An interventional study of Pharmacy Managed Diabetes Clinic (PMDC) and Standard of Care (SOC) in Diabetes Mellitus, Type 2, sponsored by William Beaumont Hospitals. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-30.
Sponsored by William Beaumont Hospitals · Not applicable, Interventional, and Treatment
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Among 3,304 studies in Diabetes Mellitus, Type 2 with a site in United States — 343 open to participants now, 478 under way, 51 of them phase 3. Diabetes Mellitus, Type 2 · United States.
Among the 3,304 studies in Diabetes Mellitus, Type 2 with a site in United States, this one is the 1,518th largest by enrollment of the 2,957 interventional ones that give a count, is one of 126 that started in 2018, is one of 1,240 with no phase, and was the 2,032nd registered.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →343 of the 3,304 studies in Diabetes Mellitus, Type 2 with a site in United States are open now. Recruiting first, the newest first:
Hoffmann-La Roche · Sites in United States, Puerto Rico
Ages 18+
University of Minnesota · Sites in United States
Ages 30–75
Pfizer · Sites in United States
Ages 18+
Rahul Sachdeva · Sites in United States
Ages 18+ · Healthy volunteers
Amgen · Sites in United States, Canada
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
3,304 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 423 · Phase 2 464 · Phase 3 613 · Phase 4 300
First in 1976; this study’s year is marked. 126 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 86 is close to the median of 80 across 8,356 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 90 across the 2,957 interventional studies, 128 across the 336 observational. Of the 2,648 that completed or were terminated, 1,165 (44%) have results posted.
This tab as a report to print or save as PDF → With an account.
1,486 of 3,304 have an industry lead sponsor. The 10 most frequent:
William Beaumont Hospitals is the lead sponsor of 111 studies on the registry; none are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 30 (100%) have results posted.
William Beaumont Hospitals has 3 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
190 of the studies in Diabetes Mellitus, Type 2 with a site in United States that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06858878Phase 3AmgenEfficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT06731075Phase 3Oramed, Ltd.A Phase 3 Study to Evaluate the Efficacy and Safety of ORMD-0801 in Subjects With Type 2 Diabetes Mellitus. | 2027-04-25 |
| NCT07220759Phase 3Novo Nordisk A/SWeight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide | 2027-05-12 |
| NCT07817251Phase 3Novo Nordisk A/SResearch Study on How People With Type 2 Diabetes Tolerate Switching From Semaglutide to Cagrisema | 2027-06-09 |
| NCT06993792Phase 3Eli Lilly and CompanyA Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes | 2027-08 |
Add all 190 to your calendar (.ics) → With an account.
Among the 3,304 studies in Diabetes Mellitus, Type 2 with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The Beaumont Hospital Royal Oak Outpatient Clinic (and other listed Beaumont recruiting locations) care for over 900 patients with diabetes. In an effort to improve the care provided to our patients, a pharmacist managed diabetes clinic (PMDC) was created. The investigators looked at patients with high-risk diabetes who have received education in the PMDC and compared them to patients that didn't not receive the pharmacy education. Our preliminary data showed a significant decrease in Hemoglobin A1c in the PMDC compared to our standard care cohort. Hemoglobin A1c is a marker of the severity of diabetes mellitus. Based on this data, we designed a randomized controlled trial to better assess the impact of a PMDC on diabetic outcomes.
Over the past 20 years, the number of adults with diabetes has tripled in the United States. According to the Centers for Disease Control (CDC), diabetes mellitus (DM) affected 30.2 million American adults in 2015.
Previous studies showed that for each 1% reduction in hemoglobin A1c (HbA1c), there was a corresponding 14% reduction in myocardial infarction, 12% reduction in stroke, and a 37% reduction of microvascular complications.
Based on our preliminary data, a Pharmacist Managed Diabetes Clinic (PMDC) had a decrease in HbA1c of 2.2% in the high-risk diabetes patients from the PMDC cohort versus 0.9% in the standard care cohort (p=0.006). At six months there was a decrease in HbA1c of 3.2% in the PMDC and 1.2% in the standard care cohort (p=0.044).
Our hypothesis is that a pharmacist managed diabetes clinic focused on patient identified diabetes management gaps and goals would have a significant positive impact on diabetes core measures and will result in a higher quality of care at a lower price. A randomized controlled trial (RCT) of our PMDC would provide further clarity on the impact on patient outcomes and important evidence with regard to how the physicians can deliver the best care for this high-risk population.
Trial design This is a randomized open-label, controlled parallel group trial of a pharmacist managed diabetes clinic in high-risk diabetes patients, with a 1:1 allocation to either standard of care (SOC) or SOC and PMDC and a 6-month and 12-month follow-up.
Methods:
The study will be conducted at the listed recruiting sites at Beaumont Hospital. Michigan. The outpatient clinic is a resident clinic that delivers medical care to over 920 patients with diabetes mellitus. The clinic is based on campus at Beaumont Hospital, Royal Oak. Potential subjects with high-risk diabetes mellitus will be identified through weekly reports and from the daily schedule and will be recruited from this pool of patients exclusively.
Intervention The patients will be enrolled over a 6-month period and will be randomly assigned to control group (usual care) and the intervention group (usual care plus PMDC visits). The PMDC is a pharmacist-led clinic that has been functioning in our outpatient clinic since January 2015 and is considered an available resource.
The intervention group patients will be managed by their assigned primary care physicians (PCPs), per standard of care and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The PMDC visits will be scheduled more frequent in the first 2 months of the intervention to ensure patients' engagement and provide enough opportunities and time to address all the patients' goals and concerns. The PMDC visit encounters will focus on patient identified goals for the management of their diabetes. Initial visit in the PMDC will be 60-90 minutes with follow up visits lasting 30-45 minutes. Patients will be asked to describe their own gaps in knowledge and to identify their own management goals. Identification of knowledge gaps will allow targeted patient education to close those gaps. Other educational opportunities will potentially include diabetes mellitus pathophysiology, blood glucose goals, HbA1c goals, management of hyperglycemic and hypoglycemic episodes, review of medications, and counseling regarding diet and exercise. Pharmacists have the discretion to make medication adjustments and initiate new medications pertinent to the management of diabetic comorbidities. The model is a collaborative practice agreement between the pharmacist and the primary care physician.
The control group patients will be managed by their assigned PCPs, per standard of care. Management per standard of care includes referrals to ophthalmology for dilated eye exam, nephrology for nephropathy management, cardiology for macrovascular complications management, neurology for neuropathy or neurologic complications, diabetic education, laboratory studies, and vaccinations and will be ordered or performed at the discretion of each patient's PCP.
Outside the intervention, the participants in both groups will be treated identical. They will participate in the standard of care visits at baseline, at 3 months and at 6 months. These visits (visit 1, 6 and 9 in the intervention group and visit 1, 2 and 3 in the standard of care group) will be provided by each patient's primary care physician
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The control group patients will be managed by their assigned PCPs, per Standard of Care (SOC), per American Diabetes Association Guidelines. Management per standard of care includes referrals to ophthalmology for dilated eye exam, nephrology for nephropathy management, cardiology for macrovascular complications management, neurology for neuropathy or neurologic complications, diabetic education, laboratory studies, and vaccinations and will be ordered or performed at the discretion of each patient's PCP
Other: Standard of Care (SOC)
The intervention group patients will be managed by their assigned primary care physicians (PCPs), per American Diabetes Association Guidelines for Standard of Care (SOC) and will have scheduled six extra face-to-face visits with the pharmacists for the 6 month duration of the intervention. The pharmacy managed diabetes clinic (PMDC) visit encounters will focus on patient identified goals for the management of their diabetes. Pharmacists have the discretion to make medication adjustments and initiate new medications pertinent to the management of diabetic comorbidities. The model is a collaborative practice agreement between the pharmacist and the primary care physician.
Behavioral: Pharmacy Managed Diabetes Clinic (PMDC) · Other: Standard of Care (SOC)
The PMDC visit encounters will focus on patient identified goals for the management of their diabetes. Initial visit in the PMDC will be 60-90 minutes with follow up visits lasting 30-45 minutes.
Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
Hemoglobin A1c at 6 Months
change from baseline in Hemoglobin A1c, measured in % DCCT (Diabetes Control and Complications Trial) units
Time frame: 6 months
Hemoglobin A1c at 12 Months
change from baseline in Hemoglobin A1c
Time frame: 12 months
Hemoglobin A1c Less Than 8% at 6 Months
Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0%
Time frame: 6 months
Hemoglobin A1c Less Than 8% at 12 Months
Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0% DCCT units
Time frame: 12 months
Change in Hemoglobin A1c From 6 to 12 Months
The change in hemoglobin A1c (HbA1c), between 6 months and 12 months after randomization.
Time frame: 12 months
Achievement of Annual Lipid Panel Testing
percentage of patients complying with annual lipid testing
Time frame: 12 months
Statin Compliance
Percentage of patients compliant with statin therapy per the 2013 American College of Cardiology / American Heart Association guidelines.
Time frame: 12 months
Blood Pressure
Percentage of patients achieving Blood pressure goal of less than 140/90 at the end of the trial period.
Time frame: 12 months
Annual Retinopathy Examination
Percentage of patients compliant with annual retinopathy examination
Time frame: 12 months
Annual Nephropathy Examination
Percentage of patients compliant with annual nephropathy examination
Time frame: 12 months
Annual Neuropathy Examination
Percentage of patients compliant with annual neuropathy examination
Time frame: 12 months
Annual Influenza Vaccine
Percentage of patients compliant with annual influenza vaccine
Time frame: 12 months
Annual Pneumonia Vaccine
Percentage of patients compliant with annual pneumonia vaccine
Time frame: 12 months
Quality of Life Assessment
Difference between quality of life assessment via the World Health Organization BREF-Quality Of Life at baseline and 12 months.The WHOQOL-BREF consists of 4 domains, Physical Health, Psychological, Social Relationships, and Environment. Each domain is comprised of multiple questions that are considered together in the derivation of each domain score. In addition to the 4 domains, the WHOQOL-BREF includes two stand-alone questions to assess rated QOL and Satisfaction with Health questionnaire administered at baseline and at the conclusion of the trial period. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life) and range from a minimum of 4 to a maximum of 20. The mean score of items within each domain is used to calculate the domain score.A Likert scale from 1-7 was used. (1 - not affected, 7- extremely affected) We compared and reported the mean difference in between 6 months data and baseline data.
Time frame: 12 months
Diabetes Related EC Visits at 6 Months
Number of Emergency Center (EC) visits related to hyperglycemia or hypoglycemia
Time frame: 6 months
Diabetes Related EC Visits at 12 Months
Number of Emergency Center (EC) visits related to hyperglycemia or hypoglycemia
Time frame: 12 months
Total EC Visits at 6 Months
Number of Emergency Center (EC) visits
Time frame: 6 months
Total EC Visits at 12 Months
Number of Emergency Center (EC) visits
Time frame: 12 months
Inpatient Visits
Total number of inpatient visits
Time frame: 12 months
Outpatient Visits
total number of outpatient visits
Time frame: 12 months
No-show
percentage of visits missed in clinic
Time frame: 12 months
| Milestone | Standard Of Care | SOC and PMDC |
|---|---|---|
| Started | 42 | 44 |
| Completed | 42 | 44 |
| Not completed | 0 | 0 |
change from baseline in Hemoglobin A1c, measured in % DCCT (Diabetes Control and Complications Trial) units
| percentage of DCCT units | Standard Of Care | SOC and PMDC |
|---|---|---|
| Hemoglobin A1c at 6 Months | -1.32 ± 1.66 | -2.85 ± 2.69 |
change from baseline in Hemoglobin A1c
| percentage of DCCT unit | Standard Of Care | SOC and PMDC |
|---|---|---|
| Hemoglobin A1c at 12 Months | -1.52 ± 1.92 | -2.79 ± 2.41 |
Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0%
| Participants | Standard Of Care | SOC and PMDC |
|---|---|---|
| Hemoglobin A1c Less Than 8% at 6 Months | 10 | 21 |
Percentage of patients achieving a hemoglobin A1c measurement of less than 8.0% DCCT units
| Participants | Standard Of Care | SOC and PMDC |
|---|---|---|
| Hemoglobin A1c Less Than 8% at 12 Months | 11 | 16 |
The change in hemoglobin A1c (HbA1c), between 6 months and 12 months after randomization.
No measurements were reported for this outcome.
percentage of patients complying with annual lipid testing
| Participants | Standard Of Care | SOC and PMDC |
|---|---|---|
| Achievement of Annual Lipid Panel Testing | 24 | 26 |
Percentage of patients compliant with statin therapy per the 2013 American College of Cardiology / American Heart Association guidelines.
| Participants | Standard Of Care | SOC and PMDC |
|---|---|---|
| Statin Compliance | 37 | 35 |
Percentage of patients achieving Blood pressure goal of less than 140/90 at the end of the trial period.
| Participants | Standard Of Care | SOC and PMDC |
|---|---|---|
| Blood Pressure | 26 | 21 |
Percentage of patients compliant with annual retinopathy examination
| Participants | Standard Of Care | SOC and PMDC |
|---|---|---|
| Annual Retinopathy Examination | 25 | 25 |
Percentage of patients compliant with annual nephropathy examination
| Participants | Standard Of Care | SOC and PMDC |
|---|---|---|
| Annual Nephropathy Examination | 30 | 26 |
Percentage of patients compliant with annual neuropathy examination
| Participants | Standard Of Care | SOC and PMDC |
|---|---|---|
| Annual Neuropathy Examination | 30 | 29 |
Percentage of patients compliant with annual influenza vaccine
| Participants | Standard Of Care | SOC and PMDC |
|---|---|---|
| Annual Influenza Vaccine | 21 | 20 |
Percentage of patients compliant with annual pneumonia vaccine
| Participants | Standard Of Care | SOC and PMDC |
|---|---|---|
| Annual Pneumonia Vaccine | 31 | 27 |
Difference between quality of life assessment via the World Health Organization BREF-Quality Of Life at baseline and 12 months.The WHOQOL-BREF consists of 4 domains, Physical Health, Psychological, Social Relationships, and Environment. Each domain is comprised of multiple questions that are considered together in the derivation of each domain score. In addition to the 4 domains, the WHOQOL-BREF includes two stand-alone questions to assess rated QOL and Satisfaction with Health questionnaire administered at baseline and at the conclusion of the trial period. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life) and range from a minimum of 4 to a maximum of 20. The mean score of items within each domain is used to calculate the domain score.A Likert scale from 1-7 was used. (1 - not affected, 7- extremely affected) We compared and reported the mean difference in between 6 months data and baseline data.
| score on a scale | Standard Of Care | SOC and PMDC |
|---|---|---|
| Quality of Life Assessment | -0.31 ± 2.05 | -0.78 ± 2.07 |
Number of Emergency Center (EC) visits related to hyperglycemia or hypoglycemia
| number of visits | Standard Of Care | SOC and PMDC |
|---|---|---|
| Diabetes Related EC Visits at 6 Months | 0.10 ± 0.37 | 0.00 ± 0.00 |
Number of Emergency Center (EC) visits related to hyperglycemia or hypoglycemia
| number of visits | Standard Of Care | SOC and PMDC |
|---|---|---|
| Diabetes Related EC Visits at 12 Months | 0.12 ± 0.40 | 0.02 ± 0.15 |
Number of Emergency Center (EC) visits
| number of visits | Standard Of Care | SOC and PMDC |
|---|---|---|
| Total EC Visits at 6 Months | 0.62 ± 0.99 | 0.68 ± 1.12 |
Number of Emergency Center (EC) visits
| number of visits | Standard Of Care | SOC and PMDC |
|---|---|---|
| Total EC Visits at 12 Months | 1.05 ± 1.29 | 1.09 ± 1.65 |
Total number of inpatient visits
| number of visits | Standard Of Care | SOC and PMDC |
|---|---|---|
| Inpatient Visits | 0.71 ± 1.94 | 0.73 ± 1.13 |
total number of outpatient visits
| number of visits | Standard Of Care | SOC and PMDC |
|---|---|---|
| Outpatient Visits | 7.60 ± 5.69 | 7.55 ± 4.25 |
percentage of visits missed in clinic
No measurements were reported for this outcome.
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Of Care | — | — | — |
| SOC and PMDC | — | — | — |
| Age, Continuous(years) | Standard Of Care | SOC and PMDC | Total |
|---|---|---|---|
| Mean | 53.40 ± 8.10 | 52.00 ± 9.67 | 52.69 ± 8.92 |
| Sex: Female, Male(Participants) | Standard Of Care | SOC and PMDC | Total |
|---|---|---|---|
| Female | 26 | 24 | 50 |
| Male | 16 | 20 | 36 |
| Race (NIH/OMB)(Participants) | Standard Of Care | SOC and PMDC | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 20 | 26 | 46 |
| White | 21 | 17 | 38 |
| More than one race | 1 | 1 | 2 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Standard Of Care | SOC and PMDC | Total |
|---|---|---|---|
| United States | 42 | 44 | 86 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in May 2020, 27 months.
Results were first posted in Jun 2021, 1 year after primary completion.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's 27 months is above that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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