CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 68 enrolled
Drug / intervention
Diabetes related psychological counseling and education +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01083433
NCT01083433N/ACompleted

Intensive Diabetes Clinic and Intermittent Continuous Glucose Monitoring in Adolescents With Type 1 Diabetes Mellitus in Poor Glycemic Control

University Hospitals Cleveland Medical Center·interventional·Posted Mar 9, 2010·Updated Jan 13, 2022

In Brief

A clinical study evaluating Diabetes related psychological counseling and education and Continuous Glucose Monitor for Type 1 Diabetes Mellitus. Completed, enrolled 68 participants across 1 site.

Detailed Summary

The purpose of this research study is to find out ways to help pre-teens and teens and their families to improve diabetes control and to help with the burden of diabetes management. Specifically, the study aims to find out if coming to diabetes clinic more frequently and for a longer period of time helps adolescents with diabetes, and if adolescents who wear a continuous glucose monitor (CGM) for 3-5 days a month will have better diabetes control.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 9, 2010
Enrollment StartMay 1, 2010
Primary CompletionSep 1, 2011
Study CompletionOct 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 16.3 years ago

Interventions

Diabetes related psychological counseling and educationbehavioral

The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.

Continuous Glucose Monitordevice

Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.