Type 1 DiabetesPhase 4REMOTE-T1DNCT01825382
Role of Mobile Technology to Improve Diabetes Care in Adults With Type 1 Diabetes: the REMOTE-T1D Study, a Pilot Study
A Phase 4 study testing iBGStar meter in people with Type 1 Diabetes, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The goal of this prospective pilot study is to evaluate the use of remote technology (iBGStar in combination with Diabetes Manager App on iPhone) to patient related outcomes, and a hypoglycemia fear questionnaire. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- iBGStar meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Nov 2013
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects that meet the following criteria will be considered for admission to the study:
- Signed informed consent before any study-related activities
- Male or female aged 18 years and older T1D duration >1 year
- A1c <10%
- Willingness to routinely practice at least 3-7 blood glucose measurements per day
- Ability and willingness to adhere to the protocol including scheduled study visits and blinded CGM wear intermittently) for 6 months. During the weeks of blinded CGM wear, subjects will not be able to use their own real-time CGMs (if they own it)
- Able to speak, read and write English
Who cannot join
- Subjects will be excluded from the study if any of the following apply:
- Pregnant or intention to become pregnant during the course of the study
- Severe unexplained hypoglycemia requiring emergency treatment in the previous 6 months
- Use of systemic or inhaled corticosteroids
- History of hemoglobinopathies
- Diagnosis of anemia
Show all 12Show fewer
- History of pancreatitis
- Extensive skin changes/diseases that inhibit wearing a sensor on normal skin
- Known allergy to adhesives
- Current participation in another investigational study protocol. Must have completed a previous study at least 30 days prior to enrollment.
- Any other condition, as determined by the investigator, which could make the subject unsuitable for the trial, impairs the subject's suitability for the trial, or impairs the validity of the informed consent
- Subjects will not be allowed to use real-time CGM during the blinded CGM wear week.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this prospective pilot study is to evaluate the use of remote technology (iBGStar in combination with Diabetes Manager App on iPhone) to patient related outcomes, and a hypoglycemia fear questionnaire. In the future, this study might lead to investigating the role of social media with mobile phones in Type 1 Diabetes (T1D) care. Moreover, the number of patients with T1D continues to increase, and such technology could conceivably help compensate for the shortages of endocrinologists providing care.
Read the detailed description
This is a single-center, prospective, randomized, 'open-label,' investigator initiated pilot study evaluating the role of mobile technology to improve diabetes care in adults with type 1 diabetes (REMOTE-T1D). We hypothesize that the use of mobile technology (iBGStar® technology [iPhone® plus the BGStar®]) will result in improvement in Patient Reported Outcomes (PRO), and Treatment Satisfactions with a possible reductions of glucose excursions, A1c, and severe hypoglycemia as compared to routine clinical care using traditional glucose meter SMBG-Accu-chek®. This study aims to demonstrate the efficacy of these technologies in a clinical setting with a hope to improve outcomes and health care cost savings.
The study will enroll 100 patients from the Barbara Davis Center Adult clinic over the age of 18 years who will be randomized in a 1:1 fashion to intervention group using mobile technology (iBG Star) vs. continued routine clinical care (control) using SMBG-Accu-chek meter. All subjects will be followed for study visits with similar frequency at baseline, 1-week, 1-month, 3-months, and 6-months and wear a continuous glucose monitor (CGM) using a DexCom SEVEN Plus® system in a blinded mode for 7 days at baseline (wk0), 1mo, 3mo, and 6mo.
Laboratory analysis for A1c will be performed at baseline, 1-month 3-months, and 6-months. Routine blood tests will be performed in all subjects at baseline, 3months, and 6-months. Blinded CGM data will be analyzed for mean blood glucose values, time spent in hyperglycemic (>240, >300mg/dl) and hypoglycemic (<50, <70, <80 mg/dl) ranges and various indices of glycemic variability.
- Conditions
- Type 1 Diabetes
- Being tested
- iBGStar meter
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iBGStar meterDevice
Subjects will receive iBGStar meter and iPhone to use as meter during the study.
| Study group | Role | What they receive |
|---|---|---|
| Accu-chek Meter | No intervention | Patients receiving the Accu-chek nano meter for use during the study. |
| iBGStar meter interventional Arm | Experimental | Subjects are given iBGstar meter along with iPhone to use as interventional meter. Receives: Device: iBGStar meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Reported Outcomes as it relates to hypoglycemia fear and quality of life.
Primary outcome is patient related outcomes and changes based on the hypoglycemia fear questionnaire and changes in patient comfort in meter use.
Measured: 6 months
Secondary outcomes (1)
Improvement in glucose control and indices off glucose variability from SMBG and CGM data.
Improvement in parameters of glycemic variability as measured by glucose excursions from SMBG and CGM downloads and various indices (J-index, mean amplitude of glycemic excursion (MAGE), high blood glucose index (HBGI), low blood glucose index (LBGI), from, CGM downloads. Reduction in A1c of 0.3% from screening to 3-months and maintained at 6-months, and reduction of hypoglycemia (measured or self reported). Cost analysis will be done based upon primary and secondary outcomes.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2013
- Study completionNov 2013
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 1 DiabetesStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi, Colorado Prevention Center
- Responsible party
- Principal investigator, Satish K. Garg, University of Colorado, Denver
- Investigators
- Satish K Garg, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01825382
- Sponsor's protocol ID
- REMOTE-T1D
- Acronym
- REMOTE-T1D
- Status last verified
- May 2014
- First submitted
- 29 Jan 2013
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Garg SK, Shah VN, Akturk HK, Beatson C, Snell-Bergeon JK. Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar(R) in Type 1 Diabetes Management. Diabetes Ther. 2017 Aug;8(4):811-819. doi: 10.1007/s13300-017-0272-5. Epub 2017 May 29.
PubMed 28555339
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Mobile Technology to Improve Diabetes Care in Adults With Type 1 Diabetes: the REMOTE-T1D Study, a Pilot Study
- ClinicalTrials.gov ID
- NCT01825382
- Acronym / sponsor ID
- REMOTE-T1D / REMOTE-T1D
- Conditions
- Type 1 Diabetes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Sanofi, Colorado Prevention Center
- Study start
- Dec 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Apr 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.
The goal of this prospective pilot study is to evaluate the use of remote technology (iBGStar in combination with Diabetes Manager App on iPhone) to patient related outcomes, and a hypoglycemia fear questionnaire. In the future, this study might lead to investigating the role of social media with mobile phones in Type 1 Diabetes (T1D) care. Moreover, the number of patients with T1D continues to increase, and such technology could conceivably help compensate for the shortages of endocrinologists providing care.
Detailed description
This is a single-center, prospective, randomized, 'open-label,' investigator initiated pilot study evaluating the role of mobile technology to improve diabetes care in adults with type 1 diabetes (REMOTE-T1D). We hypothesize that the use of mobile technology (iBGStar® technology [iPhone® plus the BGStar®]) will result in improvement in Patient Reported Outcomes (PRO), and Treatment Satisfactions with a possible reductions of glucose excursions, A1c, and severe hypoglycemia as compared to routine clinical care using traditional glucose meter SMBG-Accu-chek®. This study aims to demonstrate the efficacy of these technologies in a clinical setting with a hope to improve outcomes and health care cost savings.
The study will enroll 100 patients from the Barbara Davis Center Adult clinic over the age of 18 years who will be randomized in a 1:1 fashion to intervention group using mobile technology (iBG Star) vs. continued routine clinical care (control) using SMBG-Accu-chek meter. All subjects will be followed for study visits with similar frequency at baseline, 1-week, 1-month, 3-months, and 6-months and wear a continuous glucose monitor (CGM) using a DexCom SEVEN Plus® system in a blinded mode for 7 days at baseline (wk0), 1mo, 3mo, and 6mo.
Laboratory analysis for A1c will be performed at baseline, 1-month 3-months, and 6-months. Routine blood tests will be performed in all subjects at baseline, 3months, and 6-months. Blinded CGM data will be analyzed for mean blood glucose values, time spent in hyperglycemic (>240, >300mg/dl) and hypoglycemic (<50, <70, <80 mg/dl) ranges and various indices of glycemic variability.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accu-chek Meter | No intervention | –Patients receiving the Accu-chek nano meter for use during the study. |
| iBGStar meter interventional Arm | Experimental | Device: iBGStar meterSubjects are given iBGstar meter along with iPhone to use as interventional meter. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects that meet the following criteria will be considered for admission to the study:
Key exclusion criteria (12 listed)
- Subjects will be excluded from the study if any of the following apply:
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 |
|---|---|---|
| iBGStar meterSubjects will receive iBGStar meter and iPhone to use as meter during the study. | Device | iBGStar meter interventional Arm |
Primary outcome
Patient Reported Outcomes as it relates to hypoglycemia fear and quality of life.
Time frame: 6 months
Primary outcome is patient related outcomes and changes based on the hypoglycemia fear questionnaire and changes in patient comfort in meter use.
1 secondary outcome
Improvement in glucose control and indices off glucose variability from SMBG and CGM data.
Time frame: 6 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 21 May 2014.
- Derived from this study: PubMed 28555339Garg SK, Shah VN, Akturk HK, Beatson C, Snell-Bergeon JK. Role of Mobile Technology to Improve Diabetes Care in Adults with Type 1 Diabetes: The Remote-T1D Study iBGStar(R) in Type 1 Diabetes Management. Diabetes Ther. 2017 Aug;8(4):811-819. doi: 10.1007/s13300-017-0272-5. Epub 2017 May 29.
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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.
Satish K Garg, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing iBGStar meter in people with Type 1 Diabetes, run by University of Colorado, Denver 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 7 inclusion and 12 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 21 May 2014. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Patient Reported Outcomes as it relates to hypoglycemia fear and quality of life. (time frame: 6 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 NCT01825382, 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 21 May 2014.