Clinical trial NCT02934893: A Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control
Official title: A Randomized, Controlled, Open-label, Multi-center Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Rimidi Diabetes, Inc.
Sponsor class: INDUSTRY
First posted: 2016-10-17
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: * 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.

Eligibility criteria: 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

Primary outcomes:
measure: Hemoglobin A1C
timeFrame: change from baseline to 12 weeks
Secondary outcomes:
measure: Number of hypoglycemic events per week
timeFrame: change from 1st week to twelfth week
measure: Blood pressure
timeFrame: change from baseline to 12 weeks
measure: BMI
timeFrame: change from baseline to 12 weeks
measure: Healthcare provider satisfaction
timeFrame: through study completion, an average of 1 year
measure: A1C target attainment
timeFrame: at 12 weeks
measure: Medication titrations needed
timeFrame: 12 weeks
measure: Patient satisfaction questionnaire
timeFrame: through patient study completion, an average of 12 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Desert Oasis Healthcare
name: Michael Jardula, MD
role: PRINCIPAL_INVESTIGATOR
References: