Energy expenditure and (assessment of) glucose regulation of participants with diabetes mellitus during and after the Camino: SENSOR-D-4

Energy expenditure and (assessment of) glucose regulation of participants with diabetes mellitus during and after the Camino: SENSOR-D-4 - SENSOR-D-4

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48461

Enrollment

Registered

2019-07-30

Start date

2019-08-31

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

diabetes

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
n.a.	—

Countries

Netherlands

Outcome results