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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON54723
Enrollment
100
Registered
2021-07-19
Start date
2023-06-23
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 diabetes

Interventions

None listed

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
16 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The main study parameters are the presence of health beliefs and emotions related to nocturnal hypo- and hyperglycemia; behavior with likely hypoglycemic or hyperglycemic impact during the night; nocturnal hypo- and hyperglycemic events; sleep quality; and daytime mood, fatigue, and cognitive functioning.

Secondary

MeasureTime frame
Changes in glucose levels, sleep quality, mood, fatigue, and cognitive functioning from the first ambulatory assessment to an optional second ambulatory assessment three months later.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)