University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
NCT Number: NCT01920256
Patients with type 2 diabetes can attain superior disease outcomes if multiple therapy goals are simultaneously achieved and maintained. In reality, therapy goals are seldom achieved, and patients become susceptible to devastating complications and greater health care expenses. Studies have shown that regular monitoring and therapy adjustments are a prerequisite to achieving and maintaining therapy goals. Unfortunately implementation of regular monitoring and therapy adjustments have been hindered by high clinic workload and shortage of endocrinologists. Due to this shortage, endocrine care is accessible to less than 20% of patients with type 2 diabetes. The overwhelming majority are managed by providers who may lack the necessary expertise or time to deliver optimal disease management, particularly when insulin is prescribed.
Objectives: We hypothesize that type 2 diabetes endocrine clinics for high-risk patients that complement primary care, personalize the frequency of remote disease interventions and employ infrequent face-to-face outpatient visits, will achieve comparable clinical outcomes and patient satisfaction compared to usual endocrine clinic care, while reducing workload and increasing the clinic capacity. The intervention clinic will employ regular remote communications initiated by the endocrinologists, based on tailored individual plans. Frequent remote monitoring and interventions will reinforce attainment of the therapy goals and allow a decrease in the frequency of outpatient visits. In turn, the clinic workload will decrease and it will be able to accommodate more patients with type 2 diabetes than traditional endocrine clinics. The aims of the study are to test this new endocrine clinic model in a clinical trial by monitoring clinical parameters, patient satisfaction and clinical workload. The long-term objectives are to modify the current model of endocrine care for patients with type 2 diabetes.
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Emerging data suggests that clinical interventions may be implemented successfully by a variety of remote communications. Thus far regular monitoring and treatment adjustments by remote communications have not yet been fully integrated into endocrine practice in a scalable fashion that can be readily disseminated. The PI proposes to test a new endocrine model care clinic for high-risk patients with type 2 diabetes that employs regular communications initiated by the provider, based on a tailored individual plan. Frequent monitoring and interventions will reinforce attainment of prespecified therapy goals, enhance patient engagement, and allow a significant decrease in the frequency of outpatient visits. In turn, the clinic will be able to accommodate more patients with type 2 diabetes than traditional endocrine clinics. Data management and day-to-day clinic operation will be computerized with technology that has been developed by the institution. The project is highly significant since it proposes a new model of endocrine care for high-risk patients with type 2 diabetes that may improved disease outcome in more patients and reduce medical expenses.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
Diabetes and comorbidities management will provided by an endocrinologist
Time frame: 12 months
Measure of long-term blood glucose control and efficacy of intervention
Time frame: 12 months
Measure of total cholesterol, LDL, and Triglycerides
Time frame: 12 months
Systolic and diastolic blood pressure
Time frame: 12 months
Record deaths due to any cause
Time frame: 12 months
Cardiovascular events, cerebrovascular events, peripheral vascular events, limb ulcers and amputations, severe hypoglycemia, and other unscheduled emergency department and hospital visits
Time frame: 12 months
Short Form-36
Time frame: 12 months
Insulin Therapy Satisfaction Questionnaire
Time frame: 12 months
Missed visits, missed phone calls, lost to follow up and drops outs will be recorded for both groups
Time frame: 12 months
Resource utilization and cost for both groups
University of Michigan
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05929079
Apnea, Body Weight
Anniston, Alabama, United States
View Trial DetailsNCT06649344
Diabetes Mellitus, Diabetes Mellitus, Type 2
Tianjin, Tianjin Municipality, China
View Trial DetailsNCT07732218
Diabetes Mellitus, Diabetes Mellitus, Type 2
Peshawar, Khyber Pakhtunkhwa, Pakistan
View Trial DetailsNCT05351359
Diabetes Mellitus, Diabetes Mellitus, Type 2
Prague, Czechia
View Trial Details