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Tests treatment safety and results for Diabetes
Official title Efficacy of Automated Insulin Therapy Early Initiated After Diagnosis on Blood Glucose Control in Children and Adolescents With Type 1 Diabetes
ClinicalTrials.gov ID: NCT06283797
What this study is testing
- What it's testing
- The main objective is to assess whether hybrid closed-loop (HCL) insulin delivery initiated early after diagnosis of Type 1 diabetes (T1D) allows a better efficacy on glucose control than conventional standard insulin therapy with multiple daily insulin injections (MDI) or insulin pumps after one year of use. The secondary objectives are to assess whether HCL initiated early after diagnosis of T1D allows: (1) Higher time spent with glucose level in the near-normal range, (2) Lower time spent in hypoglycemia and hyperglycemia, (3) Lower glucose variability, (4) Lower perceived burden of diabetes management, (5) Better preserved endogenous insulin secretion, all the above after one year of use, (6) Lower occurrence of interventions for hypoglycemia, versus conventional standard insulin therapy with MDI or insulin pump.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- Aged between 2 and 17.9 years
- Diagnosis of type 1 diabetes since at least 3 months and up to 6 months based upon WHO criteria
- Identification of at least one positive plasma auto-antibody among anti-GAD, anti-IA2, anti-ZnT8 and anti-insulin
- Treatment by multiple-daily insulin injections or insulin pump. An insulin pump with a function of stopping the pump in case of predicted...
- Patient and/or parents/guardians trained in carbohydrate counting
You likely can't join if
- Unwillingness of one parent or the legally responsible party to participate in insulin treatment
- Any associated chronic disease or therapy (except insulin or L thyroxin at stable dose) affecting glucose metabolism
- Therapy by automated insulin delivery using an insulin pump connected to continuous glucose monitoring sensor with a control algorithm (hybrid...
- Cutaneous allergy or contact dermatitis to device (CGM or pod) adhesives
- Insufficient vision and/or hearing to recognise all the functions of the Omnipod 5 system, including alerts, alarms and reminders in accordance with...
- Impaired cognitive or psychological abilities of the patient and/or his/her parents or the legally responsible party which may result in defective...
See the full eligibility criteria
- Aged between 2 and 17.9 years
- Diagnosis of type 1 diabetes since at least 3 months and up to 6 months based upon WHO criteria
- Identification of at least one positive plasma auto-antibody among anti-GAD, anti-IA2, anti-ZnT8 and anti-insulin
- Treatment by multiple-daily insulin injections or insulin pump. An insulin pump with a function of stopping the pump in case of predicted hypoglycaemia is allowed.
- Patient and/or parents/guardians trained in carbohydrate counting
- Patient and/or parents/guardians must have a smartphone that supports the Dexcom G6 app download and participants must be willing to use Dexcom G6 sensor and app throughout the study
- Unwillingness of one parent or the legally responsible party to participate in insulin treatment
- Any associated chronic disease or therapy (except insulin or L thyroxin at stable dose) affecting glucose metabolism
- Therapy by automated insulin delivery using an insulin pump connected to continuous glucose monitoring sensor with a control algorithm (hybrid closed-loop system)
- Cutaneous allergy or contact dermatitis to device (CGM or pod) adhesives
- Insufficient vision and/or hearing to recognise all the functions of the Omnipod 5 system, including alerts, alarms and reminders in accordance with the instructions of utilization
- Impaired cognitive or psychological abilities of the patient and/or his/her parents or the legally responsible party which may result in defective adherence to study procedures
- Active enrolment in another clinical trial or administration of an unapproved drug within the last 4 weeks before the screening date
- Subject who is in a dependency or employment with the sponsor or the investigator
- No signed informed consent form by the patient and his/her parents/legally responsible party
- people unable to attend all scheduled visits and to comply with all trial procedures
- Law protected or deprived of liberty subject
- Pregnant and breastfeeding women
- people no covered by public health insurance
The study team makes the final eligibility decision.
Where it's taking place
- Angers, France
- Montpellier, France
- Paris, France
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Angers, France; Montpellier, France; Paris, France; Tours, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.