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Closed-Loop With Faster Aspart in Young Adults With Type 1 Diabetes

NCT03212950 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-11-06

No results posted yet for this study

Summary

A randomized, double-blinded (for insulin type), single centre, crossover design young adult study, on 20 subjects with type 1 diabetes (T1D), aged 18 to 25 (inclusive) years, measuring time in glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) under supervision of DreaMed Glucositter using either faster-acting insulin Aspart (Fiasp®, European Medicines Agency number EMEA/H/C/004046) or normal acting insulin Aspart.

Study duration will be about 3 weeks per subject, 5 month overall.

The objectives of this clinical investigation is:

1\. to evaluate the safety and efficacy of blood glucose control using the DreaMed Glucositter with Fiasp® in young adults with T1D during and after unannounced afternoon physical activity and unannounced meals, in a controlled in-hospital environment.

Primary endpoint is significant between-group difference (intervention Fast-CL versus control Regular-CL) in time within range of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl) during the unannounced afternoon exercise and unannounced standardized meals from 15:00 till 18:00 next day based on sensor glucose readings.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

DRUG

Fast-CL

After the admission we will insert new insulin (blinded) into the insulin pump. At 13:00 they will have lunch (with manual bolus). At 15:00 we will start CL control, participants/investigators will not be allowed to deliver manual bolus till the end of the study period. All meals and afternoon exercise (in the time between 16:30 and 19:30) will be unannounced and managed with CL.

DRUG

Regular-CL

After the admission we will insert new insulin (blinded) into the insulin pump. At 13:00 they will have lunch (with manual bolus). At 15:00 we will start CL control, participants/investigators will not be allowed to deliver manual bolus till the end of the study period. All meals and afternoon exercise (in the time between 16:30 and 19:30) will be unannounced and managed with CL.

Sponsors & Collaborators

  • University of Ljubljana, Faculty of Medicine

    lead OTHER

Principal Investigators

  • Tadej Battelino, Prof, MD · University of Ljubljana, Faculty of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-10
Primary Completion
2017-11-01
Completion
2017-11-01

Countries

  • Slovenia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03212950 on ClinicalTrials.gov