The VRIF Trial: Hypoglycemia Reduction With Automated-Insulin Delivery System

NCT03674281 | Completed Results FDA Device

• 2 other identifiers: 20964VRIF-FY18-002
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this pilot study is (i) to test the use of an Artificial Pancreas (AP) System as a viable therapy treatment for two vulnerable populations: 6 to 10 year-old and adults older ≥65 years old with T1D; (ii) to assess cognitive function in children and older adult patients with T1D and examine whether improved glycemic control defined by stable (more than 70% of the day in glycemic range 70-180 mg/dL) control positively influences cognitive function; and (iii) obtain preliminary data to apply to funds to continue with larger and longer clinical trials.

Conditions

Type 1 Diabetes Mellitus; Cognitive Change

Keywords

Closed-Loop Control (CLC); Sensor-Augmented Therapy (SAP); Insulin Pump; Artificial Pancreas (AP); Continuous Glucose Monitor (CGM)

Outcome Measures

Primary Outcomes (1)

• Percentage of Time of Blood Glucose in Range 70-180 mg/dL

  Percentage of time of blood glucose in range 70-180 mg/dL as measured by the continuous glucose monitor.

  One month during each study period (sensor augmented pump and closed loop control)

Secondary Outcomes (2)

• Ecological Momentary Assessments

  Assessments will be administered during the final 14 days of each study period (sensor-augmented pump and closed-loop control).

• Sleep Patterns

  Assessments will be made at baseline and at the end of each study SAP (4 weeks) and CLC (4 weeks).

Study Arms (1)

Sensor Augmented Pump (SAP)-Closed-Loop Control (CLC)

EXPERIMENTAL

SAP: Subjects will be utilizing their own insulin pumps (without automated insulin delivery) plus Dexcom G6 CGM to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period. CLC with Control-IQ plus CGM: Following SAP, subjects will be utilizing the Tandem t:slim X2 with Control-IQ along with a Dexcom G6 continuous glucose monitor to control their blood glucose for 4 weeks. Subjects will be evaluated by actigraphy watch and by Ecological Momentary Assessments in approximately the final 14 days of the 4 week period.

Device: SAP; Device: CLC

Interventions

SAP DEVICE

Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).

Also known as: Sensor-augmented Pump

Sensor Augmented Pump (SAP)-Closed-Loop Control (CLC)

CLC DEVICE

The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM.

Also known as: Tandem t:slim X2 with Control-IQ and Dexcom G6 CGM

Sensor Augmented Pump (SAP)-Closed-Loop Control (CLC)

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year, using insulin for at least 1 year and using an insulin pump for at least 6 months.
• Familiarity and use of a carbohydrate ratio for meal boluses by participants and families participating.
• Age 6-10 years old or 65 years or older
• Hemoglobin A1c \<10%
• For females of child-bearing potential, not currently known to be pregnant:
• A negative serum or urine pregnancy test will be required for all females of child-bearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
• For participants \<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency.
• Willing to disable any automated insulin delivery functionality on a personal insulin pump during study, such as Medtronic 670G in auto mode. Predictive low blood glucose suspend, such as Tandem insulin pump with Basal-IQ, will be allowed.
• Investigator has confidence that the participant and family can successfully operate all study devices and is capable of adhering to the protocol.
• Willingness to switch to lispro (Humalog) or aspart (Novolog) and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study.
• Total daily insulin dose (TDD) at least 10 U/day.
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial

You may not qualify if:

• Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 months prior to enrollment.
• Diagnosis of Diabetic Ketoacidosis in the 12 months prior to enrollment.
• Uncontrolled cardiac disease (e.g. recent myocardial infarction, severe congestive heart failure).
• Cerebrovascular accident in the 12 months prior to enrollment.
• Uncontrolled resting arterial hypertension (\>160/90 mm Hg).
• Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility).
• Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study.
• Concurrent use of any non-insulin glucose-lowering agent other than metformin (including GLP-1 agonists, pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
• Hemophilia or any other bleeding disorder
• A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study
• Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial.

Sponsors & Collaborators

• University of Virginia: lead
• Virginia Research Investment Fund: collaborator
• DexCom, Inc.: collaborator
• Tandem Diabetes Care, Inc.: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Sue Brown, MD
• Organization: University of Virginia

sab2f@virginia.edu

434-982-0602

Study Officials

• Sue Brown, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 17, 2018
• Study Start: September 24, 2018
• Primary Completion: November 21, 2019
• Study Completion: November 21, 2019
• Last Updated: January 12, 2021
• Results First Posted: January 12, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Generally after publications are complete.
• Access Criteria: Will follow data sharing policy.

Locations

US (1)