The purpose of this study is to find out if very tight blood glucose control from the onset of Type 1 Diabetes can preserve beta cell function. Study subjects will be randomly assigned to receive either standard diabetes management or intensive diabetes management, which involves several days of closed loop therapy followed by home use of a continuous glucose monitor and insulin pump.
To asses effectiveness of inpatient hybrid closed-loop control (HCLC) followed by outpatient sensor-augmented pump (SAP) therapy initiated within 7 days of diagnosis of type 1 diabetes on the preservation of β-cell function at one year.
Primary Outcome Measures: C-peptide area under the curve in response to a mixed meal at 1 year following enrollment.
Secondary Outcome Measures: incidence of the loss of the 2 hour peak C-peptide < 0.2 pmol/ml on a semi-annual MMTT
Inclusion: Patients must be between the ages of 6 and <46 with a diagnosis of Type 1 Diabetes with initiation of insulin therapy within the past 7 days to participate in this study.
Exclusion: Patients under the age of 6 or over the age of 45, who are pregnant, nursing, or plan to get pregnant in the next year will not be able to participate in this study.
In new-onset type 1 diabetes, HCLC followed by SAP therapy did not provide benefit in preserving β-cell function compared with current standards of care.
Diabetes
Interventional
5
2010-09
2013-10
Type 1 Diabetes Mellitus
Diabetes Mellitus, Type 1, Beta Cell Function, HCLC, Sensor-Augmented Pump, SAP Therapy, Hybrid Closed-Loop Control, C-Peptide
Division of Diabetes, Endocrinology, and Metabolic Diseases
Document Name | Description | Document Type | File Format | Compliance | Download |
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Dataset Name | Description | # of Records | # of Variables | File Format(s) |
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Troster Dataset | Captures data on participant randomization | 71 | sas7bdat (24 KB); csv (5.37 KB) | |
Lab Results Dataset | Captures data on laboratory results | 9357 | sas7bdat (1.02 MB); csv (587.52 KB) | |
Contacts Dataset | Captures data on participant vital signs and laboratory results | 463 | csv (60.54 KB); sas7bdat (104 KB) | |
CGM Sensor Dataset | Captures CGM data during closed loop - loaded from Medtronic spreadsheet file | 218490 | sas7bdat (10.12 MB); csv (10.07 MB) | |
Hypoglycemic Events Child Form Dataset | Contains data from completed Hypoglycemic Events Child Form | 89 | sas7bdat (24 KB); csv (5 KB) | |
Insulin Dataset | Captures data on insulin delivery during closed loop - loaded from Medtronic spreadsheet file | 44005 | sas7bdat (1.38 MB); csv (1.42 MB) | |
Enrollment Hx Form Dataset | Contains data from completed Enrollment Hx Form | 71 | sas7bdat (40 KB); csv (15.21 KB) | |
CGM Dataset | Captures data on FT-CGM sensor reading per patient and device | 5101952 | sas7bdat (511.04 MB); csv (352.24 MB) | |
HbA1c Form Dataset | Contains data from completed HbA1c Form | 649 | sas7bdat (64 KB); csv (27.71 KB) | |
Active Dataset | Captures data on automatic control intervals of closed-loop system - loaded from Medtronic spreadsheet file | 320 | csv (14.92 KB); sas7bdat (24 KB) | |
Skin Assessment Form Dataset | Contains data from completed Skin Assessment Form | 475 | sas7bdat (64 KB); csv (19.52 KB) | |
Concomitant Medications Form Dataset | Contains data from completed Concomitant Medications Form | 61 | sas7bdat (32 KB); csv (6.72 KB) | |
Follow-Up Hx Form Dataset | Contains data from completed Follow-Up Hx Form | 647 | sas7bdat (80 KB); csv (51.76 KB) | |
Adverse Event Form dataset | Contains data from completed Adverse Event Form | 28 | csv (7.02 KB); sas7bdat (40 KB) | |
CGM Sensor Use Form Dataset | Contains data from completed CGM Sensor Use Form | 465 | sas7bdat (128 KB); csv (46.15 KB) | |
Glucose Indices Dataset | Captures data on glucose laboratory results | 362 | csv (39.96 KB); sas7bdat (72 KB) | |
Closed Loop Therapy Form Dataset | Contains data from completed Closed Loop Therapy Form | 50 | sas7bdat (16 KB); csv (1013 B) | |
Meal Dataset | Captures meal data during closed loop - loaded from Medtronic spreadsheet file | 1027 | sas7bdat (96 KB); csv (53.12 KB) | |
Pre-Existing Conditions Form Dataset | Contains data from completed Pre-Existing Conditions Form | 71 | sas7bdat (56 KB); csv (21.12 KB) | |
Insulin Management Form Dataset | Contains data from completed Insulin Management Form | 647 | sas7bdat (200 KB); csv (107.38 KB) | |
Reference Glucose Dataset | Captures reference glucose data during closed loop - loaded from Medtronic spreadsheet file | 7610 | sas7bdat (744 KB); csv (447.41 KB) | |
Non Protocol Visits Form Dataset | Contains data from completed Non Protocol Visits Form | 18 | sas7bdat (16 KB); csv (1.42 KB) | |
Hypoglycemic Hyperglycemic Events Form Dataset | Contains data from completed Hypoglycemic Hyperglycemic Events Form | 50 | sas7bdat (16 KB); csv (1.29 KB) | |
Subjects Dataset | Captures miscellaneous data on study subjects | 68 | sas7bdat (24 KB); csv (11.01 KB) | |
Mixed Meal Tolerance Form Dataset | Contains data from completed Mixed Meal Tolerance Form | 623 | sas7bdat (152 KB); csv (76.68 KB) | |
Admission Discharge Form Dataset | Contains data from completed Admission Discharge Form | 50 | sas7bdat (24 KB); csv (7.24 KB) | |
Hyperglycemic Events Child Form Dataset | Contains data from completed Hyperglycemic Events Child Form | 86 | sas7bdat (24 KB); csv (5.12 KB) |
Specimen | Count |
---|---|
DNA | 249 |
PB-PBMC | 3007 |
Plasma | 6012 |
RNA | 5329 |
Serum | 5042 |
Supernatant | 1064 |