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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04443153

Acronym

DSS-2

Enrollment

Registered

2020-06-23

Start date

2020-09-04

Completion date

2024-09-19

Last updated

2025-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Behavior, Continuous Glucose Monitor (CGM), Insulin Pump, Decision Support System (DSS), Personalized Feedback (PF), Sensor Augmented Pump therapy (SAP), Multiple Daily Injections (MDI), Sensor Augmented Mode (SAM), Continuous Subcutaneous Insulin Infusion (CSII)

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.

Interventions

DEVICEPersonalized 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.

DEVICEDecision Support System

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

DEVICESensor 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.

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Glycemic Outcomes	Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention	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

Measure	Time frame	Description
Percent Time Below Recommended Threshold	Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention	Percentage of time blood glucose was below 70mg/dL as per CGM
Percent Time in Target Range	Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention	Percentage of time blood glucose was 70mg/dL and 180mg/dL as per CGM
Percent Time Above Range	Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention	Percentage of time blood glucose was above 180mg/dL as per CGM
Percent Time in Clinical Hypoglycemia	Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention	Percentage of time blood glucose was below 54mg/dL as per CGM
Average Glycemia	Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention	average of CGM values
Low Blood Glucose Index	Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention	The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values \<1 suggest low risk of hypoglycemia.
High Blood Glucose Index	Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention	The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk.
Percent Time Above 250 mg/dL	Assessed over the last 4 weeks (Weeks 4 - 8), for each intervention	Percentage of time blood glucose was above 250mg/dL as per CGM

Countries

United States

Participant flow

Recruitment details

Study enrollment began September 4, 2020, and all study activities were completed on September 19, 2024. As defined in the protocol, a participant is considered enrolled when the informed consent form has been signed by the participant and the study team. Eighty-eight (88) signed consent, and 26 participants screen failed, withdrew, or dropped prior to screening.

Pre-assignment details

Once eligibility and device training was completed, participants completed a minimum of 14 days (if CGM use within the preceding 3 months) or 4 weeks (if no CGM use within the preceding 3 months) of home use of the DiAs system in Sensor-Augmented Mode (SAM). One participant elected to withdraw from the study.

Participants by arm

Arm	Count
Escalation Subjects randomized to this arm will proceed from SAM to PF to DSS 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.	27
De-escalation Subjects randomized to this arm will proceed from DSS to PF to SAM 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.	26
Total	53

Withdrawals & dropouts

Period	Reason	FG000	FG001
First intervention (8 weeks)	Lost to Follow-up	0	2
First intervention (8 weeks)	Withdrawal by Subject	2	0
Second intervention (8 weeks)	Lost to Follow-up	2	0
Second intervention (8 weeks)	Withdrawal by Subject	1	1

Baseline characteristics

Characteristic	Escalation	Total	De-escalation
Age, Continuous	37.7 years STANDARD_DEVIATION 11.1	37.3 years STANDARD_DEVIATION 11.8	36.9 years STANDARD_DEVIATION 12.7
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants	0 Participants	0 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants	51 Participants	25 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	2 Participants	1 Participants
Health Insurance Prefer not to answer	0 Participants	1 Participants	1 Participants
Health Insurance Private insurance through my employer	19 Participants	35 Participants	16 Participants
Health Insurance Public state or federal health insurance (Medicaid, Medicare, Veteran's Health Affairs...)	3 Participants	9 Participants	6 Participants
Health Insurance Self-insured with private health insurance	3 Participants	5 Participants	2 Participants
Health Insurance Uninsured	2 Participants	3 Participants	1 Participants
Highest education level Associate degree	5 Participants	7 Participants	2 Participants
Highest education level Bachelor degree	11 Participants	19 Participants	8 Participants
Highest education level Graduate degree	5 Participants	12 Participants	7 Participants
Highest education level High school degree or equivalent (e.g., GED)	4 Participants	8 Participants	4 Participants
Highest education level Some college but no degree	2 Participants	7 Participants	5 Participants
Last year household income $100,000 - $149,999	4 Participants	12 Participants	8 Participants
Last year household income $150,000 - $199,999	3 Participants	5 Participants	2 Participants
Last year household income $20,000 - $44,999	1 Participants	3 Participants	2 Participants
Last year household income $45,000 - $99,999	15 Participants	27 Participants	12 Participants
Last year household income Less than $20,000	1 Participants	1 Participants	0 Participants
Last year household income More than $200,000	1 Participants	2 Participants	1 Participants
Last year household income Prefer not to answer	2 Participants	3 Participants	1 Participants
Number of participants with each infusion set type MDI	18 Participants	32 Participants	14 Participants
Number of participants with each infusion set type Pump	9 Participants	21 Participants	12 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) Black or African American	2 Participants	4 Participants	2 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) White	24 Participants	48 Participants	24 Participants
Sex/Gender, Customized Gender Female	16 Participants	28 Participants	12 Participants
Sex/Gender, Customized Gender Male	11 Participants	24 Participants	13 Participants
Sex/Gender, Customized Gender Prefer not to say	0 Participants	1 Participants	1 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 53	0 / 53	0 / 53
other Total, other adverse events	0 / 53	0 / 53	0 / 53
serious Total, serious adverse events	0 / 53	1 / 53	1 / 53

Outcome results

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.