Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes (DSS-2)

Adapting Diabetes Treatment Expert Systems to Patient's Expectations and Psychobehavioral Characteristics in Type 1 Diabetes

This study is evaluate the superior efficacy of a Continuous Glucose Monitor (CGM)-based advisory system in Type 1 Diabetes Mellitus (T1DM), as compared to Sensor Augmented Mode (SAM) therapy, and with characterizing the impact of psycho-behavioral factors on system performance, which will enable system individualization and lead to automated adaptation of advice delivery to optimize glycemic control and reduce the system's psychological impact.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Personalized Feedback; Device: Decision Support System; Device: Sensor Augmented Mode

Detailed Description

Four cohorts of about 25 participants each (expected retention 20 per cohort). Each cohort will continue for ~7 months. Following recruitment, screening, and a run-in period of SAM, participants will be randomized into one of two groups: escalation vs. de-escalation of devices and function. Each treatment modality (SAM - Sensor-Augmented Mode, PF - Personalized Feedback, DSS - Decision Support Systems) will continue for about 8 weeks, with the last 4 weeks used to assess glucose variability (GV) from CGM data.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Breton, PhD; Phone Number: 434-982-6484; Email: mb6nt@virginia.edu
• Study Contact Backup: Name: Emma Emory, RN; Phone Number: 434-327-0725; Email: ee9m@virginia.edu

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • Recruiting
      • University of Virginia Center for Diabetes Technology
      • Sub-Investigator: Ralf Nass, MD
      • Contact: Marc Breton, PhD; Phone Number: 434-982-6484; Email: mb6nt@virginia.edu
      • Principal Investigator: Marc Breton, PhD
      • Sub-Investigator: Chiara Fabris, PhD
      • Sub-Investigator: Leela Krishna Chaitanya Koravi, PhD
      • Sub-Investigator: Linda Gonder-Fredrick, PhD
      • Sub-Investigator: Mary Clancy-Oliveri, MS
      • Sub-Investigator: Katharine Barnard-Kelly, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 years and older
• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least one year
• HbA1c 6.0-11.0%, inclusive
• Demonstration of proper mental status and cognition for the study
• If on a non-insulin hyperglycemic therapy, stability on that therapy for the prior 3 months and willingness not to alter the therapy for the study duration.
• For females, not currently known to be pregnant
• If female and sexually active, must agree to use a highly effective form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
• Subjects must have Internet access and a computer system that meets the requirements for uploading the study equipment and ability to participate in video conferencing.
• Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol

Exclusion Criteria:

• NPH (neutral protamine hagedorn) insulin
• Use of any medication that at the discretion of the investigator is deemed to interfere with the trial.
• Current treatment of a primary seizure disorder
• Coronary artery disease or heart failure, unless written clearance is received from a cardiologist.
• Hemophilia or any other bleeding disorder

• A known medical condition, which in the opinion of the investigator or designee, would put the participant or study at risk such as the following examples:

  • Inpatient psychiatric treatment in the past 6 months
  • Presence of a known adrenal disorder
  • Abnormal liver function test results (Transaminase >3 times the upper limit of normal)
  • Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2).
  • Active gastroparesis requiring medical therapy
  • Uncontrolled thyroid disease (TSH undetectable or >10 mlU/L).
  • Abuse of alcohol or recreational drugs
  • Infectious process not anticipated to be resolved prior to study procedures (e.g. meningitis, pneumonia, osteomyelitis, deep tissue infection).
  • Uncontrolled arterial hypertension (Resting diastolic blood pressure >100 mmHg and/or systolic blood pressure >180 mmHg).
  • Uncontrolled microvascular complications such as current active proliferative diabetic retinopathy defined as proliferative retinopathy requiring treatment (e.g. laser therapy or VEGF inhibitor injections) in the past 12 months.
• A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the protocol.
• Not familiar with smart phone technology

• Current use of the following drugs and supplements:

  • Oral steroids
  • Any other medication that the investigator believes is a contraindication to the subject's participation
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: De-escalation; Subjects randomized to this arm will proceed from DSS to PF to SAM	Device: Personalized Feedback; Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.; Device: Decision Support System; CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges; Device: Sensor Augmented Mode; A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
Experimental: Escalation; Subjects randomized to this arm will proceed from SAM to PF to DSS	Device: Personalized Feedback; Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.; Device: Decision Support System; CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges; Device: Sensor Augmented Mode; A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump or Multiple Daily Injections, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glycemic Outcomes	Glucose Variability (GV) as measured by CGM-based Coefficient of Variation (CV), as recommended by the International Consensus on Use of Continuous Glucose Monitoring.	7 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
percent time in clinical hypoglycemia	percent time spent below 54mg/dL as per CGM	7 months
percent time below recommended threshold	percent time spent below 70mg/dL as per CGM	7 months
percent time in target range	percent time spent between 70mg/dL and 180mg/dL as per CGM	7 months
percent time above range	percent time spent above 180mg/dL as per CGM	7 months
percent time above 250 mg/dL	percent time spent above 250mg/dL as per CGM	7 months
Low Blood Glucose Index	average of hypoglycemia risk value per Kovatchev et al 1998 as per CGM	7 months
High Blood Glucose Index	average of hyperglycemia risk value per Kovatchev et al 1998 as per CGM	7 months
average glycemia	average of CGM values	7 months

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Marc Breton, PhD, University of Virginia Center for Diabetes Technology

Study record dates

Study Major Dates

• Study Start (Actual): September 4, 2020
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: June 20, 2020
• First Submitted That Met QC Criteria: June 20, 2020
• First Posted (Actual): June 23, 2020

Study Record Updates

• Last Update Posted (Estimate): May 5, 2023
• Last Update Submitted That Met QC Criteria: May 3, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Behavior; Continuous Glucose Monitor (CGM); Insulin Pump; Multiple Daily Injections (MDI); Decision Support System (DSS); Continuous Subcutaneous Insulin Infusion (CSII); Personalized Feedback (PF); Sensor Augmented Pump therapy (SAP); Sensor Augmented Mode (SAM)
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 200007; 2R01DK051562-19A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pending

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes