Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Project Nightlight: Efficacy and System Acceptance of Dinner/Night vs. 24hr Closed Loop Control

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679287
• Other study ID #: 18617
• Secondary ID: R01DK085623
• Status: Completed
• Phase: N/A
• Start date: February 2016
• Est. completion date: April 2019

Study information

• Verified date: June 2020
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to use an investigational type of technology called Closed-Loop Control (CLC) Medical Platform System to help control blood sugar in people with type 1 diabetes mellitus in a home setting.

Description:

The CLC is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.These functionalities occur in a randomized cross-over design, each occurring for 8 weeks. These modalities are:

1. SAP=sensor-augmented pump only

2. USS+SAP (d)= Evening and Overnight Closed-Loop Control=SAP during day and CLC starting at dinner and continuing overnight

3. USS+CLC (d)= 24/7 Closed-Loop Control=24-hour Day and Night Closed Loop Control

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• type 1 diabetes for at least one year

• using insulin for at least 1 year

• an insulin pump for at least 6 months

• willingness to switch to lispro (Humalog) or aspart (Novolog) if using glulisine (Apidra).

Exclusion Criteria:

• a medical condition or being been treated with medications that might interfere with the study

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• CLC
The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.

Locations

Country	Name	City	State
United States	University of Virginia Center for Diabetes Technology	Charlottesville	Virginia

Sponsors (6)

Lead Sponsor	Collaborator
University of Virginia	DexCom, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Roche Diagnostic Ltd., Tandem Diabetes Care, Inc., TypeZero Technologies, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time <70 mg/dl by CGM	Overnight CLC achieved by USS+SAP(d) (also known at Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c < 7.5% vs =7.5% and time of day.	8 weeks
Primary	Hemoglobin A1c	Overnight CLC achieved by USS+SAP(d) (also known as Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c < 7.5% vs =7.5% and time of day.	8 weeks
Secondary	Time Between 70-180 mg/dL by CGM	Time in target range 70-180 mg/dL measured by CGM	8 weeks
Secondary	Time >180 mg/dL by CGM	Time in hyperglycemia range >180 mg/dL measured by CGM	8 weeks
Secondary	Mean Glucose by CGM	Mean glucose measured by CGM overall in mmol/L	8 weeks
Secondary	Low Blood Glucose Index (LBGI)	Index measure of low blood glucose risk. This is an index that indicates risk of hypoglycemia with low values indicating lower risk of hypoglycemia (particularly values 1 or lower).	8 weeks
Secondary	High Blood Glucose Index (HBGI)	Index measure of high blood glucose risk.	8 weeks
Secondary	CGM <70mg/dL	Percentage time <70mg/dL measured by CGM in three study phases combining Group A and B.	8 weeks
Secondary	Hemoglobin A1c by Study Session	Hemoglobin A1c after each 8 weeks study session by Group A and Group B.	8 weeks