A fully artificial pancreas versus a hybrid artificial pancreas for type 1 diabetes: a single-centre, open-label, randomised controlled, crossover, non-inferiority trial.

Tsoukas MA, Majdpour D, Yale JF, Fathi AE, Garfield N, Rutkowski J, Rene J, Legault L, Haidar A

The Lancet. Digital health24 Sept 2021Cited by 37 (Europe PMC)

PMID34580055DOI10.1016/s2589-7500(21)00139-4PepBankPUB-34580055

Publisher page PubMedAsk about this study

Summary

BackgroundFor people with type 1 diabetes, there is currently no automated insulin delivery system that does not require meal input. We aimed to assess the efficacy of a novel faster-acting insulin aspart (Fiasp) plus pramlintide fully closed-loop system that does not require meal input.MethodsIn this open-label, randomised controlled, crossover, non-inferiority trial we compared the Fiasp (Novo Nordisk, Bagsværd, Denmark) plus pramlintide closed-loop system with no meal input (fully artificial pancreas) and the Fiasp-alone closed-loop system with precise carbohydrate counting (hybrid artificial pancreas). Adults (≥18 years) who had a clinical diagnosis of type 1 diabetes for at least 12 months, had glycated haemoglobin 12% or lower, and had been on insulin pump therapy for at least 6 months were enrolled at McGill University Health Centre, Montreal, QC, Canada. The Fiasp plus pramlintide fully closed-loop system delivered pramlintide in a basal-bolus manner with a fixed ratio of 10 μg:U relative to insulin. A research staff member counted the carbohydrate content of meals to input in the hybrid closed-loop system. Participants completed the two full-day crossover interventions in a random order allocated by a computer-generated code implementing a blocked randomisation (block size of four). The primary outcome was the percentage of time spent within the glucose target range (3·9-10·0 mmol/L), with a 6% non-inferiority margin, assessed in all participants who completed both interventions. This trial is registered with ClinicalTrials.gov, NCT03800875.FindingsBetween Feb 8, 2019, and Sept 19, 2020, we enrolled 28 adults, of whom 24 completed both interventions and were included in analyses. The percentage of time spent in the target range was 74·3% (IQR 61·5-82·8) with the fully closed-loop system versus 78·1% (66·3-87·5) with the hybrid Fiasp-alone closed-loop system (paired difference 2·6%, 95% CI -2·4 to 12·2; non-inferiority p=0·28). Eight (33%) participants had at least one hypoglycaemia event (<3·3 mmol/L) with the fully closed-loop system compared with 14 (58%) participants with the hybrid closed-loop system (2200-2200 h). Non-mild nausea was reported by three (13%) participants and non-mild bloating by one (4%) participant with the fully closed-loop system compared with zero participants with the hybrid closed-loop system.InterpretationThe Fiasp plus pramlintide fully closed-loop system was not non-inferior to the Fiasp-alone hybrid closed-loop system for the overall percentage of time in the glucose target range. However, participants still spent a high percentage of time within the target range with the fully-closed loop system. Outpatient studies comparing the fully closed-loop hybrid systems with patient-estimated, rather than precise, carbohydrate counting are warranted.FundingDiabetes Canada.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

No result from this study comes from a test of the peptide.

Studies that did not test the peptide alone4

In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Pramlintide (Symlin).

01HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome
In adults with type 1 diabetes, the Fiasp-pramlintide fully closed-loop system did not establish non-inferiority for time in target range versus the hybrid system.
In plain wordsIn type 1 diabetes, the insulin-pramlintide fully closed-loop system did not establish non-inferiority for target-range time versus the insulin-alone hybrid system.
Peptide
Pramlintide (Symlin)
Outcome
Direction not reportedTime in target glucose range
Study
n = 24
Comparator
Fiasp-alone hybrid closed-loop system with precise carbohydrate counting
Analysis
Primary
Outcome group
Glycemic control · Metabolic and weight
Measurements
Time in target range (3.9-10.0 mmol/L), median
74.3%
Fiasp plus pramlintide fully closed-loop, IQR 61.5-82.8
Time in target range (3.9-10.0 mmol/L), median
78.1%
Hybrid Fiasp-alone closed-loop, IQR 66.3-87.5
Paired difference in time in range
2.6%
95% CI -2.4 to 12.2; non-inferiority p=0.28
Source sentences
Summary
The percentage of time spent in the target range was 74·3% (IQR 61·5-82·8) with the fully closed-loop system versus 78·1% (66·3-87·5) with the hybrid Fiasp-alone closed-loop system (paired difference 2·6%, 95% CI -2·4 to 12·2; non-inferiority p=0·28).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary outcome was the percentage of time spent within the glucose target range (3·9-10·0 mmol/L), with a 6% non-inferiority margin, assessed in all participants who completed both interventions.
Summary · context
In this open-label, randomised controlled, crossover, non-inferiority trial we compared the Fiasp (Novo Nordisk, Bagsværd, Denmark) plus pramlintide closed-loop system with no meal input (fully artificial pancreas) and the Fiasp-alone closed-loop system with precise carbohydrate counting (hybrid artificial pancreas).
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Show in the study text Report a problemFND-3458005501
02HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome
In adults with type 1 diabetes, hypoglycaemia affected 33% with the Fiasp-pramlintide system versus 58% with the hybrid system.
In plain wordsIn type 1 diabetes, hypoglycaemia affected fewer participants with the insulin-pramlintide system than with the insulin-alone hybrid system.
Peptide
Pramlintide (Symlin)
Outcome
DecreaseHypoglycaemia events
Study
n = 24
Comparator
Fiasp-alone hybrid closed-loop system with precise carbohydrate counting
Outcome group
Adverse events · Metabolic and weight
Measurements
Participants with at least one hypoglycaemia event
33%
Fully closed-loop system, 8 participants
Participants with at least one hypoglycaemia event
58%
Hybrid closed-loop system, 14 participants
Source sentences
Summary
Eight (33%) participants had at least one hypoglycaemia event (<3·3 mmol/L) with the fully closed-loop system compared with 14 (58%) participants with the hybrid closed-loop system (2200-2200 h).
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label, randomised controlled, crossover, non-inferiority trial we compared the Fiasp (Novo Nordisk, Bagsværd, Denmark) plus pramlintide closed-loop system with no meal input (fully artificial pancreas) and the Fiasp-alone closed-loop system with precise carbohydrate counting (hybrid artificial pancreas).
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Show in the study text Report a problemFND-3458005502
03HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome
In adults with type 1 diabetes, non-mild nausea affected 13% with the Fiasp-pramlintide system versus zero with the hybrid system.
In plain wordsIn type 1 diabetes, non-mild nausea affected more participants with the insulin-pramlintide system than with the insulin-alone hybrid system.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseNon-mild nausea
Study
n = 24
Comparator
Fiasp-alone hybrid closed-loop system with precise carbohydrate counting
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Participants with non-mild nausea
13%
Fully closed-loop system, 3 participants
Participants with non-mild nausea
0%
Hybrid closed-loop system, 0 participants
Source sentences
Summary
Non-mild nausea was reported by three (13%) participants and non-mild bloating by one (4%) participant with the fully closed-loop system compared with zero participants with the hybrid closed-loop system.
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label, randomised controlled, crossover, non-inferiority trial we compared the Fiasp (Novo Nordisk, Bagsværd, Denmark) plus pramlintide closed-loop system with no meal input (fully artificial pancreas) and the Fiasp-alone closed-loop system with precise carbohydrate counting (hybrid artificial pancreas).
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Show in the study text Report a problemFND-3458005503
04HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome
In adults with type 1 diabetes, non-mild bloating affected 4% with the Fiasp-pramlintide system versus zero with the hybrid system.
In plain wordsIn type 1 diabetes, non-mild bloating affected more participants with the insulin-pramlintide system than with the insulin-alone hybrid system.
Peptide
Pramlintide (Symlin)
Outcome
IncreaseNon-mild bloating
Study
n = 24
Comparator
Fiasp-alone hybrid closed-loop system with precise carbohydrate counting
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Measurements
Participants with non-mild bloating
4%
Fully closed-loop system, 1 participant
Participants with non-mild bloating
0%
Hybrid closed-loop system, 0 participants
Source sentences
Summary
Non-mild nausea was reported by three (13%) participants and non-mild bloating by one (4%) participant with the fully closed-loop system compared with zero participants with the hybrid closed-loop system.
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label, randomised controlled, crossover, non-inferiority trial we compared the Fiasp (Novo Nordisk, Bagsværd, Denmark) plus pramlintide closed-loop system with no meal input (fully artificial pancreas) and the Fiasp-alone closed-loop system with precise carbohydrate counting (hybrid artificial pancreas).
In this study, Pramlintide (Symlin) was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Pramlintide (Symlin).
Show in the study text Report a problemFND-3458005504

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT03800875

Insulin-plus-pramlintide Closed-loop Strategy to Regulate Glucose Levels Without Carbohydrate Counting

McGill Universityn = 248 Feb 2019 to 19 Sept 2020

Diabetes Mellitus, Type 1

Trial page ClinicalTrials.govUpdated 8 Jun 2021

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
22 Oct 2026, 02:26 UTC
Study results updated
Version 1
21 Oct 2026, 18:59 UTC
First added · source update from Europe PMC

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