Psychological predictors and consequences of nocturnal hypo- and hyperglycemia in adults with type 1 diabetes and their main relative: the DiaN8 study

Recruiting

• Conditions: Type 1 diabetes; insulin-dependent diabetes; 10018424

• Registration Number: NL-OMON54723
• Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 8 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

In order to be eligible to participate in this study, a person must meet all of
the following criteria:
- a diagnosis of type 1 diabetes based on the medical record;
- age between 16-64 years;
- diabetes duration >=1 year.
The main relative may participate as well, provided:
- the person with diabetes consents to their participation;
- for a parent: the person with diabetes is living at the parent*s home;
- for a partner: the person with diabetes and the partner are living together.

Exclusion Criteria

A potential participant who meets any of the following criteria will be
excluded from participation in this study:
- inability to speak and read the Dutch language;
- advanced complications (low vision, blindness, kidney disease as evidenced by
Modification of Diet in Renal Disease score <45 or macroalbuminuria,
symptomatic autonomic neuropathy, amputations, stroke, myocardial infarction or
peripheral arterial disease in the previous year or with moderate to severe
residual symptom severity);
- other somatic or psychiatric comorbidities or psychosocial problems
interfering with the ability to provide informed consent or with study
participation;
- pregnancy, breast feeding;
- moderate to severe menopausal symptom severity.

Reasons for postponing participation include:
- recent or planned shift work or time zone travel.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are the presence of health beliefs and emotions<br /><br>related to nocturnal hypo- and hyperglycemia; behavior with likely hypoglycemic<br /><br>or hyperglycemic impact during the night; nocturnal hypo- and hyperglycemic<br /><br>events; sleep quality; and daytime mood, fatigue, and cognitive functioning.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Changes in glucose levels, sleep quality, mood, fatigue, and cognitive<br /><br>functioning from the first ambulatory assessment to an optional second<br /><br>ambulatory assessment three months later.</p><br>