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The benefit of drug therapy to persons with diabetes has been well established in clinical trials in terms of reducing cardiovascular risk, microvascular complications and mortality. However, treatment adherence and treatment effectiveness continue to be challenges in diabetes management.
Rimidi Diabetes has developed software algorithms to simulate the effect of anti-diabetic medications on an individual's glucose profile, allowing the clinician and their patient to visualize the anticipated outcome of a medical intervention. Use of this technology should allow for more targeted decision-making by the clinician and should facilitate a shared decision-making process with the PwD who is now privy to the thought process behind their medical management.
The proposed study is designed to test whether adding a decision support capability (Diabetes+Me Rx) that allows for modeling the anticipated effect of medication adjustments leads to improved glycemic control and a perceived benefit by healthcare providers and PwDs.
Recruitment
Study visits
The third and final study visit will occur 5 weeks following the second visit. The HCP and PwD will review the glucose profile from the previous week and identify if the PwD is meeting targets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Patient in standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me plus connected glucometer |
|
| Standard Diabetes Management | Active Comparator | Patient in standard diabetes management in the Medication Management Clinic |
|
| Primary Care | No Intervention | Matched cohort managed through their primary care physician (PCP) and standard of care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication Management Clinic | Other | referral to medication management clinic from primary care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin A1C | change from baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of hypoglycemic events per week | Decrease in frequency of hypoglycemia (# events per week | change from 1st week to twelfth week |
| Blood pressure | increase in percentage of patients with blood pressure in normotensive range |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Jardula, MD | Desert Oasis Healthcare | Principal Investigator |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Diabetes+Me plus connected glucometer | Other | Use of software and medication modeling tool as add on to medication management standard of care |
|
| change from baseline to 12 weeks |
| BMI | decrease in BMI | change from baseline to 12 weeks |
| Healthcare provider satisfaction | healthcare provider satisfaction based on scoring of questionnaire | through study completion, an average of 1 year |
| A1C target attainment | time to A1c goal attainment | at 12 weeks |
| Medication titrations needed | number of medication titrations over 12 week period needed to reach A1c goal | 12 weeks |
| Patient satisfaction questionnaire | questionnaire addresses satisfaction with care and knowledge of diabetes self-management | through patient study completion, an average of 12 weeks |