Patients with type 1 diabetes MedDRA version: 17.1 Level: LLT Classification code 10012608 Term: Diabetes mellitus insulin-dependent System Organ Class: 100000004861
Conditions
Sponsors
Hvidovre University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Age = 18 years - T1D = 2 years - Insulin pump therapy with rapid-acting analog insulin = 1 year - HbA1c = 8.5% (69 mmol/mol) - Ability and willingness to comply with all protocol procedures Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 13 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnancy or nursing - Plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection) - Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when blood glucose is < 3.0 mmol/l) - Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation - History of coronary artery disease or congestive heart failure - Abnormal ECG suggestive of coronary artery disease and increased risk of malignant arrhythmia - Allergy to glucagon or lactose - Pheochromocytoma - Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aims of this two-phase project are to 1) demonstrate proof-of-concept and 2) to compare dual-hormone with single-hormone closed-loop glucose control.;Secondary Objective: Not applicable;Primary end point(s): Percentage of time with glucose values < 3.9 mmol/l as measured by CGM and YSI* Number of CHO interventions to treat hypoglycemia* ;Timepoint(s) of evaluation of this end point: Evaluation is performed after completion of the second study session, i.e. after two times 33-hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Number of hypoglycemic episodes overnight and during daytime* Nadir blood glucose value for each hypoglycemic episode as measured by CGM and YSI Duration of each hypoglycemic event as measured by YSI and CGM Low Blood Glucose Index (LBGI) overnight and during daytime (YSI and CGM)* Percentage of time with glucose values < 3.3 mmol/l as measured by CGM and YSI* Percentage of time with glucose values in the range 3.9-8.0 mmol/l measured by CGM and YSI* Percentage of time with glucose values in the range 3.9-10.0 mmol/l measured by CGM and YSI* Mean blood glucose value measured by CGM and YSI* Percentage of patients with a mean blood glucose value (YSI and CGM) = 8.6 mmol/l (corresponding to an estimated HbA1c of 7.0% / 53 mmol/mol) Percentage of patients with a mean blood glucose value (YSI and CGM) = their standard therapy mean glucose value (calculated based on HbA1c measurement) Difference in percentage of time with glucose values <3.3, < 3.9 mmol/l, 3.9-8.0 mmol/l, 3.9-10.0 mmol/l (pairwise comparison between previous two weeks and single-hormone and dual-hormone studies, respectively) Mean Absolute Relative Difference (MARD) between CGM and YSI glucose* Blood pressure Pulse rate Steps per 33 hours (pedometer) Nausea level (VAS) Mean insulin dose Mean bolus insulin dose Mean basal insulin dose Mean glucagon dose CHO counting ability (pictures vs. actual meals) Self-assessment of glucose levels (Clarke Error Grid) Accuracy of Navigator Flash (mean absolute relative difference) ;Timepoint(s) of evaluation of this end point: Evaluation is performed after completion of the second study session, i.e. after two times 33-hours | — |
Countries
Denmark
Contacts
Public ContactSigne Schmidt
Hvidovre University Hospital
Outcome results
None listed