Hybrid Closed Loop System for Patients on Multiple Daily Insulin Injections

Hamad Medical Corporation (HMC)

Status: Unknown

Conditions: Type 1 Diabetes

Treatments: Device: Medtronic Minimed 670G insulin pump

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04145804

MRC-01-19-296

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of type 1 diabetes. Diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not required.
2. HbA1c < 12.5%
3. Age18-65 years at the initiation of the 670G system
4. Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1 week period
5. Willing and able (access to internet from home) to download information into the Medtronic CareLink software
6. Clinically planning to and be able to start the Medtronic 670G HCL system
7. History of 3 clinic visits in the last year
8. With history of cardiovascular event 1 year or more from the time of screening, must have clearance from a cardiologist.

Exclusion criteria

1. Diabetic Ketoacidosis in the 6 months prior to screening visit
2. Type 2 diabetes
3. Hyperthyroidism at time of screening
4. Using Pramlintide, Dipeptidyl peptidase 4 (DPP-4) inhibitor, Glucagon-like peptide-1 (GLP-1) agonists, metformin, sodium-glucose transport protein 2 (SGLT2) inhibitors at time of screening.
5. Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV steroids during the course of the study.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)