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Type 1 DiabetesNCT04145804

Hybrid Closed Loop System for Patients on Multiple Daily Insulin Injections

A study testing Medtronic Minimed 670G insulin pump in people with Type 1 Diabetes, run by Hamad Medical Corporation at 1 site in Qatar.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
Medtronic Minimed 670G insulin pump
Type of treatment
Medical device
How many people
40 participants
Where
1 siteQatar
Study dates
1 Jan 2020to Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Dabia Al Mohanadi, MD, FRCPC contact

+974-55524801

DAlMohanadi@hamad.qa

Goran Petrovski, MD, PhD contact

+974-70745178

gpetrovski@sidra.org

Qatar1 site, 1 recruiting

  • Hamad Medical Corporation

    Doha, 3050

    Dabia Almohanadi, MD, FRCPC, +97455524801, DAlMohanadi@hamad.qa

    Khaled Baagar, MD, FACE

    Recruiting

Other trials in Qatar

About this study

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

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).

Read the 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.

Conditions
Type 1 Diabetes
Being tested
Medtronic Minimed 670G insulin pump
Keywords
Time in range, Hybrid closed loop system, Multiple daily insulin injection
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medtronic Minimed 670G insulin pumpDevice

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

Secondary outcomes (10)

  1. percentage of patients achieving TIR > 67% in Time in Range (70-180 mg/dl)

    Measured: 3 months

  2. percentage of patients achieving TIR <3% Time below Range ( <70 mg/dl)

    Measured: 3 months

  3. percentage of patients achieving both TIR > 67% and <3% Time below Range

    Measured: 3 months

  4. Change in HBA1C from baseline

    Change in HbA1c levels from previous treatment (multiple daily injections) compared to Minimed 670G treatment

    Measured: 3 months

  5. Change in sensor glucose values from baseline

    Change in sensor glucose values from previous treatment (multiple daily injections) compared to Minimed 670G treatment

    Measured: 3 months

  6. 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

    Measured: 3 months

  7. Number of severe hypoglycemia episodes

    Measured: 3 months

  8. Number of Diabetic Ketoacidosis episodes

    Measured: 3 months

  9. Total daily insulin dose

    Measured: 3 months

  10. 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

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2019
  2. Study start1 Jan 2020
  3. Primary completionJul 2021 (estimated)
  4. Study completionJan 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04145804
Sponsor's protocol ID
MRC-01-19-296
Status last verified
Feb 2020
First submitted
20 Oct 2019
Last updated
21 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Medtronic Minimed 670G insulin pump in people with Type 1 Diabetes, run by Hamad Medical Corporation at 1 site in Qatar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Dabia Al Mohanadi, MD, FRCPC (+974-55524801, DAlMohanadi@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The achievable percentage of time in range (TIR) 70 - 180 mg/dL for the whole study population after 3 months. (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04145804.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021; AzTrials last refreshed its copy on 1 Nov 2026.

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