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Smartphone application and web portal for Type 2 Diabetes

N/A

Waitlist Available

Led By Linda Siminerio, RN, PhD, CDE

Research Sponsored by Linda Siminerio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up months 3 to 6

Awards & highlights

Study Summary

This trial is testing an app called My Dose Coach to see if it can help people with type 2 diabetes (T2DM) adjust their insulin doses. The app is being studied in two phases: first, to see if it can help participants get their blood glucoses to the target level; and second, to see if it can help participants keep their blood glucoses in the target range.

Eligible Conditions

Type 2 Diabetes (Insulin-Treated)

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ months 3 to 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~months 3 to 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and months 3 to 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change From Baseline in Glycemic Control at 3 Months

Secondary outcome measures

Change From 3 Months in Diabetes Distress at 6 Months

Change From 3 Months in Fasting Blood Glucose at 6 Months

Change From 3 Months in Hemoglobin A1c at 6 Months

+11 more

Other outcome measures

Frequency of Escalation of Care

Number of Technical Complaints

Participant Use of My Dose Coach

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: My Dose Coach (Insulin Dosing Support App)Experimental Treatment2 Interventions

Phase 1 Titration: Patients receive insulin therapy education from diabetes educator (DE). Plus, DE trains patients to use My Dose Coach (MDC) for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients are asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reach glycemic target are invited to Phase 2. Other patients are invited to continue titrating for another 3 months. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trains patients the MDC Maintenance Module to support proper insulin dosing. Patients are asked to return for follow-up clinic visits at mo 6. Patients are surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.

Group II: Usual Care GroupActive Control1 Intervention

A retrospective comparative group will be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group will be identified using data available in the electronic medical record system. Propensity score matching will be used to pair intervention and usual care participants during phase 1 of the study (baseline to 3 months).

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Who is running the clinical trial?

Linda SiminerioLead Sponsor

SanofiIndustry Sponsor

2,164 Previous Clinical Trials

3,514,920 Total Patients Enrolled

Linda Siminerio, RN, PhD, CDEPrincipal Investigator - Professor

University of Pittsburgh

4 Previous Clinical Trials

5,219 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this particular research project open to individuals above 25 years of age?

"This particular clinical trial is open to individuals aged between 18 and 75. For those younger than 18, there are 192 other trials that can be considered. Meanwhile, 1067 studies have been established for patients beyond the age of 65."

Answered by AI

Who would be an ideal candidate for participation in this research trial?

"This trial is currently enrolling 180 diabetes mellitus patients, aged 18-75, who are not dependent on insulin. Furthermore, to be eligible for this research study participants must meet a variety of criteria: receiving treatment from UPMC Diabetes Outpatient or Inpatient services; demonstrating basic understanding of survival skills and treatments associated with hypoglycemia; receiving basal insulin within the three years prior to the start date; possessing an iOS or Android enabled device as well as reliable internet access; being willing and able to use the MDC app."

Answered by AI

Is there still an opportunity to join the experiment?

"Clinicaltrials.gov confirms the status of this trial as inactive, with its first post date on February 15th 2021 and most recent update occurring July 7th 2022. However, 1392 other trials are currently recruiting patients across various medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

My Dose Coach Mobile App to Support Insulin Titration and Maintenance

Linda Siminerio 2021. "My Dose Coach Mobile App to Support Insulin Titration and Maintenance". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04678661.