Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

— DSS-2  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04443153
• Other study ID #: 200007
• Secondary ID: 2R01DK051562-19A
• Status: Recruiting
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2023
• Source: University of Virginia
• Contact: Marc Breton, PhD
• Phone: 434-982-6484
• Email: mb6nt[@]virginia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

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.
• Decision Support System
CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
• 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.

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

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