Assessment of Two Insulin Pump Insulin Delivery Systems in Type 1 Diabetes.
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|ClinicalTrials.gov Identifier: NCT04073576|
Recruitment Status : Recruiting
First Posted : August 29, 2019
Last Update Posted : August 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type1diabetes||Device: AHCL Device: SAP+PLGM||Not Applicable|
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:
- Advanced Hybrid Closed Loop (AHCL - the new algorithm)
- 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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official 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.|
|Actual Study Start Date :||May 20, 2019|
|Estimated Primary Completion Date :||October 11, 2019|
|Estimated Study Completion Date :||October 11, 2019|
Advanced Hybrid Closed Loop
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
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.
- Performance of the AHCL system [ Time Frame: 4 weeks ]percentage of sensor glucose values between 3.9 - 10.0 mmol/L
- Safety of the AHCL system [ Time Frame: 4 weeks ]percentage of sensor glucose values <3.9 mmol/L and > 10 mmol/L
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04073576
|Christchurch Clinical Studies Trust||Recruiting|
|Christchurch, Canterbury, New Zealand, 8011|
|Contact: Jo Sanders +6433729477 email@example.com|