Hybrid Closed Loop System for Patients on Multiple Daily Insulin Injections

Last updated: February 18, 2021
Sponsor: Hamad Medical Corporation
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Mellitus, Type 1

Diabetes And Hypertension

Diabetes Mellitus Types I And Ii

Treatment

N/A

Clinical Study ID

NCT04145804
MRC-01-19-296
  • Ages 18-65
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinical diagnosis of type 1 diabetes. Diagnosis of type 1 diabetes is based on theinvestigator'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 greatthan 8.0 units per day over a 1 week period
  5. Willing and able (access to internet from home) to download information into theMedtronic 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, musthave clearance from a cardiologist.

Exclusion

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 attime of screening.
  5. Has taken any oral, injectable, or intravenous (IV) steroids within 8 weeks from timeof screening visit, or plans to take any oral, injectable, or IV steroids during thecourse of the study.

Study Design

Total Participants: 40
Study Start date:
January 01, 2020
Estimated Completion Date:
January 31, 2022

Study 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.

Connect with a study center

  • Hamad Medical Corporation

    Doha, 3050
    Qatar

    Active - Recruiting

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