Type 2 Diabetes Treated With Insulin
Conditions
Keywords
Patient Centered Multi-Agent Decision Support System (PCM-DSS), Continuous Glucose Monitor (CGM), Insulin pen
Brief summary
Decision Support System (Software) for multi antidiabetic drug therapy use in type 2 diabetes (T2D).
Detailed 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.
Interventions
OTHERContinuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS)
Continuous Glucose Monitor (CGM) + Patient Centered Multi-Agent Decision Support System (PCM-DSS) PCM-DSS
OTHERContinuous Glucose Monitor (CGM) + Usual Care
Continuous Glucose Monitor (CGM) + Usual Care (Physician)
Sponsors
University of Virginia
Daniel Chernavvsky, MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical efficacy | 22 weeks | Measured by improved glycemic control (HbA1c change and CGM-derived metrics). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 22 weeks | Patient satisfaction which will be assessed through Diabetes Distress Scale Survey (DDS) questionnaire, measured after Screening and at End of Study, and the Participant Satisfaction Survey (PSS) measured at End of Study. DDS asks the participant to consider the degree distress they felt to 17 items during the past month. PSS is six questions asking the participant about the experience in this study. |
Countries
United States
Contacts
Primary ContactCarlene Alix
Backup ContactLaura Kollar, RN
Outcome results
None listed