Type 2 Diabetes MellitusNCT03705260
Quality Initiative to Improve Glucose Control in Type 2 Diabetic Patients
A study testing Intensive Behavioral Intervention and Monthly Screening for Risk in people with Type 2 Diabetes Mellitus, run by University of Michigan at 1 site in United States.
Trial summary
The goal of the Twine / University of Michigan Diabetes Quality Improvement Initiative is to improve diabetes care quality using real time feedback with continuous glucose monitoring (CGM) and dietary coaching for lower carbohydrate consumption in a high-risk sub-cohort of outpatients with type 2 diabetes (T2D). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Intensive Behavioral Intervention and Monthly Screening for Risk
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2018to 20 Jan 2021
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Michigan Medicine patient treated by a physician in the Family Medicine Department at the Chelsea Health Center
- Diagnosis of T2D as recorded in the patient's problem list or as documented by medication list and lab results
- HbA1C >8 for the high-risk sub-cohort
Who cannot join
- Individuals for whom tight control (ie A1C < 8) is not safe or recommended, including but not limited to older frail individuals at high-risk of hypoglycemia and falls or those with a life expectancy of less than 6 months due to a comorbid condition
- Individuals with cognitive or psychological diagnoses that might make CGM or low carbohydrate dieting risky, such as patients with eating disorders, uncontrolled psychotic - mental illness or those patients with dementia
- Women who are pregnant or breast feeding
- Individuals who had previous bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Achieving Improved Control of Blood Glucose Among Type 2 Diabetes Patients Through Continuous Glucose Monitoring & Care Coordinator Mediated Gains in Patient Self-Management Sophistication
The goal of the Twine / University of Michigan Diabetes Quality Improvement Initiative is to improve diabetes care quality using real time feedback with continuous glucose monitoring (CGM) and dietary coaching for lower carbohydrate consumption in a high-risk sub-cohort of outpatients with type 2 diabetes (T2D).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Usual Care, Intensive Behavioral Intervention, Monthly Screening for Risk
- 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.
Usual CareOther
Usual care from Primary Care Physician and dietitian.
Intensive Behavioral InterventionBehavioural
The intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring.
Monthly Screening for RiskOther
Monthly screening of HbA1C to identify patents who have become poorly controlled in the interval.
| Study group | Role | What they receive |
|---|---|---|
| Comparator- High Risk | Active comparator | A high risk sub group of those assigned to the comparator arm will be identified by their most recent A1C > 8. Patients in this group will receive usual care from their Primary Care Physician and dietitian. Receives: Other: Usual Care |
| Comparator- Well Controlled | Active comparator | The low risk sub group from the comparator arm (A1C < 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their Primary Care Physician and their dietitian. Receives: Other: Usual Care |
| Enhanced Care- High Risk | Experimental | A high risk sub group of those assigned to the enhanced care arm will be identified by their most recent A1C > 8. Patients in this group will receive the intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring. Receives: Behavioral: Intensive Behavioral Intervention |
| Enhanced Care- Well Controlled. | Experimental | The low risk sub group from the enhanced care arm (A1C < 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their PCP and their dietitian. If they are found to be poorly controlled through monthly screening for risk, they may have the opportunity to move into the Enhanced Care High Risk group. Receives: Other: Usual Care; Other: Monthly Screening for Risk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin A1C
Hemoglobin A1C
Measured: 1 year
Secondary outcomes (6)
Weight Change
Difference in patient's weight measured in pounds.
Measured: baseline to 1 year
Change in diabetes medication requirements
Change in average daily doses of diabetes medications
Measured: baseline to 1 year
Change in percentage of time glucose is out of range
Change in percentage of time glucose is out of range (70 mg/dl-140 mg/dl) on CGM.
Measured: baseline to 1 year
Blood Pressure
Blood Pressure
Measured: 1 year
Change in rate of Micro-vascular complications
Change in rate of micro-vascular complications. (The micro-vascular complications assessed will be retinopathy, neuropathy, nephropathy)
Measured: Baseline to 1 Year
Change in rate of symptomatic hypoglycemia requiring medical intervention
Change in rate of symptomatic hypoglycemia requiring medical intervention
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start26 Nov 2018
- Primary completion7 Feb 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Twine Clinical Consulting
- Responsible party
- Principal investigator, Caroline Richardson, University of Michigan
- Investigators
- Caroline Richardson, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03705260
- Sponsor's protocol ID
- HUM00147295
- Status last verified
- Feb 2021
- First submitted
- 8 Oct 2018
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Achieving Improved Control of Blood Glucose Among Type 2 Diabetes Patients Through Continuous Glucose Monitoring & Care Coordinator Mediated Gains in Patient Self-Management Sophistication
- ClinicalTrials.gov ID
- NCT03705260
- Acronym / sponsor ID
- HUM00147295
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Twine Clinical Consulting
- Study start
- 26 Nov 2018 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 15 Oct 2018 (actual)
- 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.
The goal of the Twine / University of Michigan Diabetes Quality Improvement Initiative is to improve diabetes care quality using real time feedback with continuous glucose monitoring (CGM) and dietary coaching for lower carbohydrate consumption in a high-risk sub-cohort of outpatients with type 2 diabetes (T2D).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Comparator- High Risk | Active comparator | Other: Usual CareA high risk sub group of those assigned to the comparator arm will be identified by their most recent A1C > 8. Patients in this group will receive usual care from their Primary Care Physician and dietitian. |
| Comparator- Well Controlled | Active comparator | Other: Usual CareThe low risk sub group from the comparator arm (A1C < 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their Primary Care Physician and their dietitian. |
| Enhanced Care- High Risk | Experimental | Behavioral: Intensive Behavioral InterventionA high risk sub group of those assigned to the enhanced care arm will be identified by their most recent A1C > 8. Patients in this group will receive the intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring. |
| Enhanced Care- Well Controlled. | Experimental | Other: Usual Care, Other: Monthly Screening for RiskThe low risk sub group from the enhanced care arm (A1C < 8) and those who are unlikely to benefit from an intensive behavioral intervention will get usual care by their PCP and their dietitian. If they are found to be poorly controlled through monthly screening for risk, they may have the opportunity to move into the Enhanced Care High Risk group. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Michigan Medicine patient treated by a physician in the Family Medicine Department at the Chelsea Health Center
- Diagnosis of T2D as recorded in the patient's problem list or as documented by medication list and lab results
- HbA1C >8 for the high-risk sub-cohort
Key exclusion criteria (4 listed)
- Individuals for whom tight control (ie A1C < 8) is not safe or recommended, including but not limited to older frail individuals at high-risk of hypoglycemia and falls or those with a life expectancy of less than 6 months due to a comorbid condition
- Individuals with cognitive or psychological diagnoses that might make CGM or low carbohydrate dieting risky, such as patients with eating disorders, uncontrolled psychotic - mental illness or those patients with dementia
- Women who are pregnant or breast feeding
- Individuals who had previous bariatric surgery
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 |
|---|---|---|
| Usual CareUsual care from Primary Care Physician and dietitian. | Other | Comparator- High Risk, Comparator- Well Controlled, Enhanced Care- Well Controlled. |
| Intensive Behavioral InterventionThe intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring. | Behavioural | Enhanced Care- High Risk |
| Monthly Screening for RiskMonthly screening of HbA1C to identify patents who have become poorly controlled in the interval. | Other | Enhanced Care- Well Controlled. |
Primary outcome
Hemoglobin A1C
Time frame: 1 year
Hemoglobin A1C
6 secondary outcomes
Weight Change
Time frame: baseline to 1 year
Change in diabetes medication requirements
Time frame: baseline to 1 year
Change in percentage of time glucose is out of range
Time frame: baseline to 1 year
Blood Pressure
Time frame: 1 year
Change in rate of Micro-vascular complications
Time frame: Baseline to 1 Year
Change in rate of symptomatic hypoglycemia requiring medical intervention
Time frame: Baseline to 1 year
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 4 Feb 2021.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes Mellitus
Not yet recruiting
SWitching to Appropriate Prescription in Cardiovascular-Kidney-Metabolic Syndrome
Cardiovascular-kidney-metabolic Syndrome, Diabete Type 2
Active, not recruiting
Pilot of Continuous Glucose Monitor-Augmented Food Is Medicine
Nutrition, Type 2 Diabetes
Recruiting
Whole Food for Families: A Pilot RCT of a Dietary Guidelines-Based Intervention to Prevent Type 2 Diabetes
PreDiabetes, Diet, Healthy
Not yet recruiting
Safety and Efficacy of the Fully Closed Loop iLet Bionic Pancreas in Adults With Type 1 and Type 2 Diabetes
Diabetes (Insulin-requiring, Type 1 or Type 2)
Recruiting
6-Weeks of Blood Flow Restriction Training on Immune Cell Function and Bioenergetics
Type 2 Diabetes
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.
Caroline Richardson, M.D. 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 Intensive Behavioral Intervention and Monthly Screening for Risk in people with Type 2 Diabetes Mellitus, 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 3 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 4 Feb 2021. 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?
Hemoglobin A1C (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2021; AzTrials last refreshed its copy on 2 Nov 2026.