NCT04073576

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Christchurch Clinical Studies Trust Ltd · Industry
• Sex: All
• Age: 7 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Type1diabetes

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2019-05-20
• Primary completion: 2019-10-11
• Completion: 2019-10-11
• First posted: 2019-08-29
• Last updated: 2019-08-29

Locations

1 site across 1 country: New Zealand

Regulatory

• FDA-regulated device study