Type 1 Diabetes Clinical Trial
Official title:
Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)
NCT number | NCT04051632 |
Other study ID # | IRB-P00028472 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 13, 2018 |
Est. completion date | July 30, 2019 |
Verified date | August 2019 |
Source | Boston Children’s Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Observational study of patients at Boston Childrens Hospital with type 1 diabetes (T1D) who elected to treat their diabetes with the Medtronic 670 G hybrid closed loop insulin pump.
Status | Completed |
Enrollment | 96 |
Est. completion date | July 30, 2019 |
Est. primary completion date | July 30, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 5 Years to 25 Years |
Eligibility |
Inclusion Criteria: - clinical diagnosis of T1D - patient of Boston Childrens Hospital diabetes program - deemed to be adequate candidates for hybrid closed loop technology by their diabetes health care team - patient received Medtronic 670G training at Boston Childrens Hospital - patient received follow up diabetes care at Boston Childrens Hospital for at least 3 months after starting on the 670G Exclusion Criteria: - patients not trained at Boston Childrens Hospital or self started |
Country | Name | City | State |
---|---|---|---|
United States | Boston Childrens Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children’s Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful implementation of hybrid closed loop technology | Percent of Type 1 Diabetes patients who were properly trained on the use of the 670G that continue to use Hybrid Closed Loop technology at 0, 6, 12, 18 and 24 months post training. | 0-24 months | |
Secondary | Impact of hybrid closed loop technology on glycemic control | Assess impact of hybrid closed loop technology on glycemic control by comparing hemoglobin A1c measurements 0-6 months prior to treatment versus 0-6, 6-12, 12-18, 18-24 months post treatment | 0-24 months | |
Secondary | Assess impact of hybrid closed loop technology on glycemic control by analysis of sensor glucose data. | Compare sensor glucose data: 1) percent time in range (70-180 mg/dl), 2)percent time in auto-mode, 3) percent time sensor usage versus hemoglobin A1c data over time. | 0-24 months. |
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