Clinical trial NCT04145804: Hybrid Closed Loop System for Patients on Multiple Daily Insulin Injections
Official title: Evaluation Of Hybrid Closed Loop (HCL) System On-Boarding Protocol, For Patients With Type 1 Diabetes On Multiple Daily Insulin Injections (MDI) Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Time in range
Hybrid closed loop system
Multiple daily insulin injection
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Sidra Medicine
First posted: 2019-10-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The achievable percentage of time in range (TIR) 70 - 180 mg/dL for the whole study population after 3 months.
timeFrame: 3 months
Secondary outcomes:
measure: percentage of patients achieving TIR > 67% in Time in Range (70-180 mg/dl)
timeFrame: 3 months
measure: percentage of patients achieving TIR <3% Time below Range ( <70 mg/dl)
timeFrame: 3 months
measure: percentage of patients achieving both TIR > 67% and <3% Time below Range
timeFrame: 3 months
measure: Change in HBA1C from baseline
timeFrame: 3 months
measure: Change in sensor glucose values from baseline
timeFrame: 3 months
measure: Percentage of time above Range (>180 mg/dl) for the whole study population
timeFrame: 3 months
measure: Number of severe hypoglycemia episodes
timeFrame: 3 months
measure: Number of Diabetic Ketoacidosis episodes
timeFrame: 3 months
measure: Total daily insulin dose
timeFrame: 3 months
measure: Percentage of time spend in Auto Mode
timeFrame: 3 months
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Hamad Medical Corporation
Study officials:
affiliation: Hamad Medical Corporation
name: Dabia Al Mohanadi, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: Sidra Medicine
name: Goran Petrovski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: