NCT04145804

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

February 21, 2021

Status Verified

February 1, 2020

Enrollment Period

1.5 years

First QC Date

October 20, 2019

Last Update Submit

February 18, 2021

Conditions

Type 1 Diabetes

Keywords

Time in rangeHybrid closed loop systemMultiple daily insulin injection

Outcome Measures

Primary Outcomes (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.

    3 months

Secondary Outcomes (10)

  • 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

    3 months

  • Change in sensor glucose values from baseline

    3 months

  • +5 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamad Medical Corporation

Doha, 3050, Qatar

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Dabia Al Mohanadi, MD, FRCPC

    Hamad Medical Corporation

    PRINCIPAL INVESTIGATOR

  • Goran Petrovski, MD, PhD

    Sidra Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dabia Al Mohanadi, MD, FRCPC

CONTACT

+974-55524801DAlMohanadi@hamad.qa

Goran Petrovski, MD, PhD

CONTACT

+974-70745178gpetrovski@sidra.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2019

First Posted

October 31, 2019

Study Start

January 1, 2020

Primary Completion

July 1, 2021

Study Completion

January 1, 2022

Last Updated

February 21, 2021

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

QA(1)