Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-31 @ 4:37 AM
Study NCT ID:
NCT01787903
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2013-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of RT-CGM on Glycemia and QoL in Patients With T1DM and IHA
Sponsor:
Amsterdam UMC, location VUmc
Organization:
Study Overview
Official Title:
The Effects of Real-time Continuous Glucose Monitoring on Glycemia and Quality of Life in Patients With Type 1 Diabetes Mellitus and Impaired Hypoglycemia Awareness
Status:
COMPLETED
Status Verified Date:
2017-07
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:
INCONTROL
Brief Summary:
The purpose of this study is to determine what the effects are of real-time continuous glucose monitoring on glycemia and quality of life in patients with type 1 diabetes mellitus and impaired hypoglycemia awareness.
Detailed Description:
The investigators hypothesize that the use of RT-CGM, relative to a control intervention using masked CGM, will result in improvement of various measures of glycemia and indicators of quality of life, reduce the occurrence of hypoglycemia and hyperglycemia and restore hypoglycemia awareness in T1DM patients with IHA. We will test this hypothesis by addressing the following research questions:
What is the effect of 16 weeks of RT-CGM use, versus 16 weeks of CGM use, in patients with T1DM and IHA on
1. (primary objective:) time spent in euglycemia
2. (secondary objectives:)
* (diabetes-specific) markers of QoL, covering diabetes-related emotional distress (PAID-5), fear of hypoglycemia (HFS-2), self-efficacy (CIDS), health status (EQ5D) and emotional well-being (WHO-5)
* other glycemia variables, including HbA1c and time spent in hypo- and - hyperglycemia ranges
* the incidence and duration of hypoglycemic episodes
* changes in hypoglycemia awareness score according to Gold et al.,
3. (tertiary objectives:)
* measures of glucose variability
* the autonomic nervous system balance
* the duration of wear of the RT-CGM device
* patients' therapy adjustments during the interventions
* hypoglycemia awareness scores according to Clarke et al.
* satisfaction with use of CGM
* the number of contact moments not planned according to the study schedule
* absence of work of patient (and spouse)
* the global estimated costs of use of health care
What is the effect of 16 weeks of RT-CGM use, versus 16 weeks of CGM use, in patients with T1DM and IHA on
1. (primary objective:) time spent in euglycemia
2. (secondary objectives:)
* (diabetes-specific) markers of QoL, covering diabetes-related emotional distress (PAID-5), fear of hypoglycemia (HFS-2), self-efficacy (CIDS), health status (EQ5D) and emotional well-being (WHO-5)
* other glycemia variables, including HbA1c and time spent in hypo- and - hyperglycemia ranges
* the incidence and duration of hypoglycemic episodes
* changes in hypoglycemia awareness score according to Gold et al.,
3. (tertiary objectives:)
* measures of glucose variability
* the autonomic nervous system balance
* the duration of wear of the RT-CGM device
* patients' therapy adjustments during the interventions
* hypoglycemia awareness scores according to Clarke et al.
* satisfaction with use of CGM
* the number of contact moments not planned according to the study schedule
* absence of work of patient (and spouse)
* the global estimated costs of use of health care
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: