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Hybrid Closed Loop System for Patients on Multiple Daily Insulin Injections

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Medtronic Minimed 670G insulin pump
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Time in range, Hybrid closed loop system, Multiple daily insulin injection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hamad Medical CorporationRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

percentage of patients achieving TIR > 67% in Time in Range (70-180 mg/dl)
percentage of patients achieving TIR <3% Time below Range ( <70 mg/dl)
percentage of patients achieving both TIR > 67% and <3% Time below Range
Change in HBA1C from baseline
Change in HbA1c levels from previous treatment (multiple daily injections) compared to Minimed 670G treatment
Change in sensor glucose values from baseline
Change in sensor glucose values from previous treatment (multiple daily injections) compared to Minimed 670G treatment
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
Number of severe hypoglycemia episodes
Number of Diabetic Ketoacidosis episodes
Total daily insulin dose
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

Full Information

First Posted
October 20, 2019
Last Updated
February 18, 2021
Sponsor
Hamad Medical Corporation
Collaborators
Sidra Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04145804
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
July 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation
Collaborators
Sidra Medicine

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Time in range, Hybrid closed loop system, Multiple daily insulin injection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. HbA1c < 12.5% Age18-65 years at the initiation of the 670G system Multiple Daily Injections (Basal Bolus therapy) with Total daily insulin use of great than 8.0 units per day over a 1 week period Willing and able (access to internet from home) to download information into the Medtronic CareLink software Clinically planning to and be able to start the Medtronic 670G HCL system History of 3 clinic visits in the last year With history of cardiovascular event 1 year or more from the time of screening, must have clearance from a cardiologist. Exclusion Criteria: Diabetic Ketoacidosis in the 6 months prior to screening visit Type 2 diabetes Hyperthyroidism at time of screening 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dabia Al Mohanadi, MD, FRCPC
Phone
+974-55524801
Email
DAlMohanadi@hamad.qa
First Name & Middle Initial & Last Name or Official Title & Degree
Goran Petrovski, MD, PhD
Phone
+974-70745178
Email
gpetrovski@sidra.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dabia Al Mohanadi, MD, FRCPC
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Goran Petrovski, MD, PhD
Organizational Affiliation
Sidra Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamad Medical Corporation
City
Doha
ZIP/Postal Code
3050
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dabia Almohanadi, MD, FRCPC
Phone
+97455524801
Email
DAlMohanadi@hamad.qa
First Name & Middle Initial & Last Name & Degree
Khaled Baagar, MD, FACE
First Name & Middle Initial & Last Name & Degree
Hamda Ali, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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Hybrid Closed Loop System for Patients on Multiple Daily Insulin Injections

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