Type 1 DiabetesNCT01657630
Accu-Chek Combo in Young Patients
An observational study of Type 1 Diabetes, run by Rabin Medical Center at 1 site in Israel.
Trial summary
This is an open, prospective, descriptive study aiming to evaluate the change in treatment satisfaction of primary care givers of young children who use the Accu-Chek Combo System. Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System on visit 1. Read more about this study
- Who is it for?
- Ages 6 months to 6 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Accu-Chek Combo System
- Type of treatment
- Medical device
- How many people
- 13 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2012to Dec 2014
- Phase
- Observational
- 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 6 months to 6 years
- All sexes
- No healthy volunteers
- Child
Study population: Young patients with type 1 Diabetes treated at the institute of Endocrinology and Diabetes, Schneider Children's Medical Center, which is a tertiary hospital
Who may be able to join
- Diabetes Mellitus type 1
- Continuous Subcutaneous Insulin Infusion(CSII)therapy(for at least 6 months)
- Age below 6 years
- Planned and scheduled change to a Accu-Chek Combo System within the next 3 weeks at least
- Signing on an Inform Consent Form
Who cannot join
- Patient has been diagnosed with progressive/serious diseases that in judgment of the physician preclude successful completion of the observational period
- primary care giver not skilled enough to comment in a qualitative way
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Use of the Accu-Chek Combo System in Young Patients With Type 1 Diabetes
This is an open, prospective, descriptive study aiming to evaluate the change in treatment satisfaction of primary care givers of young children who use the Accu-Chek Combo System. Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes related therapeutic information will be collected and data about the use of the device components will be downloaded from the Accu-Chek Combo System
- Conditions
- Type 1 Diabetes
- Being tested
- Accu-Chek Combo System
- Keywords
- Insulin Pump Therapy, Type 1 Diabetes, Treatment Satisfaction
- 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.
Accu-Chek Combo SystemDevice
12 weeks using the Accu Chek Combo System, which is an insulin pump system that offers a remote control integrating a bolus calculator, a blood glucose meter, data storage and analysis function.
| Study group | Role | What they receive |
|---|---|---|
| Accu-Chek Combo | 15 type 1 young patients under 6 years old who begin to use the Accu-Chek Combo System Receives: Device: Accu-Chek Combo System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Treatment Satisfaction
we will assess patient's treatment satisfaction using Treatment Satisfaction Questionnaires
Measured: after 12 weeks
Study device acceptance
We will assess study device acceptance using a distinct Acceptance Questionnaire
Measured: after 12 weeks
Secondary outcomes (9)
Mean Blood Glucose level
we will compare mean blood glucose level at baseline and after 12 weeks
Measured: after 12 weeks
Number of Hypoglycemia Events
we will compare the number of hypoglycemia events at baseline and after 12 weeks
Measured: after 12 weeks
Number of Hyperglycemia Events
We will compare the number of hyperglycemia events at baseline and after 12 weeks
Measured: after 12 weeks
HbA1c
We will compare HbA1c level at baseline and after 12 weeks
Measured: after 12 weeks
postprandial SMBG (self monitoring blood glucose)
We will compare between postprandial SMBG at baseline and after 12 weeks
Measured: after 12 weeks
Overall number of BG (Blood glucose) measurements
We will compare between number of BG measurements at baseline and after 12 weeks
Measured: after 12 weeks
Number of ketosis events
We will compare number of ketosis events (without documented acidosis with home/hospital management)at baseline and after 12 weeks
Measured: after 12 weeks
Number of Diabetic Ketoacidosis (DKA) events
We will compare number of Diabetic ketoacidosis events at baseline and after 12 weeks
Measured: after 12 weeks
preprandial SMBG (self monitoring blood glucose)
We will compare between preprandial SMBG at baseline and after 12 weeks
Measured: after 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionDec 2014
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Sponsor
- Investigators
- Moshe Phillip, Prof, Principal investigator, Schneider Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657630
- Sponsor's protocol ID
- Accu-Chek Combo
- Status last verified
- Mar 2015
- First submitted
- 2 Aug 2012
- Last updated
- 12 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Use of the Accu-Chek Combo System in Young Patients With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01657630
- Acronym / sponsor ID
- Accu-Chek Combo
- Conditions
- Type 1 Diabetes
- Keywords
- Insulin Pump Therapy, Type 1 Diabetes, Treatment Satisfaction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 6 Aug 2012 (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.
This is an open, prospective, descriptive study aiming to evaluate the change in treatment satisfaction of primary care givers of young children who use the Accu-Chek Combo System. Patients will routinely be scheduled and start their therapy with the Accu-Chek Combo System on visit 1. Twelve weeks later the final acquisition of data will occur. Diabetes Treatment Satisfaction Questionnaires (DTSQ) will be completed at baseline and after 12 weeks, a distinct acceptance questionnaires will be completed at final visit. In addition, Diabetes related therapeutic information will be collected and data about the use of the device components will be downloaded from the Accu-Chek Combo System
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Accu-Chek Combo | – | Device: Accu-Chek Combo System15 type 1 young patients under 6 years old who begin to use the Accu-Chek Combo System |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Young patients with type 1 Diabetes treated at the institute of Endocrinology and Diabetes, Schneider Children's Medical Center, which is a tertiary hospital
Key inclusion criteria (5 listed)
- Diabetes Mellitus type 1
- Continuous Subcutaneous Insulin Infusion(CSII)therapy(for at least 6 months)
- Age below 6 years
- Planned and scheduled change to a Accu-Chek Combo System within the next 3 weeks at least
- Signing on an Inform Consent Form
Key exclusion criteria (2 listed)
- Patient has been diagnosed with progressive/serious diseases that in judgment of the physician preclude successful completion of the observational period
- primary care giver not skilled enough to comment in a qualitative way
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 Combo System12 weeks using the Accu Chek Combo System, which is an insulin pump system that offers a remote control integrating a bolus calculator, a blood glucose meter, data storage and analysis function. | Device | Accu-Chek Combo |
Primary outcome
Diabetes Treatment Satisfaction
Time frame: after 12 weeks
we will assess patient's treatment satisfaction using Treatment Satisfaction Questionnaires
Study device acceptance
Time frame: after 12 weeks
We will assess study device acceptance using a distinct Acceptance Questionnaire
9 secondary outcomes
Mean Blood Glucose level
Time frame: after 12 weeks
Number of Hypoglycemia Events
Time frame: after 12 weeks
Number of Hyperglycemia Events
Time frame: after 12 weeks
HbA1c
Time frame: after 12 weeks
postprandial SMBG (self monitoring blood glucose)
Time frame: after 12 weeks
Overall number of BG (Blood glucose) measurements
Time frame: after 12 weeks
Number of ketosis events
Time frame: after 12 weeks
Number of Diabetic Ketoacidosis (DKA) events
Time frame: after 12 weeks
preprandial SMBG (self monitoring blood glucose)
Time frame: after 12 weeks
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 12 Mar 2015.
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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.
Moshe Phillip, Prof principal investigator
Schneider Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by Rabin Medical Center 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 5 inclusion and 2 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 12 Mar 2015. 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 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?
Diabetes Treatment Satisfaction (time frame: after 12 weeks). 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 12 Mar 2015; AzTrials last refreshed its copy on 30 Oct 2026.