Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes
NCT ID: NCT04949867
Last Updated: 2022-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
11 participants
INTERVENTIONAL
2021-05-20
2022-04-26
Brief Summary
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To assess the efficacy and safety of an insulin-glucagon dual-hormone (DH) closed-loop system compared with an insulin-only single-hormone (SH) closed-loop system in adolescent with type 1 diabetes.
Methods:
In a 26-h, randomized, crossover, inpatient study, 20 children and adolescents with type 1 diabetes used two modes of the DiaCon Artificial Pancreas system: DH and SH closed-loop control. During each study period, participants will have one overnight stay, received three meals and performed exercise for 45 min (bicycle with estimated 50% V02max).
Endpoint:
The primary endpoint is sensor-derived percentage of time in hypoglycemia (\<3.9 mmol/L).
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Detailed Description
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In addition, participants are provided with a blinded wearable activity and sleep monitoring device (ActiGraph GT9X Link, Pensacola, FL) for activity level estimation and sleep assessment during study participation. The Actigraph is connected to a Bluetooth® Polar heart rate monitors during the exercise session.
Female participants deliver a urine sample for pregnancy testing. A sampling cannula is placed in an antecubital vein. The CGM will be calibrated with fingerpick glucose meter (Contour next®, Ascensia Diabetes Care) before initiating the closed-loop control. Even though it is not needed to calibrate the sensor, the accuracy of the sensor is better after one calibration.
At day 1 17:00 the study is initiated, and the closed-loop system takes over glucose control. Except from the control approach (single- vs. dual-hormone), the study days are identical. During the study visit, participants can move around freely, but they can only perform actual exercise during the stationary bike exercise session at day 2 16:30. At nighttime, the participants are encouraged to be in bed and, if possible, sleep.
At predefined timepoints, the investigators measure blood pressure and pulse, and the investigators ask the participants to rate their nausea level on a visual analog scale (VAS) from 1 to 100 to assess possible side effects of glucagon (vomiting rates as 100). In addition, the investigators ask them to self-rate blood glucose levels before bedtime (23:00), upon wake-up (07:00-08:00), before each meal, before exercise, and every 10 minutes during exercise.
Single-hormone and dual-hormone closed-loop control study sessions end 26 hours after study start. The study pumps and the CGMs are disconnected and the participants reconnect their own pumps and CGMs.
The two study sessions are separated by at least 36 hours.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Dual-hormone Closed-loop
FiAsp® and GlucaGen®.
Glucagon
Glucagon is filled in the pump and given automatically in case of hypoglycemia or pending hypoglycemia.
Closed-loop System
Closed-loop system comprise of two DANA RS (R) insulin pumps (FiAsp-GlucaGen vs FiAsp-saline), one DexCom G6 sensor, and a smartphone for the control algorithm.
Single-Hormone Closed-loop
FiAsp® and isotonic saline.
Closed-loop System
Closed-loop system comprise of two DANA RS (R) insulin pumps (FiAsp-GlucaGen vs FiAsp-saline), one DexCom G6 sensor, and a smartphone for the control algorithm.
Interventions
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Glucagon
Glucagon is filled in the pump and given automatically in case of hypoglycemia or pending hypoglycemia.
Closed-loop System
Closed-loop system comprise of two DANA RS (R) insulin pumps (FiAsp-GlucaGen vs FiAsp-saline), one DexCom G6 sensor, and a smartphone for the control algorithm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* T1D duration ≥ 2 years
* Insulin pump therapy ≥ 1 year
* Using CGM or isCGM (Flash Libre)
* HbA1c ≤ 9.0% (75 mmol/mol)
* Using carbohydrate counting
Exclusion Criteria
* Allergy to faster insulin aspart (FiAsp)
* Pheochromocytoma
* Self-reported lack of hypoglycemia symptoms when blood glucose is \< 3.0 mmol/l
* Inability to follow study procedures, e.g. exercise, sleeping, blood sampling, and meal intake
* Pregnancy, nursing, plan to become pregnant or sexually active and not using adequate contraceptive methods (intrauterine device, contraceptive pill, patch or injection)
* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation
* Other concomitant medical or psychological condition that according to the investigator's assessment makes the participant unsuitable for study participation
13 Years
17 Years
ALL
No
Sponsors
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Technical University of Denmark
OTHER
Herlev Hospital
OTHER
Steno Diabetes Center Copenhagen
OTHER
Responsible Party
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Locations
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Steno Diabetes Center Copenhagen
Gentofte Municipality, , Denmark
Herlev Hospital
Herlev, , Denmark
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2020-005836-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2021-0409-34
Identifier Type: OTHER
Identifier Source: secondary_id
PD002-19
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-21000207
Identifier Type: -
Identifier Source: org_study_id
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