Ignite Creation Date:
2024-05-06 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03549104
Status:
COMPLETED
Last Update Posted:
2024-06-06
First Post:
2018-04-24
Brief Title:
A Cognitive Behavioral Therapy CBT Intervention to Reduce Fear of Hypoglycemia in Type 1 Diabetes
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
A Cognitive Behavioral Intervention to Reduce Fear of Hypoglycemia in Young Adults With T1DM
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CBT
Brief Summary:
All persons with type 1 diabetes are at risk for developing hypoglycemia low blood sugar This is a life-threatening condition that leads to profound fear of hypoglycemia and reduced quality of life Fear of hypoglycemia results in glucose fluctuations from high to low glucose levels Young adults are particularly at risk because they report high levels of fear of hypoglycemia and poor glucose control Currently no diabetes self-management programs specifically address how to cope with fear of hypoglycemia The investigators propose to pilot test a fear reduction intervention Fear Reduction Efficacy Evaluation FREE and its effects on fear of hypoglycemia diabetes self-management glucose control and glucose variability
Detailed Description:
In persons with type 1 diabetes T1DM hypoglycemia is the major limiting factor in achieving optimal blood glycemic control All persons with T1DM are at risk for hypoglycemia blood glucose level 70 mgdl which is life-threatening and accompanied by serious physical and psychological symptoms resulting in a profound fear of hypoglycemia FOH and reduced quality of life Young adults with T1DM are at greater risk for FOH and have worse glycemic control and self-management behavior than other age groups with T1DM The investigators preliminary research identified that 77 of young adults with T1DM reported FOH and FOH resulted in increased glycemic variability Glycemic variability GV is the minute-to-minute fluctuation in blood glucose that can be missed if looking only at A1C a longer-term measure Increased GV is dangerous because it is associated with cardiovascular events and diabetes complications A major gap exists in how to manage FOH as a component of diabetes self-management The Investigators specifically aim to 1 determine the feasibility and acceptability of a fear reduction program in young adults with T1DM who experience FOH and 2 determine the impact of an 8-week cognitive behavioral therapy CBT-based intervention on the outcomes FOH self-management behavior glycemic control and GV To achieve these aims the investigators propose a randomized controlled trial in 50 young adults aged 18 to 35 years with T1DM At completion FOH will be measured and glycemic patterns will be analyzed to determine differences between the FREE and control groups Findings from this proposed pilot study will serve as the foundation for a larger clinical trial to reduce FOH and improve self-management glycemic control and GV This program of research promises to reduce the development of diabetes complications and improve quality of life for young adults with T1DM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21DK116146 | NIH | None | httpsreporternihgovquickSearchR21DK116146 |