MedStar Health Type 2 Diabetes Pathway to Control (T2DMBC)

• 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: Medstar Health Research Institute
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Intervention	Matched Controls
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

Baseline Characteristics

Arm/Group Title		Intervention	Matched Controls	Total
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
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%

Outcome Measures

1. Primary Outcome

Title	Percentage Change in Hemoglobin A1C From Baseline to 3 Months
Description	Comparison of the percentage change in A1C from baseline to 3 months between the intervention and the control group
Time Frame	3 months

Outcome Measure Data

Analysis Population Description

Boot camp completers during the study period were compared to concurrent, propensity-matched chart controls.

Arm/Group Title	Intervention	Matched Controls
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)

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.
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

Outcome Measure Data

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
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
Description	Change in Adherence to Diabetes Medications as Measured Using MMS From Baseline to 3 Months for Intervention Subjects
Time Frame	90 days

Outcome Measure Data

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
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
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

Outcome Measure Data

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
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.

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Intervention	Matched Controls
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	--/--	--/--
Serious Adverse Events
	Intervention	Matched Controls
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/121 (0.00%)	0/294 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr Michelle Magee
• Organization: Medstar Health Research Institute
• Phone: 2028772383
• EMail: michelle.f.magee@medstar.net

Publications:

Magee MF, Baker KM, Fernandez SJ, Huang CC, Mete M, Montero AR, Nassar CM, Sack PA, Smith K, Youssef GA, Evans SR. Redesigning ambulatory care management for uncontrolled type 2 diabetes: a prospective cohort study of the impact of a Boot Camp model on outcomes. BMJ Open Diabetes Res Care. 2019 Nov 13;7(1):e000731. doi: 10.1136/bmjdrc-2019-000731. eCollection 2019.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Montero AR, Toro-Tobon D, Gann K, Nassar CM, Youssef GA, Magee MF. Implications of remote monitoring Technology in Optimizing Traditional Self-Monitoring of blood glucose in adults with T2DM in primary care. BMC Endocr Disord. 2021 Nov 10;21(1):222. doi: 10.1186/s12902-021-00884-6.

• 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