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

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).

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Medtronic Minimed 670G insulin pump

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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dabia Al Mohanadi, MD, FRCPC; Phone Number: +974-55524801; Email: DAlMohanadi@hamad.qa
• Study Contact Backup: Name: Goran Petrovski, MD, PhD; Phone Number: +974-70745178; Email: gpetrovski@sidra.org

Study Locations

• Qatar
  • Doha, Qatar, 3050
    • Recruiting
    • Hamad medical corporation
    • Contact: Dabia Almohanadi, MD, FRCPC; Phone Number: +97455524801; Email: DAlMohanadi@hamad.qa
    • Sub-Investigator: Khaled Baagar, MD, FACE
    • Sub-Investigator: Hamda Ali, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The achievable percentage of time in range (TIR) 70 - 180 mg/dL for the whole study population after 3 months.	The achievable Time in Range (TIR) in the first 3 months of MiniMed 670G following onboarding of MDI to HCL by the protocol in a real-life setting.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percentage of patients achieving TIR > 67% in Time in Range (70-180 mg/dl)		3 months
percentage of patients achieving TIR <3% Time below Range ( <70 mg/dl)		3 months
percentage of patients achieving both TIR > 67% and <3% Time below Range		3 months
Change in HBA1C from baseline	Change in HbA1c levels from previous treatment (multiple daily injections) compared to Minimed 670G treatment	3 months
Change in sensor glucose values from baseline	Change in sensor glucose values from previous treatment (multiple daily injections) compared to Minimed 670G treatment	3 months
Percentage of time above Range (>180 mg/dl) for the whole study population	Percentage of glucose values more than 180 mg/dl on Minimed 670G	3 months
Number of severe hypoglycemia episodes		3 months
Number of Diabetic Ketoacidosis episodes		3 months
Total daily insulin dose		3 months
Percentage of time spend in Auto Mode	Percentage of time in Auto Mode, where Minimed 670G automatic adjusts the basal insulin dose according glucose levels	3 months

Collaborators and Investigators

• Sponsor: Hamad Medical Corporation
• Collaborators: Sidra Medicine
• Investigators: Principal Investigator: Goran Petrovski, MD, PhD, Sidra Medicine; Principal Investigator: Dabia Al Mohanadi, MD, FRCPC, Hamad medical corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: October 20, 2019
• First Submitted That Met QC Criteria: October 29, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Time in range; Hybrid closed loop system; Multiple daily insulin injection
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin
• Other Study ID Numbers: MRC-01-19-296

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes