Type 1 DiabetesNCT00675311
Remote Monitoring in Diabetes Disease Management
A study testing DM-Standard and Disease Management Plus in people with Type 1 Diabetes and Type 2 Diabetes, run by LifeScan at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease than a standard disease management program. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Type 1 Diabetes, Type 2 Diabetes
- What is being tested?
- DM-Standard and Disease Management Plus
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Dec 2009
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Between 18 and 64 years of age as of January 1, 2008
- Diagnosis of diabetes mellitus (listed ICD-9-CM diagnosis code on two or more outpatient claims, or on one or more inpatient admissions or emergency room claims in the most recent 12-month period)
- Continuously enrolled in a health plan with pharmacy and medical benefits for the most recent 12-month period or with one period of non-enrollment up to only 30 days
- Able to provide written informed consent for study participation
Who cannot join
- Advanced renal disease (one or more claims in the most recent 12-month period) as defined by a claim for nephropathy or creatinine greater than 2.5 mg/dl
- Selected cancers (one or more claims in the most recent 12-month period)
- HIV/AIDS (one or more claims in the most recent 12-month period)
- Heart, liver, kidney, or multiple organ transplant (one or more claims in the most recent 12-month period)
- Cirrhosis of the liver (one or more claims in the most recent 12-month period)
- Current participation in another LifeScan study or other diabetes-related clinical trials
- Medicare is primary source of insurance coverage
- Unable to understand written and spoken English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Study of the Clinical and Economic Impact of Remote Monitoring Program With Disease Management Compared to Conventional Diabetes Disease Management Interventions
The primary objective of this study is to determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease than a standard disease management program.
Read the detailed description
To determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease.
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Being tested
- DM-Standard, Disease Management Plus
- Keywords
- Remote monitoring, Type 1 Diabetes, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DM-StandardBehavioural
Device/t+ Medical Diabetes Management System
Disease Management PlusBehavioural
Plus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology.
| Study group | Role | What they receive |
|---|---|---|
| DM-Standard | Active comparator | The conventional disease management group will receive management under the site's usual program offering, which includes, but is not limited to, compliance with the prescribed treatment regimens, dietary management, exercise programs, and other measures recommended by the American Diabetes Association (ADA) and the Association of American Endocrinologists (AACE). Receives: Behavioral: DM-Standard |
| DM-Plus | Active comparator | Plus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology that includes mobile phone client software with web-based companion software, Bluetooth glucose meter cradle, and web-based clinical management software for the clinical management team. The core of the system is the patient's cell phone which is used as an input device and which enables patients to maintain an electronic diary of information such as meal times, blood glucose, insulin use, weight, blood pressure, and exercise. The device is customizable to collect only the information relevant to the patient with diabetes and their healthcare provider. The patient with diabetes enters diary information on his or her mobile phone. No immediate or real-time information is provided to patients as part of this study. Receives: Behavioral: Disease Management Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study measures for this study include glycemic control and LDL levels, satisfaction with diabetes care, and adherence to diabetes medications and self-monitoring recommendations
Measured: 1 Year
Secondary outcomes (1)
Secondary measures include diabetes-related health-care utilization and physiologic data.
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startMar 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LifeScan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Donald Fetterolf, MD, Principal investigator, Matria Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675311
- Sponsor's protocol ID
- 7021
- Status last verified
- Dec 2009
- First submitted
- 7 May 2008
- Last updated
- 18 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study of the Clinical and Economic Impact of Remote Monitoring Program With Disease Management Compared to Conventional Diabetes Disease Management Interventions
- ClinicalTrials.gov ID
- NCT00675311
- Acronym / sponsor ID
- 7021
- Conditions
- Type 1 Diabetes, Type 2 Diabetes
- Keywords
- Remote monitoring, Type 1 Diabetes, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- LifeScanIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 May 2008 (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.
The primary objective of this study is to determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease than a standard disease management program.
Detailed description
To determine whether remote monitoring in diabetes management is more effective at helping patients manage their disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DM-Standard | Active comparator | Behavioral: DM-StandardThe conventional disease management group will receive management under the site's usual program offering, which includes, but is not limited to, compliance with the prescribed treatment regimens, dietary management, exercise programs, and other measures recommended by the American Diabetes Association (ADA) and the Association of American Endocrinologists (AACE). |
| DM-Plus | Active comparator | Behavioral: Disease Management PlusPlus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology that includes mobile phone client software with web-based companion software, Bluetooth glucose meter cradle, and web-based clinical management software for the clinical management team. The core of the system is the patient's cell phone which is used as an input device and which enables patients to maintain an electronic diary of information such as meal times, blood glucose, insulin use, weight, blood pressure, and exercise. The device is customizable to collect only the information relevant to the patient with diabetes and their healthcare provider. The patient with diabetes enters diary information on his or her mobile phone. No immediate or real-time information is provided to patients as part of this study. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between 18 and 64 years of age as of January 1, 2008
- Diagnosis of diabetes mellitus (listed ICD-9-CM diagnosis code on two or more outpatient claims, or on one or more inpatient admissions or emergency room claims in the most recent 12-month period)
- Continuously enrolled in a health plan with pharmacy and medical benefits for the most recent 12-month period or with one period of non-enrollment up to only 30 days
- Able to provide written informed consent for study participation
Key exclusion criteria (8 listed)
- Advanced renal disease (one or more claims in the most recent 12-month period) as defined by a claim for nephropathy or creatinine greater than 2.5 mg/dl
- Selected cancers (one or more claims in the most recent 12-month period)
- HIV/AIDS (one or more claims in the most recent 12-month period)
- Heart, liver, kidney, or multiple organ transplant (one or more claims in the most recent 12-month period)
- Cirrhosis of the liver (one or more claims in the most recent 12-month period)
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 |
|---|---|---|
| DM-StandardDevice/t+ Medical Diabetes Management System | Behavioural | DM-Standard |
| Disease Management PlusPlus is one of the randomized arms of the study. Patients assigned to this arm receive support from Disease Management nurses and technology. | Behavioural | DM-Plus |
Primary outcome
The primary study measures for this study include glycemic control and LDL levels, satisfaction with diabetes care, and adherence to diabetes medications and self-monitoring recommendations
Time frame: 1 Year
1 secondary outcome
Secondary measures include diabetes-related health-care utilization and physiologic data.
Time frame: 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 18 Dec 2009.
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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.
Donald Fetterolf, MD principal investigator
Matria Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DM-Standard and Disease Management Plus in people with Type 1 Diabetes and Type 2 Diabetes, run by LifeScan 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 4 inclusion and 8 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 18 Dec 2009. 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?
The primary study measures for this study include glycemic control and LDL levels, satisfaction with diabetes care, and adherence to diabetes medications and self-monitoring recommendations (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 18 Dec 2009.