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

Sponsor
University of Virginia (Other)
Overall Status
Recruiting
CT.gov ID
NCT04443153
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) (NIH)
100
1
2
34.9
2.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Personalized Feedback
  • Device: Decision Support System
  • Device: Sensor Augmented Mode
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Adapting Diabetes Treatment Expert Systems to Patient's Expectations and Psychobehavioral Characteristics in Type 1 Diabetes
Actual Study Start Date :
Sep 4, 2020
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. percent time in clinical hypoglycemia [7 months]

    percent time spent below 54mg/dL as per CGM

  2. percent time below recommended threshold [7 months]

    percent time spent below 70mg/dL as per CGM

  3. percent time in target range [7 months]

    percent time spent between 70mg/dL and 180mg/dL as per CGM

  4. percent time above range [7 months]

    percent time spent above 180mg/dL as per CGM

  5. percent time above 250 mg/dL [7 months]

    percent time spent above 250mg/dL as per CGM

  6. average gycemia [7 months]

    average of CGM values

  7. Low Blood Glucose Index [7 months]

    average of hypoglycemia risk value per Kovatchev et al 1998 as per CGM

  8. High Blood Glucose Index [7 months]

    average of hyperglycemia risk value per Kovatchev et al 1998 as per CGM

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Virginia Center for Diabetes Technology Charlottesville Virginia United States 22903

Sponsors and Collaborators

  • University of Virginia
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Marc Breton, PhD, University of Virginia Center for Diabetes Technology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Marc Breton, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier:
NCT04443153
Other Study ID Numbers:
  • 200007
  • 2R01DK051562-19A1
First Posted:
Jun 23, 2020
Last Update Posted:
Jan 26, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Marc Breton, Associate Professor, University of Virginia
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 26, 2022