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Search / Trial NCT06488469

Behavioural Problems and Cognition in Children With Hypoglycemia Unawareness in Type-1 Diabetes Mellitus

Launched by UNIVERSITY OF PITTSBURGH · Jun 27, 2024

Trial Information

Current as of July 23, 2025

Not yet recruiting

Keywords

Hypoglycemia Type 1 Diabetes Parent Management Techniques

ClinConnect Summary

This clinical trial is looking at how different types of support can help children aged 6 to 16 who have Type 1 diabetes and experience a condition called hypoglycemia unawareness. This means that their blood sugar levels can drop dangerously low (below 70 mg/dl) without them feeling any warning signs. The study will test a combination of psychological help, changes in diet, specific therapies, and support for parents to see if these can improve the children's behavior and thinking skills.

To be eligible for this trial, children must have been using insulin for at least six months and need to have documented episodes of hypoglycemia unawareness. However, children with known psychiatric disorders, those on steroid medications, or those with learning disabilities are not able to participate. If your child qualifies and you choose to take part, you can expect to be involved in various supportive activities designed to help your child manage their condition better. This trial is not yet recruiting participants, but it's an important step towards finding better ways to support children with diabetes.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Children should be between 6-16 years of age.
  • Children must be having Hypoglycemia Unawareness as documented by Continuous Glucose Monitoring. (Blood sugar \<70 mg/dl without symptoms)
  • Children must be on treatment with Insulin for a minimum period of 6 months
  • The care giver/parent must give written informed consent for the child and himself/herself and the child should give assent.
  • Exclusion Criteria:
  • Children with known psychiatric disorders.
  • Children who are on steroids and
  • Children with documented Learning Disability from a certified psychologist.

About University Of Pittsburgh

The University of Pittsburgh is a leading research institution known for its commitment to advancing medical science and improving patient care through innovative clinical trials. With a robust infrastructure for research and a multidisciplinary approach, the university fosters collaboration among experts in various fields, facilitating the development of novel therapies and interventions. Its clinical trial programs emphasize ethical standards, patient safety, and the integration of cutting-edge technology, making the University of Pittsburgh a pivotal contributor to the landscape of clinical research and a trusted partner in the pursuit of health advancements.

Locations

Tiruvalla, Kerala, India

Patients applied

0 patients applied

Trial Officials

Vishwajit L Nimgaonkar, MD, PhD

Principal Investigator

University of Pittsburgh

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported