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

Completed

• Conditions: Type 1 Diabetes; Biomedical Technology
• Interventions: Device: Medtronic 670G insulin pump

• Registration Number: NCT04051632
• Lead Sponsor: Boston Children's Hospital

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.

Detailed 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.

Study Timeline

• Study Start: 2018-06-13
• Primary Completion: 2019-07-30
• Study Completion: 2019-07-30
• Status Verified: 2019-08
• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-07
• Last Update Submitted: 2019-08-07
• Study First Posted: 2019-08-09
• Last Update Posted: 2019-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Type 1 Diabetes patients treated with the Medtronic 670G	Medtronic 670G insulin pump	Type 1 Diabetes patients treated with the Medtronic 670G at Boston Childrens Hospital

Primary Outcome Measures

Name	Time	Method
Successful implementation of hybrid closed loop technology	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.

Secondary Outcome Measures

Name	Time	Method
Impact of hybrid closed loop technology on glycemic control	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.	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.

Trial Locations

Locations (1)

Boston Childrens Hospital; 🇺🇸 Boston, Massachusetts, United States