An observational study in Biomedical Technology and Type 1 Diabetes, sponsored by Boston Children's Hospital. Completed at 1 site in United States. Open to participants aged 5 Years to 25 Years. Per ClinicalTrials.gov, last updated 2019-08-09.
Sponsored by Boston Children's Hospital · 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.
Outcome study of 90-100 patients with type 1 diabetes who elected to use the Medtronic 670G.
Major outcome measure was to assess the percent of patients who were able to successfully continue to use the 670G technology over time.
Additional outcome variables included hemoglobin A1c pre and post treatment with the 670G, time in desired glucose range 70-180.
10,926 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 96 is below the median of 233 across 2,220 observational studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Boston Children's Hospital is the lead sponsor of 598 studies on the registry; 150 are open to participants now.
Of its 31 completed or terminated interventional studies of FDA-regulated products, 18 (58%) have results posted.
Counted across the registry records on this site, refreshed daily.
Single institution clinic population.
Exclusion Criteria:
Type 1 Diabetes patients treated with the Medtronic 670G at Boston Childrens Hospital
Device: Medtronic 670G insulin pump
* percent of patients who continue to use Medtronic 670G over time * impact of 670G on glycemic control: hemoglobin A1c, time in range
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.
Time frame: 0-24 months
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
Time frame: 0-24 months
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.
Time frame: 0-24 months.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Boston Children's Hospital