Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)
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|ClinicalTrials.gov Identifier: NCT04051632|
Recruitment Status : Completed
First Posted : August 9, 2019
Last Update Posted : August 9, 2019
|Condition or disease||Intervention/treatment|
|Biomedical Technology Type 1 Diabetes||Device: Medtronic 670G 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.
|Study Type :||Observational|
|Actual Enrollment :||96 participants|
|Official Title:||Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)|
|Actual Study Start Date :||June 13, 2018|
|Actual Primary Completion Date :||July 30, 2019|
|Actual Study Completion Date :||July 30, 2019|
Type 1 Diabetes patients treated with the Medtronic 670G
Type 1 Diabetes patients treated with the Medtronic 670G at Boston Childrens Hospital
Device: Medtronic 670G insulin pump
- Successful implementation of hybrid closed loop technology [ Time Frame: 0-24 months ]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.
- Impact of hybrid closed loop technology on glycemic control [ Time Frame: 0-24 months ]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
- Assess impact of hybrid closed loop technology on glycemic control by analysis of sensor glucose data. [ Time Frame: 0-24 months. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04051632
|United States, Massachusetts|
|Boston Childrens Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Gregory Goodwin, MD||Boston Children’s Hospital|