Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable closed Loop format, APPEL 5

Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable closed Loop format, APPEL 5 - APPEL 5

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON46864

Enrollment

Registered

2015-12-14

Start date

2019-03-10

Completion date

Unknown

Last updated

2024-04-23

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 two weeks closed loop control of blood glucose with the miniaturized prototype. The prototype uses two subcutaneous glucose sensors, two subcutaneous infusion sets, and incorpora

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosed with diabetes mellitus type 1; Treated with sensor augmented pump therapy or insulin pump for a minimum of 6 months; Age between 18 and 75 years.

Exclusion criteria

Exclusion criteria: Impaired awareness of hypoglycemia; BMI > 35 kg/m2; HbA1c > 97 mmol/mol.

Design outcomes

Primary

Measure	Time frame
Main study parameter is the percentage of time spent in the target range (3.9-10 mmol/l), which will be compared between open and closed loop.	—

Secondary

Measure	Time frame
Secondary parameters are: -The proportion of time spent in hypoglycemia and hyperglycemia; -The number of carbohydrate-treated hypoglycemic events; -Mean or median glucose concentration; -Glycemic variability; -Day, night, and postprandial mean or median sensor glucose concentration; -Day and night time spent in hypo-, hyper- and euglycemia; -Quality of life and treatment satisfaction scores; -Percentage of time that the closed loop algorithm is active; -Mean absolute relative difference for the glucose sensor of the closed loop system.	—

Measure

Time frame

Secondary parameters are: -The proportion of time spent in hypoglycemia and hyperglycemia; -The number of carbohydrate-treated hypoglycemic events; -Mean or median glucose concentration; -Glycemic variability; -Day, night, and postprandial mean or median sensor glucose concentration; -Day and night time spent in hypo-, hyper- and euglycemia; -Quality of life and treatment satisfaction scores; -Percentage of time that the closed loop algorithm is active; -Mean absolute relative difference for the glucose sensor of the closed loop system.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)