Prevention of Hypoglycemia After Exercise Using Closed Loop System in Children and Adolescents With Type 1 Diabetes

NCT02657083 | Completed

• 1 other identifier: PD-MC-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The Study will compare treatment with Closed Loop (CL) system - DreaMed MD-AID to the standard treatment without computer algorithm decisions - SAP therapy in 20 children and adolescents with Type 1 Diabetes (T1D) during and after afternoon physical activity. The aims of the study are:

• to demonstrate that the use of DreaMed MD-AID is safe during physical activity
• to investigate the risk of hypoglycemia among children and adolescents with T1D after afternoon exercise during closed-loop control.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• to evaluate the safety and efficacy of blood glucose control using the DreaMed MD-AID in children and adolescents with T1D during and after planned physical activity, in a controlled in-hospital environment.

  Primary endpoint is significant between-group difference (intervention DreaMed MD-AID versus control SAP) in time of hypoglycemia below 3.3 mmol/l (60 mg/dl) during the afternoon exercise and the afternoon/night after (till 13:00 next day) based on sensor glucose readings with a minimum duration of 20 minutes.

  After all patients completed their 30 days of study treatment.

Secondary Outcomes (1)

• to evaluate the physiologic responses and risk of hypoglycemia among children and adolescents with T1D after afternoon exercise during closed-loop control in a controlled in-hospital environment

  After all patients completed their 30 days of study treatment.

Study Arms (2)

Glucose control using DreaMed MD-AID

EXPERIMENTAL

In this group the subjects use a closed loop system (DreaMed Substance Administration Device) that combines glucose monitoring system (S.C wired sensor, named Sof® Sensor™ or Enlite® Sensor™), which provides real-time interstitial glucose values, with a modern insulin pump (MiniMed® Paradigm® Veo™, Medtronic) and computer algorithm, which directs insulin delivery in response to glucose sensor data.

Device: DreaMed Substance Administration Device

Glucose control using SAP

ACTIVE COMPARATOR

In this group the subjects use a standard treatment (Sensor Augmented Pump), characterised by glucose monitoring system (S.C wired sensor, named Sof® Sensor™ or Enlite® Sensor™) which provides real-time interstitial glucose values and a modern insulin pump (MiniMed® Paradigm® Veo™, Medtronic) without computer algorithm decisions.

Device: Sensor Augmented Pump (SAP)

Interventions

DreaMed Substance Administration Device DEVICE

2 exercise days under DreaMed MD-AID control with afternoon exercise (in the time between 16:30 and 19:30). New infusion set and two continuous glucose sensors (one for back-up) will be inserted in the subcutaneous tissue of the arm and then calibrated the day before each visit from 3 to 6. The continuous glucose sensor continuously will measure interstitial glucose levels and these values will be sent by the Minilink™ via wireless, low-powered, radio frequency to the Paradigm Veo every 5 minutes for up to 6 days. The DreaMed MD-AID uses a vendor-supplied and self-developed (communication module) communication application programming interface (API) in order to retrieve glucose / insulin data from the Paradigm Veo and set insulin treatment according to the algorithm decision.

Glucose control using DreaMed MD-AID

Sensor Augmented Pump (SAP) DEVICE

2 exercise days under Sensor Augmented Pump with afternoon exercise (in the time between 16:30 and 19:30). New infusion set and two continuous glucose sensors (one for back-up) will be inserted in the subcutaneous tissue of the arm and then calibrated the day before each visit from 3 to 6. The continuous glucose sensor continuously will measure interstitial glucose levels and these values will be sent by the Minilink™ via wireless, low-powered, radio frequency to the Paradigm Veo every 5 minutes for up to 6 days. During the exercise the group will turn off the insulin pump and lower their basal insulin for 20% for the next 4 hours after the exercise

Glucose control using SAP

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Informed consent signed by a parent/legal guardian and informed assent signed by the study participant prior study entry.
• Diagnosed with T1D, as defined by the American Diabetes Association and World Health Organization (ADA/WHO) for at least 1 year prior to study enrolment.
• Documented evidence should exist within the patient history of T1D.
• Age between 10 and 17 years (inclusive) at the time of enrolment.
• Treatment with insulin pump therapy for at least 3 months.
• HbA1C value ≤ 9% based on analysis from the local laboratory at the time of enrolment (A1C testing must follow National Glycohemoglobin Standardization Program (NGSP) standards).
• Willing to follow all study instructions (child and parent should be evaluated as one)
• Availability for the entire study duration and follow-up visits
• Willing to perform daily self-monitoring of blood glucose (SMBG) and required sensor calibrations
• If also present celiac/Hashimoto disease, the disease has to be adequately treated as determined by the investigator
• BMI above 5th centile and below 95th centile for age, respectively.

You may not qualify if:

• 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.
• Significant co-morbidity that, in the opinion of the investigators would preclude participation in the study (e.g. current treatment for cancer, mental disorder)
• Any concomitant oral or parenteral glucocorticoids therapy within 1 month prior to screening, or planning to take oral or parenteral glucocorticoids during the study. (Exceptions: Short term oral glucocorticoids up to 7 days, inhaled steroids).
• Any concomitant therapy with antidiabetic agents or other medications, which could be a contraindication to participation in the study by the judgment of the investigator.
• Participation 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).
• Female subject of child-bearing potential who is pregnant, breast-feeding, or planning to become pregnant during the study.
• Subject that has known hypoglycemic unawareness or recurrent severe hypoglycemic events with seizure and/or coma (more than two episodes) within 6 months prior to screening.
• History of one or more episodes of Diabetic Ketoacidosis (DKA) requiring hospitalization within a month prior to the screening.
• Current or recent history of alcohol or drug abuse.
• 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).

Sponsors & Collaborators

• University of Ljubljana, Faculty of Medicine: lead

Study Sites (1)

University of Ljubljana, Faculty of Medicine

Ljubljana, 1000, Slovenia

Location

Related Publications (22)

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• Adolfsson P, Nilsson S, Albertsson-Wikland K, Lindblad B. Hormonal response during physical exercise of different intensities in adolescents with type 1 diabetes and healthy controls. Pediatr Diabetes. 2012 Dec;13(8):587-96. doi: 10.1111/j.1399-5448.2012.00889.x.

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• Beraki A, Magnuson A, Sarnblad S, Aman J, Samuelsson U. Increase in physical activity is associated with lower HbA1c levels in children and adolescents with type 1 diabetes: results from a cross-sectional study based on the Swedish pediatric diabetes quality registry (SWEDIABKIDS). Diabetes Res Clin Pract. 2014 Jul;105(1):119-25. doi: 10.1016/j.diabres.2014.01.029. Epub 2014 Feb 23.

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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. doi: 10.1016/j.jpeds.2005.04.065.

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• Rosenbauer J, Dost A, Karges B, Hungele A, Stahl A, Bachle C, Gerstl EM, Kastendieck C, Hofer SE, Holl RW; DPV Initiative and the German BMBF Competence Network Diabetes Mellitus. Improved metabolic control in children and adolescents with type 1 diabetes: a trend analysis using prospective multicenter data from Germany and Austria. Diabetes Care. 2012 Jan;35(1):80-6. doi: 10.2337/dc11-0993. Epub 2011 Nov 10.

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• Hovorka R, Allen JM, Elleri D, Chassin LJ, Harris J, Xing D, Kollman C, Hovorka T, Larsen AM, Nodale M, De Palma A, Wilinska ME, Acerini CL, Dunger DB. Manual closed-loop insulin delivery in children and adolescents with type 1 diabetes: a phase 2 randomised crossover trial. Lancet. 2010 Feb 27;375(9716):743-51. doi: 10.1016/S0140-6736(09)61998-X. Epub 2010 Feb 4.

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• Ly TT, Breton MD, Keith-Hynes P, De Salvo D, Clinton P, Benassi K, Mize B, Chernavvsky D, Place J, Wilson DM, Kovatchev BP, Buckingham BA. Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp. Diabetes Care. 2014 Aug;37(8):2310-6. doi: 10.2337/dc14-0147. Epub 2014 May 30.

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• Sherr JL, Cengiz E, Palerm CC, Clark B, Kurtz N, Roy A, Carria L, Cantwell M, Tamborlane WV, Weinzimer SA. Reduced hypoglycemia and increased time in target using closed-loop insulin delivery during nights with or without antecedent afternoon exercise in type 1 diabetes. Diabetes Care. 2013 Oct;36(10):2909-14. doi: 10.2337/dc13-0010. Epub 2013 Jun 11.

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• Phillip M, Battelino T, Atlas E, Kordonouri O, Bratina N, Miller S, Biester T, Stefanija MA, Muller I, Nimri R, Danne T. Nocturnal glucose control with an artificial pancreas at a diabetes camp. N Engl J Med. 2013 Feb 28;368(9):824-33. doi: 10.1056/NEJMoa1206881.

  PMID: 23445093 BACKGROUND

• Oron T, Farfel A, Muller I, Miller S, Atlas E, Nimri R, Phillip M. A remote monitoring system for artificial pancreas support is safe, reliable, and user friendly. Diabetes Technol Ther. 2014 Nov;16(11):699-705. doi: 10.1089/dia.2014.0090. Epub 2014 Sep 11.

  PMID: 25211216 BACKGROUND

• Dauber A, Corcia L, Safer J, Agus MS, Einis S, Steil GM. Closed-loop insulin therapy improves glycemic control in children aged <7 years: a randomized controlled trial. Diabetes Care. 2013 Feb;36(2):222-7. doi: 10.2337/dc12-1079. Epub 2012 Oct 1.

  PMID: 23033237 BACKGROUND

• Elleri D, Allen JM, Kumareswaran K, Leelarathna L, Nodale M, Caldwell K, Cheng P, Kollman C, Haidar A, Murphy HR, Wilinska ME, Acerini CL, Dunger DB, Hovorka R. Closed-loop basal insulin delivery over 36 hours in adolescents with type 1 diabetes: randomized clinical trial. Diabetes Care. 2013 Apr;36(4):838-44. doi: 10.2337/dc12-0816. Epub 2012 Nov 27.

  PMID: 23193217 BACKGROUND

• Nimri R, Danne T, Kordonouri O, Atlas E, Bratina N, Biester T, Avbelj M, Miller S, Muller I, Phillip M, Battelino T. The "Glucositter" overnight automated closed loop system for type 1 diabetes: a randomized crossover trial. Pediatr Diabetes. 2013 May;14(3):159-67. doi: 10.1111/pedi.12025. Epub 2013 Feb 28.

  PMID: 23448393 BACKGROUND

• Nimri R, Muller I, Atlas E, Miller S, Fogel A, Bratina N, Kordonouri O, Battelino T, Danne T, Phillip M. MD-Logic overnight control for 6 weeks of home use in patients with type 1 diabetes: randomized crossover trial. Diabetes Care. 2014 Nov;37(11):3025-32. doi: 10.2337/dc14-0835. Epub 2014 Jul 30.

  PMID: 25078901 BACKGROUND

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• Guelfi KJ, Jones TW, Fournier PA. The decline in blood glucose levels is less with intermittent high-intensity compared with moderate exercise in individuals with type 1 diabetes. Diabetes Care. 2005 Jun;28(6):1289-94. doi: 10.2337/diacare.28.6.1289.

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• Bussau VA, Ferreira LD, Jones TW, Fournier PA. A 10-s sprint performed prior to moderate-intensity exercise prevents early post-exercise fall in glycaemia in individuals with type 1 diabetes. Diabetologia. 2007 Sep;50(9):1815-1818. doi: 10.1007/s00125-007-0727-8. Epub 2007 Jun 22.

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• Dovc K, Macedoni M, Bratina N, Lepej D, Nimri R, Atlas E, Muller I, Kordonouri O, Biester T, Danne T, Phillip M, Battelino T. Closed-loop glucose control in young people with type 1 diabetes during and after unannounced physical activity: a randomised controlled crossover trial. Diabetologia. 2017 Nov;60(11):2157-2167. doi: 10.1007/s00125-017-4395-z. Epub 2017 Aug 24.

  PMID: 28840263 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Tadej Battelino, Prof, MD

  University of Ljubljana, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2016
• First Posted: January 15, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 21, 2017

Record last verified: 2016-08

Locations

SL (1)