Diabetes Mellitus, Type I
Conditions
Keywords
type 1 diabetes, advanced hybrid closed loop, diabetes onset
Brief summary
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.
Interventions
DEVICEAdvanced Hybrid Closed Loop from onset of type 1 diabetes in children
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.
Sponsors
Aghia Sophia Children's Hospital of Athens
National and Kapodistrian University of Athens
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
7 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CGMS metrics | 3 and 6 months (extension phase) | 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. |
| HbA1c | 3 months and 6 months (extension phase) | HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TBR (Time Below Range) (<70mg/dl) | 3 and 6 months (extension phase) | 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. |
| AHCL use | 3 and 6 months (extension phase) | 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. |
| Total daily insulin requirements | 3 and 6 months (extension phase) | 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. |
| Hypoglycemia Fear Survey for Children and Parents (HFS-C & P) | baseline, 3 months and 6 months (extension phase) | 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) |
| Acceptance of AHCL | 3 months | 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. |
| Brief Illness Perception Questionnaire | baseline, 3 months and 6 months (extension phase) | QoL of the study participants before, 3 months and 6 months after initiation of the study, with the use of questionnaire Brief Illness Perception Questionnaire |
| Fasting c-peptide, ΒΜΙ-SDS from baseline to 3 and 6 months | baseline, 3 months and 6 months (extension phase) | Assess the change in fasting c-peptide from baseline to 3 and 6 months |
| ΒΜΙ-SDS | baseline, 3 months and 6 months (extension phase) | Assess the change in ΒΜΙ-SDS from baseline to 3 and 6 months |
| PedsQL 3.0 Diabetes Module [Child (8-12 years of age) and Parent-Proxy Report for Children (ages 8-12), Adolescent (13-18 years of age), where appropriate | baseline, 3 months and 6 months (extension phase) | QoL of the study participants before, 3 months and 6 months after initiation of the study, with the use of questionnaire PedsQL 3.0 Diabetes Module \[Child (8-12 years of age) and Parent-Proxy Report for Children (ages 8-12), Adolescent (13-18 years of age), where appropriate |
| TAR (Time Above Range) (>180mg/dl) | 3 months and 6 months (extension phase) | 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. |
Countries
Greece
Contacts
Primary ContactChristina Kanaka- Gantenbein, Professor
Outcome results
None listed