Patient Centered Multi-Agent Decision Support System (PCM-DSS) for Healthcare Providers (TREAT2D)

Daniel Chernavvsky, MD

Status: Enrolling

Conditions: Type 2 Diabetes Treated With Insulin

Treatments: Other: Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS); Other: Continuous Glucose Monitor (CGM) + Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT07063420

302621

Details and patient eligibility

About

Decision Support System (Software) for multi antidiabetic drug therapy use in type 2 diabetes (T2D).

Full description

The purpose of this study is to test the safety and feasibility of using a patient centered decision support system (software) aim for healthcare providers to treat people with type 2 diabetes under multi antidiabetic drug therapy.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥18.0 years old at time of consent.
2. Clinical diagnosis, based on investigator assessment, of type 2 diabetes for at least 6 months.
3. Hemoglobin A1c (HbA1c) ≥ 7.0%.
4. Currently using an approved long-acting insulin for at least 3 months (e.g., insulin glargine, insulin degludec).
5. Treated or about to be treated with multi-drug therapies for T2D.
6. If using a CGM, willingness to wear an additional study CGM during the duration of the study.
7. Access to the internet and willingness to upload data during the study as needed.
8. If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females who self-report that they are of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.

Exclusion criteria

1. Currently using rapid insulin for at least three months (e.g., insulin aspart, insulin lispro, insulin regular).

2. Currently being treated for a seizure disorder.

3. A known medical condition that in the judgment of the investigator might interfere with the completion of the protocol, such as but not limited to, the following examples:

   1. Seizure disease
   2. Decompensated cardiac disease

4. Inpatient psychiatric treatment in the past 6 months

5. Presence of a known adrenal disorder

6. Currently pregnant or intent to become pregnant during the trial.

7. Anticipated surgical, interventional procedures or prolonged periods of fasting during this study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups, including a placebo group

CGM + Patient Centered Multi-Agent Decision Support System (PCM-DSS) (TREAT2)

Experimental group

Description:

Participants will use their personal insulin pen and study continuous glucose monitor (CGM). Participants will adjust therapy guided by the study physician who receives the TREAT2D Report for a 16-week period. TREAT2D Report is generated by the Patient Centered Multi-Agent Decision Support System (PCM-DSS). Participant will then complete a 2-week Maintenance Phase where therapy established during the Intervention Phase will be maintained.

Treatment:

Other: Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS)

CGM + Usual Care (Physician)

Placebo Comparator group

Description:

Participants will use a study CGM and their personal insulin pen. They will have their insulin therapy guided by the study physician for a 16-week period. Participants will be contacted by study personnel as per standard care to adjust their therapy if needed. Participants will then complete a 2-week Maintenance Phase where therapy established during the Intervention Phase will be maintained.

Treatment:

Other: Continuous Glucose Monitor (CGM) + Usual Care