Randomized cross over trial comparing advanced hybrid closed loop mode with sensor augmented pump therapy in type 1 diabetes.

Not Applicable

Completed

• Conditions: Type 1 diabetes mellitus; Metabolic and Endocrine - Diabetes

• Registration Number: ACTRN12619000007134
• Lead Sponsor: Medtronic Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-08
• Study Completion: 2019-10-10
• Last Update Posted: 6 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Male or female aged 7 – 80 years inclusive.
Type I diabetes as per the American Diabetes Association Classification, diagnosed at least 1 year prior to Study Day 1.
On insulin pump therapy for at least 6 months prior to study Day 1.
Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
Willing and able to adhere to the study protocol.
Access to the internet and a computer system that meets requirements for uploading the study pump.

Exclusion Criteria

1.Mean HbA1c of 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.
4.History or current evidence of significant seizure disorder, renal impairment or cardiovascular disease (including uncontrolled hypertension), in the opinion of the Investigator.
5.History of severe visual impairment, in the opinion of the Investigator.
6.If female, is pregnant or plans to become pregnant while participating in the study. A positive urine pregnancy test at screening is exclusionary.
7.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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time spent in target glycaemic range (sensor glucose level 3.9 - 10 mmol/l) obtained with:<br>- The MiniMed™ 670G insulin pump running in advanced hybrid closed loop (AHCL) mode <br>- The MiniMed™ 670G insulin pump running as sensor augmented pump therapy (SAP) with predictive low-glucose management (PLGM)<br><br>[Two 4 week treatment periods ( day 15-42 and 57-84)];Time spent in hyperglycaemic range (sensor glucose level > 10 mmol/L) obtained with:<br>- The MiniMed™ 670G insulin pump running in AHCL mode <br>- The MiniMed™ 670G insulin pump running as SAP therapy with PLGM [Two 4 week treatment periods ( day 15-42 and 57-84)]