Diabetes Mellitus, Type 1DEEPNCT04100070
Intensive Versus Standard One Year Monitoring on Glycaemic Control After Initiating CSII in Children With DT1. DEEP Study
A study testing Monitoring of the patients in people with Diabetes Mellitus, Type 1 and Pediatric ALL, run by ISIS Diabete Service at 1 site in France.
Trial summary
More than half of type 1 diabetes (DT1) children are under CSII (Continuous Subcutaneous Insulin Infusion). Several studies showed that despite a patients' follow-up mostly by hospital-based paediatricians, there are still some concerns on long-term glycaemic control with inconstant results on glycaemic control either… Read more about this study
- Who is it for?
- Ages 12 months to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Pediatric ALL
- What is being tested?
- Monitoring of the patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteFrance
- Study dates
- 2 Sep 2019to 31 Dec 2021
- 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 12 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children (<18 yo) with not controlled type 1 diabetes seen by diabetologists/paediatricians immediately following the initiation of CSII.
- Children for whom it is the first initiation of CSII.
- Children (or their parents if necessary) having read the information note and having dated and signed the informed consent form.
Who cannot join
- Children with a history of diabetes less than 12 months.
- Children with HbA1c values below 7.5 or above 10 before CSII initiation.
- Children treated by CSII for more than 3 months.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Isis Diabete Service
Gennevilliers, Île-de-France Region
Arnaud Jerome, PhD
Alix Geissler
About this study
Official title: Impact of an Intensive Monitoring on Glycaemic Control One Year After Initiating Continuous Subcutaneous Insulin Infusion in Children With Type 1 Diabetes.
More than half of type 1 diabetes (DT1) children are under CSII (Continuous Subcutaneous Insulin Infusion).
Several studies showed that despite a patients' follow-up mostly by hospital-based paediatricians, there are still some concerns on long-term glycaemic control with inconstant results on glycaemic control either due to CSII adherence or nutrition management issues.
Consequently, this real life study aims to compare two monitoring methods (standard versus intensive) in children initiating a CSII treatment and assess the impact on glycaemic control after one year.
Read the detailed description
As CSII becomes more and more the gold standard therapy in children with type 1 diabetes, there have been some questions regarding the long-term effect of these treatments with some concerns on the inconstant results on glycaemic control either due to CSII adherence or nutrition management issues.
The DCCT (Diabetes Control and Complications Trial) study has already shown in diabetic adults that intensification of treatment and follow-up could result in significative improvement of glycaemic control.
This study aims to test this hypothesis of significant improvement after one year following CSII initiation on glycaemic control.
Two parallel arms will be compared in real life conditions; one with standard recommendations-based follow-up by both diabetologists/pediatricians and service provider and the other with intensive follow-up with higher frequency of provider's nurses visits and personalization of patient status transferred to the physician for each diabetologists/pediatricians visit.
Thus, investigators could determine after one year if the glycaemic control is better with one or the other of these follow-up procedures.
Glycaemic control will be assessed both by the evolution of HbA1c during the study period and its last level at the end of the study. Its evaluation will be completed by counting of all symptomatic hypoglycemia occurence during the study.
- Conditions
- Diabetes Mellitus, Type 1, Pediatric ALL
- Being tested
- Monitoring of the patients
- Medical subject headings
- Diabetes Mellitus, Type 1, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monitoring of the patientsBehavioural
Follow-up of the patients during the 12 months study periods including :
- visits with the diabetologist/pediatrician
- contacts with the service provider (nurses' visits) (more in intensive group)
- personalized monitoring of glycemic data transferred to the diabetologist/pediatrician for each visit (only in intensive group)
| Study group | Role | What they receive |
|---|---|---|
| Standard monitoring | Other | Usual follow-up of children by pediatricians as recommended by relevant Authorities (HAS) both in terms of frequency of visits and rhythm of biological controls.
Standard technical training, maintenance and monitoring by the CSII service provider as defined by the official specifications (LPPR) Receives: Behavioral: Monitoring of the patients |
| Intensive monitoring | Other | Usual follow-up of children by pediatricians as recommended by relevant Authorities (HAS) both in terms of frequency of visits and rhythm of biological controls completed by a personalized vision of the patient glycaemic data along the study.
Intensive technical training, maintenance and monitoring by the CSII service provider with a higher frequency of contacts during the period (additional nurse visits). Receives: Behavioral: Monitoring of the patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact on glycaemic control one year after CSII initiation
Evolution of HbA1c measurement between last measure before CSII initiation and 12 months after.
Measured: HbA1c values at inclusion and last known measurement at the 12 months last visit
Impact on glycaemic control all along the study
Unplanned hospitalization rate during the study Severe hypoglycemia during the study period
Measured: Assessment and counting of all unplanned hospitalizations during the 12 months period
Secondary outcomes (1)
Impact on glycaemic control upon age classes
sub-groups based one age (<7 years old [yo], 7-12 yo, 13-17 yo)
Measured: HbA1c values at inclusion and last known measurement at the 12 months last visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start2 Sep 2019
- Primary completion31 Oct 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
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.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized parallel groups open study
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ISIS Diabete Service
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Nicolino, MD PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04100070
- Sponsor's protocol ID
- 2018-A02932-53
- Acronym
- DEEP
- Status last verified
- Dec 2020
- First submitted
- 20 Sep 2019
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of an Intensive Monitoring on Glycaemic Control One Year After Initiating Continuous Subcutaneous Insulin Infusion in Children With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT04100070
- Acronym / sponsor ID
- DEEP / 2018-A02932-53
- Conditions
- Diabetes Mellitus, Type 1, Pediatric ALL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- ISIS Diabete ServiceUniversity, hospital or other
- Study start
- 2 Sep 2019 (actual)
- Primary completion
- 31 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Sep 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.
More than half of type 1 diabetes (DT1) children are under CSII (Continuous Subcutaneous Insulin Infusion).
Several studies showed that despite a patients' follow-up mostly by hospital-based paediatricians, there are still some concerns on long-term glycaemic control with inconstant results on glycaemic control either due to CSII adherence or nutrition management issues.
Consequently, this real life study aims to compare two monitoring methods (standard versus intensive) in children initiating a CSII treatment and assess the impact on glycaemic control after one year.
Detailed description
As CSII becomes more and more the gold standard therapy in children with type 1 diabetes, there have been some questions regarding the long-term effect of these treatments with some concerns on the inconstant results on glycaemic control either due to CSII adherence or nutrition management issues.
The DCCT (Diabetes Control and Complications Trial) study has already shown in diabetic adults that intensification of treatment and follow-up could result in significative improvement of glycaemic control.
This study aims to test this hypothesis of significant improvement after one year following CSII initiation on glycaemic control.
Two parallel arms will be compared in real life conditions; one with standard recommendations-based follow-up by both diabetologists/pediatricians and service provider and the other with intensive follow-up with higher frequency of provider's nurses visits and personalization of patient status transferred to the physician for each diabetologists/pediatricians visit.
Thus, investigators could determine after one year if the glycaemic control is better with one or the other of these follow-up procedures.
Glycaemic control will be assessed both by the evolution of HbA1c during the study period and its last level at the end of the study. Its evaluation will be completed by counting of all symptomatic hypoglycemia occurence during the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized parallel groups open study
| Arm | Type | Receives |
|---|---|---|
| Standard monitoring | Other | Behavioral: Monitoring of the patientsUsual follow-up of children by pediatricians as recommended by relevant Authorities (HAS) both in terms of frequency of visits and rhythm of biological controls. Standard technical training, maintenance and monitoring by the CSII service provider as defined by the official specifications (LPPR) |
| Intensive monitoring | Other | Behavioral: Monitoring of the patientsUsual follow-up of children by pediatricians as recommended by relevant Authorities (HAS) both in terms of frequency of visits and rhythm of biological controls completed by a personalized vision of the patient glycaemic data along the study. Intensive technical training, maintenance and monitoring by the CSII service provider with a higher frequency of contacts during the period (additional nurse visits). |
Who may qualify
- Ages
- 12 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children (<18 yo) with not controlled type 1 diabetes seen by diabetologists/paediatricians immediately following the initiation of CSII.
- Children for whom it is the first initiation of CSII.
- Children (or their parents if necessary) having read the information note and having dated and signed the informed consent form.
Key exclusion criteria (3 listed)
- Children with a history of diabetes less than 12 months.
- Children with HbA1c values below 7.5 or above 10 before CSII initiation.
- Children treated by CSII for more than 3 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 |
|---|---|---|
| Monitoring of the patientsFollow-up of the patients during the 12 months study periods including : * visits with the diabetologist/pediatrician * contacts with the service provider (nurses' visits) (more in intensive group) * personalized monitoring of glycemic data transferred to the diabetologist/pediatrician for each visit (only in intensive group) | Behavioural | Intensive monitoring, Standard monitoring |
Primary outcome
Impact on glycaemic control one year after CSII initiation
Time frame: HbA1c values at inclusion and last known measurement at the 12 months last visit
Evolution of HbA1c measurement between last measure before CSII initiation and 12 months after.
Impact on glycaemic control all along the study
Time frame: Assessment and counting of all unplanned hospitalizations during the 12 months period
Unplanned hospitalization rate during the study Severe hypoglycemia during the study period
1 secondary outcome
Impact on glycaemic control upon age classes
Time frame: HbA1c values at inclusion and last known measurement at the 12 months last visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus, Type 1
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
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.
Marc Nicolino, MD PhD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monitoring of the patients in people with Diabetes Mellitus, Type 1 and Pediatric ALL, run by ISIS Diabete Service at 1 site in France.
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 3 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: status not confirmed, as of the sponsor's last update on 4 Dec 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Jerome, PhD (00 (33) 6 19 85 67 07, arnaud.jerome@isisdiabete.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact on glycaemic control one year after CSII initiation (time frame: HbA1c values at inclusion and last known measurement at the 12 months last visit). 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 4 Dec 2020.