Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Personalized Feedback; Device: Decision Support System; Device: Sensor Augmented Mode

• Registration Number: NCT04443153
• Lead Sponsor: 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 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.

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 Timeline

• Study First Submitted: 2020-06-20
• Study First Submitted QC: 2020-06-20
• Study First Posted: 2020-06-23
• Study Start: 2020-09-04
• Primary Completion: 2024-09-19
• Study Completion: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-04
• Last Update Posted: 2024-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Escalation	Personalized Feedback	Subjects randomized to this arm will proceed from SAM to PF to DSS
De-escalation	Sensor Augmented Mode	Subjects randomized to this arm will proceed from DSS to PF to SAM
Escalation	Sensor Augmented Mode	Subjects randomized to this arm will proceed from SAM to PF to DSS
De-escalation	Personalized Feedback	Subjects randomized to this arm will proceed from DSS to PF to SAM
De-escalation	Decision Support System	Subjects randomized to this arm will proceed from DSS to PF to SAM
Escalation	Decision Support System	Subjects randomized to this arm will proceed from SAM to PF to DSS

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Virginia Center for Diabetes Technology; 🇺🇸 Charlottesville, Virginia, United States