 13 | 0 / 17 |
Outcome results
Primary
CGM Time Above 180 mg/dL
CGM-measured percentage above 180 mg/dl, compared to baseline
Time frame: 14 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall | CGM Time Above 180 mg/dL | Open-Loop | 37 percentage of time | Standard Deviation 20 |
| Overall | CGM Time Above 180 mg/dL | Baseline | 44 percentage of time | Standard Deviation 25 |
| Overall | CGM Time Above 180 mg/dL | Control-IQ | 29 percentage of time | Standard Deviation 18 |
| Basal Insulin Only (Group A) | CGM Time Above 180 mg/dL | Open-Loop | 34 percentage of time | Standard Deviation 22 |
| Basal Insulin Only (Group A) | CGM Time Above 180 mg/dL | Baseline | 39 percentage of time | Standard Deviation 15 |
| Basal Insulin Only (Group A) | CGM Time Above 180 mg/dL | Control-IQ | 26 percentage of time | Standard Deviation 15 |
| Multiple Daily Injections (Group B) | CGM Time Above 180 mg/dL | Baseline | 48 percentage of time | Standard Deviation 31 |
| Multiple Daily Injections (Group B) | CGM Time Above 180 mg/dL | Control-IQ | 31 percentage of time | Standard Deviation 20 |
| Multiple Daily Injections (Group B) | CGM Time Above 180 mg/dL | Open-Loop | 39 percentage of time | Standard Deviation 19 |
Comparison: For Control-IQ Versus Baselinep-value: 0.004t-test, 2 sided
Primary
CGM Time Below 54 mg/dL
CGM-measured percentage below 54 mg/dl, compared to baseline
Time frame: 14 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall | CGM Time Below 54 mg/dL | Open-Loop | 0.00 percentage of time |
| Overall | CGM Time Below 54 mg/dL | Baseline | 0.00 percentage of time |
| Overall | CGM Time Below 54 mg/dL | Control-IQ | 0.02 percentage of time |
| Basal Insulin Only (Group A) | CGM Time Below 54 mg/dL | Open-Loop | 0.00 percentage of time |
| Basal Insulin Only (Group A) | CGM Time Below 54 mg/dL | Baseline | 0.00 percentage of time |
| Basal Insulin Only (Group A) | CGM Time Below 54 mg/dL | Control-IQ | 0.02 percentage of time |
| Multiple Daily Injections (Group B) | CGM Time Below 54 mg/dL | Baseline | 0.00 percentage of time |
| Multiple Daily Injections (Group B) | CGM Time Below 54 mg/dL | Control-IQ | 0.02 percentage of time |
| Multiple Daily Injections (Group B) | CGM Time Below 54 mg/dL | Open-Loop | 0.00 percentage of time |
Secondary
CGM Mean Glucose mg/dL
CGM measured mean glucose mg/dL, compared to baseline
Time frame: 14 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall | CGM Mean Glucose mg/dL | Open-Loop | 172 mg/dL | Standard Deviation 32 |
| Overall | CGM Mean Glucose mg/dL | Baseline | 184 mg/dL | Standard Deviation 42 |
| Overall | CGM Mean Glucose mg/dL | Control-IQ | 163 mg/dL | Standard Deviation 28 |
| Basal Insulin Only (Group A) | CGM Mean Glucose mg/dL | Open-Loop | 170 mg/dL | Standard Deviation 35 |
| Basal Insulin Only (Group A) | CGM Mean Glucose mg/dL | Baseline | 174 mg/dL | Standard Deviation 22 |
| Basal Insulin Only (Group A) | CGM Mean Glucose mg/dL | Control-IQ | 159 mg/dL | Standard Deviation 23 |
| Multiple Daily Injections (Group B) | CGM Mean Glucose mg/dL | Baseline | 192 mg/dL | Standard Deviation 52 |
| Multiple Daily Injections (Group B) | CGM Mean Glucose mg/dL | Control-IQ | 166 mg/dL | Standard Deviation 32 |
| Multiple Daily Injections (Group B) | CGM Mean Glucose mg/dL | Open-Loop | 174 mg/dL | Standard Deviation 30 |
Comparison: For Control-IQ Versus Baselinep-value: 0.01t-test, 2 sided
Secondary
CGM Time Above 250 mg/dL
CGM-measured percentage above 250 mg/dl, compared to baseline
Time frame: 14 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall | CGM Time Above 250 mg/dL | Open-Loop | 6.7 percentage of time |
| Overall | CGM Time Above 250 mg/dL | Baseline | 8.5 percentage of time |
| Overall | CGM Time Above 250 mg/dL | Control-IQ | 2.9 percentage of time |
| Basal Insulin Only (Group A) | CGM Time Above 250 mg/dL | Open-Loop | 8.1 percentage of time |
| Basal Insulin Only (Group A) | CGM Time Above 250 mg/dL | Baseline | 12.9 percentage of time |
| Basal Insulin Only (Group A) | CGM Time Above 250 mg/dL | Control-IQ | 1.9 percentage of time |
| Multiple Daily Injections (Group B) | CGM Time Above 250 mg/dL | Baseline | 6.8 percentage of time |
| Multiple Daily Injections (Group B) | CGM Time Above 250 mg/dL | Control-IQ | 2.9 percentage of time |
| Multiple Daily Injections (Group B) | CGM Time Above 250 mg/dL | Open-Loop | 6.3 percentage of time |
Comparison: For Control-IQ Versus Baselinep-value: 0.03t-test, 2 sided
Secondary
CGM Time Below 70 mg/dL
CGM-measured percentage below 70 mg/dl, compared to baseline
Time frame: 14 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall | CGM Time Below 70 mg/dL | Open-Loop | 0.10 percentage of time |
| Overall | CGM Time Below 70 mg/dL | Baseline | 0.05 percentage of time |
| Overall | CGM Time Below 70 mg/dL | Control-IQ | 0.12 percentage of time |
| Basal Insulin Only (Group A) | CGM Time Below 70 mg/dL | Open-Loop | 0.19 percentage of time |
| Basal Insulin Only (Group A) | CGM Time Below 70 mg/dL | Baseline | 0.00 percentage of time |
| Basal Insulin Only (Group A) | CGM Time Below 70 mg/dL | Control-IQ | 0.09 percentage of time |
| Multiple Daily Injections (Group B) | CGM Time Below 70 mg/dL | Baseline | 0.11 percentage of time |
| Multiple Daily Injections (Group B) | CGM Time Below 70 mg/dL | Control-IQ | 0.13 percentage of time |
| Multiple Daily Injections (Group B) | CGM Time Below 70 mg/dL | Open-Loop | 0.03 percentage of time |
Comparison: For Control-IQ Versus Baselinep-value: 0.54t-test, 2 sided
Secondary
CGM Time In Range 70-140 mg/dL
CGM-measured percentage in range 70-140 mg/dl, compared to baseline
Time frame: 14 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall | CGM Time In Range 70-140 mg/dL | Open-Loop | 34 percentage of time | Standard Deviation 22 |
| Overall | CGM Time In Range 70-140 mg/dL | Baseline | 30 percentage of time | Standard Deviation 17 |
| Overall | CGM Time In Range 70-140 mg/dL | Control-IQ | 42 percentage of time | Standard Deviation 18 |
| Basal Insulin Only (Group A) | CGM Time In Range 70-140 mg/dL | Open-Loop | 38 percentage of time | Standard Deviation 23 |
| Basal Insulin Only (Group A) | CGM Time In Range 70-140 mg/dL | Baseline | 32 percentage of time | Standard Deviation 13 |
| Basal Insulin Only (Group A) | CGM Time In Range 70-140 mg/dL | Control-IQ | 45 percentage of time | Standard Deviation 17 |
| Multiple Daily Injections (Group B) | CGM Time In Range 70-140 mg/dL | Baseline | 28 percentage of time | Standard Deviation 20 |
| Multiple Daily Injections (Group B) | CGM Time In Range 70-140 mg/dL | Control-IQ | 40 percentage of time | Standard Deviation 19 |
| Multiple Daily Injections (Group B) | CGM Time In Range 70-140 mg/dL | Open-Loop | 31 percentage of time | Standard Deviation 21 |
Comparison: For Control-IQ Versus Baselinep-value: 0.001t-test, 2 sided
Secondary
CGM Time In Range 70-180 mg/dL
CGM-measured percentage in range 70-180 mg/dl, compared to baseline
Time frame: 14 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall | CGM Time In Range 70-180 mg/dL | Open-Loop | 63 percentage of time | Standard Deviation 20 |
| Overall | CGM Time In Range 70-180 mg/dL | Baseline | 56 percentage of time | Standard Deviation 25 |
| Overall | CGM Time In Range 70-180 mg/dL | Control-IQ | 71 percentage of time | Standard Deviation 18 |
| Basal Insulin Only (Group A) | CGM Time In Range 70-180 mg/dL | Open-Loop | 66 percentage of time | Standard Deviation 22 |
| Basal Insulin Only (Group A) | CGM Time In Range 70-180 mg/dL | Baseline | 61 percentage of time | Standard Deviation 15 |
| Basal Insulin Only (Group A) | CGM Time In Range 70-180 mg/dL | Control-IQ | 74 percentage of time | Standard Deviation 15 |
| Multiple Daily Injections (Group B) | CGM Time In Range 70-180 mg/dL | Baseline | 52 percentage of time | Standard Deviation 31 |
| Multiple Daily Injections (Group B) | CGM Time In Range 70-180 mg/dL | Control-IQ | 68 percentage of time | Standard Deviation 20 |
| Multiple Daily Injections (Group B) | CGM Time In Range 70-180 mg/dL | Open-Loop | 61 percentage of time | Standard Deviation 18 |
Comparison: For Control-IQ Versus Baselinep-value: 0.004t-test, 2 sided
Secondary
Coefficient of Variation (CV)
CGM measured glucose variability measured with the coefficient of variation (CV), compared to baseline
Time frame: 14 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall | Coefficient of Variation (CV) | Open-Loop | 29 percentage of coefficient of variation |
| Overall | Coefficient of Variation (CV) | Baseline | 28 percentage of coefficient of variation |
| Overall | Coefficient of Variation (CV) | Control-IQ | 28 percentage of coefficient of variation |
| Basal Insulin Only (Group A) | Coefficient of Variation (CV) | Open-Loop | 30 percentage of coefficient of variation |
| Basal Insulin Only (Group A) | Coefficient of Variation (CV) | Baseline | 29 percentage of coefficient of variation |
| Basal Insulin Only (Group A) | Coefficient of Variation (CV) | Control-IQ | 27 percentage of coefficient of variation |
| Multiple Daily Injections (Group B) | Coefficient of Variation (CV) | Baseline | 25 percentage of coefficient of variation |
| Multiple Daily Injections (Group B) | Coefficient of Variation (CV) | Control-IQ | 30 percentage of coefficient of variation |
| Multiple Daily Injections (Group B) | Coefficient of Variation (CV) | Open-Loop | 29 percentage of coefficient of variation |
Comparison: For Control-IQ Versus Baselinep-value: 0.8t-test, 2 sided
Other Pre-specified
All Serious Adverse Events
The number of Serious Adverse Events
Time frame: 14 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | All Serious Adverse Events | 0 events |
| Basal Insulin Only (Group A) | All Serious Adverse Events | 0 events |
| Multiple Daily Injections (Group B) | All Serious Adverse Events | 0 events |
Other Pre-specified
DKA
The number of DKA events
Time frame: 14 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | DKA | 0 events |
| Basal Insulin Only (Group A) | DKA | 0 events |
| Multiple Daily Injections (Group B) | DKA | 0 events |
Other Pre-specified
Hyperosmolar Hyperglycemic Syndrome
The number of Hyperosmolar Hyperglycemic Syndrome events
Time frame: 14 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | Hyperosmolar Hyperglycemic Syndrome | 0 events |
| Basal Insulin Only (Group A) | Hyperosmolar Hyperglycemic Syndrome | 0 events |
| Multiple Daily Injections (Group B) | Hyperosmolar Hyperglycemic Syndrome | 0 events |
Other Pre-specified
Severe Hypoglycemia (Needing Assistance)
The number of severe hypoglycemic events (needing assistance)
Time frame: 14 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | Severe Hypoglycemia (Needing Assistance) | 0 events |
| Basal Insulin Only (Group A) | Severe Hypoglycemia (Needing Assistance) | 0 events |
| Multiple Daily Injections (Group B) | Severe Hypoglycemia (Needing Assistance) | 0 events |
Other Pre-specified
Unanticipated Adverse Device Effects
The number of Unanticipated Adverse Device Effects
Time frame: 14 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall | Unanticipated Adverse Device Effects | 0 events |
| Basal Insulin Only (Group A) | Unanticipated Adverse Device Effects | 0 events |
| Multiple Daily Injections (Group B) | Unanticipated Adverse Device Effects | 0 events |