Assessment of Two Insulin Pump Insulin Delivery Systems in Type 1 Diabetes.

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.

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.

Study Overview

• Status: Unknown
• Conditions: Type1diabetes
• Intervention / Treatment: Device: AHCL; Device: SAP+PLGM

Detailed Description

Insulin delivery systems are an increasingly popular treatment option for Type I Diabetes (T1D). Delivery systems consist of an insulin pump, a glucose sensor with a transmitter attached, and a maths program (algorithm) built into the pump. The algorithm uses sensor glucose levels to decide how much insulin should be delivered by the pump.

This study aims to see how well a new algorithm controls blood glucose levels in T1D. The study uses the MiniMed 670G 4.0 insulin pump and compares two different algorithms:

1. Advanced Hybrid Closed Loop (AHCL - the new algorithm)
2. Sensor augmented pump therapy with predictive low-glucose management (SAP with PLGM).

Approximately 60 participants with T1D, aged 7 - 80 years, will take part in the study.

Every participant will receive the following two treatment algorithms in random order, with a two-week washout between treatments:

• MiniMed 670G 4.0 insulin pump in AHCL mode for 4 weeks.
• MiniMed 670G 4.0 insulin pump in SAP + PLGM mode for 4 weeks.

During the study insulin pump data will be uploaded and changes in health will be monitored. In addition, participants will complete 3-day food diaries and a number of questionnaires. Participants at the Dunedin site will also be asked to complete home sleep studies during the trial (optional).

The results of the study will be used to further develop insulin delivery systems. It is hoped this may improve treatment for people with diabetes.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Canterbury
    • Christchurch, Canterbury, New Zealand, 8011
      • Recruiting
      • Christchurch Clinical Studies Trust
      • Contact: Jo Sanders; Phone Number: +6433729477; Email: jo@ccst.co.nz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AHCL; Advanced Hybrid Closed Loop	Device: 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.
Active Comparator: SAP+PLGM; Sensor Augmented Pump with Predictive Low Glucose Monitoring	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance of the AHCL system	percentage of sensor glucose values between 3.9 - 10.0 mmol/L	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety of the AHCL system	percentage of sensor glucose values <3.9 mmol/L and > 10 mmol/L	4 weeks

Collaborators and Investigators

• Sponsor: Christchurch Clinical Studies Trust Ltd
• Collaborators: Medtronic

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2019
• Primary Completion (Anticipated): October 11, 2019
• Study Completion (Anticipated): October 11, 2019

Study Registration Dates

• First Submitted: August 27, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 29, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CH-1803-AHCL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes