Diabetes Mellitus, Type 1
Conditions
Keywords
Diabetes, Type 1
Brief summary
The purpose of this study is to obtain clinical data in Chinese patients to support product registration of the MiniMed™ 670G system with the National Medical Product Administration (NMPA) in China. The results from the study will be submitted to the NMPA for product registration.
Detailed description
This study is a multi-center, single arm study in insulin-requiring subjects with type 1 diabetes who are 14 years of age and older. The run-in period will be approximately up to 35 days long, followed by a study period that will be approximately up to 33 days in duration. The study is anticipated to last no longer than 13 months from investigational center initiation to completion of all data entry and monitoring procedures. The study will target approximately 5 months to complete subject enrollment. Subjects can expect to participate for approximately 2-3 months including the run-in and study periods. A total of up to 75 subjects (aged 14-75) will be enrolled at a minimum 2 investigational centers and up to 6 investigational centers (hospitals) in China to have at least 50 subjects who complete the study. The MiniMed™ HCL system that was employed in this study was the MiniMed™ 670G Bluetooth version (MMT-1883). The MiniMed™ 670G system with Bluetooth™ technology is the MiniMed™ 770G system.
Interventions
DEVICEMiniMed™ 670G system
Hybrid closed loop insulin pump with associated CGM and blood glucose meter
Sponsors
Medtronic Diabetes
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject is age 14- 75 years at time of Screening. 2. Subject has a clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis. Study-specific inclusion criteria 3. Subject is willing to perform ≥ 4 finger stick BG measurements daily. 4. Subject is willing to perform required sensor calibrations. 5. Subject is willing to wear the system continuously throughout the study. 6. Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units. 7. Subject has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by the investigational center lab or their contracted Local Lab) at time of Screening visit. 8. Subject has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference range the Free T3 is below or within the lab's reference range and Free T4 is within the normal reference range. Prior labs in the last 6 months are sufficient. 9. Subject has been on pump therapy for greater than 6 months prior to screening (with or without CGM experience). 10. Subject is willing to upload data from the study pump and meter at home. 11. If subject has celiac disease, it has been adequately treated as determined by the investigator. 12. Subject has been taking and is willing to take one of the following insulins throughout the course of the study: * Humalog™\* (insulin lispro injection) * NovoLog™\* (insulin aspart) 13. Subject must be able to carbohydrate count or willing to learn how to carbohydrate count for the study.
Exclusion criteria
1. Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to Screening: 1. Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization) 2. Coma 3. Seizures 2. Subject has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes. 3. Subject has had DKA in the 6 months prior to Screening. 4. Subject is unable to tolerate tape adhesive in the area of sensor placement. 5. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection). 6. Subject is a female of child-bearing potential who has a positive pregnancy test at Screening or plans to become pregnant during the course of the study. 7. Subject is a female who is sexually active and able to conceive should be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator. 8. Subject has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease. 9. Subject is being treated for hyperthyroidism at time of Screening. 10. Subject has a diagnosis of adrenal insufficiency. 11. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of Screening, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study. 12. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks. (Please note participation in an observational study is acceptable.) 13. Subject is currently abusing illicit drugs. 14. Subject is currently abusing alcohol. 15. Subject is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of Screening. 16. Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator. 17. Subject has elective surgery planned that requires general anesthesia during the course of the study. 18. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of Screening 19. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation. 20. Subject diagnosed with current eating disorder such as anorexia or bulimia 21. Subject has been diagnosed with chronic kidney disease that results in chronic anemia. 22. Subject has a hematocrit (Hct) that is below the normal reference range of lab used. Prior labs in the last 6 months are sufficient. 23. Subject is on dialysis. 24. Subject has an estimated glomerular filtration rate (eGFR) of \< 30. 25. Subject has a pediatric BMI category of underweight (less than the 5th percentile) as defined by Centers for Disease Control (CDC) (https://www.cdc.gov/healthyweight/assessing/bmi/childrens\_bmi/about\_childrens\_bmi.html) 26. Subject is a member the research staff involved with the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Time in Target Range (% of Sensor Glucose (SG)): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) | Baseline to end of 1-month study | The overall mean change in % of time in target range from run-in period to study period will be estimated and compared by a simple superiority paired test and a significance level of 0.025 (one-sided). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in Hypoglycemic Range | 1-month study | Time in hypoglycemic range (% of SG): SG \< 70 mg/dL (3.9 mmol/L), SG \< 60 mg/dL (3.3 mmol/L), SG \< 54 mg/dL (3.0 mmol/L) will be summarized. |
| Time in Hyperglycemic Range: SG > 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L) | 1-month study | Time in hyperglycemic range (SG \> 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L)) will be summarized. |
| Standard Deviation (SD) of SG in mmol/L | 1-month study | In order to evaluate glucose variation, we calculated standard deviation. The standard deviation (SD) of SG will be summarized in the unit of mmol/L |
| Standard Deviation (SD) of SG in mg/dL | 1-month study | In order to evaluate glucose variation, we calculated standard deviation. The standard deviation (SD) of SG will be summarized in the unit of mg/dL. |
| Coefficient of Variation (CV) of SG | 1-month study | In order to evaluate glucose variation, we calculated coefficient of variation (CV) of SG. The glucose coefficient of variation (CV) will be summarized in percentage. |
| Change of Total Daily Dose (TDD) of Insulin From Baseline to End of Study (EOS) | Baseline to end of 1-month study | Change of Total Daily Dose (TDD) of insulin from baseline to EOS will be summarized. |
| Change of Weight From Baseline to EOS | Baseline to end of 1-month study | Change of weight from baseline to EOS will be summarized. |
| Time Spent in Auto Mode (HCL) Versus Time Spent in Manual Mode (Open Loop) | 1-month study | Time spent in Auto Mode (HCL) and time spent in Manual Mode (open loop) will be summarized. |
| Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | 1-month study | Time in target range (% of SG): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) in study period Time in hypoglycemic range (% of SG): SG \< 70 mg/dL (3.9 mmol/L), 60 mg/dL (3.3 mmol/L) and 54 mg/dL (3.0 mmol/L) in study period Time in hyperglycemic range: SG \> 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L) in study period |
Countries
China
Participant flow
Recruitment details
Recruitment started on 31Oct2020 and ended on 30Apr2021. Recruitment was conducted at four hospitals.
Pre-assignment details
There were 74 participants screened in the study. Of the 74 participants, 8 participants failed screening, and 1 participant was withdrawn prior to run-in. Therefore, 65 participants started run-in period. A total of 3 participants were withdrawn during the run-in period. Therefore, a total of 62 participants were included in the Intention to Treat Population and started the study period.
Participants by arm
| Arm | Count |
|---|---|
| Participants With Type 1 Diabetes Wearing HCL Pump System Participants 14-75 years of age who have been diagnosed with Type 1 diabetes and wore MiniMed™ 670G system during study period. | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study Period | Pregnancy | 1 |
| Overall Study Period | Withdrawn by Parent/Guardian | 1 |
| Run-in Period | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Participants With Type 1 Diabetes Wearing HCL Pump System |
|---|---|
| Age, Continuous | 33.4 years STANDARD_DEVIATION 13.3 |
| BMI | 22.1 kg/m^2 STANDARD_DEVIATION 3 |
| Race/Ethnicity, Customized Han Chinese | 62 Participants |
| Sex: Female, Male Female | 44 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 62 |
| other Total, other adverse events | 6 / 65 | 9 / 62 |
| serious Total, serious adverse events | 0 / 65 | 0 / 62 |
Outcome results
Primary
Change in Time in Target Range (% of Sensor Glucose (SG)): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L)
The overall mean change in % of time in target range from run-in period to study period will be estimated and compared by a simple superiority paired test and a significance level of 0.025 (one-sided).
Time frame: Baseline to end of 1-month study
Population: Intention to Treat Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Type 1 Diabetes Wearing HCL Pump System | Change in Time in Target Range (% of Sensor Glucose (SG)): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) | Baseline | 75.3 percentage of total readings | Standard Deviation 12.4 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Change in Time in Target Range (% of Sensor Glucose (SG)): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) | 1-month Study | 80.9 percentage of total readings | Standard Deviation 7.5 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Change in Time in Target Range (% of Sensor Glucose (SG)): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) | Change | 5.6 percentage of total readings | Standard Deviation 9.1 |
p-value: <0.00195% CI: [3.3, 7.9]Wilcoxon (Mann-Whitney)
Secondary
Change of Total Daily Dose (TDD) of Insulin From Baseline to End of Study (EOS)
Change of Total Daily Dose (TDD) of insulin from baseline to EOS will be summarized.
Time frame: Baseline to end of 1-month study
Population: Intention to Treat Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Type 1 Diabetes Wearing HCL Pump System | Change of Total Daily Dose (TDD) of Insulin From Baseline to End of Study (EOS) | Baseline | 42.8 Units/Day | Standard Deviation 19.8 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Change of Total Daily Dose (TDD) of Insulin From Baseline to End of Study (EOS) | End of 1-month study | 40.7 Units/Day | Standard Deviation 18.9 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Change of Total Daily Dose (TDD) of Insulin From Baseline to End of Study (EOS) | Change | -2.1 Units/Day | Standard Deviation 9.8 |
Secondary
Change of Weight From Baseline to EOS
Change of weight from baseline to EOS will be summarized.
Time frame: Baseline to end of 1-month study
Population: Intention to Treat Population with available data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Type 1 Diabetes Wearing HCL Pump System | Change of Weight From Baseline to EOS | Baseline | 61.0 Kg | Standard Deviation 10.5 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Change of Weight From Baseline to EOS | End of 1-month study | 61.0 Kg | Standard Deviation 10.1 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Change of Weight From Baseline to EOS | Change | 0.1 Kg | Standard Deviation 1.9 |
Secondary
Coefficient of Variation (CV) of SG
In order to evaluate glucose variation, we calculated coefficient of variation (CV) of SG. The glucose coefficient of variation (CV) will be summarized in percentage.
Time frame: 1-month study
Population: Intention to Treat Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Type 1 Diabetes Wearing HCL Pump System | Coefficient of Variation (CV) of SG | 30.6 Percentage | Standard Deviation 4.2 |
Secondary
Standard Deviation (SD) of SG in mg/dL
In order to evaluate glucose variation, we calculated standard deviation. The standard deviation (SD) of SG will be summarized in the unit of mg/dL.
Time frame: 1-month study
Population: Intention to Treatment Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Type 1 Diabetes Wearing HCL Pump System | Standard Deviation (SD) of SG in mg/dL | 43.2 mg/dL | Standard Deviation 7.8 |
Secondary
Standard Deviation (SD) of SG in mmol/L
In order to evaluate glucose variation, we calculated standard deviation. The standard deviation (SD) of SG will be summarized in the unit of mmol/L
Time frame: 1-month study
Population: Intention to Treat Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants With Type 1 Diabetes Wearing HCL Pump System | Standard Deviation (SD) of SG in mmol/L | 2.4 mmol/L | Standard Deviation 0.4 |
Secondary
Time in Hyperglycemic Range: SG > 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L)
Time in hyperglycemic range (SG \> 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L)) will be summarized.
Time frame: 1-month study
Population: Intention to Treat Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Hyperglycemic Range: SG > 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L) | SG > 180 mg/dL (10 mmol/L) | 16.9 percentage of total readings | Standard Deviation 7.5 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Hyperglycemic Range: SG > 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L) | SG > 250 mg/dL (13.9 mmol/L) | 2.4 percentage of total readings | Standard Deviation 2.4 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Hyperglycemic Range: SG > 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L) | SG > 350 mg/dL (19.4 mmol/L) | 0.1 percentage of total readings | Standard Deviation 0.2 |
Secondary
Time in Hypoglycemic Range
Time in hypoglycemic range (% of SG): SG \< 70 mg/dL (3.9 mmol/L), SG \< 60 mg/dL (3.3 mmol/L), SG \< 54 mg/dL (3.0 mmol/L) will be summarized.
Time frame: 1-month study
Population: Intention to Treat Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Hypoglycemic Range | SG < 54 mg/dL (3.0 mmol/L) | 0.4 percentage of total readings | Standard Deviation 0.4 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Hypoglycemic Range | SG < 60 mg/dL (3.3 mmol/L) | 0.8 percentage of total readings | Standard Deviation 0.7 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Hypoglycemic Range | SG < 70 mg/dL (3.9 mmol/L) | 2.2 percentage of total readings | Standard Deviation 1.5 |
Secondary
Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%)
Time in target range (% of SG): 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) in study period Time in hypoglycemic range (% of SG): SG \< 70 mg/dL (3.9 mmol/L), 60 mg/dL (3.3 mmol/L) and 54 mg/dL (3.0 mmol/L) in study period Time in hyperglycemic range: SG \> 180 mg/dL (10 mmol/L), 250 mg/dL (13.9 mmol/L) and 350 mg/dL (19.4 mmol/L) in study period
Time frame: 1-month study
Population: Intention to Treat Population at each subgroup.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG < 70 mg/dL (3.9 mmol/L) | 2.0 percentage of total readings | Standard Deviation 1.4 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) | 85.1 percentage of total readings | Standard Deviation 5.6 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG > 350 mg/dL (19.4 mmol/L) | 0.0 percentage of total readings | Standard Deviation 0.1 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG < 54 mg/dL (3.0 mmol/L) | 0.3 percentage of total readings | Standard Deviation 0.3 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG > 250 mg/dL (13.9 mmol/L) | 1.2 percentage of total readings | Standard Deviation 1.1 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG > 180 mg/dL (10 mmol/L) | 12.9 percentage of total readings | Standard Deviation 5.4 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG < 60 mg/dL (3.3 mmol/L) | 0.7 percentage of total readings | Standard Deviation 0.6 |
| Participants With Baseline 7% ≤ HbA1c < 7.5% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG > 250 mg/dL (13.9 mmol/L) | 2.9 percentage of total readings | Standard Deviation 1.9 |
| Participants With Baseline 7% ≤ HbA1c < 7.5% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG > 350 mg/dL (19.4 mmol/L) | 0.1 percentage of total readings | Standard Deviation 0.2 |
| Participants With Baseline 7% ≤ HbA1c < 7.5% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG < 60 mg/dL (3.3 mmol/L) | 0.8 percentage of total readings | Standard Deviation 0.7 |
| Participants With Baseline 7% ≤ HbA1c < 7.5% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG < 70 mg/dL (3.9 mmol/L) | 2.0 percentage of total readings | Standard Deviation 1.4 |
| Participants With Baseline 7% ≤ HbA1c < 7.5% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) | 78.1 percentage of total readings | Standard Deviation 5.6 |
| Participants With Baseline 7% ≤ HbA1c < 7.5% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG < 54 mg/dL (3.0 mmol/L) | 0.4 percentage of total readings | Standard Deviation 0.4 |
| Participants With Baseline 7% ≤ HbA1c < 7.5% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG > 180 mg/dL (10 mmol/L) | 19.9 percentage of total readings | Standard Deviation 5.4 |
| Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) | 80.0 percentage of total readings | Standard Deviation 5.2 |
| Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG < 54 mg/dL (3.0 mmol/L) | 0.4 percentage of total readings | Standard Deviation 0.3 |
| Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG > 350 mg/dL (19.4 mmol/L) | 0.1 percentage of total readings | Standard Deviation 0.1 |
| Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG > 250 mg/dL (13.9 mmol/L) | 2.6 percentage of total readings | Standard Deviation 1.5 |
| Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG < 70 mg/dL (3.9 mmol/L) | 2.2 percentage of total readings | Standard Deviation 0.8 |
| Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG < 60 mg/dL (3.3 mmol/L) | 0.9 percentage of total readings | Standard Deviation 0.4 |
| Participants With Baseline 7.5% ≤ HbA1c ≤ 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG > 180 mg/dL (10 mmol/L) | 17.9 percentage of total readings | Standard Deviation 5.1 |
| Participants With Baseline HbA1c > 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG > 350 mg/dL (19.4 mmol/L) | 0.3 percentage of total readings | Standard Deviation 0.3 |
| Participants With Baseline HbA1c > 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG < 54 mg/dL (3.0 mmol/L) | 0.6 percentage of total readings | Standard Deviation 0.6 |
| Participants With Baseline HbA1c > 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG < 70 mg/dL (3.9 mmol/L) | 3.1 percentage of total readings | Standard Deviation 2.1 |
| Participants With Baseline HbA1c > 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | 70 mg/dL (3.9 mmol/L) ≤ SG ≤ 180 mg/dL (10 mmol/L) | 72.8 percentage of total readings | Standard Deviation 8.6 |
| Participants With Baseline HbA1c > 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG > 180 mg/dL (10 mmol/L) | 24.1 percentage of total readings | Standard Deviation 9.8 |
| Participants With Baseline HbA1c > 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG > 250 mg/dL (13.9 mmol/L) | 4.9 percentage of total readings | Standard Deviation 3.9 |
| Participants With Baseline HbA1c > 8.0% | Time in Specific Range Stratified by Baseline HbA1c Ranges (< 7%, 7 - < 7.5%, 7.5 - 8%, > 8%) | SG < 60 mg/dL (3.3 mmol/L) | 1.3 percentage of total readings | Standard Deviation 1 |
Secondary
Time Spent in Auto Mode (HCL) Versus Time Spent in Manual Mode (Open Loop)
Time spent in Auto Mode (HCL) and time spent in Manual Mode (open loop) will be summarized.
Time frame: 1-month study
Population: Intention to Treat Population.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time Spent in Auto Mode (HCL) Versus Time Spent in Manual Mode (Open Loop) | Time spent in Manual Mode | 6.5 percentage of time | Standard Deviation 8.2 |
| Participants With Type 1 Diabetes Wearing HCL Pump System | Time Spent in Auto Mode (HCL) Versus Time Spent in Manual Mode (Open Loop) | Time spent in Auto Mode | 93.5 percentage of time | Standard Deviation 8.2 |