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

NCT04051632 | Completed FDA Device

• 1 other identifier: IRB-P00028472
• Study Type: observational
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Biomedical Technology; Type 1 Diabetes

Keywords

Medtronic 670G

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Impact of hybrid closed loop technology on glycemic control

  0-24 months

• Assess impact of hybrid closed loop technology on glycemic control by analysis of sensor glucose data.

  0-24 months.

Study Arms (1)

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

Interventions

Medtronic 670G insulin pump DEVICE

* percent of patients who continue to use Medtronic 670G over time * impact of 670G on glycemic control: hemoglobin A1c, time in range

Type 1 Diabetes patients treated with the Medtronic 670G

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Single institution clinic population.

You may qualify if:

• 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

You may not qualify if:

• patients not trained at Boston Childrens Hospital or self started

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Gregory Goodwin, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Physician in Medicine

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 9, 2019
• Study Start: June 13, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)