Trial Outcomes & Findings for Technology-assisted Case Management in Adults With Type 2 Diabetes (NCT NCT01373489)

NCT ID: NCT01373489

Last Updated: 2024-07-12

Results Overview

Hemoglobin A1c (HbA1c) was measured at 6 months post randomization

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 113 participants
• Primary outcome timeframe: 6 months post randomization
• Results posted on: 2024-07-12

Participant Flow

Participant milestones

Measure	Usual Care Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy.	Technology-assisted Case Management (TACM) This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach. Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time.
Overall Study STARTED	59	54
Overall Study COMPLETED	44	41
Overall Study NOT COMPLETED	15	13

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Technology-assisted Case Management in Adults With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Usual Care n=59 Participants Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy.	Technology-assisted Case Management (TACM) n=54 Participants This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach. Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time.	Total n=113 Participants Total of all reporting groups
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants	54 Participants n=7 Participants	113 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants	44 Participants n=7 Participants	92 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	46 Participants n=5 Participants	39 Participants n=7 Participants	85 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	11 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months post randomization

Population: Final analysis used baseline A1c analysis of covariance for differences in levels of A1c at 6 months between the treatment groups with baseline A1c as covariate.

Hemoglobin A1c (HbA1c) was measured at 6 months post randomization

Outcome measures

Measure	Usual Care n=59 Participants Typical office-based practice. In this setting the patient is custodian of his/her own care. Between scheduled visits, the patient is responsible for complying with prescribed treatment including medications, diet and exercise regimen, blood glucose monitoring, and follow up visits. Contact between scheduled visits is patient-initiated and occurs when the patient perceives a problem with the treatment plan. For patients with poorly controlled T2DM, which is often asymptomatic prior to the onset of serious complications, this is a particularly ineffective strategy.	Technology-assisted Case Management (TACM) n=54 Participants This model capitalizes on information technology like the FORA system to link a case manager to poorly controlled diabetics in real time. Clearly a model that is applicable only to patients in need of intensive intervention, the advantages includes accurate data transfer to a medical decision maker and positive reinforcement/feedback to the patient via the FORA system to enhance adherence. If the case manager has physician-supervised prescriptive authority, then medication adjustments can be made daily or weekly, if needed, to achieve and maintain control. More frequent interventions, combined with improved compliance with medications and testing frequency, the strategies that are known to work, are enabled by this approach. Technology-Assisted Case Management (TACM with the FORA 2-in-1 Telehealth System): The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time.
Hemoglobin A1c (HbA1c) at 6 Months Post Randomization	10.0 percentage of glycosylated hemoglobin Standard Deviation 2.7	9.0 percentage of glycosylated hemoglobin Standard Deviation 1.9

Adverse Events

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Technology-assisted Case Management (TACM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jennifer Campbell

Medical College of Wisconsin

Phone: 4149558829

Email: jacampbell@mcw.edu

Results disclosure agreements

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