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The relation between sleep characteristics and glycemic control in patients with type 1 diabetes mellitus (with a special focus on role of the skin temperature regulation in relation to sleep)

The relation between sleep characteristics and glycemic control in patients with type 1 diabetes mellitus (with a special focus on role of the skin temperature regulation in relation to sleep) - Sleep characteristics and glycemic control

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON33263
Enrollment
128
Registered
2010-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

Diabetes Glucose Metabolism Disorders

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Type 1 diabetes mellitus or healthy control Infomed consent Age > 18 and

Exclusion criteria

Exclusion criteria: Peripheral vascular disease or findings suggestive of peripheral vascular disease on examination (reduced or unobtainable pulses in the feet) Pain caused by diabetic polyneuropathy Psychiatric disorder and/or use of antipsychotic or antidepressant drugs Working on night shifts (last 3 months) Pregnancy comorbidity that influence microvascular or thermoregulatory function Hypertension (>140/90 mmHg) Use of medication known to affect glucose metabolism (e.g. prednison) Chronic use of sleep medication and/or melatonin Medication that influences temperature regulation (e.g. paracetamol, aspirin) Presence of a medical disorder (other than DM) known to be associated with neuropathy Caffeine-, Nicotine-, Alcohol- abuse Use of soft-, harddrugs

Design outcomes

Primary

MeasureTime frame
Glucose levels (only DM1) by subcutaneous, continuous glucosesensor (Only in diabetic patients) Body temperature recordings: - Registration of distal and proximal skin temperature by iButton - Core body temperature measured by JONAH-capsule Sleep-wake cycle by Actigraphy Subjective sleep and daytime sleepiness by sleep questionnaires and SART Quantitative Sensory testing by the modified Toronto clinical neuropathy score (mTCNs) and the Thermal Sensory Analyzer (TSA) Objective sleep characteristics by Polysomnography (PSG)

Secondary

MeasureTime frame
None

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)