NCT04454827

Brief Summary

Acute symptoms of hypoglycemia influence all aspects of every day life and reduce quality of life of children and adolescents with type 1 diabetes and their parents. Encountering with hypoglycemia can result in fobic fear of low blood glucose levels in patients with type 1 diabetes and their parents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
316

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2020

Completed
Last Updated

July 2, 2020

Status Verified

June 1, 2020

Enrollment Period

5 months

First QC Date

June 30, 2020

Last Update Submit

June 30, 2020

Conditions

Type 1 Diabetes MellitusFear of Hypoglycemia

Keywords

Type 1 Diabetes MellitusFear of Hypoglycemia

Outcome Measures

Primary Outcomes (1)

  • Fear of Hypoglycemia

    Questionnaires

    5 months

Secondary Outcomes (2)

  • Time in ranges (below 3.9, 3.9-10, above 10 mmol/l

    1 year

  • HbA1c

    1 year

Eligibility Criteria

Age1 Year - 25 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children and adolescents with type 1 diabetes and their parents

You may qualify if:

  • Type 1 diabetes for more than 0.5 year
  • Age ≥ 1 year up to 25 years (inclusive)
  • The subject/carer is willing to follow study specific instructions

You may not qualify if:

  • Youth with maturity-onset diabetes of the young, hybrid, other, or missing type
  • Any significant diseases / conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study
  • Current use of the following medications: medications that are used to lower blood glucose such as Pramlintide, Metformin and GLP-1 analogs. Beta blockers, glucocorticoids and other medications, which in the judgment of the investigator would be a contraindication to participation in the study (Anticoagulant therapy e.g. Plavix, LMW heparin, Coumadin, Immunosuppressant therapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Children's Hospital Ljubljana

Ljubljana, Slovenija/Osrednja Regija, 1000, Slovenia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 2, 2020

Study Start

April 1, 2019

Primary Completion

August 31, 2019

Study Completion

September 30, 2019

Last Updated

July 2, 2020

Record last verified: 2020-06

Locations

SL(1)