A Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control

Study Overview
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Brief Summary
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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.

Detailed Description
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Recruitment Recruitment of persons with diabetes through a community diabetes management center according to inclusion and exclusion criteria below. This is a three-armed study. Enrollees will be randomized to continue diabetes care with standard diabetes management in the Medication Management Clinic or the Intervention Group and compared to a matched cohort managed through their primary care physician (PCP) and standard of care. The Intervention Group will be standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me with a connected glucometer. Upon recruitment, PwD will be oriented to the Diabetes+Me application and instructed on how to complete a glucose profile and how to enter data into the application. Baseline hemoglobin A1C will be measured. Enrollees will complete a brief survey of satisfaction with their diabetes management. Study visits The first study visit will be 2 weeks following enrollment. Weight, number of medications, number of medication titrations, the presence of insulin and blood pressure will be measured at each study visit. Frequency of hypoglycemia in the preceding week will be documented at each visit. Adherence to medical prescription to be documented at each visit. If the PwD has not entered data into Diabetes+Me this will be done at the beginning of each study visit. At the first study visit, the HCP will review the glucose profile from the previous week, identify areas where the PwD is not meeting targets and model adjustments to their medications to achieve the desired anticipated effect. If indicated, a new prescription will be issued and the PwD instructed to collect a new glucose profile the week preceding the next visit. The second study visit will occur 5 weeks following the initial visit. The HCP and PwD will review the glucose profile from the previous week, identify areas where the PwD is not meeting targets and model adjustments to their medications to achieve the desired anticipated effect. If indicated, a new prescription will be issued and the PwD instructed to collect a new glucose profile the week preceding the final visit. 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.

Official Title
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A Randomized, Controlled, Open-label, Multi-center Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Medication Management Clinic
* Other: Diabetes+Me plus connected glucometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician diagnosis of type 1 or type 2 diabetes Glycated hemoglobin > 9% within 3 months Age 18-80 Not currently managed by study clinicians Exclusion Criteria: Pregnant Active substance abuse Severe hearing or visual impairment No internet or email access

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Patient in standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me plus connected glucometer | Other: Medication Management Clinic<br>* referral to medication management clinic from primary care<br>Other: Diabetes+Me plus connected glucometer<br>* Use of software and medication modeling tool as add on to medication management standard of care<br>|
| Active Comparator: Standard Diabetes Management<br>Patient in standard diabetes management in the Medication Management Clinic | Other: Medication Management Clinic<br>* referral to medication management clinic from primary care<br>|
| No Intervention: Primary Care<br>Matched cohort managed through their primary care physician (PCP) and standard of care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin A1C |  | change from baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |