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

Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02934893
• Other study ID #: RD-DOHC
• Status: Enrolling by invitation
• Phase: N/A
• First received: August 17, 2016
• Last updated: October 13, 2016
• Start date: April 2015
• Est. completion date: November 2016

Study information

• Verified date: October 2016
• Source: Rimidi Diabetes, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 129
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Other:
• Medication Management Clinic
referral to medication management clinic from primary care
• Diabetes+Me plus connected glucometer
Use of software and medication modeling tool as add on to medication management standard of care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rimidi Diabetes, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hemoglobin A1C		change from baseline to 12 weeks	No
Secondary	Number of hypoglycemic events per week	Decrease in frequency of hypoglycemia (# events per week	change from 1st week to twelfth week	No
Secondary	Blood pressure	increase in percentage of patients with blood pressure in normotensive range	change from baseline to 12 weeks	No
Secondary	BMI	decrease in BMI	change from baseline to 12 weeks	No
Secondary	Healthcare provider satisfaction	healthcare provider satisfaction based on scoring of questionnaire	through study completion, an average of 1 year	No
Secondary	A1C target attainment	time to A1c goal attainment	at 12 weeks	No
Secondary	Medication titrations needed	number of medication titrations over 12 week period needed to reach A1c goal	12 weeks	No
Secondary	Patient satisfaction questionnaire	questionnaire addresses satisfaction with care and knowledge of diabetes self-management	through patient study completion, an average of 12 weeks	No