Diabetes Mellitus, Metabolic and Nutritional Disorders, Type 1 Diabetes
Conditions
Keywords
Hormone, Diabetes, Mellitus, Type 1, Immune, Metabolic disorder
Brief summary
The purpose of this study is to evaluate a treat-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes.
Detailed description
The purpose of this study is to demonstrate the safety and efficacy of a closed-loop treat-to-range (TTR) system in an inpatient clinical research center setting. The TTR system only effects insulin delivery when the glucose is projected to be above or below specified target ranges. These initial studies will assess the safety of this algorithm (mathematical equation) under the extreme conditions of a missed meal insulin bolus and meal over-insulinization. This is a hybrid system, which allows the research team to deliver insulin boluses manually with the TTR controller only becoming active when blood glucose levels are projected to be out of the specified range.
Interventions
DEVICETTR controller (Medtronic)
Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus.
Sponsors
Medtronic
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 30 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year. 2. Age 15 years to less than 30 years old. 3. HbA1c \< 10%. 4. Subject has used a downloadable insulin pump for at least 3 months. 5. Parent/guardian and subject understand the study protocol and agree to comply with it. 6. Subject comprehends written English. 7. Subject has a home computer with email access. 8. For females, subject not intending to become pregnant during the study. 9. No expectation that subject will be moving out of the area of the clinical center during the study. 10. Informed Consent Form signed by the subject or guardian. 11. Subjects cannot have had a severe hypoglycemic event described as a seizure, loss of consciousness requiring an emergency department visit or hospitalization within 6 months of enrollment.
Exclusion criteria
1. Asthma if treated with systemic or inhaled corticosteroids in the last 6 months; Subject has taken oral or injectable corticosteroids within the last 30 days; Current use of oral/inhaled Glucocorticoids 2. Cystic fibrosis 3. Inpatient psychiatric treatment in the past 6 months for either the subject or the subject's primary care giver (i.e., parent or guardian) 4. Use of non-insulin medications that may affect blood glucose (eg Symlin), 5. Systolic blood pressure \>140 on screening; Diastolic blood pressure \>90 on screening 6. History of seizure or loss of consciousness in the last 6 months. 7. Adhesive allergies; Active skin condition that would affect sensor placement 8. History of heart disease 9. Active Graves disease; 10. Currently on beta blocker medication; 11. Unwilling or unable to follow the protocol; 12. History of diagnosed medical eating disorder; 13. History of known illicit drug abuse or prescription drug abuse; 14. History of current alcohol abuse; 15. History of visual impairment which would not allow subject to participate 16. Currently participating in an investigational study (drug or device); 17. Other major illness that in the judgment of the investigator might interfere with the completion of the protocol: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions | Day of hospital admission (12 hours) | A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TTR Controller The intervention will consist of using the TTR controller (Medtronic) for post-prandial glucose control following high and low glycemic meals
TTR controller (Medtronic): Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus. | 22 |
| Total | 22 |
Baseline characteristics
| Characteristic | TTR Controller |
|---|---|
| Age, Categorical <=18 years | 6 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 6 / 22 |
| serious Total, serious adverse events | 0 / 22 |
Outcome results
Primary
Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions
A successful hospital admission was defined as requiring no more than 2 TTR closed-loop control system adjustments of algorithm tuning parameters after initial set up, and not meeting any stopping criteria. The system was considered feasible if 75% of hospital admissions were successful.
Time frame: Day of hospital admission (12 hours)
Population: A total of 25 admissions were completed. 1 participant was admitted twice in Cohort A1, and 2 participants were admitted first in Cohort A1 and then again in Cohort B.
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Cohort A1 - Missed Bolus Meal | Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions | Successful Admission | 7 Admissions |
| Cohort A1 - Missed Bolus Meal | Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions | Unsuccessful Admission | 2 Admissions |
| Cohort A2 - Missed Bolus Meal | Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions | Successful Admission | 4 Admissions |
| Cohort A2 - Missed Bolus Meal | Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions | Unsuccessful Admission | 3 Admissions |
| Cohort B - Overbolus Meal | Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions | Successful Admission | 7 Admissions |
| Cohort B - Overbolus Meal | Safety and Feasibility of TTR Closed-loop Control System as Measure by the Count of Successful Hospital Admissions | Unsuccessful Admission | 2 Admissions |