APPEL 3: Algorithm to control Postprandial, Post exercise and night glucose Excursions in a portable closed Loop format

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN68932175

Enrollment

Registered

2013-01-29

Start date

2012-01-01

Completion date

Unknown

Last updated

2019-02-11

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

Conditions

Diabetes mellitus type 1 treated with insulin pump Nutritional, Metabolic, Endocrine Insulin-dependent diabetes mellitus

Interventions

All participants have type 1 diabetes and are treated with an insulin pump. All participants start with open loop: the participants will wear CGM for 60 hours. This is followed after several weeks wi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Diabetes mellitus type 1 treated with continuous subcutaneous insulin infusion (CSII) for a minimum of 6 months 2. Age: 18-75, either sex 3. Willing and able to sign informed consent

Exclusion criteria

Exclusion criteria: 1. Impaired awareness of hypoglycaemia according to Gold [7] and / or Clarke [8] method 2. Body mass index (BMI) > 35 kg/m2 3. Glycated haemoglobin (HbA1c) > 11.0% 4. Use of heparin, coumarin derivatives or oral corticosteroids 5. Skin condition prohibiting needle insertion 6. Pregnancy and/or breastfeeding 7. Any condition that the local investigator feels would interfere with trial participation or the evaluation of results

Design outcomes

Primary

Measure	Time frame
To assess the efficacy of the closed loop system, defined as the time spent in euglycemia. Euglycemia is defined as glucose concentration between 3.5 mmol/l -10 mmol/l. The proportions of time spent in eu-, hypo and hyperglycaemia in closed loop will be compared to open loop. Time points of measurement are the last 48 hours divided in first 24 hours and last 24 hours. Furthermore to analyze for a meal and three hours postprandial Night: from 00.00 till 7.00 AM	—

Measure

Time frame

To assess the efficacy of the closed loop system, defined as the time spent in euglycemia. Euglycemia is defined as glucose concentration between 3.5 mmol/l -10 mmol/l. The proportions of time spent in eu-, hypo and hyperglycaemia in closed loop will be compared to open loop. Time points of measurement are the last 48 hours divided in first 24 hours and last 24 hours. Furthermore to analyze for a meal and three hours postprandial Night: from 00.00 till 7.00 AM

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Secondary

Measure	Time frame
1. Difference in overall mean sensor glucose comparing closed loop system to open loop 2. Difference in postprandial, post exercise and night sensor glucose excursions measured as area under the curve comparing closed loop to open loop 3. Difference in numbers of hypoglycaemias (glucose at or below 3.5 mmol/l) comparing the closed loop to open loop Time points of measurement are the last 48 hours divided in first 24 hours and last 24 hours. Furthermore to analyze for a meal and three hours postprandial Night: from 00.00 till 7.00 AM	—

Measure

Time frame

1. Difference in overall mean sensor glucose comparing closed loop system to open loop 2. Difference in postprandial, post exercise and night sensor glucose excursions measured as area under the curve comparing closed loop to open loop 3. Difference in numbers of hypoglycaemias (glucose at or below 3.5 mmol/l) comparing the closed loop to open loop Time points of measurement are the last 48 hours divided in first 24 hours and last 24 hours. Furthermore to analyze for a meal and three hours postprandial Night: from 00.00 till 7.00 AM

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Countries

Netherlands

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026