Chronic fatigue in Diabetes type 1: Is it a problem and can fatigue maintaining factors be identified?

Chronic fatigue in Diabetes type 1: Is it a problem and can fatigue maintaining factors be identified? - Chronic fatigue in diabetes type 1

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36185

Enrollment

200

Registered

2011-04-28

Start date

2011-05-01

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

diabetes diabetes mellitus type 1

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with diabetes mellitus type 1 DM type 1 diagnosed at least one year previously Being 18 years of age or older. Being able to read and write and understand Dutch

Exclusion criteria

Exclusion criteria: no additional criteria

Design outcomes

Primary

Measure	Time frame
1a) Fatigue severity will be assessed using the fatigue subscale of the Checklist Individual Strength (CIS) a widely used, reliable and well-validated instrument. The fatigue subscale of the CIS consists of 8 items scored on a 7 point Likert scale (8-56). A cut-off score of 35 or higher is an indication for severe fatigue. Chronic fatigue is defined as scoring 35 or higher and indicating that fatigue lasted 6 months or longer. 1b Functional impairments will be assessed with the Sickness Impact Profile (SIP-8). The SIP-8 assesses impairments on eight domains of functioning: mental functioning, sleep/rest, work limitations, homemaking, leisure activities, mobility, social interactions and ambulation. A total score on the SIP-8 higher than 700 is an indication for substantially impaired daily functioning. 1c) Patients will be asked whether they have experienced 36 different symptoms, including fatigue in the past month. If the symptom did occur patients are asked to indicate how troublesome the symptom was on a five point scale from 1 (not at all) to 5 (extremely). The mean will be calculated over how troublesome symptoms were and means will be ranked. 2) - Diabetes self-care behaviours: Diabetic Self-Care Inventory (CIDS) and Diabetic-related distress (Problem areas in diabetes scale (PAID)) -Fatigue related cognitions and behaviours: Self-efficacy concerning fatigue (Self-efficacy Scale (SES-26)), focusing on fatigue (Illness Management Questionnaire (IMQ)), catastrophising concerning fatigue (JFCS), Physical activity (VLA), somatic attributions concerning fatigue (CAL) Blood glucose variability: A subgroup of patients (n=100) will be asked to use a continuous blood glucose monitor (CGM) to determine blood glucose levels every few minutes for a period of 5 days. A CGM system consists of a disposable glucose sensor placed just under the skin, and an electronic receiver. Blood glucose variability will be determined by calculating the standard	—

Measure

Time frame

1a) Fatigue severity will be assessed using the fatigue subscale of the Checklist Individual Strength (CIS) a widely used, reliable and well-validated instrument. The fatigue subscale of the CIS consists of 8 items scored on a 7 point Likert scale (8-56). A cut-off score of 35 or higher is an indication for severe fatigue. Chronic fatigue is defined as scoring 35 or higher and indicating that fatigue lasted 6 months or longer. 1b Functional impairments will be assessed with the Sickness Impact Profile (SIP-8). The SIP-8 assesses impairments on eight domains of functioning: mental functioning, sleep/rest, work limitations, homemaking, leisure activities, mobility, social interactions and ambulation. A total score on the SIP-8 higher than 700 is an indication for substantially impaired daily functioning. 1c) Patients will be asked whether they have experienced 36 different symptoms, including fatigue in the past month. If the symptom did occur patients are asked to indicate how troublesome the symptom was on a five point scale from 1 (not at all) to 5 (extremely). The mean will be calculated over how troublesome symptoms were and means will be ranked. 2) - Diabetes self-care behaviours: Diabetic Self-Care Inventory (CIDS) and Diabetic-related distress (Problem areas in diabetes scale (PAID)) -Fatigue related cognitions and behaviours: Self-efficacy concerning fatigue (Self-efficacy Scale (SES-26)), focusing on fatigue (Illness Management Questionnaire (IMQ)), catastrophising concerning fatigue (JFCS), Physical activity (VLA), somatic attributions concerning fatigue (CAL) Blood glucose variability: A subgroup of patients (n=100) will be asked to use a continuous blood glucose monitor (CGM) to determine blood glucose levels every few minutes for a period of 5 days. A CGM system consists of a disposable glucose sensor placed just under the skin, and an electronic receiver. Blood glucose variability will be determined by calculating the standard

—

Secondary

Measure	Time frame
The level of fatigue will be assessed in non-responders using a set of three questions (vermoeidheidsvragenlijst, VVV).	—

Countries

Netherlands

Outcome results