NCT04145804

Hybrid Closed Loop System for Patients on Multiple Daily Insulin Injections

Evaluation Of Hybrid Closed Loop (HCL) System On-Boarding Protocol, For Patients With Type 1 Diabetes On Multiple Daily Insulin Injections (MDI) Therapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Hamad Medical Corporation · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess structured group education onboarding protocol of the 670 G Hybrid Closed Loop (HCL) systems in achieving glucose control of patients on Multiple Daily Insulin Injections (MDI).

Detailed description

Goal The objective of this study is to assess structured group education onboarding protocol of the 670 G Hybrid Closed Loop systems in achieving glucose control of patients on MDI. Methods This study is a single-arm, single-center, clinical investigation in subjects with type 1 diabetes on HCL insulin pump (Minimed 670G) in a period of 3 months. A total of 40 subjects (age 18-65) will be enrolled in order to reach 34 subjects who will complete the HCL study. The investigators will start the clinical process for initiating an insulin pump, which is typically done with pre-pump classes. HbA1c, derived from Continuous Glucose Monitoring (CGM) will be performed at baseline and at the end of the 3-month study period. The following parameters will be analyzed" % patients achieving glucose readings Time in Range (TIR) \> 67% in (70-180 mg/dl); % patients achieving \<3% Time below Range ( \<70 mg/dl) and % patients achieving both TIR \> 67% and \<3% Time below Range.Collection of demographics and medical history, data for diabetes devices (eg meters, sensors, pumps) and brief clinical physical exam including vital signs and skin assessment will be obtained via Hospital Electronic Medical File (Cerner Millennium) and will be kept as electronic data on a separate research server.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Medtronic Minimed 670G insulin pump	It is an insulin pump to deliver insulin to the patient and associated with a sensor to monitor the glucose levels of the patient. The new feature in this device is the automode algorithm which regulates insulin delivery to the patient automatically to keep glucose levels within target.

Timeline

• Start date: 2020-01-01
• Primary completion: 2021-07-01
• Completion: 2022-01-01
• First posted: 2019-10-31
• Last updated: 2021-02-21

Locations

1 site across 1 country: Qatar