Neurocognitive Performance During Hyperglycemia , and Brain Tissue Integrity in Youth With Type 1 Diabetes and in Healthy

Summary

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

Conditions

• Diabetes Mellitus, Type 1

Interventions

DEVICE

MRI including DTI , EEG, CGMS

Will be connected to continuous simultaneous systems

BEHAVIORAL

Neurocognitive tests

Will perform multiple tests of neurocognitive functions after lunch

Sponsors & Collaborators

• Bar-Ilan University, Israel

  collaborator OTHER

• Hadassah Medical Organization

  collaborator OTHER

• Assaf-Harofeh Medical Center

  lead OTHER_GOV

Principal Investigators

• Marianna Rachmiel, M.D · Assaf-Harofeh Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-03-01

Primary Completion

2019-10-15

Completion

2025-05-15

Countries

• Israel

Study Locations