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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Other: Medication Management Clinic; Other: Diabetes+Me plus connected glucometer

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.

• Study Type: Interventional
• Enrollment (Anticipated): 129
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Rimidi Diabetes, Inc.
• Investigators: Principal Investigator: Michael Jardula, MD, Desert Oasis Healthcare

Study record dates

Study Major Dates

• Study Start: April 1, 2015
• Primary Completion (Anticipated): October 1, 2016
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: October 13, 2016
• First Posted (Estimate): October 17, 2016

Study Record Updates

• Last Update Posted (Estimate): October 17, 2016
• Last Update Submitted That Met QC Criteria: October 13, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: RD-DOHC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided