Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes

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

Sponsors

Lead Sponsor: University of Virginia

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Source University of Virginia
Brief 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 Pump (SAP) 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.

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 SAP, participants will be randomized into one of two groups: escalation vs. de-escalation of devices and function. Each treatment modality (SAP - Sensor-Augmented Pump therapy, 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.

Overall Status Recruiting
Start Date September 4, 2020
Completion Date August 1, 2023
Primary Completion Date August 1, 2023
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Glycemic Outcomes 7 Months
Secondary Outcome
Measure Time Frame
percent time in clinical hypoglycemia 7 months
percent time below recommended threshold 7 months
percent time in target range 7 months
percent time above range 7 months
percent time above 250 mg/dL 7 months
average gycemia 7 months
Low Blood Glucose Index 7 months
High Blood Glucose Index 7 months
Enrollment 100
Condition
Intervention

Intervention Type: Device

Intervention Name: Personalized Feedback

Description: 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.

Intervention Type: Device

Intervention Name: Decision Support System

Description: CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges

Intervention Type: Device

Intervention Name: Sensor-Augmented Pump therapy

Description: A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.

Eligibility

Criteria:

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 6.5-11.0%, inclusive

- Using established parameters for carbohydrate counting including carbohydrate ratio, insulin sensitivity factor and glucose goal for at least 6 months

- 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:

- 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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Marc Breton, PhD Principal Investigator University of Virginia Center for Diabetes Technology
Overall Contact

Last Name: Marc Breton, PhD

Phone: 434-982-6484

Email: [email protected]

Location
Facility: Status: Contact: Investigator: University of Virginia Center for Diabetes Technology Marc Breton, PhD 434-982-6484 [email protected] Marc Breton, PhD Principal Investigator Ralf Nass, MD Sub-Investigator Stacey Anderson, MD Sub-Investigator Chiara Fabris, PhD Sub-Investigator Leela Krishna Chaitanya Koravi, PhD Sub-Investigator John Hughes, PhD Sub-Investigator Linda Gonder-Fredrick, PhD Sub-Investigator Alessandro Bisio, MD Sub-Investigator Christian Wakeman, MS Sub-Investigator Thibault Gautier, MS Sub-Investigator John Corbett, MS Sub-Investigator
Location Countries

United States

Verification Date

September 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Virginia

Investigator Full Name: Marc Breton

Investigator Title: Associate Professor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: De-escalation

Type: Experimental

Description: Subjects randomized to this arm will proceed from DSS to PF to SAP

Label: Escalation

Type: Experimental

Description: Subjects randomized to this arm will proceed from SAP to PF to DSS

Acronym DSS-2
Patient Data Yes
Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov