Diabetes MellitusNCT02934893
A Study to Evaluate the Effect and Benefit of Diabetes Management Decision Support Software for Blood Glucose Control
A study testing Medication Management Clinic and Diabetes+Me plus connected glucometer in people with Diabetes Mellitus, run by Rimidi Diabetes, Inc..
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Medication Management Clinic and Diabetes+Me plus connected glucometer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Physician diagnosis of type 1 or type 2 diabetes
- Glycated hemoglobin > 9% within 3 months
- Age 18-80
- Not currently managed by study clinicians
Who cannot join
- Pregnant
- Active substance abuse
- Severe hearing or visual impairment
- No internet or email access
About this study
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
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.
Read the 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.
- Conditions
- Diabetes Mellitus
- Being tested
- Medication Management Clinic, Diabetes+Me plus connected glucometer
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medication Management ClinicOther
referral to medication management clinic from primary care
Diabetes+Me plus connected glucometerOther
Use of software and medication modeling tool as add on to medication management standard of care
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Patient in standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me plus connected glucometer Receives: 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 Receives: Other: Medication Management Clinic |
| Primary Care | No intervention | Matched cohort managed through their primary care physician (PCP) and standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
Measured: change from baseline to 12 weeks
Secondary outcomes (7)
Number of hypoglycemic events per week
Decrease in frequency of hypoglycemia (# events per week
Measured: change from 1st week to twelfth week
Blood pressure
increase in percentage of patients with blood pressure in normotensive range
Measured: change from baseline to 12 weeks
BMI
decrease in BMI
Measured: change from baseline to 12 weeks
Healthcare provider satisfaction
healthcare provider satisfaction based on scoring of questionnaire
Measured: through study completion, an average of 1 year
A1C target attainment
time to A1c goal attainment
Measured: at 12 weeks
Medication titrations needed
number of medication titrations over 12 week period needed to reach A1c goal
Measured: 12 weeks
Patient satisfaction questionnaire
questionnaire addresses satisfaction with care and knowledge of diabetes self-management
Measured: through patient study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startApr 2015
- Primary completionOct 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 129 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rimidi Diabetes, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Jardula, MD, Principal investigator, Desert Oasis Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02934893
- Sponsor's protocol ID
- RD-DOHC
- Status last verified
- Oct 2016
- First submitted
- 17 Aug 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02934893
- Acronym / sponsor ID
- RD-DOHC
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 129 participants (estimated)
- Lead sponsor
- Rimidi Diabetes, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: Medication Management Clinic, Other: Diabetes+Me plus connected glucometerPatient in standard diabetes management in the Medication Management Clinic plus the use of Diabetes+Me plus connected glucometer |
| Standard Diabetes Management | Active comparator | Other: Medication Management ClinicPatient in standard diabetes management in the Medication Management Clinic |
| Primary Care | No intervention | –Matched cohort managed through their primary care physician (PCP) and standard of care. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Physician diagnosis of type 1 or type 2 diabetes
- Glycated hemoglobin > 9% within 3 months
- Age 18-80
- Not currently managed by study clinicians
Key exclusion criteria (4 listed)
- Pregnant
- Active substance abuse
- Severe hearing or visual impairment
- No internet or email access
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medication Management Clinicreferral to medication management clinic from primary care | Other | Intervention Group, Standard Diabetes Management |
| Diabetes+Me plus connected glucometerUse of software and medication modeling tool as add on to medication management standard of care | Other | Intervention Group |
Primary outcome
Hemoglobin A1C
Time frame: change from baseline to 12 weeks
7 secondary outcomes
Number of hypoglycemic events per week
Time frame: change from 1st week to twelfth week
Blood pressure
Time frame: change from baseline to 12 weeks
BMI
Time frame: change from baseline to 12 weeks
Healthcare provider satisfaction
Time frame: through study completion, an average of 1 year
A1C target attainment
Time frame: at 12 weeks
Medication titrations needed
Time frame: 12 weeks
Patient satisfaction questionnaire
Time frame: through patient study completion, an average of 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Jardula, MD principal investigator
Desert Oasis Healthcare
Questions about this trial
What is this clinical trial studying?
A study testing Medication Management Clinic and Diabetes+Me plus connected glucometer in people with Diabetes Mellitus, run by Rimidi Diabetes, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin A1C (time frame: change from baseline to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016; AzTrials last refreshed its copy on 6 Nov 2026.