Type 1 Diabetes
Conditions
Keywords
Control-IQ technology, type 1 diabetes
Brief summary
The goal of this clinical trial is to assess safety of and explore glycemic outcomes with Control-IQ technology 2.0 in adults, children and preschoolers with type 1 diabetes.
Detailed description
This feasibility study is a prospective, randomized, two-period crossover multi-center study of Control-IQ technology 2.0. After a two week run-in period, the automated insulin dosing (AID) system will be evaluated in multiple age groups over 4 weeks of use.
Interventions
DEVICEt:slim X2 insulin pump with Control-IQ technology 2.0
t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor.
Sponsors
Tandem Diabetes Care, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 2 to ≤ 81 years * Diagnosis of type 1 diabetes for at least 1 year, or at least 6 months for age 2-5 years at enrollment * Prior Dexcom CGM user, with at least 11 of the prior 14 days of CGM use available for download at the screening visit to confirm eligibility * Total Daily Insulin Dose (TDD) at least 2 units/day * Weight ≥ 20 lbs * HbA1c ≤ 10.5% * For participants \<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia, present with the participant during and after the meal challenges, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. * For participants ≥18 years old, availability of a local contact who has access to the study participant, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. If the participant lives alone, the local contact must live within 30 minutes and have access to the subject overnight. * Investigator has confidence that the participant and/or parent/guardian can successfully operate all study devices and is capable of adhering to the protocol. * Willing to use only aspart (novolog) or lispro (humalog) insulin with the study devices, with no use of long-acting basal insulin injections, or inhaled insulin with the study devices. * Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one) * Willing and able to perform study meal challenges.
Exclusion criteria
* More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months * More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months * Inpatient psychiatric treatment in the past 6 months * For Female: Currently pregnant or planning to become pregnant during the time period of study participation 1. A negative pregnancy test will be required for all females of child-bearing potential 2. Counseling on appropriate birth control options will be provided to all females of child-bearing potential * Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas). * Hemophilia or any other bleeding disorder * Hemoglobinopathy * History of heart, liver, lung or kidney disease determined by investigator to interfere with the study * History of allergic reaction to Humalog or Novolog * Use of any medications determined by investigator to interfere with study * Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis * Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea * History of adrenal insufficiency * History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated * History of gastroparesis * A condition, which in the opinion of the investigator or designee, would put the participant or study at risk * Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation * Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Severe Hypoglycemic Events | 2 weeks | Number of severe hypoglycemic events (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry over a 3-month time period |
| Number of Diabetic Ketoacidosis (DKA) Events | 2 weeks | Number of diabetic ketoacidosis during study compared with data on DKA events, compared with data on DKA events reported by T1D Exchange clinic registry over a 3-month time period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Time 70-180 mg/dL | 2 weeks | CGM percent time 70-180 mg/dL during each study period. |
| Percent Time > 180 mg/dL | 2 weeks | CGM percent time \>180 mg/dL during each study period. |
| Percent Time > 250 mg/dL | 2 weeks | CGM percent time \>250 mg/dL during each study period. |
| Percent of Time <70 mg/dL | 2 weeks | CGM percent time \<70 mg/dL during each study period. |
| Glucose SD | 2 weeks | Glucose SD mg/dL during each study period. |
| Glucose Coefficient of Variation | 2 weeks | Glucose Coefficient of Variation (%) during each study period. |
| Percent of Time <54 mg/dL | 2 weeks | CGM percent time \<54 mg/dL during each study period. |
| Mean Glucose | 2 weeks | Mean CGM glucose mg/dL during each study period. |
| Percent Time 70-140 mg/dL | 2 weeks | CGM percent time 70-140 mg/dL during each study period. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control-IQ 2.0 Lower Range First, Then Standard Range After a two week run in period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 with a lower range for two weeks, followed by use of t:slim X2 pump with Control-IQ technology 2.0 with a standard range for two weeks. | 36 |
| Control-IQ 2.0 Standard Range First, Then Lower Range After a two week run in period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 with a standard range for two weeks, followed by use of t:slim X2 pump with Control-IQ technology 2.0 with a lower range for two weeks. | 36 |
| Total | 72 |
Baseline characteristics
| Characteristic | Control-IQ 2.0 Standard Range First, Then Lower Range | Total | Control-IQ 2.0 Lower Range First, Then Standard Range |
|---|---|---|---|
| Age, Continuous | 16.3 years STANDARD_DEVIATION 12.1 | 17.0 years STANDARD_DEVIATION 13.1 | 17.7 years STANDARD_DEVIATION 14.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 10 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 61 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 5 Participants | 2 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 | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 64 Participants | 32 Participants |
| Sex: Female, Male Female | 18 Participants | 35 Participants | 17 Participants |
| Sex: Female, Male Male | 18 Participants | 37 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 72 |
| other Total, other adverse events | 6 / 72 | 15 / 72 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 |
Outcome results
Primary
Number of Diabetic Ketoacidosis (DKA) Events
Number of diabetic ketoacidosis during study compared with data on DKA events, compared with data on DKA events reported by T1D Exchange clinic registry over a 3-month time period
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lower Range | Number of Diabetic Ketoacidosis (DKA) Events | 0 events |
| Standard Range | Number of Diabetic Ketoacidosis (DKA) Events | 0 events |
Primary
Number of Severe Hypoglycemic Events
Number of severe hypoglycemic events (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry over a 3-month time period
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lower Range | Number of Severe Hypoglycemic Events | 0 events |
| Standard Range | Number of Severe Hypoglycemic Events | 0 events |
Secondary
Glucose Coefficient of Variation
Glucose Coefficient of Variation (%) during each study period.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Range | Glucose Coefficient of Variation | 38.1 percentage of coefficient of variation |
| Standard Range | Glucose Coefficient of Variation | 37.3 percentage of coefficient of variation |
Secondary
Glucose SD
Glucose SD mg/dL during each study period.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Range | Glucose SD | 63.5 mg/dL |
| Standard Range | Glucose SD | 61.3 mg/dL |
Secondary
Mean Glucose
Mean CGM glucose mg/dL during each study period.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Range | Mean Glucose | 160.2 mg/dL |
| Standard Range | Mean Glucose | 166.0 mg/dL |
Secondary
Percent of Time <54 mg/dL
CGM percent time \<54 mg/dL during each study period.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Range | Percent of Time <54 mg/dL | 0.4 percentage of time |
| Standard Range | Percent of Time <54 mg/dL | 0.3 percentage of time |
Secondary
Percent of Time <70 mg/dL
CGM percent time \<70 mg/dL during each study period.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Range | Percent of Time <70 mg/dL | 2.0 percentage of time |
| Standard Range | Percent of Time <70 mg/dL | 1.6 percentage of time |
Secondary
Percent Time > 180 mg/dL
CGM percent time \>180 mg/dL during each study period.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Range | Percent Time > 180 mg/dL | 30.5 percentage of time |
| Standard Range | Percent Time > 180 mg/dL | 33.0 percentage of time |
Secondary
Percent Time > 250 mg/dL
CGM percent time \>250 mg/dL during each study period.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Range | Percent Time > 250 mg/dL | 9.9 percentage of time |
| Standard Range | Percent Time > 250 mg/dL | 10.6 percentage of time |
Secondary
Percent Time 70-140 mg/dL
CGM percent time 70-140 mg/dL during each study period.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Range | Percent Time 70-140 mg/dL | 43.9 percentage of time |
| Standard Range | Percent Time 70-140 mg/dL | 39.2 percentage of time |
Secondary
Percent Time 70-180 mg/dL
CGM percent time 70-180 mg/dL during each study period.
Time frame: 2 weeks
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lower Range | Percent Time 70-180 mg/dL | 68.0 percentage of time |
| Standard Range | Percent Time 70-180 mg/dL | 65.8 percentage of time |