Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2025-12-24 @ 7:43 PM
NCT ID:
NCT01787903
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
Study:
NCT01787903
Study Brief:
Protocol Section:
NCT01787903