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

NCT02934893 | Unknown

• 1 other identifier: RD-DOHC
• Study Type: interventional
• Target: 129
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  change from baseline to 12 weeks

Secondary Outcomes (7)

• Number of hypoglycemic events per week

  change from 1st week to twelfth week

• Blood pressure

  change from baseline to 12 weeks

• BMI

  change from baseline to 12 weeks

• Healthcare provider satisfaction

  through study completion, an average of 1 year

• A1C target attainment

  at 12 weeks

Study Arms (3)

Intervention Group

EXPERIMENTAL

Patient in standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me plus connected glucometer

Other: Medication Management Clinic; Other: Diabetes+Me plus connected glucometer

Standard Diabetes Management

ACTIVE COMPARATOR

Patient in standard diabetes management in the Medication Management Clinic

Other: Medication Management Clinic

Primary Care

NO INTERVENTION

Matched cohort managed through their primary care physician (PCP) and standard of care.

Interventions

Medication Management Clinic OTHER

referral to medication management clinic from primary care

Intervention Group; Standard Diabetes Management

Diabetes+Me plus connected glucometer OTHER

Use of software and medication modeling tool as add on to medication management standard of care

Intervention Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physician diagnosis of type 1 or type 2 diabetes
• Glycated hemoglobin \> 9% within 3 months
• Age 18-80
• Not currently managed by study clinicians

You may not qualify if:

• Pregnant
• Active substance abuse
• Severe hearing or visual impairment
• No internet or email access

Sponsors & Collaborators

• Rimidi Diabetes, Inc.: lead

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michael Jardula, MD

  Desert Oasis Healthcare

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 17, 2016
• First Posted: October 17, 2016
• Study Start: April 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 17, 2016

Record last verified: 2016-10