Analysis of Glycemic Control in Type 1 Diabetes Patients Using Hybrid Closed Loop Insulin Pump Therapy (Medtronic 670G)

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04051632
• Other study ID #: IRB-P00028472
• Status: Completed
• Start date: June 13, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: August 2019
• Source: Boston Children’s Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• 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

Related Conditions & MeSH terms

• Biomedical Technology
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Boston Childrens Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children’s Hospital

Country where clinical trial is conducted

United States, 

Outcome

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.