Trial Outcomes & Findings for MedStar Diabetes Pathway Chart Reviews (NCT NCT03442595)

NCT ID: NCT03442595

Last Updated: 2020-10-20

Results Overview

Change in Hemoglobin A1C from baseline to 12-16 weeks for both cases and controls

• Recruitment status: COMPLETED
• Target enrollment: 826 participants
• Primary outcome timeframe: 12-16 weeks
• Results posted on: 2020-10-20

Participant Flow

Participant milestones

Measure	Cases patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.	Matched Controls patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
Overall Study STARTED	460	366
Overall Study COMPLETED	366	366
Overall Study NOT COMPLETED	94	0

Reasons for withdrawal

Measure	Cases patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.	Matched Controls patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
Overall Study Lost to Follow-up	94	0

Baseline Characteristics

460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis

Baseline characteristics by cohort

Measure	Cases n=366 Participants Adult patients with uncontrolled type 2 diabetes mellitus and A1C\>/= 9% that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.	Concurrent Matched Controls n=366 Participants Adult patients with uncontrolled type 2 diabetes and A1C\>/=9% that propensity match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider	Total n=732 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis	0 Participants n=7 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis	0 Participants n=5 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis
Age, Categorical Between 18 and 65 years	293 Participants n=5 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis	293 Participants n=7 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis	586 Participants n=5 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis
Age, Categorical >=65 years	73 Participants n=5 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis	73 Participants n=7 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis	146 Participants n=5 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis
Sex: Female, Male Female	225 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	233 Participants n=7 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	458 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis
Sex: Female, Male Male	141 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	133 Participants n=7 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	274 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis	3 Participants n=7 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis	7 Participants n=5 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis
Ethnicity (NIH/OMB) Not Hispanic or Latino	362 Participants n=5 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis	363 Participants n=7 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis	725 Participants n=5 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis	0 Participants n=7 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis	0 Participants n=5 Participants • 460 patients were enrolled but only the 366 that completed the boot camp were included in the analysis
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	0 Participants n=7 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	0 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis
Race (NIH/OMB) Asian	4 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	4 Participants n=7 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	8 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	2 Participants n=7 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	6 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis
Race (NIH/OMB) Black or African American	296 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	284 Participants n=7 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	580 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis
Race (NIH/OMB) White	48 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	53 Participants n=7 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	101 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis
Race (NIH/OMB) More than one race	5 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	5 Participants n=7 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	10 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	18 Participants n=7 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis	27 Participants n=5 Participants • 460 patients were enrolled but only the 366 patients that completed the boot camp were included in the analysis
Region of Enrollment United States	366 participants n=5 Participants • 460 were enrolled but only the 366 patients that completed the boot camp were included in the final analysis of results.	366 participants n=7 Participants • 460 were enrolled but only the 366 patients that completed the boot camp were included in the final analysis of results.	732 participants n=5 Participants • 460 were enrolled but only the 366 patients that completed the boot camp were included in the final analysis of results.
Hemoglobin A1C >/=9%	11.2 % STANDARD_DEVIATION 1.7 • n=5 Participants • A total of 460 patients started the diabetes boot camp (cases) during the study period, but only 366 completed it and were included in the results analysis.	11.3 % STANDARD_DEVIATION 1.6 • n=7 Participants • A total of 460 patients started the diabetes boot camp (cases) during the study period, but only 366 completed it and were included in the results analysis.	11.23 % STANDARD_DEVIATION 1.6 • n=5 Participants • A total of 460 patients started the diabetes boot camp (cases) during the study period, but only 366 completed it and were included in the results analysis.

PRIMARY outcome

Timeframe: 12-16 weeks

Population: Hemoglobin A1C was measured at baseline and at 3 months in both groups.

Change in Hemoglobin A1C from baseline to 12-16 weeks for both cases and controls

Outcome measures

Measure	Cases n=366 Participants patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.	Matched Controls n=366 Participants patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
Percent Change in A1C	-3.06 % change Standard Deviation 1.98	-1.44 % change Standard Deviation 2.11

SECONDARY outcome

Timeframe: 30 days

Comparison of risk of incurring an emergency room visits at 30 days from baseline for cases and controls. This was done by calculating and comparing the incidence risk ratio for an ER visit for each group and comparing them.

Outcome measures

Measure	Cases n=366 Participants patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.	Matched Controls n=366 Participants patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
Risk for Emergency Room Visits at 30 Days From Baseline as Measured by Incidence Risk Ratio	0.79 ratio of risk incidences Interval 0.42 to 1.47	0.39 ratio of risk incidences Interval 0.22 to 0.71

SECONDARY outcome

Timeframe: 30 days

Comparison of risk for experiencing a hospital visit within 30 days from baseline in both group. This was done by calculating the incidence risk ratio for hospitalizations for cases and controls at 30 days from baseline and comparing them.

Outcome measures

Measure	Cases n=366 Participants patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.	Matched Controls n=366 Participants patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
Risk for Hospitalizations at 30 Days From Baseline	0.21 ratio of risk incidences Interval 0.07 to 0.6	1.14 ratio of risk incidences Interval 0.47 to 2.75

SECONDARY outcome

Timeframe: 30 days

Comparison for risk of experiencing a visit to the emergency room and/or the hospital at 30 days from baseline. This was measured by calculating the Incidence risk ratio for acute care utilization at 30 days from baseline for both cases and controls and comparing them.

Outcome measures

Measure	Cases n=366 Participants patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.	Matched Controls n=366 Participants patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
Risk for Composite of Emergency Room Visits and Hospitalizations at 30 Days From Baseline	0.55 ratio of risk incidences Interval 0.34 to 0.9	0.53 ratio of risk incidences Interval 0.33 to 0.84

SECONDARY outcome

Timeframe: 90 days

Comparison of the risk of experiencing an emergency room visit at 90 days from baseline in both groups. This was done by calculating the Incidence risk ratio for an emergency room visit at 90 days for both cases and controls and comparing them

Outcome measures

Measure	Cases n=366 Participants patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.	Matched Controls n=366 Participants patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
Risk for Emergency Room Visits at 90 Days From Baseline	0.62 ratio of risk incidences Interval 0.42 to 0.92	0.66 ratio of risk incidences Interval 0.45 to 0.96

SECONDARY outcome

Timeframe: 90 days

Comparison of the risk for experiencing a hospitalization within 90 days from baseline in both groups. This was done by calculating the Incidence Risk Ratio for hospitalizations for cases and controls within 90 days of baseline and comparing them.

Outcome measures

Measure	Cases n=366 Participants patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.	Matched Controls n=366 Participants patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
Risk for Hospitalizations at 90 Days From Baseline	0.23 ratio of risk incidences Interval 0.11 to 0.5	1.58 ratio of risk incidences Interval 0.75 to 3.33

SECONDARY outcome

Timeframe: 90 days

Comparison of the risk for experiencing a hospitalization and/or emergency room visit within 90 days from baseline for both groups. This was done by calculating then comparing the incidence risk ratio for acute care utilization within 90 days from baseline for cases and controls.

Outcome measures

Measure	Cases n=366 Participants patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.	Matched Controls n=366 Participants patients with uncontrolled type 2 diabetes that match the cases on 5 criteria and received standard of care diabetes management with a MedStar provider
Composite of Risk for Hospitalizations and Emergency Room Visits Within 90 Days From Baseline	0.49 ratio of risk incidences Interval 0.36 to 0.67	0.80 ratio of risk incidences Interval 0.58 to 1.1

Adverse Events

Cases

Serious events: 5 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cases n=460 participants at risk patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.
Cardiac disorders worsening pre-existing heart failure	0.22% 1/460 • Number of events 1 • Adverse events were collected during the 90 days that patients were enrolled in the diabetes boot camp The definition of adverse events used was the same as from clinicaltrials.gov. Deaths and adverse events were not monitored/assessed for the matched controls as these patients were receiving diabetes standard of care and the matching was performed once the cases had completed the intervention.
Cardiac disorders Chest pain requiring hospitalization	0.43% 2/460 • Number of events 2 • Adverse events were collected during the 90 days that patients were enrolled in the diabetes boot camp The definition of adverse events used was the same as from clinicaltrials.gov. Deaths and adverse events were not monitored/assessed for the matched controls as these patients were receiving diabetes standard of care and the matching was performed once the cases had completed the intervention.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) New diagnosis of breast cancer	0.22% 1/460 • Number of events 1 • Adverse events were collected during the 90 days that patients were enrolled in the diabetes boot camp The definition of adverse events used was the same as from clinicaltrials.gov. Deaths and adverse events were not monitored/assessed for the matched controls as these patients were receiving diabetes standard of care and the matching was performed once the cases had completed the intervention.
Vascular disorders Deep vein Thrombosis requiring intervention	0.22% 1/460 • Number of events 1 • Adverse events were collected during the 90 days that patients were enrolled in the diabetes boot camp The definition of adverse events used was the same as from clinicaltrials.gov. Deaths and adverse events were not monitored/assessed for the matched controls as these patients were receiving diabetes standard of care and the matching was performed once the cases had completed the intervention.

Other adverse events

Measure

Cases n=460 participants at risk patients with uncontrolled type 2 diabetes mellitus that participate in the MedStar Diabetes Pathway Intensive diabetes education and medication management: Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.

Musculoskeletal and connective tissue disorders Diabetic neuropathy

0.65% 3/460 • Number of events 3 • Adverse events were collected during the 90 days that patients were enrolled in the diabetes boot camp The definition of adverse events used was the same as from clinicaltrials.gov. Deaths and adverse events were not monitored/assessed for the matched controls as these patients were receiving diabetes standard of care and the matching was performed once the cases had completed the intervention.

Additional Information

Dr Michelle F Magee, Director MedStar Diabetes Institute

MedStar Health

Phone: 202-877-2383

Email: michelle.f.magee@medstar.net

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place