Diabetes Mellitus, Type 1NCT04201171
The Impact of Different CSII and CGM Systems on Different Clinical Outcome Variables in Children and Adolescents With Type 1 Diabetes. An Observational Study Form the Norwegian Childhood Diabetes Registry (NCDR)
An observational study of Diabetes Mellitus, Type 1, run by Helse Fonna.
Trial summary
To examine the effect of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) on metabolic control, in a large population-based nationwide observational study under real life conditions. Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- CSII and CGM
- Type of treatment
- Medical device
- How many people
- 2,749 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2017
- How long will I take part?
- 1 Year
- 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 0 to 18 years
- All sexes
- Child, Adult
Study population: Our cohort consists of 2749 patients with type 1 diabetes, 45.5 % females; mean age was 12.9 years (SD 3.9, min 1.7, max 20.2) and mean diabetes duration was 5.3 years (SD 3.7)
Who may be able to join
- All registered subjects with type 1 diabetes in the 2017 annual cohort of the NCDR
Who cannot join
- None
About this study
Official title: The Impact of Different CSII and CGM Systems on Metabolic Control and Quality of Life in Children and Adolescents With Type 1 Diabetes. An Observational Study Form the Norwegian Childhood Diabetes Registry (NCDR)
To examine the effect of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) on metabolic control, in a large population-based nationwide observational study under real life conditions.
All children and adolescents with type 1 diabetes are investigated,using annual data in 2017 from the population-based Norwegian Childhood Diabetes Registry (NCDR). HbA1c, incidence of diabetes ketoacidosis (DKA) and severe hypoglycemia (SH) are evaluated depending on the use of CSII and CGM in a linear mixed-effects and linear regression model adjusted for age, biologic gender and diabetes duration. Health-related quality of Life (HRQOL) is assessed by using the DISABKIDS diabetes specific module (DDM-10), and associations with the use of CSII, CGM, age, gender and diabetes duration are evaluated.
Read the detailed description
In Norway, all children with diabetes 0-18 years should, due to a recommendation from the national health care authority, receive their diabetes follow-up in a pediatric department. All pediatric departments participate in the NCDR reporting standardized clinical data on their patients to the NCDR, at diabetes onset and annually, until the patients reach 18 years of age. The data completeness of NCDR is high, on individual level 99 % at diabetes onset, and 98 % on the annual examinations in 2016 - 2017.
In addition, HRQOL data were collected in 2017, using the DISABKIDS diabetes specific module (DDM-10). Children 10-17 years with type 1 diabetes were invited to independently fill out the questionnaire regarding their own disease-related quality of life. All parents to children with type 1 diabetes (independent of the child's age) were invited to fill out the same questionnaire, giving a proxy evaluation of their child's quality of life.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- CSII and CGM
- Keywords
- T1D, CSII, CGM, diabetic ketoacidosis, hypoglycemia, HRQOL
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetic Ketoacidosis, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSII and CGMDevice
use of CSII as insulin delivery or CGM as glucose monitoring
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: measured at annual follow-up in 2017
DKA
diabetic ketoacidosis leading to hospitalization
Measured: registered at annual follow-up in 2017
SH
Severe hypoglycemia
Measured: registered at annual follow-up in 2017
HRQOL
health-related quality of life measured with the DISABKIDS diabetes module DDM-10
Measured: participation connected to annual follow-up in 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2019
- Study start1 Jan 2017
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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 Diabetes Mellitus, Type 1Studies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 2,749 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Helse Fonna
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Helse Vest, University of Bergen, Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Heiko Bratke, MD, Principal investigator, Haugesund Hospital, Fonna Health Trust, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04201171
- Sponsor's protocol ID
- 2016/1613
- Status last verified
- Sep 2021
- First submitted
- 13 Dec 2019
- Last updated
- 6 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bratke H, Margeirsdottir HD, Assmus J, Njolstad PR, Skrivarhaug T. Does Current Diabetes Technology Improve Metabolic Control? A Cross-Sectional Study on the Use of Insulin Pumps and Continuous Glucose Monitoring Devices in a Nationwide Pediatric Population. Diabetes Ther. 2021 Sep;12(9):2571-2583. doi: 10.1007/s13300-021-01127-6. Epub 2021 Aug 13.
PubMed 34389930
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Different CSII and CGM Systems on Metabolic Control and Quality of Life in Children and Adolescents With Type 1 Diabetes. An Observational Study Form the Norwegian Childhood Diabetes Registry (NCDR)
- ClinicalTrials.gov ID
- NCT04201171
- Acronym / sponsor ID
- 2016/1613
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- T1D, CSII, CGM, diabetic ketoacidosis, hypoglycemia, HRQOL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,749 participants (actual)
- Lead sponsor
- Helse FonnaUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Helse Vest, University of Bergen, Haukeland University Hospital
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 17 Dec 2019 (actual)
- 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.
To examine the effect of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitoring (CGM) on metabolic control, in a large population-based nationwide observational study under real life conditions.
All children and adolescents with type 1 diabetes are investigated,using annual data in 2017 from the population-based Norwegian Childhood Diabetes Registry (NCDR). HbA1c, incidence of diabetes ketoacidosis (DKA) and severe hypoglycemia (SH) are evaluated depending on the use of CSII and CGM in a linear mixed-effects and linear regression model adjusted for age, biologic gender and diabetes duration. Health-related quality of Life (HRQOL) is assessed by using the DISABKIDS diabetes specific module (DDM-10), and associations with the use of CSII, CGM, age, gender and diabetes duration are evaluated.
Detailed description
In Norway, all children with diabetes 0-18 years should, due to a recommendation from the national health care authority, receive their diabetes follow-up in a pediatric department. All pediatric departments participate in the NCDR reporting standardized clinical data on their patients to the NCDR, at diabetes onset and annually, until the patients reach 18 years of age. The data completeness of NCDR is high, on individual level 99 % at diabetes onset, and 98 % on the annual examinations in 2016 - 2017.
In addition, HRQOL data were collected in 2017, using the DISABKIDS diabetes specific module (DDM-10). Children 10-17 years with type 1 diabetes were invited to independently fill out the questionnaire regarding their own disease-related quality of life. All parents to children with type 1 diabetes (independent of the child's age) were invited to fill out the same questionnaire, giving a proxy evaluation of their child's quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Our cohort consists of 2749 patients with type 1 diabetes, 45.5 % females; mean age was 12.9 years (SD 3.9, min 1.7, max 20.2) and mean diabetes duration was 5.3 years (SD 3.7)
Key inclusion criteria (1 listed)
- All registered subjects with type 1 diabetes in the 2017 annual cohort of the NCDR
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| CSII and CGMuse of CSII as insulin delivery or CGM as glucose monitoring | Device | – |
Primary outcome
HbA1c
Time frame: measured at annual follow-up in 2017
DKA
Time frame: registered at annual follow-up in 2017
diabetic ketoacidosis leading to hospitalization
SH
Time frame: registered at annual follow-up in 2017
Severe hypoglycemia
HRQOL
Time frame: participation connected to annual follow-up in 2017
health-related quality of life measured with the DISABKIDS diabetes module DDM-10
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 6 Oct 2021.
- Derived from this study: PubMed 34389930Bratke H, Margeirsdottir HD, Assmus J, Njolstad PR, Skrivarhaug T. Does Current Diabetes Technology Improve Metabolic Control? A Cross-Sectional Study on the Use of Insulin Pumps and Continuous Glucose Monitoring Devices in a Nationwide Pediatric Population. Diabetes Ther. 2021 Sep;12(9):2571-2583. doi: 10.1007/s13300-021-01127-6. Epub 2021 Aug 13.
- 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.
Heiko Bratke, MD principal investigator
Haugesund Hospital, Fonna Health Trust, Norway
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 1, run by Helse Fonna.
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 1 inclusion and 1 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 6 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
HbA1c (time frame: measured at annual follow-up in 2017). The study lists 4 primary outcomes in all. 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 NCT04201171, 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 6 Oct 2021.