T1DMNCT03697369
Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps
An observational study of T1DM, run by Assaf-Harofeh Medical Center.
Trial summary
Background: The use of insulin pumps in pediatric patients with type 1 diabetes(T1D) has expanded, with lack of data comparing between the different devices. Objective: to compare prospectively glycemic control, technical difficulties and quality of life (QOL) between 3 pump devices during the first year of use . Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- T1DM
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 31 May 2015to 31 Aug 2017
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The study population included all individuals with T1D ages 0-20 years who switched management modality from MDI to pump as part of their clinical care, and were managed by the pediatric diabetes teams from the AWeSoMe Study Group ( four pediatric diabetes multidisciplinary clinics in Israel; Assaf Harofeh Medical Center, E. Wolfson Medical Center, Edmond and Lily Safra Children's Hospital, and Maccabi National Juvenile Diabetes Center).
Who may be able to join
- Diagnosis of T1D recorded by a pediatric endocrinologist
- Attending periodic clinic visits, and starting pump mode of therapy between May 2015 and March 2017.
Who cannot join
- No restrictions on HbA1c value at study recruitment or on use of CGMS -
About this study
Background: The use of insulin pumps in pediatric patients with type 1 diabetes(T1D) has expanded, with lack of data comparing between the different devices.
Objective: to compare prospectively glycemic control, technical difficulties and quality of life (QOL) between 3 pump devices during the first year of use .
Methods: a prospective observational trial, based on clinical data retrieved during 12 months of follow- up. Inclusion criteria included T1D patients, ages 1-18 years, who started pump therapy as part of their clinical care in 4 university affiliated medical centers. The devices fully reimbursed by national health insurance are: MiniMed™ 640G , MiniMed® Veo™, Animas® Vibe®, and Abbott Omnipod®. Comparison parameters included quality of life (QOL), frequency of technical difficulties, skin reactions, discontinuation rate, glycated hemoglobin (HBA1C), mean glucose, total daily insulin dose (TDD) , pump setting parameters and BMI.
- Conditions
- T1DM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Observation group | Individuals with T1D ages 0-20 years who switched management modality from MDI to pump as part of their clinical care and were followed up prospectively in the next 12 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technical difficulties differences
All patients were asked 5 questions regarding monthly frequency of technical problems including the need to use extra sets and the level of pain at catheter insertion
Measured: 2 years from patient first enrollment
Quality Of Life (QOL)
QOL assessment was performed utilizing The Diabetes Treatment Satisfaction Questionnaires (DTSQ) for teens and for parents, separately [14]. The teens DTSQ contained 12 items scores on six-point scales, of which 9 were summed, the parents DTSQ contained 14 items, of which 9 were summed. Maximal grade was 42.
Measured: 2 years from patient first enrollment
Skin reactions differences
skin assessment at the pump insertion site (itching and redness).
Measured: 2 years from patient first enrollment
Discontinuation rate differences
Comparison between constant pump users and those who discontinued
Measured: 2 years from patient first enrollment
Secondary outcomes (5)
Glycemic control and metabolic parameters differences: Insulin TDD
The difference in glycemic control parameters and metabolic parameters after 3, 6 and 12 months of follow up, between the pumps devices. Insulin TDD, as reported by pump printout data
Measured: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences: HbA1c%
The difference in HbA1c% as measured by each center ll local lab.
Measured: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences:Glucose Mean & SD
Glucose Mean \& SD as recorded by SMBG
Measured: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences:Number of SMBG per day
Data derived from data recorded by SMBG
Measured: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences:BMI SDS
according to Center for Disease Control (CDC) growth charts scale
Measured: 2 years from patient first enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start31 May 2015
- Primary completion31 Jul 2017
- Study completion31 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for T1DMStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Collaborators
- Wolfson Medical Center, Sheba Medical Center, Maccabi Healthcare Services, Israel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697369
- Sponsor's protocol ID
- 0073-15-ASF
- Status last verified
- Oct 2018
- First submitted
- 16 Jul 2018
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glycemic Control and Treatment Satisfaction in Children With Type 1 Diabetes Using Insulin Pumps
- ClinicalTrials.gov ID
- NCT03697369
- Acronym / sponsor ID
- 0073-15-ASF
- Conditions
- T1DM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Collaborators
- Wolfson Medical Center, Sheba Medical Center, Maccabi Healthcare Services, Israel
- Study start
- 31 May 2015 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Aug 2017 (actual)
- First posted
- 5 Oct 2018 (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.
Background: The use of insulin pumps in pediatric patients with type 1 diabetes(T1D) has expanded, with lack of data comparing between the different devices.
Objective: to compare prospectively glycemic control, technical difficulties and quality of life (QOL) between 3 pump devices during the first year of use .
Methods: a prospective observational trial, based on clinical data retrieved during 12 months of follow- up. Inclusion criteria included T1D patients, ages 1-18 years, who started pump therapy as part of their clinical care in 4 university affiliated medical centers. The devices fully reimbursed by national health insurance are: MiniMed™ 640G , MiniMed® Veo™, Animas® Vibe®, and Abbott Omnipod®. Comparison parameters included quality of life (QOL), frequency of technical difficulties, skin reactions, discontinuation rate, glycated hemoglobin (HBA1C), mean glucose, total daily insulin dose (TDD) , pump setting parameters and BMI.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observation group | – | –Individuals with T1D ages 0-20 years who switched management modality from MDI to pump as part of their clinical care and were followed up prospectively in the next 12 months. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The study population included all individuals with T1D ages 0-20 years who switched management modality from MDI to pump as part of their clinical care, and were managed by the pediatric diabetes teams from the AWeSoMe Study Group ( four pediatric diabetes multidisciplinary clinics in Israel; Assaf Harofeh Medical Center, E. Wolfson Medical Center, Edmond and Lily Safra Children's Hospital, and Maccabi National Juvenile Diabetes Center).
Key inclusion criteria (2 listed)
- Diagnosis of T1D recorded by a pediatric endocrinologist
- Attending periodic clinic visits, and starting pump mode of therapy between May 2015 and March 2017.
Key exclusion criteria (1 listed)
- No restrictions on HbA1c value at study recruitment or on use of CGMS -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Technical difficulties differences
Time frame: 2 years from patient first enrollment
All patients were asked 5 questions regarding monthly frequency of technical problems including the need to use extra sets and the level of pain at catheter insertion
Quality Of Life (QOL)
Time frame: 2 years from patient first enrollment
QOL assessment was performed utilizing The Diabetes Treatment Satisfaction Questionnaires (DTSQ) for teens and for parents, separately [14]. The teens DTSQ contained 12 items scores on six-point scales, of which 9 were summed, the parents DTSQ contained 14 items, of which 9 were summed. Maximal grade was 42.
Skin reactions differences
Time frame: 2 years from patient first enrollment
skin assessment at the pump insertion site (itching and redness).
Discontinuation rate differences
Time frame: 2 years from patient first enrollment
Comparison between constant pump users and those who discontinued
5 secondary outcomes
Glycemic control and metabolic parameters differences: Insulin TDD
Time frame: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences: HbA1c%
Time frame: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences:Glucose Mean & SD
Time frame: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences:Number of SMBG per day
Time frame: 2 years from patient first enrollment
Glycemic control and metabolic parameters differences:BMI SDS
Time frame: 2 years from patient first enrollment
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 5 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of T1DM, run by Assaf-Harofeh Medical Center.
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 2 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 5 Oct 2018. 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?
Technical difficulties differences (time frame: 2 years from patient first enrollment). 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?
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 5 Oct 2018.