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MedStar Health Type 2 Diabetes Pathway to Control (T2DMBC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02925312
Recruitment Status : Completed
First Posted : October 5, 2016
Results First Posted : July 17, 2020
Last Update Posted : September 23, 2020
Sponsor:
Information provided by (Responsible Party):
Michelle Magee, Medstar Health Research Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Type 2 Diabetes Mellitus
Hyperglycemia
Intervention Other: Diabetes Pathway
Enrollment 419
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intervention Matched Controls
Hide Arm/Group Description

Patients receive the full diabetes pathway intervention

Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication

patients receive standard of care
Period Title: Overall Study
Started 125 294
Completed 98 294
Not Completed 27 0
Reason Not Completed
Lost to Follow-up             25             0
Adverse Event             2             0
Arm/Group Title Intervention Matched Controls Total
Hide Arm/Group Description

Patients receive the full diabetes pathway intervention

Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication

patients receive standard of care Total of all reporting groups
Overall Number of Baseline Participants 121 294 415
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
age between 21 and 75 Number Analyzed 121 participants 294 participants 415 participants
121
 100.0%
294
 100.0%
415
 100.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 121 participants 294 participants 415 participants
Female
67
  55.4%
162
  55.1%
229
  55.2%
Male
54
  44.6%
132
  44.9%
186
  44.8%
1.Primary Outcome
Title Percentage Change in Hemoglobin A1C From Baseline to 3 Months
Hide Description Comparison of the percentage change in A1C from baseline to 3 months between the intervention and the control group
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
Boot camp completers during the study period were compared to concurrent, propensity-matched chart controls.
Arm/Group Title Intervention Matched Controls
Hide Arm/Group Description:

Patients receive the full diabetes pathway intervention

Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication

patients receive standard of care
Overall Number of Participants Analyzed 121 294
Mean (Standard Deviation)
Unit of Measure: percentage
3.08  (2.01) 1.64  (1.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention, Matched Controls
Comments The study was powered to detect a difference of 0.5 in the change in HbA1c with SD=2 with 80% power at alpha=0.05 with a sample size of 128 in each group (paired t-test). Differences in patient characteristics and the unadjusted differences in the outcome measures between the intervention and control groups were tested using linear mixed models, McNemar tests and conditional logistic models due to matching.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
2.Secondary Outcome
Title Risk of Experiencing a Composite Endpoint of All Cause ED Visits and Hospitalizations at 6 Months Post Intervention vs 6 Months Pre-intervention for Cases and Controls.
Hide Description Health care utilization measure. We compared the risk of experiencing an emergency room and/or hospital visit at 6 months from baseline for both groups. this was done by calculating he Incidence Risk Ratio of ED visits/hospitalizations for intervention and control patients to assess whether the pathway impacted the risk for ED visits/hospitalizations at 6 months from baseline and comparing them. We looked at these measures for the 6-month period that preceded the baseline visit and the 6-month period that followed the baseline visit.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Poisson Regression Models of all utilizations (ED + hospitalization) at 6-month visits by Study Groups: Incidence rate ratios (IRRs) reported. In the six months after enrollment, controls are expected to have 0.646 admissions on average, and cases are expected to have 56.8% of the number of admissions that the controls had, or a reduction of 43.2%
Arm/Group Title Intervention Matched Controls
Hide Arm/Group Description:

Patients receive the full diabetes pathway intervention

Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication

patients receive standard of care
Overall Number of Participants Analyzed 98 294
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: ratio of risk incidences
0.568
(0.398 to 0.812)
0.646
(0.561 to 0.745)
3.Secondary Outcome
Title Adherence to Prescribed Diabetes Medications
Hide Description Change in Adherence to Diabetes Medications as Measured Using MMS From Baseline to 3 Months for Intervention Subjects
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was eliminated during the course of the study and data was not collected
Arm/Group Title Intervention Matched Controls
Hide Arm/Group Description:

Patients receive the full diabetes pathway intervention

Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication

patients receive standard of care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Frequency of Eye Exams
Hide Description Change in the Proportion of Patients Receiving an Eye Exam in the 6 Months Following the Start of the Intervention as Compared to Baseline and to Concurrent Chart Controls
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Technology to perform eye exams in primary care offices was not deployed as had been anticipated, therefore data was not collected for this outcome
Arm/Group Title Intervention Matched Controls
Hide Arm/Group Description:

Patients receive the full diabetes pathway intervention

Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication

patients receive standard of care
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Matched Controls
Hide Arm/Group Description

Patients receive the full diabetes pathway intervention

Diabetes Pathway: Medication algorithm, survival skills education, enhanced patient-provider communication

patients receive standard of care
All-Cause Mortality
Intervention Matched Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Intervention Matched Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/121 (0.00%)   0/294 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Matched Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/121 (0.00%)   0/294 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Michelle Magee
Organization: Medstar Health Research Institute
Phone: 2028772383
EMail: michelle.f.magee@medstar.net
Layout table for additonal information
Responsible Party: Michelle Magee, Medstar Health Research Institute
ClinicalTrials.gov Identifier: NCT02925312    
Other Study ID Numbers: 2014-191
First Submitted: October 4, 2016
First Posted: October 5, 2016
Results First Submitted: February 16, 2018
Results First Posted: July 17, 2020
Last Update Posted: September 23, 2020