Type 2 DiabetesNCT01920256
Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care
A study testing Remote, personalized type 2 diabetes care. and Usual Endocrine care. in people with Type 2 Diabetes, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Remote, personalized type 2 diabetes care. and Usual Endocrine care.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men or women aged ≥18 years of age;
- Clinical diagnosis of type 2 diabetes (as defined by the American Diabetes Association 2);
- Treated with insulin or at least two diabetes medications;
- Have A1C ≥8.0% and ≤11.0%;
- Able and willing to use telephone or other sorts of communication regularly between clinic visits.
Who cannot join
- Do not speak English;
- Unwilling or unable to provide informed consent;
- Have any condition associated with life expectancy of less than 3 years;
- Have an active mental illness or substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Health System
Ann Arbor, Michigan, 48109
About this study
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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Remote, personalized type 2 diabetes care., Usual Endocrine care.
- Keywords
- Insulin therapy, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote, personalized type 2 diabetes care.Other
Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
Usual Endocrine care.Other
Diabetes and comorbidities management will provided by an endocrinologist
| Study group | Role | What they receive |
|---|---|---|
| Personalized type 2 diabetes care. | Experimental | Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments. Receives: Other: Remote, personalized type 2 diabetes care. |
| Usual Endocrine Care | Active comparator | Usual Endocrine care will be provided by an endocrinologist. Receives: Other: Usual Endocrine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in baseline A1C (glycated hemoglobin) at 12 months
Measure of long-term blood glucose control and efficacy of intervention
Measured: 12 months
Secondary outcomes (6)
Change in baseline lipids at 12 months
Measure of total cholesterol, LDL, and Triglycerides
Measured: 12 months
Change in baseline blood pressure at 12 months
Systolic and diastolic blood pressure
Measured: 12 months
All cause mortality
Record deaths due to any cause
Measured: 12 months
Acute complications
Cardiovascular events, cerebrovascular events, peripheral vascular events, limb ulcers and amputations, severe hypoglycemia, and other unscheduled emergency department and hospital visits
Measured: 12 months
Change in baseline Quality of life at 12 months
Short Form-36
Measured: 12 months
Change in baseline insulin satisfaction at 12 months
Insulin Therapy Satisfaction Questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionMar 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Israel Hodish MD PhD, University of Michigan
- Investigators
- Israel Hodish, MD, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01920256
- Sponsor's protocol ID
- UMichigan
- Status last verified
- Oct 2018
- First submitted
- 2 Aug 2013
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: Experimental group patients informed of A1C results.
Publications
Klingeman H, Funnell M, Jhand A, Lathkar-Pradhan S, Hodish I. Type 2 diabetes specialty clinic model for the accountable care organization era. J Diabetes Complications. 2017 Oct;31(10):1521-1526. doi: 10.1016/j.jdiacomp.2017.05.011. Epub 2017 May 25.
PubMed 28793967
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Provider-Initiated Regular Remote Interventions for Optimal Type 2 Diabetes Care
- ClinicalTrials.gov ID
- NCT01920256
- Acronym / sponsor ID
- UMichigan
- Conditions
- Type 2 Diabetes
- Keywords
- Insulin therapy, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Mar 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 9 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized type 2 diabetes care. | Experimental | Other: Remote, personalized type 2 diabetes care.Remote, personalized type 2 diabetes clinic provided by an endocrinologist using frequent remote contacts for medication adjustments. |
| Usual Endocrine Care | Active comparator | Other: Usual Endocrine care.Usual Endocrine care will be provided by an endocrinologist. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men or women aged ≥18 years of age;
- Clinical diagnosis of type 2 diabetes (as defined by the American Diabetes Association 2);
- Treated with insulin or at least two diabetes medications;
- Have A1C ≥8.0% and ≤11.0%;
- Able and willing to use telephone or other sorts of communication regularly between clinic visits.
Key exclusion criteria (4 listed)
- Do not speak English;
- Unwilling or unable to provide informed consent;
- Have any condition associated with life expectancy of less than 3 years;
- Have an active mental illness or substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Remote, personalized type 2 diabetes care.Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely. | Other | Personalized type 2 diabetes care. |
| Usual Endocrine care.Diabetes and comorbidities management will provided by an endocrinologist | Other | Usual Endocrine Care |
Primary outcome
Change in baseline A1C (glycated hemoglobin) at 12 months
Time frame: 12 months
Measure of long-term blood glucose control and efficacy of intervention
6 secondary outcomes
Change in baseline lipids at 12 months
Time frame: 12 months
Change in baseline blood pressure at 12 months
Time frame: 12 months
All cause mortality
Time frame: 12 months
Acute complications
Time frame: 12 months
Change in baseline Quality of life at 12 months
Time frame: 12 months
Change in baseline insulin satisfaction at 12 months
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2018.
- Background: PubMed 28793967Klingeman H, Funnell M, Jhand A, Lathkar-Pradhan S, Hodish I. Type 2 diabetes specialty clinic model for the accountable care organization era. J Diabetes Complications. 2017 Oct;31(10):1521-1526. doi: 10.1016/j.jdiacomp.2017.05.011. Epub 2017 May 25.
- Individual participant dataSharing planned: No. Experimental group patients informed of A1C results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Israel Hodish, MD, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote, personalized type 2 diabetes care. and Usual Endocrine care. in people with Type 2 Diabetes, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in baseline A1C (glycated hemoglobin) at 12 months (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01920256, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2018.