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

NCT06488469 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-12-02

No results posted yet for this study

Summary

The study is designed to explore if a multi-pronged intervention strategy comprising of Psychological Interventions, Dietary Modifications, Targeted therapy and Counselling on Parental Attitude would bring about favorable changes in behavior and cognition in children with Hypoglycemia Unawareness.

Conditions

Interventions

BEHAVIORAL

Psychological Interventions for children and adolescents

Psychological Interventions for children and adolescents: * Behavioral modifications using Functional Analysis and Parent Management Techniques * Illness Management behavior - Motivational Interviewing, Cognitive Therapy to identify thinking errors posing challenges to self-management, Behavioral Modification to enhance self-management of illness, Solution focused therapy to manage identified barriers in illness -management * Managing emotional problems- Cognitive Behavioral Therapy techniques Psychological Interventions for Parents/ Caregivers: * Parent management techniques- Identification of problem behaviors/deficit * Education on Dysfunctional attitude and their effects Psycho-education for Children could be delivered best in Combined with Health Education and Nutritional education leading to dietary modifications. * Individualized Treatment targets and Resetting targets

Sponsors & Collaborators

  • Fogarty International Center of the National Institute of Health

    collaborator NIH

  • Believers Church Medical College, Thiruvalla, Kerala, India.

    collaborator UNKNOWN

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Vishwajit L Nimgaonkar, MD, PhD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2026-12-30
Completion
2026-12-31

Countries

  • India

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06488469 on ClinicalTrials.gov