Assessment of an Automatic Closed-loop Insulin Delivery System
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|ClinicalTrials.gov Identifier: NCT02366767|
Recruitment Status : Completed
First Posted : February 19, 2015
Results First Posted : February 6, 2017
Last Update Posted : March 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Device: Automatic closed-loop insulin delivery Device: Control||Not Applicable|
This study will be completed in two parts.
The initial part of this study will be an inpatient evaluation of the system with the primary goal of assessing safety and feasibility. This will involve 8 subjects with type 1 diabetes, aged 14 - 40 years, admitted for up to 60 hour. Plasma glucose levels will be collected hourly and tested by YSI (YSI 2300, Yellow Springs Instrument). These studies will be performed at Stanford University and will include group sporting activities to mimic the diabetes camp environment. Capillary blood glucose testing will be performed every 2-3 hours before meals, snacks, exercise, and prebed by subjects with research staff supervision during the day and at 00:00, 03:00 and 07:00 by research staff. These data will be reviewed by the DSMB before proceeding to camp studies.
The second part of this study will be to test the efficacy of the system during diabetes summer camps. We will test the system in subjects with type 1 diabetes, aged 14-40 years, attending diabetes camp. There will be 20 subjects recruited, with 10 subjects randomized to the control arm Medtronic 530G system with threshold suspend (control group) and 10 subjects randomized to the automatic closed-loop insulin delivery (intervention group). Capillary blood glucose testing will be performed every 2-3 hours before meals, snacks, exercise and prebed by subjects with research staff supervision and at 00:00, 03:00 and 07:00 by research staff. The primary aim of this study is to generate preliminary data of system safety and efficacy in a closely supervised environment that challenges glucose control.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of an Automatic Closed-loop Insulin Delivery System|
|Study Start Date :||June 2014|
|Actual Primary Completion Date :||September 2014|
|Actual Study Completion Date :||September 2014|
Experimental: automatic closed-loop insulin delivery
The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes
Device: Automatic closed-loop insulin delivery
Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes.
Active Comparator: Control
The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.
Other Name: 530G Pump
- Safety of Automatic Closed Loop Insulin Delivery System in Adolescents and Adults With Type 1 Diabetes [ Time Frame: 6 days ]
- As measured by the number of events of plasma glucose values ≤ 50 mg/dL OR frequency of system alerts preceding a plasma glucose value of ≤ 50 mg/dL in all subjects
- As measured by the number of events of system alerts of plasma glucose values >300 mg/dL lasting for more than one hour in all subjects.
- As measured by number of events of serum ketones >3 mmol/L in all subjects
- As measured by the number of events meeting the criteria for severe hypoglycemia, defined as hypoglycemic seizure, loss of consciousness or coma or an event requiring administration of glucagon or IV glucose in all subjects
- Feasibility of Using the Automatic Closed Loop Delivery System in Adolescents and Adults With Type 1 Diabetes [ Time Frame: 6 days ]
- As measured by the system initiating and operating properly for at least 75% of the time for 75% of subjects.
- As measure by the completion of study enrollment procedures and education on system use within 2 hours for 75% of the subjects.
- Efficacy of Hybrid Closed-loop System in Comparison With Control [ Time Frame: 6 days ]As measured by overall mean sensor glucose percent time in range 70-180 mg/dL.
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): NCT02366767
|United States, California|
|Angelus Oaks, California, United States, 92305|
|Packard El Camino Hospital|
|Mountain View, California, United States, 94040|
|Lucile Packard Children's Hospital|
|Palo Alto, California, United States, 94304|
|Principal Investigator:||Bruce Buckingham, MD||Stanford University|