Type 1 Diabetes MellitusPHYSI-DREAMNCT02657083
Prevention of Hypoglycemia After Exercise Using Closed Loop System in Children and Adolescents With Type 1 Diabetes
A study testing DreaMed Substance Administration Device and Sensor Augmented Pump (SAP) in people with Type 1 Diabetes Mellitus, run by University of Ljubljana, Faculty of Medicine at 1 site in Slovenia.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- DreaMed Substance Administration Device and Sensor Augmented Pump (SAP)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSlovenia
- Study dates
- Jan 2016to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevention of Hypoglycemia After Exercise Using DreaMed Substance Administration Device in Children and Adolescents With Type 1 Diabetes (The PHYSI-DREAM Study)
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.
Read the detailed description
This is investigator initiated, single-center, open-label, crossover, randomized, interventional, in-hospital pediatric study, performed at the University Children's Hospital, University Medical Center Ljubljana.
Study duration will be about 4 weeks per subject, 6 month overall. The study will compare Continuous Glucose Monitoring (CGM) based time in hypoglycemia in an intervention arm (Glucose control using DreaMed MD-AID) to a control arm (Glucose control using SAP).
Each arm includes two exercise days with 1 week in-between. Subjects will be randomly assigned to participate first in the intervention arm (10 subjects) or first in the control arm (10 subjects). At the end of the first period patients will be asked to participate in another, i.e. the other arm with at least one week between arms.
Subjects will be instructed to consume a similar diet and avoid caffeine, alcohol, and physical activity in the 48 hours before the exercise day visit.
The start of the run-in period can be scheduled as a separate visit, but not more than 2 days after screening.
All subjects will attend the clinic on six occasions:
- Visit 1: Screening and sensor/pump education, detailed physical examination will be performed, all subject will have to meet inclusion/exclusion criteria.
- Visit 2: Baseline assessment of the DreaMed MD-AID profile, subjects will perform resting electrocardiography (ECG) and determination of the maximal oxygen consumption rate (VO2max) on a cycle ergometer Ganshorn LF8.5G™ and Schiller software, with BG measurements before, at the end of the exercise and 2 hours after exercise. Subjects will be instructed to refrain from physical activity for 48 hours prior to visits 3 - 6.
- Visit 3: 24 hours DreaMed MD-AID or SAP with afternoon exercise (in the time between 16:30 and 19:30): an i.v. catheter will be inserted in the antecubital or cephalic vein (for plasma BG and emergency). Cycle ergometer will be adjusted for each subject (work rate, seat height,..), they will be instructed to pedal at steady rate of 50-60 rotations per minute (RPM).The subjects will cycle for 40 minutes at 55% Vo2max load (starting work rate set to 30 watts (W) with linear loading to reach 55% VO2max on 5:00 minute exercise time) - the aim of this session is to induce delayed hypoglycemia.
- Visit 4: 24 hours DreaMed MD-AID or SAP with afternoon exercise (in the time between 16:30 and 19:30): an i.v. catheter will be inserted in the antecubital or cephalic vein (for plasma BG and emergency). Cycle ergometer will be adjusted for each subject (work rate, seat height,..), they will be instructed to pedal at steady rate of 50-60 rotations per minute (RPM). The subjects will cycle for 40minutes - high intensity interval training (2 - 6 sprints of 20 seconds at 80% VO2max with interval of 6 minutes low-moderate activity (55% VO2max (total of ~40 minutes) between the sprint. The aim of this session is to imitate children's physical activity (bursts of intensive physical activity interspersed with varying intervals of activity of low and moderate intensity.
- Visit 5\&6: Same as visits 3 and 4, cross over from DreaMed MD-AID to SAP or vice versa.
During the exercise, a continuous ECG will be recorded and inhaled O2 and exhaled Carbon Dioxide (CO2) will be measured.
BG and lactate will be taken during the exercise visits: at the beginning of the exercise, after every 15 min exercise session, and every half an hour for the next 2 hours thereafter.
All hypoglycemia will be confirmed with SBGM: glucose values <3.3 (60 mg/dl) mmol/l if symptomatic, and all hypoglycemia with self blood glucose monitoring (SBGM) values <2.8 mmol/l (50 mg/dl) (regardless of symptoms) will be treated with rescue carbohydrates as per standard in-hospital procedure (15 g sugar per 10 kg of body weight (BW), re-evaluate and repeat if necessary in 15-30 minutes).
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.
Schedule for all exercise days will be similar:
- 12:00 hospital admission
- 13:00 lunch
- 13:30 to 16:00 rest
- 16:00 afternoon snack
- 16:30 to 19:30 exercise protocol
- 19:45 dinner
- 21:00 to 7:30 next day: bed time
- 8:00 breakfast.
- 13:00 lunch and end of study
Subjects will have standardized and similar meals on all exercise days (lunch at 13:00, afternoon snack at 16:00, dinner at 19:45, and breakfast at 8:00 the next day), based on the weight, with calculated carbohydrates and calories: 1 gram of carbohydrates per kilogram, the content of the meal according to the recommendation: comprising of 50% carbohydrate, 20% protein, and 30% fat, of which no more than 10% will be saturated fat. During the exercise the SAP group will turn off the insulin pump and lower their basal insulin for 20% for the next 4 hours after the exercise.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- DreaMed Substance Administration Device, Sensor Augmented Pump (SAP)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DreaMed Substance Administration DeviceDevice
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.
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Sensor Augmented Pump (SAP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
- Time of hypoglycemia below 3.9 mmol/l (70 mg/dl) based on sensor glucose readings.
- Time of hyperglycemia above 13.9 mmol/l (250 mg/dl) based on sensor glucose readings.
- Time of glucose values within 3.9 - 10 mmol/l (70-180 mg/dl).
Measured: After all patients completed their 30 days of study treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ljubljana, Faculty of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tadej Battelino, Prof, MD, Principal investigator, University of Ljubljana, Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02657083
- Sponsor's protocol ID
- PD-MC-01
- Acronym
- PHYSI-DREAM
- Status last verified
- Aug 2016
- First submitted
- 12 Jan 2016
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
American Diabetes Association. Executive summary: Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S5-13. doi: 10.2337/dc14-S005. No abstract available.
PubMed 24357214Adolfsson 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.
PubMed 23173876Beraki 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.
PubMed 24846445Tsalikian 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.
PubMed 16227041Rosenbauer 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.
PubMed 22074726Hovorka 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.
PubMed 20138357Ly 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.
PubMed 24879841Sherr 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.
PubMed 23757427Phillip 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.
PubMed 23445093Oron 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.
PubMed 25211216Dauber 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.
PubMed 23033237Elleri 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.
PubMed 23193217Nimri 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.
PubMed 23448393Nimri 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.
PubMed 25078901Bailey RC, Olson J, Pepper SL, Porszasz J, Barstow TJ, Cooper DM. The level and tempo of children's physical activities: an observational study. Med Sci Sports Exerc. 1995 Jul;27(7):1033-41. doi: 10.1249/00005768-199507000-00012.
PubMed 7564970
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Hypoglycemia After Exercise Using DreaMed Substance Administration Device in Children and Adolescents With Type 1 Diabetes (The PHYSI-DREAM Study)
- ClinicalTrials.gov ID
- NCT02657083
- Acronym / sponsor ID
- PHYSI-DREAM / PD-MC-01
- Conditions
- Type 1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Ljubljana, Faculty of MedicineUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 15 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is investigator initiated, single-center, open-label, crossover, randomized, interventional, in-hospital pediatric study, performed at the University Children's Hospital, University Medical Center Ljubljana.
Study duration will be about 4 weeks per subject, 6 month overall. The study will compare Continuous Glucose Monitoring (CGM) based time in hypoglycemia in an intervention arm (Glucose control using DreaMed MD-AID) to a control arm (Glucose control using SAP).
Each arm includes two exercise days with 1 week in-between. Subjects will be randomly assigned to participate first in the intervention arm (10 subjects) or first in the control arm (10 subjects). At the end of the first period patients will be asked to participate in another, i.e. the other arm with at least one week between arms.
Subjects will be instructed to consume a similar diet and avoid caffeine, alcohol, and physical activity in the 48 hours before the exercise day visit.
The start of the run-in period can be scheduled as a separate visit, but not more than 2 days after screening.
All subjects will attend the clinic on six occasions:
- Visit 1: Screening and sensor/pump education, detailed physical examination will be performed, all subject will have to meet inclusion/exclusion criteria.
- Visit 2: Baseline assessment of the DreaMed MD-AID profile, subjects will perform resting electrocardiography (ECG) and determination of the maximal oxygen consumption rate (VO2max) on a cycle ergometer Ganshorn LF8.5G™ and Schiller software, with BG measurements before, at the end of the exercise and 2 hours after exercise. Subjects will be instructed to refrain from physical activity for 48 hours prior to visits 3 - 6.
- Visit 3: 24 hours DreaMed MD-AID or SAP with afternoon exercise (in the time between 16:30 and 19:30): an i.v. catheter will be inserted in the antecubital or cephalic vein (for plasma BG and emergency). Cycle ergometer will be adjusted for each subject (work rate, seat height,..), they will be instructed to pedal at steady rate of 50-60 rotations per minute (RPM).The subjects will cycle for 40 minutes at 55% Vo2max load (starting work rate set to 30 watts (W) with linear loading to reach 55% VO2max on 5:00 minute exercise time) - the aim of this session is to induce delayed hypoglycemia.
- Visit 4: 24 hours DreaMed MD-AID or SAP with afternoon exercise (in the time between 16:30 and 19:30): an i.v. catheter will be inserted in the antecubital or cephalic vein (for plasma BG and emergency). Cycle ergometer will be adjusted for each subject (work rate, seat height,..), they will be instructed to pedal at steady rate of 50-60 rotations per minute (RPM). The subjects will cycle for 40minutes - high intensity interval training (2 - 6 sprints of 20 seconds at 80% VO2max with interval of 6 minutes low-moderate activity (55% VO2max (total of ~40 minutes) between the sprint. The aim of this session is to imitate children's physical activity (bursts of intensive physical activity interspersed with varying intervals of activity of low and moderate intensity.
- Visit 5\&6: Same as visits 3 and 4, cross over from DreaMed MD-AID to SAP or vice versa.
During the exercise, a continuous ECG will be recorded and inhaled O2 and exhaled Carbon Dioxide (CO2) will be measured.
BG and lactate will be taken during the exercise visits: at the beginning of the exercise, after every 15 min exercise session, and every half an hour for the next 2 hours thereafter.
All hypoglycemia will be confirmed with SBGM: glucose values <3.3 (60 mg/dl) mmol/l if symptomatic, and all hypoglycemia with self blood glucose monitoring (SBGM) values <2.8 mmol/l (50 mg/dl) (regardless of symptoms) will be treated with rescue carbohydrates as per standard in-hospital procedure (15 g sugar per 10 kg of body weight (BW), re-evaluate and repeat if necessary in 15-30 minutes).
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.
Schedule for all exercise days will be similar:
- 12:00 hospital admission
- 13:00 lunch
- 13:30 to 16:00 rest
- 16:00 afternoon snack
- 16:30 to 19:30 exercise protocol
- 19:45 dinner
- 21:00 to 7:30 next day: bed time
- 8:00 breakfast.
- 13:00 lunch and end of study
Subjects will have standardized and similar meals on all exercise days (lunch at 13:00, afternoon snack at 16:00, dinner at 19:45, and breakfast at 8:00 the next day), based on the weight, with calculated carbohydrates and calories: 1 gram of carbohydrates per kilogram, the content of the meal according to the recommendation: comprising of 50% carbohydrate, 20% protein, and 30% fat, of which no more than 10% will be saturated fat. During the exercise the SAP group will turn off the insulin pump and lower their basal insulin for 20% for the next 4 hours after the exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glucose control using DreaMed MD-AID | Experimental | Device: DreaMed Substance Administration DeviceIn 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. |
| Glucose control using SAP | Active comparator | Device: Sensor Augmented Pump (SAP)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. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DreaMed Substance Administration Device2 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. | Device | Glucose control using DreaMed MD-AID |
| Sensor Augmented Pump (SAP)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 | Device | Glucose control using SAP |
Primary outcome
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.
Time frame: After all patients completed their 30 days of study treatment.
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.
1 secondary outcome
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
Time frame: After all patients completed their 30 days of study treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2017.
- Background: PubMed 24357214American Diabetes Association. Executive summary: Standards of medical care in diabetes--2014. Diabetes Care. 2014 Jan;37 Suppl 1:S5-13. doi: 10.2337/dc14-S005. No abstract available.
- Background: PubMed 23173876Adolfsson 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.
- Background: PubMed 24846445Beraki 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.
- Background: PubMed 16227041Tsalikian 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.
- Background: PubMed 22074726Rosenbauer 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.
- Background: PubMed 20138357Hovorka 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.
- Background: PubMed 24879841Ly 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.
- Background: PubMed 23757427Sherr 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.
- Background: PubMed 23445093Phillip 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.
- Background: PubMed 25211216Oron 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.
- Background: PubMed 23033237Dauber 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.
- Background: PubMed 23193217Elleri 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tadej Battelino, Prof, MD principal investigator
University of Ljubljana, Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DreaMed Substance Administration Device and Sensor Augmented Pump (SAP) in people with Type 1 Diabetes Mellitus, run by University of Ljubljana, Faculty of Medicine at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: After all patients completed their 30 days of study treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02657083, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2017; AzTrials last refreshed its copy on 29 Oct 2026.