A Phase 2 interventional study of 15-week intervention with sensor-augmented pump and 15-week intervention with single-hormone closed-loop in Type 1 Diabetes, sponsored by Institut de Recherches Cliniques de Montreal. Withdrawn. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2019-07-23.
Sponsored by Institut de Recherches Cliniques de Montreal · Phase 2, Interventional, and Treatment
Closed-loop strategy is composed of three components: glucose sensor to read glucose levels, insulin pump to infuse insulin and a dosing mathematical algorithm to decide on the required insulin dosages based on the sensor's readings. A dual-hormone closed loop strategy regulates glucose levels through the infusion of two hormones: insulin and glucagon.
The objective of this study is to compare, in a randomized multicenter trial, the effectiveness of single-hormone closed-loop, dual-hormone closed-loop, and sensor-augmented pump therapy with low-glucose suspend in regulating day-and-night glucose levels in outpatient settings for 15 weeks in adolescents and adults.
The investigators hypothesize that dual-hormone closed-loop will reduce time spent in hypoglycemia compared to single-hormone closed-loop, which in turn will be more effective than sensor-augmented pump therapy with low-glucose suspend.
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Exclusion Criteria:
Participants will use sensor-augmented pump therapy with low-glucose suspend to regulate glucose levels. The low-glucose suspend feature available in the MiniMed® Paradigm® Veo™, Medtronic combined with the Enlite sensor® will be used. This feature allows for suspension of insulin delivery at a pre-set sensor glucose value for up to 2 hours.
Other: 15-week intervention with sensor-augmented pump · Device: Insulin pump · Device: Continuous glucose monitoring system · Drug: Insulin
Variable subcutaneous insulin infusion will be used to regulate glucose levels. Participant's usual fast-acting insulin analog will be infused using a subcutaneous infusion pump (MiniMed® Paradigm® Veo™, Medtronic). Every 10 minutes, the glucose levels as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pump.
Other: 15-week intervention with single-hormone closed-loop · Device: Insulin pump · Device: Continuous glucose monitoring system · Drug: Insulin
Variable subcutaneous insulin and glucagon mini-boluses will be infused using two separate subcutaneous infusion pumps to regulate glucose levels (MiniMed® Paradigm® Veo™, Medtronic). Participant's usual fast-acting insulin analog and Glucagon (Eli Lilly) will be used. Every 10 minutes, the glucose level as measured by the sensor (Enlite sensor®, Medtronic) will be transferred automatically to a smartphone, that harbors the algorithm, that will calculate the recommended doses and will send it wirelessly to the infusion pumps. Newly reconstituted glucagon will be used every 24 hours.
Other: 15-week intervention with dual-hormone closed-loop · Device: Insulin pump · Device: Continuous glucose monitoring system · Drug: Insulin · Drug: Glucagon
A sensor will be inserted on the day before the start of the intervention by the participant. The participant will also have to install the study insulin pump. Participants will be advised to continue with study intervention at home for the next 15 weeks. Participants will have been previously shown how to use the study insulin pump.
A sensor will be inserted on the day before the start of the intervention by the participant. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 15 weeks.
A sensor will be inserted on the day before the start of the intervention by the participant. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 15 weeks. Participants will have to reconstitute glucagon everyday.
MiniMed® Paradigm® Veo™, Medtronic
Enlite sensor®, Medtronic
Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)
Glucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy.
Percentage of time of glucose levels below 3.9 mmol/L
Time frame: 15 weeks
HbA1c
Time frame: 15 weeks
Percentage of time of glucose levels spent in the target range
Target range is defined to be between 4 and 10 mmol/L from 7:00 to 22:00 and between 4 and 7.8 mmol/L from 22:00 to 7:00
Time frame: 15 weeks
Area under the curve of glucose levels below 3.9 mmol/L
Time frame: 15 weeks
Area under the curve of glucose levels below 3.3 mmol/L
Time frame: 15 weeks
Area under the curve of glucose levels below 2.8 mmol/L
Time frame: 15 weeks
Percentage of time of glucose levels below 3.3 mmol/L
Time frame: 15 weeks
Percentage of time of glucose levels below 2.8 mmol/L
Time frame: 15 weeks
Total number of hypoglycemic events below 3.1 mmol/L
Time frame: 15 weeks
Percentage of time of glucose levels above 7.8 mmol/L
Time frame: 15 weeks
Percentage of time of glucose levels above 10.0 mmol/L
Time frame: 15 weeks
Mean glucose levels
Time frame: 15 weeks
Standard deviation of glucose levels
Time frame: 15 weeks
Coefficient of variation of glucose levels
Time frame: 15 weeks
Total daily dose of insulin
Time frame: 24 hours
Total daily dose of glucagon
Time frame: 24 hours
Percentage of time of closed-loop operation
Time frame: 15 weeks
Percentage of time of glucose sensor availability
Time frame: 15 weeks
Time between failures due to glucose sensor unavailability
Time frame: 15 weeks
Time between failures due to pump connectivity
Time frame: 15 weeks
Percentage of time when patients switched back to insulin pump therapy
Time frame: 15 weeks
Percentage of time when the closed-loop was automatically switched to insulin pump therapy
Time frame: 15 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Institut de Recherches Cliniques de Montreal