Crossover Feasibility Study of Portable AP Device With Zone-MPC and HMS and Adapted I:C and Basal Insulin (DP3)
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|ClinicalTrials.gov Identifier: NCT01929798|
Recruitment Status : Completed
First Posted : August 28, 2013
Last Update Posted : October 21, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Device: portable Artificial Pancreas||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Crossover Feasibility Study of Artificial Pancreas Device (AP) Using Zone-MPC Controller (Zone-Model Predictive Control) and Health Monitoring System (HMS) With and Without Basal and Insulin-to-Carbohydrate Bolus Initialization|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||November 2014|
Experimental: Optimized basal/bolus with artificial pancreas
Portable artificial pancreas with optimization
Device: portable Artificial Pancreas
The artificial pancreas system will be allowed to employ its Model Predictive Control algorithm to make decisions about insulin delivery based on measured glucose levels.
No Intervention: Nominal basal/bolus treatment
Portable artificial pancreas without optimization.
- time spent in safe blood glucose range [ Time Frame: 24-hour closed-loop ]The percentage time spent in safe blood glucose range of [80-140] mg/dl will be the primary endpoint. More time spent inside the desired range will be considered successful. Expected levels are [70-180] mg/dl the 5 hours after meals and [70-150] mg/dl 3 hours after exercise.
- glucose level extremes and need for outside intervention [ Time Frame: 24-hour closed loop ]The secondary endpoint measures glucose extremes and the need for outside intervention to prevent hypoglycemia or hyperglycemia. Interventions would be insulin injections or oral carbohydrates given to the subject by the physician. No need for physician intervention will be considered a successful outcome.
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): NCT01929798
|United States, California|
|Sansum Diabetes Research Institutute|
|Santa Barbara, California, United States, 93105|