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ID
Source
Brief title
Health condition
Type 1 diabetes, insulin depedent diabetes mellitus
Sponsors and support
-Continuous glucose monitoring devices and glucose sensors provided by Medtronic
Intervention
Outcome measures
Primary outcome
-Twenty-four-hour blood glucose homeostasis as measured by continuous glucose monitoring (specifically: average 24-h glucose concentrations, glycemic variability, hyperglycaemia, hypoglycaemia).
-Dosing of exogenous insulin.
Secondary outcome
-Physical activity level
-Dietary intake
Background summary
Twenty-four-hour glycemic control will be assessed in 10 patients with type 1 diabetes. These patients will be monitored over the 2 days prior to and during the 'Four Days Marches Nijmegen' event. The 2 days prior to the Four Days Marches will provide a reference frame for patients’ 24-h glycemic control (non-exercise control period). The subsequent 4-day period will be used to assess changes in patients’ glycemic control (hyperglycemia, hypoglycemic, glycemic variability) and insulin administration in response to ultra-endurance exercise. The unique character of the Four Days Marches event will provide novel insight into patients’ glycemic response to ultra-endurance exercise.
Study objective
We hypothesize that exogenous insulin requirements will be substantially reduced during the days with prolonged physical activity as opposed to the control condition. Moreover, we expect that these reduced insulin requirements will not be accompanied by an increased occurrence of hyperglycemic episodes.
Study design
Measurements are conducted over the 2 days prior to the marching event, and over the 4 subsequent days of the marching event.
Intervention
Twenty-four-hour blood glucose homeostasis will be assessed by continuous glucose monitoring in type diabetic patients participating in the world’s largest marching event: The Four Days Marches Nijmegen.
Continuous glucose monitoring will be applied on the 2 days prior to (reference period), and during 4 subsequent of prolonged walking exercise.
Inclusion criteria
-Voluntary participation for the Four Days Marches, July 16-19, 2013
-Type 1 diabetes
Exclusion criteria
-HbA1c >10%
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL3899 |
NTR-old | NTR4061 |
Other | : 2012/186/1 |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |