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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Day and Night Closed-Loop Glycemic Control With Faster-Acting Insulin Aspart in Young Adults With Type 1 Diabetes Using DreaMed Glucositter - The Fast PHYSI-DREAM Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03212950
• Other study ID #: PD-FAST-01
• Status: Completed
• Phase: N/A
• First received: July 3, 2017
• Last updated: November 2, 2017
• Start date: July 10, 2017
• Est. completion date: November 1, 2017

Study information

• Verified date: November 2017
• Source: University of Ljubljana, Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 1, 2017
• Est. primary completion date: November 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

1. The subject has documented T1D, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least 1 year prior to study enrolment

2. Documented evidence should exist within the patient history of T1D

3. The subject is between 18 and 25 years of age (inclusive) at the time of enrolment

4. The subject has been treated with an insulin pump for at least 3 months

5. The subject has an A1C value = 9% based on analysis from the local laboratory at the time of enrolment

? A1C testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.

6. The subject is willing to follow all study instructions

7. Subject is available for the entire study duration and follow-up visits

8. Subject is willing to perform daily self-monitoring of blood glucose (SMBG) and required sensor calibrations

9. If subject has celiac/Hashimoto disease, the disease has to be adequately treated as determined by the investigator

10. Subject has a BMI above 5th centile and below 95th centile for age, respectively.

Exclusion Criteria:

1. Concomitant diseases that influence metabolic control (e.g. anemia, significantly impaired hepatic function, renal failure, history of adrenal insufficiency) or other medical conditions, which in the investigator's opinion, may compromise patient safety; Note: Adequately treated thyroid disease and celiac disease do not exclude subjects from enrollment.

2. Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (e.g. current treatment for cancer, mental disorder)

3. Subject is taking or has taken oral or parenteral glucocorticoids within 1 month prior to screening, or plans to take oral or parenteral glucocorticoids during the study. Exceptions: Short term oral glucocorticoids up to 7 days, inhaled steroids.

4. Subject is taking antidiabetic agents or other medications, which could be a contraindication to participation in the study by the judgment of the investigator.

5. Subject is participating in another study of a medical device or drug that could affect glucose measurements or glucose management or Receipt of any investigational medical product within 1 month prior to screening (Visit 1).

6. Female subject of child-bearing potential who is pregnant, breast-feeding, or planning to become pregnant during the study.

7. Subject has a history of one or more episodes of Diabetic Ketoacidosis (DKA) requiring hospitalization within a month prior to the screening.

8. Subject has current or recent history of alcohol or drug abuse.

9. Subject has visual impairment or hearing loss, which in the investigator's opinion, may compromise patient ability to perform study procedures safely (child and parent should be evaluated as a unit).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
Slovenia	UMC-University Children's Hospital	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
University of Ljubljana, Faculty of Medicine

Country where clinical trial is conducted

Slovenia, 

References & Publications (27)

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Bode BW, Johnson JA, Hyveled L, Tamer SC, Demissie M. Improved Postprandial Glycemic Control with Faster-Acting Insulin Aspart in Patients with Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion. Diabetes Technol Ther. 2017 Jan;19(1):25-33. doi: 10.1089/dia.2016.0350. Epub 2017 Jan 5. — View Citation

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DeBoer MD, Cherñavvsky DR, Topchyan K, Kovatchev BP, Francis GL, Breton MD. Heart rate informed artificial pancreas system enhances glycemic control during exercise in adolescents with T1D. Pediatr Diabetes. 2017 Nov;18(7):540-546. doi: 10.1111/pedi.12454. Epub 2016 Oct 13. — View Citation

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Heise T, Zijlstra E, Nosek L, Rikte T, Haahr H. Pharmacological properties of faster-acting insulin aspart vs insulin aspart in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion: A randomized, double-blind, crossover trial. Diabetes Obes Metab. 2017 Feb;19(2):208-215. doi: 10.1111/dom.12803. Epub 2016 Nov 14. — View Citation

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Riddell MC, Gallen IW, Smart CE, Taplin CE, Adolfsson P, Lumb AN, Kowalski A, Rabasa-Lhoret R, McCrimmon RJ, Hume C, Annan F, Fournier PA, Graham C, Bode B, Galassetti P, Jones TW, Millán IS, Heise T, Peters AL, Petz A, Laffel LM. Exercise management in type 1 diabetes: a consensus statement. Lancet Diabetes Endocrinol. 2017 May;5(5):377-390. doi: 10.1016/S2213-8587(17)30014-1. Epub 2017 Jan 24. Review. — View Citation

Riddell MC, Zaharieva DP, Yavelberg L, Cinar A, Jamnik VK. Exercise and the Development of the Artificial Pancreas: One of the More Difficult Series of Hurdles. J Diabetes Sci Technol. 2015 Oct 1;9(6):1217-26. doi: 10.1177/1932296815609370. Review. — View Citation

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Taleb N, Emami A, Suppere C, Messier V, Legault L, Ladouceur M, Chiasson JL, Haidar A, Rabasa-Lhoret R. Efficacy of single-hormone and dual-hormone artificial pancreas during continuous and interval exercise in adult patients with type 1 diabetes: randomised controlled crossover trial. Diabetologia. 2016 Dec;59(12):2561-2571. Epub 2016 Oct 4. — View Citation

Tauschmann M, Allen JM, Wilinska ME, Thabit H, Stewart Z, Cheng P, Kollman C, Acerini CL, Dunger DB, Hovorka R. Day-and-Night Hybrid Closed-Loop Insulin Delivery in Adolescents With Type 1 Diabetes: A Free-Living, Randomized Clinical Trial. Diabetes Care. 2016 Jul;39(7):1168-74. doi: 10.2337/dc15-2078. Epub 2016 Jan 6. — View Citation

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Tsalikian E, Mauras N, Beck RW, Tamborlane WV, Janz KF, Chase HP, Wysocki T, Weinzimer SA, Buckingham BA, Kollman C, Xing D, Ruedy KJ; Diabetes Research In Children Network Direcnet Study Group. Impact of exercise on overnight glycemic control in children with type 1 diabetes mellitus. J Pediatr. 2005 Oct;147(4):528-34. — View Citation

Turksoy K, Paulino TM, Zaharieva DP, Yavelberg L, Jamnik V, Riddell MC, Cinar A. Classification of Physical Activity: Information to Artificial Pancreas Control Systems in Real Time. J Diabetes Sci Technol. 2015 Oct 6;9(6):1200-7. doi: 10.1177/1932296815609369. — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time within range 3.9 - 10 mmol/l (70 - 180 mg/dl)	Primary endpoint is significant between-group difference (intervention Fast-CL versus control Regular-CL) in time within range 3.9 - 10 mmol/l (70 - 180 mg/dl) during the unannounced afternoon exercise and the afternoon/night after (till 18:00 next day) based on sensor glucose readings.	28 hours