Diabetes Mellitus, Type 1 or 2NCT03017287
Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI
A study testing GlucoMe App in people with Diabetes Mellitus, Type 1 or 2, run by GlucoMe at 1 site in Israel.
Trial summary
The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with uncontrolled diabetes treated with MDI. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Type 1 or 2
- What is being tested?
- GlucoMe App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to Aug 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both type 1 and type 2 diabetes
- HbA1c 7-11%
- Treated with MDI for at least 3 months
- Ability to use the system at home, mobile phone
Who cannot join
- Active CAD, CVA during last 6 months
- Treatment with steroids or other glucose modifying drugs
- Chronic infection/cancer/other severe disease
Trial locations and contacts
1 site in 1 country.
About this study
The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with uncontrolled diabetes treated with MDI.
Read the detailed description
GlucoMe is an interactive system, which provides glucose management tools to both the patient and health care team (HCT). The system includes a decision support system to be used by the HCT aiming to aid clinical decision making with mathematical models. The system does not intend to replace clinical judgement and all recommendations are to be approved by the HCT.
Forty (40) diabetic patients on multiple daily insulin injection (MDI) with abnormal HbA1c and identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Patient's daily blood glucose will be measured and the GlucoMe App will give its recommendations for change in insulin dose, as well as recommendations for pre and post-meal carbohydrate and exercise. Patient's daily blood glucose levels will be followed by the HCT biweekly for 12 weeks and patients will be instructed to change their insulin doses according to the decision of the treating physician. At the end of the study, the HCT's recommendations for treatment adjustment will be compared to those of the system for both safety and efficacy. Study subjects and the HCT will be asked to complete a questionnaire regarding the GlucoMe system usability.
- Conditions
- Diabetes Mellitus, Type 1 or 2
- Being tested
- GlucoMe App
- Keywords
- Glucose blood measurements, glucometer, BGM, Diabetes App
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoMe AppDevice
Assessment of the the GlucoMe App
| Study group | Role | What they receive |
|---|---|---|
| GlucoMe App | Experimental | Self monitoring of glucose blood measurements using the GlucoMe glucose monitoring glucose device and App Receives: Device: GlucoMe App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemic and Hyperglycemic Events
Number and severity of hypoglycemic and severe hyperglycemic events
Measured: At 12 weeks of the study
Correlation between GlucoMe and HCT recommendations
Correlation between GlucoMe and HCT recommendations for changing insulin dose and the treating physician/HCT advice.
Measured: At 12 weeks of the study
Secondary outcomes (1)
Target HbA1C/glucose achievement
Percent of patients that achieve HbA1C/glucose targets
Measured: At 12 weeks of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionMay 2017
- Study completionAug 2017
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1 or 2Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlucoMe
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03017287
- Sponsor's protocol ID
- Clin-002-00
- Status last verified
- Sep 2020
- First submitted
- 9 Jan 2017
- Last updated
- 23 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI
- ClinicalTrials.gov ID
- NCT03017287
- Acronym / sponsor ID
- Clin-002-00
- Conditions
- Diabetes Mellitus, Type 1 or 2
- Keywords
- Glucose blood measurements, glucometer, BGM, Diabetes App
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 40 participants (actual)
- Lead sponsor
- GlucoMeIndustry (pharma, biotech, devices)
- Study start
- Jan 2017
- Primary completion
- May 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 11 Jan 2017 (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 study will evaluate the safety and efficacy of computerized GlucoMe App in patients with uncontrolled diabetes treated with MDI.
Detailed description
GlucoMe is an interactive system, which provides glucose management tools to both the patient and health care team (HCT). The system includes a decision support system to be used by the HCT aiming to aid clinical decision making with mathematical models. The system does not intend to replace clinical judgement and all recommendations are to be approved by the HCT.
Forty (40) diabetic patients on multiple daily insulin injection (MDI) with abnormal HbA1c and identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Patient's daily blood glucose will be measured and the GlucoMe App will give its recommendations for change in insulin dose, as well as recommendations for pre and post-meal carbohydrate and exercise. Patient's daily blood glucose levels will be followed by the HCT biweekly for 12 weeks and patients will be instructed to change their insulin doses according to the decision of the treating physician. At the end of the study, the HCT's recommendations for treatment adjustment will be compared to those of the system for both safety and efficacy. Study subjects and the HCT will be asked to complete a questionnaire regarding the GlucoMe system usability.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GlucoMe App | Experimental | Device: GlucoMe AppSelf monitoring of glucose blood measurements using the GlucoMe glucose monitoring glucose device and App |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both type 1 and type 2 diabetes
- HbA1c 7-11%
- Treated with MDI for at least 3 months
- Ability to use the system at home, mobile phone
Key exclusion criteria (3 listed)
- Active CAD, CVA during last 6 months
- Treatment with steroids or other glucose modifying drugs
- Chronic infection/cancer/other severe 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 |
|---|---|---|
| GlucoMe AppAssessment of the the GlucoMe App | Device | GlucoMe App |
Primary outcome
Hypoglycemic and Hyperglycemic Events
Time frame: At 12 weeks of the study
Number and severity of hypoglycemic and severe hyperglycemic events
Correlation between GlucoMe and HCT recommendations
Time frame: At 12 weeks of the study
Correlation between GlucoMe and HCT recommendations for changing insulin dose and the treating physician/HCT advice.
1 secondary outcome
Target HbA1C/glucose achievement
Time frame: At 12 weeks of the study
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2020.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlucoMe App in people with Diabetes Mellitus, Type 1 or 2, run by GlucoMe at 1 site in Israel.
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 3 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: stopped early, as of the sponsor's last update on 23 Sep 2020. 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 Israel. 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 was stopped early (reason given: Poor accrual). Results are not available in the source record.
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?
Hypoglycemic and Hyperglycemic Events (time frame: At 12 weeks of the study). The study lists 2 primary outcomes in all. 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 23 Sep 2020.