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The study is an open label single centre randomised cross over study to evaluate the impact of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin administration (640G® with the Smart Guard feature) versus the use of the same pump for insulin administration with 'only' continuous glucose measurements (not interacting with the pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia. Exploratory endpoints are the effect on sleep and quality of life in children with type 1 diabetes and their caregivers.
Optimising metabolic control in children with Type 1Diabetes Mellitus (T1DM) is essential to prevent late complications. Fear of nocturnal hypoglycemia is pervasive amongst parents of children with T1DM, leading to a heightened vigilance by parents to control regularly their children's blood sugar values or to check the sensor information during the night. This leads to chronic sleep interruption and to lack of sleep as well in the parents as in their children with diabetes.
In this study, the impact of new technologies on glucose time in target , hypo fear and quality of life will be evaluated, using continuous interstitial glucose measurements either with a direct impact on insulin administration (640G medtronic pump (R)) and with alerts , or without impact on insulin administration and without alerts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM augmented pump with PLGS (A) | Experimental | Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with integrated continuous glucose monitoring and predicted low glucose suspense (PLGS) Randomised cross over treatment during 5 weeks |
|
| Insulin pump with CGM (B) | Active Comparator | Administration of Subcutaneous administration of Continuous subcutaneous insulin infusion with second device measuring continuous glucose Randomised cross over treatment during 5 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CGM augmented pump with PLGS , | Device | 5 weeks treatment CGM augmented pump with PLGS compared with 5 weeks treatment with insulin pump with CGM , without integration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time in glucose target | Percent time in glucose target (3.9 -8 mmol/l) , measured by blinded CGM | Last 6 days of treatment arm A and last 6 days of treatment arm B |
| Measure | Description | Time Frame |
|---|---|---|
| time below glucose target | Percent time spent below glucose target (<3.0mmol/l and < 2,5 mmol/l) measured by blinded CGM (I-Pro 2) | Last 6 days of treatment arm A and last 6 days of treatment arm B |
| Time above glucose target |
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Inclusion Criteria:
Exclusion Criteria:
. No parental consent
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| Name | Affiliation | Role |
|---|---|---|
| Carine de Beaufort, MD,PhD | Centre Hospitalier du Luxembourg | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique des Enfants CHluxembourg | Luxembourg | 1210 | Luxembourg |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39736868 | Derived | Schierloh U, Aguayo GA, Fichelle M, De Melo Dias C, Schritz A, Vaillant M, Barnard-Kelly K, Cohen O, Gies I, de Beaufort C. Fear of hypoglycemia and sleep in children with type 1 diabetes and their parents. Front Endocrinol (Lausanne). 2024 Dec 16;15:1419502. doi: 10.3389/fendo.2024.1419502. eCollection 2024. | |
| 35712259 | Derived |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 23, 2022 | Mar 15, 2022 | 2 |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Insulin pump with CGM | Device | 5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration, |
|
|
Percent time spent above glucose target (>10.0mmol/l ) measured by blinded CGM (I-Pro 2)
| Last 6 days of treatment arm A and last 6 days of treatment arm B |
| Sleep quantity in patients and caregivers | Total sleep and wake time , number of awakenings measured by wireless actigraph | baselines ( before treatment arm starts) and last week of treatment arm A and last week of treatment arm B |
| perception of quality of sleep and quality of life in patients and caregivers | validated questionnaires | baseline and last week of treatment arm A and last week of treatment arm B |
| hypoglycaemia fear in patients and caregivers | Hypoglycemia fear survey for parents and children | baseline and last week of treatment arm A and last week of treatment arm B |
| Schierloh U, Aguayo GA, Schritz A, Fichelle M, De Melo Dias C, Vaillant MT, Cohen O, Gies I, de Beaufort C. Intermittent Scanning Glucose Monitoring or Predicted Low Suspend Pump Treatment: Does It Impact Time in Glucose Target and Treatment Preference? The QUEST Randomized Crossover Study. Front Endocrinol (Lausanne). 2022 May 31;13:870916. doi: 10.3389/fendo.2022.870916. eCollection 2022. |
| 30509293 | Derived | Schierloh U, Aguayo GA, Fichelle M, De Melo Dias C, Celebic A, Vaillant M, Barnard K, Cohen O, de Beaufort C. Effect of predicted low suspend pump treatment on improving glycaemic control and quality of sleep in children with type 1 diabetes and their caregivers: the QUEST randomized crossover study. Trials. 2018 Dec 4;19(1):665. doi: 10.1186/s13063-018-3034-4. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |