Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable closed Loop format, APPEL 4

Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable closed Loop format, APPEL 4 - APPEL 4

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40156

Enrollment

Registered

2013-09-04

Start date

2014-06-06

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 Mellitus type 1 / diabetes

Interventions

The intervention is four days of closed loop control of blood glucose with the miniaturized prototype. The prototype uses two subcutaneous glucose sensors, two subcutaneous infusion sets, and incorp

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosed with diabetes mellitus type 1; Treated with continuous subcutaneous insulin infusion for a minimum of 6 months; Age between 18 and 75 years.

Exclusion criteria

Exclusion criteria: Impaired awareness of hypoglycaemia according to Gold and/or Clarke questionnaire ; BMI > 35 kg/m2; HbA1c > 11.0%.

Design outcomes

Primary

Measure	Time frame
Main study parameter is the mean sensor glucose concentration, which will be compared between open and closed loop.	—

Secondary

Measure	Time frame
Secondary parameters are: -the proportion of time spent and the number of events in the following categories: low glucose, very low glucose, dangerously low glucose, high glucose, very high glucose, and dangerously high glucose; -the number of carbohydrate-treated hypoglycemic events; -the proportion of time spent in euglycemia; -glycemic variability; -day, night, and postprandial mean glucose concentration; -MARD (mean absolute relative difference) of the glucose sensors compared to self-monitored blood glucose; -Heart rate and physical activity; -Mean glucose concentration per day (closed loop only); -Time that the control algorithm is inactive (closed loop only).	—

Measure

Time frame

Secondary parameters are: -the proportion of time spent and the number of events in the following categories: low glucose, very low glucose, dangerously low glucose, high glucose, very high glucose, and dangerously high glucose; -the number of carbohydrate-treated hypoglycemic events; -the proportion of time spent in euglycemia; -glycemic variability; -day, night, and postprandial mean glucose concentration; -MARD (mean absolute relative difference) of the glucose sensors compared to self-monitored blood glucose; -Heart rate and physical activity; -Mean glucose concentration per day (closed loop only); -Time that the control algorithm is inactive (closed loop only).

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)