Effect of Advanced Hybrid Closed Loop System, MiniMed 780G in Newly Diagnosed Children and Adolescents With Type 1 Diabetes on Glycemic Control and Patient Reported Outcomes Compared to Standard Insulin Therapy Historical Data (AHCL in New Onset T1D Children Study)

N/ARecruitingNCT06919029

National and Kapodistrian University of Athens30 enrolled

Overview

The objective of this study is to evaluate glycemic control of users of the AHCL system MiniMed 780G with GS4 calibration-free sensor in children and adolescents with newly diagnosed T1D implemented directly upon T1D diagnosis in combination with continuous glucose monitoring system (CGMS) compared with those treated with MDI retrieved from historical data- in a single- arm open-label prospective observational study, assessed at 3 months. After the initial study period there will be a 3month extension phase of the study.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetes Mellitus, Type I

Interventions

Advanced Hybrid Closed Loop from onset of type 1 diabetes in childrenDEVICE

Eligibility

Sex: ALLMin age: 7 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Clinical diagnosis of type 1 diabetes (WHO criteria). Diagnosis of type 1 diabetes is based on international criteria and the investigator's judgment; C peptide level and antibody determinations are not required. 2. Age range 7 to 17 years. 3. Literate in Greek or English. 4. Willing to wear study devices. 5. Willing to follow study-specific instructions. 6. Total daily insulin dose greater than 8.0 units over 1 week period 7. Willing and able (access to internet from home) to download information into the Medtronic CareLink software 8. Clinically eligible to start the AHCL system Exclusion Criteria: * Type 2 diabetes mellitus or MODY diabetes * Any untreated comorbidities of type 1 diabetes * Medication affecting metabolic control or interfering in the interpretation of HbA1c * Pregnancy * Untreated diabetes retinopathy, or other causes that in the investigator's opinion, precludes the individual from participating in the trial. * Known or suspected allergy to insulin. * Regular use of acetaminophen. * Lack of reliable telephone facility for contact. * Living alone. * Severe visual or hearing impairment. * Medically documented allergy to the adhesive of plasters or unable to tolerate tape adhesive around sensor placement. * Serious skin lesions at areas of the body used for insertion of the glucose sensor. * Illicit drugs abuse. * Alcohol abuse. * Sickle cell disease, haemoglobinopathy, receiving red blood cell transfusion or erythropoietin within 3 months prior to time of enrollment. * Eating disorder including anorexia/bulimia. * Milk protein allergy.

Outcomes

Primary Outcomes

CGMS metrics

CGMS metrics including Time in Range (70-180 mg/dl) during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.

Time frame: 3 and 6 months (extension phase)

HbA1c

Time frame: 3 months and 6 months (extension phase)

Secondary Outcomes

Acceptance of AHCL

Assess the percentage of the study participants willing to continue their therapy with AHCL as shown by prescribing the 780G insulin pump after the 3 months' time of their participation to the study.

Time frame: 3 months

TAR (Time Above Range) (>180mg/dl)

Time Above Range (\>180mg/dl) from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.

Time frame: 3 months and 6 months (extension phase)

TBR (Time Below Range) (<70mg/dl)

TBR (Time Below Range) during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.

Time frame: 3 and 6 months (extension phase)

AHCL use

Advanced Hybrid Closed Loop use during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from AHCL data. The same metric will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.

Time frame: 3 and 6 months (extension phase)

Total daily insulin requirements

Total daily insulin requirements during the 3 months' study period, i.e. from baseline to 3 months (90 days) extracted from the CGMS data from both the study group and children and adolescents in MDI- FGM/CGM group (historical data from age and sex matched children and adolescents followed in the same Diabetes Center). The same metrics will be evaluated in the extension phase of the study, namely at 6-months post initiation of the study.

Time frame: 3 and 6 months (extension phase)

Hypoglycemia Fear Survey for Children and Parents (HFS-C & P)

QoL of the study participants before, 3 months and 6 months after initiation of the study, with the use of the questionnaire "Hypoglycemia Fear Survey for Children and Parents (HFS-C \& P)"