DiabetesNCT00956800
Remote Management of Diabetic Patients Via Data Transmission by Accu-Chek 360 Software
A study testing Accu-Chek 360 software and Normal care in people with Diabetes, run by Columbus Research Foundation at 1 site in United States.
Trial summary
The purpose of this study is to determine if providing some care to diabetic patients remotely, using Accuchek 360 yields at least the same clinical results for their diabetes care, according to existing guidelines, as providing all care to patients in person. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Accu-Chek 360 software and Normal care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jun 2011
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and Female
- 19-65 years of age
- Type 1 and 2 diabetes
- Computer literate
- Independent care of diabetes
- Insulin pump allowed (Spirit pump only)
- Females on birth control
- Can demonstrate competency in the use of the Accuchek Aviva meter, reliability in doing regular home blood sugar determinations
Who cannot join
- Creatinine clearance < 30 cc/min
- Severe loss of vision (diabetic retinopathy)
- Severe diabetic neuropathy
- Known or suspected diabetic gastroparesis
- Patients with heart disease
- Patients with liver disease
Show all 10Show fewer
- Drug or substantial alcohol use
- Use of pharmacological doses of glucocorticoids or other medications that affect blood sugar and blood pressure
- Females that are pregnant or are capable of becoming pregnant
- Insulin pump use other than Accucheck Spirit pump
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbus Research Foundation
Columbus, Georgia, 31904
About this study
The purpose of this study is to determine if providing some care to diabetic patients remotely, using Accuchek 360 yields at least the same clinical results for their diabetes care, according to existing guidelines, as providing all care to patients in person.
Read the detailed description
This will be a non-inferiority study between two groups: a control group, which will receive 5 routine office visits in one year; and a study group which will receive 3 routine office visits in the same time, and have two visits conducted by computer interaction, using the Accuchek 360 software. All will be capable of independent care of their diabetes. All patients will be 19-65 years of age. The end-points will include similar changes in hemoglobin A1c, systolic and diastolic blood pressure, body mass index, lipid fractions, and similar levels of patient satisfaction with care.
There will be 50 patients in each group, matched for age and sex distribution, educational level, computer literacy, and type of diabetes.
- Conditions
- Diabetes
- Being tested
- Accu-Chek 360 software, Normal care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accu-Chek 360 softwareOther
Study group which will receive 3 routine office visits in the same time, and have two visits conducted by computer interaction, using the Accu-Chek 360 software.
Normal careOther
Control group will receive 5 routine office visits in one year
| Study group | Role | What they receive |
|---|---|---|
| telemedicine/study group | Experimental | Not described Receives: Other: Accu-Chek 360 software |
| control group | Active comparator | Not described Receives: Other: Normal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbus Research Foundation will take the objective data that constitutes the defined end-points of the study and enter it for each patient into an Access data base, using the established data base management system of Columbus Research Foundation.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbus Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Investigators
- Steven B Leichter, M.D., Principal investigator, Endocrine Consultants
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956800
- Sponsor's protocol ID
- Roche 360
- Status last verified
- Jun 2011
- First submitted
- 7 Aug 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Management of Diabetic Patients Via Data Transmission by Accu-Chek 360 Software
- ClinicalTrials.gov ID
- NCT00956800
- Acronym / sponsor ID
- Roche 360
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Columbus Research FoundationUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Sep 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 11 Aug 2009 (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 purpose of this study is to determine if providing some care to diabetic patients remotely, using Accuchek 360 yields at least the same clinical results for their diabetes care, according to existing guidelines, as providing all care to patients in person.
Detailed description
This will be a non-inferiority study between two groups: a control group, which will receive 5 routine office visits in one year; and a study group which will receive 3 routine office visits in the same time, and have two visits conducted by computer interaction, using the Accuchek 360 software. All will be capable of independent care of their diabetes. All patients will be 19-65 years of age. The end-points will include similar changes in hemoglobin A1c, systolic and diastolic blood pressure, body mass index, lipid fractions, and similar levels of patient satisfaction with care.
There will be 50 patients in each group, matched for age and sex distribution, educational level, computer literacy, and type of diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| telemedicine/study group | Experimental | Other: Accu-Chek 360 software |
| control group | Active comparator | Other: Normal care |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and Female
- 19-65 years of age
- Type 1 and 2 diabetes
- Computer literate
- Independent care of diabetes
Key exclusion criteria (10 listed)
- Creatinine clearance < 30 cc/min
- Severe loss of vision (diabetic retinopathy)
- Severe diabetic neuropathy
- Known or suspected diabetic gastroparesis
- Patients with heart disease
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 |
|---|---|---|
| Accu-Chek 360 softwareStudy group which will receive 3 routine office visits in the same time, and have two visits conducted by computer interaction, using the Accu-Chek 360 software. | Other | telemedicine/study group |
| Normal careControl group will receive 5 routine office visits in one year | Other | control group |
Primary outcome
Columbus Research Foundation will take the objective data that constitutes the defined end-points of the study and enter it for each patient into an Access data base, using the established data base management system of Columbus Research Foundation.
Time frame: 18 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 27 Jun 2011.
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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.
Steven B Leichter, M.D. principal investigator
Endocrine Consultants
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accu-Chek 360 software and Normal care in people with Diabetes, run by Columbus Research Foundation 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 8 inclusion and 10 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 27 Jun 2011. 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?
Columbus Research Foundation will take the objective data that constitutes the defined end-points of the study and enter it for each patient into an Access data base, using the established data base management system of Columbus Research Foundation. (time frame: 18 months). 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 27 Jun 2011.