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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AHCL | Experimental | Advanced Hybrid Closed Loop |
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| SAP+PLGM | Active Comparator | Sensor Augmented Pump with Predictive Low Glucose Monitoring |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AHCL | Device | Closed loop algorithm contained in the MiniMedâ„¢ 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Performance of the AHCL system | percentage of sensor glucose values between 3.9 - 10.0 mmol/L | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of the AHCL system | percentage of sensor glucose values <3.9 mmol/L and > 10 mmol/L | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Christchurch Clinical Studies Trust | Recruiting | Christchurch | Canterbury | 8011 | New Zealand |
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| SAP+PLGM | Device | Sensor Augmented Pump (SAP) Therapy Mode with Predictive Low Glucose Management (PLGM), contained in the the MiniMedâ„¢ 670G 4.0 pump to be used in the study. |
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