Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04073576




Registration number
NCT04073576
Ethics application status
Date submitted
27/08/2019
Date registered
29/08/2019
Date last updated
29/08/2019

Titles & IDs
Public title
Assessment of Two Insulin Pump Insulin Delivery Systems in Type 1 Diabetes.
Scientific title
Randomized Cross Over Trial of the MiniMed™ 670G 4.0 Insulin Pump, Comparing Advanced Hybrid Closed Loop Mode With Sensor Augmented Pump Therapy in Type 1 Diabetes.
Secondary ID [1] 0 0
CH-1803-AHCL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type1diabetes 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - AHCL
Treatment: Devices - SAP+PLGM

Experimental: AHCL - Advanced Hybrid Closed Loop

Active comparator: SAP+PLGM - Sensor Augmented Pump with Predictive Low Glucose Monitoring


Treatment: Devices: AHCL
Closed loop algorithm contained in the MiniMed™ 670G 4.0 pump to be used in the study; includes a modified proportional integrative derivative (PID) model, with insulin feedback, an auto correction bolus feature and additional safety features.

Treatment: Devices: SAP+PLGM
Sensor Augmented Pump (SAP) Therapy Mode with Predictive Low Glucose Management (PLGM), contained in the the MiniMed™ 670G 4.0 pump to be used in the study.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Performance of the AHCL system
Timepoint [1] 0 0
4 weeks
Secondary outcome [1] 0 0
Safety of the AHCL system
Timepoint [1] 0 0
4 weeks

Eligibility
Key inclusion criteria
1. Male or female aged 7 - 80 years inclusive.
2. Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1.
3. On insulin pump therapy for at least 6 months prior to study Day 1.
4. Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
5. Willing and able to adhere to the study protocol.
6. Access to the internet and a computer system that meets requirements for uploading the study pump.
Minimum age
7 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Mean HbA1c more than 10.0% (86 mmol/mol) within 6 months prior to Study Day 1 (minimum of one test).
2. Use of a medication indicative of diabetes complications (ACE inhibitors and statins are permitted).
3. Use of systemic glucocorticoids within 2 weeks prior to the Baseline visit.
4. Current use of SGLT-2 or GLP-1 medications.
5. History or current evidence of significant seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), in the opinion of the Investigator.
6. History of severe visual impairment, in the opinion of the Investigator.
7. If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at Screening is exclusionary.
8. Any clinically significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
11/10/2019
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Christchurch Clinical Studies Trust Ltd
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Medtronic
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This is a study of the Minimed 670G 4.0 insulin pump, assessing the efficacy of the Advanced Hybrid Closed Loop (AHCL) algorithm in controlling blood glucose levels in Type 1 Diabetes.
Trial website
https://clinicaltrials.gov/study/NCT04073576
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04073576