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Efficacy of a bihormonal closed loop system.

Efficacy of a bihormonal closed loop system to control postprandial and post exercise glucose excursions.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20851
Enrollment
10
Registered
2011-07-14
Start date
2011-01-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

diabetes type 1 Artificial pancreas closed loop glucagon kunstalvleesklier

Interventions

Open loop (insulin pump treatment) is compared to closed loop. 10 patients attend the CRC. In open loop, the patients will be responsible for the glucose control during postprandial breakfast, post e

Sponsors

AMC Amsterdam
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Diabetes mellitus type 1 treated with CSII for a minimum of 6 months; 2. Age: 18-75; 3. Willing and able to sign informed consent.

Exclusion criteria

Exclusion criteria: 1. BMI > 35 kg/m2; 2. HbA1c > 11.0%; 3. Use of heparin, coumarin derivatives or oral corticosteroids; 4. Skin condition prohibiting needle insertion; 5. Pregnancy and/or breastfeeding; 6. Any condition that the local investigator feels would interfere with trial participation or the evaluation of results.

Design outcomes

Primary

MeasureTime frame
1. Difference in postprandial and post exercise venous glucose excursions measured as area under the curve comparing closed loop format to usual care; 2. Difference in postprandial and post exercise sensor glucose excursions measured as area under the curve comparing closed loop format to usual care.

Secondary

MeasureTime frame
1. Difference in the proportion of time spent in euglycaemia (glucose 4.0 – 7.0 mmol/l) comparing the closed loop format to usual care; 2. Difference in numbers of hypoglycaemias (glucose at or below 3.9 mmol/l) comparing the closed loop format to usual care.

Contacts

Public ContactA.C. Bon, van

AMC Amsterdam Meibergdreef 9

a.c.vanbon@amc.nl+31 (0)20 5669111

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)