Diabetes Mellitus, Type 1 Clinical Trial
Official title:
Determination of Sleep Disorder and Chronotype in Children and Adolescents With Type 1 Diabetes; Observation of the Impact on Glycemic Control and Treatment
Type 1 diabetes is the most common metabolic disorder in children and adolescents. Sleep is important for prognosis and several sleep parameters are related to metabolic control. However, limited number of studies in children and adolescents showed mixed results and recommendations about how to address sleep in the clinical care of diabetes in children are still lacking. There is a need to examine the potential role of sleep in developing preventive interventions for diabetes management in children and adolescents. The authors aimed to describe sleep/wake patterns ,sleep problems, and chronotype of children and adolescents with type 1 diabetes, and to assess the relation of sleep measures with metabolic control and treatment. The study has a prospective observational cross-sectional design. An estimated sample size is calculated as 83. Children diagnosed with type 1 diabetes between 6 to 18 years of age will be recruited from two pediatric endocrinology centers specialized in diabetes. Sleep/wake pattern will be assessed by actigraphy, and sleep diaries. Sleep disorder will be assessed by the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Sleep Disorder Scale, and Chronotype Questionnaire will be used to determine the chronotype.
Type 1 diabetes is the most common metabolic disorder in children and adolescents. Sleep is important for prognosis and several sleep parameters are related to metabolic control. However, limited number of studies in children and adolescents showed mixed results and recommendations about how to address sleep in the clinical care of diabetes in children are still lacking. There is a need to examine the potential role of sleep in preventive interventions. The authors aimed to describe sleep/wake patterns ,sleep problems, and chronotype of children and adolescents with type 1 diabetes, and to assess the relation of sleep measures with metabolic control and treatment. The study has a prospective observational cross-sectional design. An estimated sample size is calculated as 83. Children diagnosed with type 1 diabetes between 6 to 18 years of age will be recruited from two pediatric endocrinology centers specialized in diabetes. Sleep/wake pattern will be assessed by actigraphy, and sleep diaries. Sleep wake patterns will be assessed by Philips Respironics Mini-Mitter Actiwatch-2 for at least 3 days at home environment and sleep diaries within 5-minute intervals will be filled out by parents. Actigraphy is a validated wristwatch-like device that distinguishes sleep from wakefulness based on accelerometer measured movement. Sleep disorder will be assessed by the Diagnostic and Statistical Manual for Mental Disorders (DSM-5) Sleep Disorder Scale, and Chronotype Questionnaire will be used to determine the chronotype. For metabolic control, targeted standard values will be used for continuous glucose measurement. (Target daily blood glucose ranges 70-180 mg/dl, <4% <70 mg/dl, <1% <54 mg/dl, <25% >180 mg/dl, <5% rate >250 mg/dl). The latest Hemoglobin A1c level will also be evaluated. A questionnaire developed by the investigators including sociodemographic characteristics, and diabetes related information will be gathered from the patient records. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04030091 -
Pulsatile Insulin Infusion Therapy in Patients With Type 1 and Type 2 Diabetes Mellitus
|
Phase 4 | |
| Terminated |
NCT03605329 -
Evaluation of the Severity of Cardiovascular Autonomic Neuropathy in Type 1 Diabetic Patients With OSAS
|
N/A | |
| Completed |
NCT01696266 -
An International Survey on Hypoglycaemia Among Insulin-treated Patients With Diabetes
|
||
| Recruiting |
NCT06050642 -
Study of the Impact of PROximity Support for Patients With Type 1 DIABetes Treated With an Insulin Pump or Closed Loop.
|
N/A | |
| Completed |
NCT05107544 -
Metabolic, Physical Fitness and Mental Health Effects of High Intensity Interval Training (HIIT) in Adolescents With Type 1 Diabetes
|
N/A | |
| Active, not recruiting |
NCT04443153 -
Adapting Diabetes Treatment Expert Systems to Patient in Type 1 Diabetes
|
N/A | |
| Completed |
NCT04569994 -
A Study to Look at the Safety of NNC0363-0845 in Healthy People and People With Type 1 Diabetes
|
Phase 1 | |
| Completed |
NCT04521634 -
Glycaemic Variability in Acute Stroke
|
||
| Completed |
NCT04089462 -
Effects of Frequency and Duration of Exercise in People With Type 1 Diabetes A Randomized Crossover Study
|
N/A | |
| Completed |
NCT03143816 -
Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study-STAT Study
|
Phase 4 | |
| Completed |
NCT01892319 -
An International Non-interventional Cohort Study to Evaluate the Safety of Treatment With Insulin Detemir in Pregnant Women With Diabetes Mellitus. Diabetes Pregnancy Registry
|
||
| Recruiting |
NCT04039763 -
RT-CGM in Young Adults at Risk of DKA
|
N/A | |
| Completed |
NCT04042207 -
Diabeloop for Highly Unstable Type 1 Diabetes
|
N/A | |
| Not yet recruiting |
NCT06068205 -
COMPARATIVE ANALYSIS OF THE MORPHO-MECHANICAL PROPERTIES OF RED BLOOD CELLS EXTRACTED FROM DIABETIC PATIENTS WITH AND WITHOUT MICROVASCULAR COMPLICATIONS
|
||
| Recruiting |
NCT05909800 -
Prolonged Remission Induced by Phenofibrate in Children Newly Diagnosed With Type 1 Diabetes.
|
Phase 2 | |
| Active, not recruiting |
NCT04974528 -
Afrezza® INHALE-1 Study in Pediatrics
|
Phase 3 | |
| Completed |
NCT04530292 -
Home Intervention and Social Precariousness in Childhood Diabetes
|
N/A | |
| Completed |
NCT05428943 -
OPT101 in Type 1 Diabetes Patients
|
Phase 1 | |
| Recruiting |
NCT03988764 -
Monogenic Diabetes Misdiagnosed as Type 1
|
||
| Completed |
NCT05597605 -
The SHINE Study: Safety of Implant and Preliminary Performance of the SHINE SYSTEM in Diabetic Subjects
|
N/A |