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Pharmacist-Led Care for Diabetes

Waitlist Available
Led By Kathryn E. Callahan, MD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Currently taking a sulfonylurea or insulin for Type 2 Diabetes Mellitus (T2DM)
At least 2 consecutive International Classification of Diseases 10th Revision (ICD-10) codes for type two diabetes mellitus in the prior 2 years
Screening 3 weeks
Treatment Varies
Follow Up baseline through month 18
Awards & highlights

Study Summary

This trial is testing whether a pharmacist-led diabetes management program can help optimize care and lower blood sugar for older adults with diabetes, by meeting with them and potentially adjusting their medications.

Who is the study for?
This trial is for older adults with Type 2 Diabetes who are taking certain diabetes medications, have had a specific level of blood sugar control in the past two years, and can communicate in English by phone. They must be part of a specific healthcare organization and not have severe hearing loss or dementia.Check my eligibility
What is being tested?
The study tests if a pharmacist-led program can improve diabetes care for older adults by adjusting their medication to meet guidelines. Participants will work with pharmacists alongside their doctors and undergo routine bloodwork as part of the management program.See study design
What are the potential side effects?
Potential side effects may include changes related to medication adjustments such as low blood sugar levels (hypoglycemia), especially since insulin or sulfonylureas are involved which commonly cause this when dosages are altered.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am currently using insulin or sulfonylurea for my Type 2 Diabetes.
I have been diagnosed with type 2 diabetes in the last 2 years.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through month 18
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through month 18 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 in HbA1c
Estimated Change in Out-of-Pocket Costs
Feasibility Measures: Effort Required to Enroll-Average Call Duration
+8 more
Secondary outcome measures
Implementation Metric- Value
Implementation Metric-- Acceptability
Implementation Metric-- Appropriateness
+5 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Active InterventionExperimental Treatment1 Intervention
Subjects are mailed Information about Type 2 Diabetes Mellitus (T2DM) Guidelines and Appointment Information (Face to face [F2F] or Telehealth). They attend up to 3 pharmacist visits, depending on if they reach target glucose levels. And they attend interviews. They also have month 6 follow up.
Group II: Active DeclinersActive Control1 Intervention
Subjects who decline intervention. Standard of care treatment with month 6 follow up.
Group III: ControlActive Control1 Intervention
Subjects in this arm will receive standard of care treatment with no intervention. They will receive month 6 follow up.

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,239 Previous Clinical Trials
1,004,083 Total Patients Enrolled
Kathryn E. Callahan, MDPrincipal InvestigatorAtrium Health Wake Forest Baptist Health
1 Previous Clinical Trials
2,050 Total Patients Enrolled

Media Library

Pharmacist-Led Optimization Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05047237 — N/A
Type 2 Diabetes Research Study Groups: Active Decliners, Control, Active Intervention
Type 2 Diabetes Clinical Trial 2023: Pharmacist-Led Optimization Intervention Highlights & Side Effects. Trial Name: NCT05047237 — N/A
Pharmacist-Led Optimization Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05047237 — N/A

Frequently Asked Questions

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

What are the main goals of this clinical trial?

"The primary metric this trial will monitor through 6 months after the baseline is patients' out-of-pocket costs. The secondary metrics encompass an appropriateness questionnaire (ranging from 4 to 20, with a higher score implying more favourable responses), mortality rate (from EHR and NC death registry data) as well as acceptability of the intervention by participants via another questionnaire ranging from 4 to 20."

Answered by AI

How many participants are engaged in this research project?

"Indeed, clinicaltrials.gov confirms that this investigation is currently recruiting participants. It was launched on October 29th 2021 and the data was last revised in November 1st 2022; it seeks to enroll 100 individuals from one medical centre."

Answered by AI

Does this research endeavor currently have vacancies for enrollees?

"Confirmative; the clinical trial is actively sourcing participants according to information available on clinicaltrials.gov. This research project was initially posted on October 29th, 2021 and has since had its details updated as recently as November 1st, 2022."

Answered by AI
~17 spots leftby Nov 2024