Within the proposed study design it is possible to answer more study questions within the same population and within the same timeframe without adding much burden to the study participants. measurements and analyses will be performed both during a…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part 1 - study a: Sensewear use
Some hypotheses with regards to energy expenditure can be formulated:
1. TEE, BEE and AEE are influenced by (the presence of DM and) the degree of
chronic glucose control (as measured by HbA1c)
2. TEE, BEE and AEE are influenced by the presence of microvascular
complications, especially autonomic neuropathy
3. the deviations will fluctuate in intensity with different degrees of actual
blood glucose concentrations (as assessed by the readings of the DG6)
Whether all these points can be addressed in the proposed study, remains to be
seen. Since it is proposed to only study people with diabetes, there will be no
non-diabetic control group.
study b: DG6 use and buddy function
Supporting users of the DG6 to recognize (early) forewarnings and signs of
hypoglycemia by adding a buddy might add to a higher received QoL and safety :
1. use of the buddy function of the DG6 will result in more confidence of users
during exercise
2. Use of the buddy function of the DG6 will result in less time in
hypoglycemia on exercise days with the buddy function vs exercise days without
the buddy function
study c: assessment of accuracy, reliability and user-friendliness of DG6
Accuracy and reliability of the both devices will be tested, using the same
protocol as in earlier studies, with the request to the participants to control
their capillary glucose levels at least six times daily.
Secondary outcome
n.a.
Background summary
People known with diabetes do benefit from regular exercise, especially when
this exercise is part of a healthy lifestyle. Despite this fact, starting and
maintaining a healthy lifestyle including regular exercise, remains a challenge
for a considerable part of the population known with diabetes.
Barriers can be both somatic as psychological. As for the somatic barriers, it
is known that in subjects with diabetes, maximum levels of energy expenditure
(EE) may be lower during heavy exercise than can be attained by non-diabetic
subjects; furthermore, subjects with diabetes apparently do not reach a resting
energy expenditure as low as non-diabetic subjects. Those differences are known
to be more pronounced when diabetes is less controlled.
Another factor limiting the amount of exercise is actual glucose control,
especially the occurrence of hypoglycemia when exercising. Many people with
diabetes struggle to find an equilibrium between intensity and duration of
exercise, insulin dose, and energy uptake. Continuous or flash glucose
monitoring may help to support decision making and diagnosing dysglycemia
during exercise, but only to a certain extent. Hypoglycemia signals can be
masked by the body reactions to the exercise strains, such as sweating,
dizziness, and tachycardia.
The proposed study will include assessment of various measures of energy
expenditure (as measured with a Sensewear device) in relation to the degree of
metabolic control (specifically during a week of exercise: walking part of the
Camino, and the week thereafter, in order to be able to compare results between
a week of comparatively high energy expenditure and a week of normal daily
activities).
Furthermore, a new tools for continuous glucose monitoring (CGM), the Dexcom G6
will be used, in order to monitor glucose levels throughout the two weeks, and
to assess their accuracy and user friendliness during the two weeks.
Study objective
Within the proposed study design it is possible to answer more study questions
within the same population and within the same timeframe without adding much
burden to the study participants. measurements and analyses will be performed
both during a period of prolonged moderate exercise (walking part of the
Camino), and during a week of normal daily activities.
Study a: In the proposed first study, the DG6 will be used as the provider of
actual glucose information in relation to the energy expenditure as measured
with Sensewear devices.
Study b: In the second study, each user of the DG6 will be allocated to a
buddy, which will get the same information and warning signals as the user.
Study c: In the third study, readings of DG6 will be compared
Study design
observational study
Study burden and risks
In principle, CGM is a common use in subjects with diabetes performing
exercise. The extra burden is that one extra sensor will be placed. No extra
risks involved.
Dr. van Heesweg 2
Zwolle 8025AB
NL
Dr. van Heesweg 2
Zwolle 8025AB
NL
Listed location countries
Age
Inclusion criteria
Subjects with type 1 or type 2 diabetes mellitus, using insulin either by MDI
or by CSII
Being fit enough to participate in the Camino walking challenge September 2019.
Exclusion criteria
Those subjects who participate in the Camino challenge but abstain from
participating in the study. Unable to understand the proposals in Dutch or
Spanish
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL70456.075.19 |