Cross-sectional, Case Control Study of Electrical Activity and Neurocognitive Performance During Hyperglycemia and Near Normoglycemia, and Brain Tissue Integrity in Children and Youth With Type 1 Diabetes and in Healthy Population
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Association between interstitial glucose concentration and EEG power
研究概览
简要总结
Study population : 90 Participants. 60 with T1DM , and 30 healthy controls. T1DM patients will be recruited by research publication in diabetes mellitus forums.
Baseline visit: informed consent signing. Medical history data, vital signs, physical exam and neurocognitive testing. Capillary glucose prior to testing > 70 mg/dl.
Session 2 - combined simultaneous EEG , continuous glucose monitor system (CGMS) assessment, neurocognitive testing, and sleep quality assessment.
Participants will be hospitalized for 30 hours in the continuous-EEG unit at the Pediatric Neurology Department, Assaf-Harofeh Medical Center. Continuous simultaneous EEG and CGMS monitoring, and two separate sessions of neurocognitive assessments at glucose > 240 mg/dl and at glucose < 180 mg/dl, respectively.
Neurocognitive assessment will be performed after lunch on day 1, and after lunch on day 2. Day 1, regular insulin dose before lunch, and a cognitive assessment which will be performed with glucose level > 70 mg/dl and below 180 mg/dl.
On day 2, with no regular insulin dose before lunch and the same cognitive test will be performed with glucose level > 240 mg/dl During the 30 hours the participants will be connected to continuous EEG recording, sleep monitoring and CGMS. The study participants and research team will be blinded to the EEG and CGMS readings while recorded.
Participants will be able to convey their daily activities in their room. They will have their regular diet and regular daily activities.
Participants will measure at least 4 blood glucose measurements by prick tests, insulin management by multiple daily injections or pump therapy and meals.
Healthy participants will measure twice daily as required for CGMS calibration. The participants will stay connected to the CGMS for additional 4 days at their home setting for complete sleep quality assessment by sleep diary and actigraph.
The first night in hospital is to assess the association between actigraph and EEG and CGMS variability. The 4 nights at home are for assessment of CGMS, quality of life and actigraph readings.
Control group (healthy) will perform only one session of neurocognitive studies on day 1, after lunch with no insulin injection and will be discharged after 24 hours, with the CGMS and actigraph
详细描述
An inter-disciplinary repeated measures case control design study is proposed, whereby novel methods of brain imaging, brain electrophysiological activity, neuropsychological tests will be examined in concert with the children's dynamic changes in glucose levels. This will be compared to healthy population.
Study population Participants with T1DM and healthy siblings will be recruited by research publication in diabetes mellitus forums, and through the Pediatric Endocrinology Association. It will include mainly participants from the Pediatric Diabetes Mellitus Clinics at Assaf Harofeh; however, every child who complies with the inclusion and exclusion criteria will be recruited.
Inclusion criteria: Families living in areas with high access to medical care. Age: 12-18 years old having diagnosed with T1DM for longer than 2 years.
Exclusions: head injuries, epileptic episodes, psychiatric medications, lack of Hebrew abilities, disagreement to keep with all study requests, history of more than one episode of severe hypoglycemic event in the past, including loss of consciousness or more than one episode of diabetic ketoacidosis (DKA) . Patients with significant renal or liver function abnormalities will be excluded.
Similar exclusion criteria for healthy control population. All parents will sign informed consent and children will assent, according to Ethics committee regulations, prior to beginning study sessions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Families living in areas with high access to medical care.
- •Age:12-18 years old having diagnosed with T1DM for longer than 2 years.
排除标准
- •Head injuries
- •Epileptic episodes
- •Psychiatric medications
- •Lack of Hebrew abilities
- •Disagreement to keep with all study requests
- •History of more than one episode of severe hypoglycemic event in the past including loss of consciousness or more than one episode of diabetic ketoacidosis.
- •Patients with significant renal or liver function abnormalities.
结局指标
主要结局
Association between interstitial glucose concentration and EEG power
时间窗: 2 years
continuous monitoring of both EEG readings and glucose
次要结局
- Association between interstitial glucose concentration and neurocognitive functions(2 years)
研究者
Marianna Rachmiel
Dr. Marianna Rachmiel
Assaf-Harofeh Medical Center