Diabetes Mellitus Type 1Insight KidsNCT02403375
Comparing Continuous Subcutaneous Insulin Infusion With Multiple Daily Injections to Reach HbA1c Targets in Children and Adolescents With Type 1 Diabetes
A study testing Accu-Chek Insight Pump System in people with Diabetes Mellitus Type 1, run by Hoffmann-La Roche at 9 sites in 3 countries.
Trial summary
This study is to compare metabolic control, treatment satisfaction, and quality of life during continuous subcutaneous insulin infusion (CSII ) therapy with a new insulin pump system with multiple daily injections (MDI) therapy. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Diabetes Mellitus Type 1
- What is being tested?
- Accu-Chek Insight Pump System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 17 May 2015to 26 Oct 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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents at least 24 months of age, and not more than 17 years of age at screening
- Diagnosed with type 1 diabetes
- Diagnosis of type 1 diabetes established > 6 months before study start if >5 years of age
- Indication for insulin pump therapy according to local guidelines
- Subject's most recent HbA1c is equal or above 7.0% (53.0 mmol/mol) - measured at last assessment before screening within the past 2 months prior to the Baseline Visit into the study
- Willingness to use automated bolus advice obtained from the Accu-Chek Insight diabetes therapy system during the study
- Willingness and ability to participate and comply with study procedures
Who cannot join
- Disease or condition that in the opinion of the investigator is likely to affect compliance or the ability to complete the study
- Not willing or able to start insulin pump therapy
- Not willing to self-measure blood glucose at least four times daily
- Significantly impaired awareness of hypoglycemia
- More than one hospitalization for severe hypoglycemia during the last 12 months
- History of recurrent ketoacidosis during intensive insulin therapy
Show all 15Show fewer
- Known strong plaster incompatibility and/or allergy
- Unstable chronic disease other than diabetes (e.g. impaired hepatic function, impaired renal function, impaired cardiac function, uncontrolled vascular complications) and any other condition interfering with the study procedures, as per Investigator´s discretion.
- If on antihypertensive, thyroid, anti-depressant or lipid-lowering medication, lack of stability on the medication for the past 2 months prior to the Baseline Visit in the study
- Chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
- Prescription medications other than insulin interfering with diabetes management
- Acute illness or abnormality (e.g. impaired vision, impaired motor function, acute pain) at the time of screening interfering with study procedures, affecting compliance, or the ability to complete the study as per Investigator´s discretion
- Either pregnant or breastfeeding
- Drug dependency
- Dependency on sponsor or Investigator (e.g. co-worker or family member)
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Germany4 sites
Kinderkrankenhaus auf der Bult
Hanover, 30173
Gemeinschaftspraxis für Kinder- und Jugendmedizin
Herford, 32051
Practice for Pediatric and Adolescent Diabetology
Münster, 48155
Universitatsklinikum Tubingen
Tübingen, 72076
Austria3 sites
Medical University Graz
Graz, 8036
Universitatsklinik fur PadiatrieI, Padiatrische Diabetologie und Endokrinologie
Innsbruck, 6020
Medical University of Vienna-Dept of Pediatrics
Vienna, 1090
United Kingdom2 sites
Birmingham Children's Hospital Foundation Trust
Birmingham, B46NH
St. James's University Hospital
Leeds, LS97TF
About this study
Official title: Insight Kids Study: Reaching HbA1c Targets in Children and Adolescents With Type 1 Diabetes
This study is to compare metabolic control, treatment satisfaction, and quality of life during continuous subcutaneous insulin infusion (CSII ) therapy with a new insulin pump system with multiple daily injections (MDI) therapy. Furthermore, this study will add clinical data originating from clinical investigation in a special population, i.e. children and adolescents of ages 2 - 17 years , to the existing clinical data of the ACCU-CHEK Insight insulin pump.
- Conditions
- Diabetes Mellitus Type 1
- Being tested
- Accu-Chek Insight Pump System
- 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 Insight Pump SystemDevice
Continuous subcutaneous insulin infusion pump
| Study group | Role | What they receive |
|---|---|---|
| Continuous Subcutaneous Insulin Infusion (CSII) | Experimental | Continuous Subcutaneous Insulin Infusion (CSII) in Children and Adolescents 2-17 Years of Age Receives: Device: Accu-Chek Insight Pump System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Children and Adolescents of Ages 2 to 17 Years Reaching an HbA1c target of <7.5%
This HbA1c target of <7.5% proportion is statistically tested against a proportion of 25%, composed of the anticipated population proportion of 15% of children and adolescents using multiple daily insulin injections plus a safety margin of 10%.
Measured: 26 weeks
Secondary outcomes (6)
Score on Insulin Pump Questionnaire
Measured: 26 weeks
Score on Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Measured: 26 weeks
Score on Pediatric Quality of Life Inventory (PedsQL)
Measured: 26 weeks
Change from Baseline in HbA1c
Measured: 26 weeks
Change from Baseline in Blood Glucose
Measured: 26 weeks
Number of Subjects, Who Report a Diabetes-Related Adverse Event (i.e., Symptomatic Hypoglycemia, Severe Hypoglycemia, Diabetic Ketoacidosis)
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2015 (estimated)
- Study start17 May 2015
- Primary completion26 Oct 2017
- Study completion26 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 1Studies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Roche Diabetes Care
- Responsible party
- Sponsor
- Investigators
- Cosima Rieger, Dr., Study director, Roche Diabetes Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02403375
- Sponsor's protocol ID
- RD002177
- Acronym
- Insight Kids
- Status last verified
- Nov 2017
- First submitted
- 26 Mar 2015
- Last updated
- 27 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insight Kids Study: Reaching HbA1c Targets in Children and Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02403375
- Acronym / sponsor ID
- Insight Kids / RD002177
- Conditions
- Diabetes Mellitus Type 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Collaborators
- Roche Diabetes Care
- Study start
- 17 May 2015 (actual)
- Primary completion
- 26 Oct 2017 (actual)
- Study completion
- 26 Oct 2017 (actual)
- First posted
- 31 Mar 2015 (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 study is to compare metabolic control, treatment satisfaction, and quality of life during continuous subcutaneous insulin infusion (CSII ) therapy with a new insulin pump system with multiple daily injections (MDI) therapy. Furthermore, this study will add clinical data originating from clinical investigation in a special population, i.e. children and adolescents of ages 2 - 17 years , to the existing clinical data of the ACCU-CHEK Insight insulin pump.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Continuous Subcutaneous Insulin Infusion (CSII) | Experimental | Device: Accu-Chek Insight Pump SystemContinuous Subcutaneous Insulin Infusion (CSII) in Children and Adolescents 2-17 Years of Age |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children and adolescents at least 24 months of age, and not more than 17 years of age at screening
- Diagnosed with type 1 diabetes
- Diagnosis of type 1 diabetes established > 6 months before study start if >5 years of age
- Indication for insulin pump therapy according to local guidelines
- Subject's most recent HbA1c is equal or above 7.0% (53.0 mmol/mol) - measured at last assessment before screening within the past 2 months prior to the Baseline Visit into the study
Key exclusion criteria (15 listed)
- Disease or condition that in the opinion of the investigator is likely to affect compliance or the ability to complete the study
- Not willing or able to start insulin pump therapy
- Not willing to self-measure blood glucose at least four times daily
- Significantly impaired awareness of hypoglycemia
- More than one hospitalization for severe hypoglycemia during the last 12 months
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 Insight Pump SystemContinuous subcutaneous insulin infusion pump | Device | Continuous Subcutaneous Insulin Infusion (CSII) |
Primary outcome
Percentage of Children and Adolescents of Ages 2 to 17 Years Reaching an HbA1c target of <7.5%
Time frame: 26 weeks
This HbA1c target of <7.5% proportion is statistically tested against a proportion of 25%, composed of the anticipated population proportion of 15% of children and adolescents using multiple daily insulin injections plus a safety margin of 10%.
6 secondary outcomes
Score on Insulin Pump Questionnaire
Time frame: 26 weeks
Score on Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: 26 weeks
Score on Pediatric Quality of Life Inventory (PedsQL)
Time frame: 26 weeks
Change from Baseline in HbA1c
Time frame: 26 weeks
Change from Baseline in Blood Glucose
Time frame: 26 weeks
Number of Subjects, Who Report a Diabetes-Related Adverse Event (i.e., Symptomatic Hypoglycemia, Severe Hypoglycemia, Diabetic Ketoacidosis)
Time frame: 26 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 27 Nov 2017.
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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.
Cosima Rieger, Dr. study director
Roche Diabetes Care
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accu-Chek Insight Pump System in people with Diabetes Mellitus Type 1, run by Hoffmann-La Roche at 9 sites in 3 countries.
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 15 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 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, Austria, United Kingdom. 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?
Percentage of Children and Adolescents of Ages 2 to 17 Years Reaching an HbA1c target of <7.5% (time frame: 26 weeks). 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 Nov 2017.