Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
22 participants
INTERVENTIONAL
2011-12-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
15 Years
30 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Stanford University
OTHER
Responsible Party
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Bruce A. Buckingham
Director, Pediatric Endocrinology
Principal Investigators
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Bruce Buckingham, MD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University and Stanford Hospital & Clinics
Stanford, California, United States
Countries
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Other Identifiers
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SPO 53117
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
G110143
Identifier Type: -
Identifier Source: org_study_id