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Study · Non-randomized trial · n = 4 · 2021

6 results

Alleviating carbohydrate counting with a FiASP-plus-pramlintide closed-loop delivery system (artificial pancreas): Feasibility and pilot studies.

Tsoukas MA, Cohen E, Legault L, von Oettingen JE, Yale JF, Vallis M, Odabassian M, El Fathi A, Rutkowski J, Jafar A, Ghanbari M, Gouchie-Provencher N, René J, Palisaitis E, Haidar A

Diabetes, obesity & metabolism21 Jun 2021Cited by 15 (Europe PMC)

PMID34047449 (opens in a new tab)DOI10.1111/dom.14447 (opens in a new tab)PepBankPUB-34047449
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

2 results from studies that gave the peptide. 2 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In the pilot study, time in range was 70% with FiASP-pramlintide and 60% with FiASP-placebo, both with simple meal announcement.

    In plain wordsIn the pilot study, time in range was 70% with insulin-pramlintide versus 60% with insulin-placebo, both using simple meal announcement.

    Peptide
    Pramlintide (Symlin)
    Outcome
    IncreasePilot time in range versus simple meal announcement
    Study

    n = 4

    Comparator
    FiASP-placebo with simple meal announcement
    Outcome group
    Glycemic control · Metabolic and weight
    Studied dose
    1 U:10 μg FiASP:pramlintideAs given in this study (human).

    Measurements

    Time in 3.9-10 mmol/L
    70%
    FiASP-and-pramlintide with SMA
    Time in 3.9-10 mmol/L
    60%
    FiASP-and-placebo with SMA

    Source sentences

    Summary
    Time spent in 3.9-10 mmol/L was similar between the FiASP-and-placebo with FCC and FiASP-and-pramlintide with SMA interventions (70%), but was lower in the FiASP-and-placebo with SMA intervention (60%).
    3 context sentences
    Summary · context
    Four participants were included in the pilot analysis.
    Summary · context
    We conducted a subsequent 12-day outpatient pilot study comparing a FiASP-and-placebo system with FCC, a FiASP-and-pramlintide system with SMA, and a FiASP-and-placebo system with SMA.
    Summary · context
    Basal-bolus FiASP-and-pramlintide were delivered at a fixed ratio (1 U:10 μg).
  2. 02HumanNon-randomized trialEfficacy outcome

    In the pilot study, emotional distress was moderate at baseline and after the FiASP-placebo interventions and fell after FiASP-pramlintide with simple meal announcement.

    In plain wordsIn the pilot study, emotional distress stayed moderate after insulin-placebo interventions and fell after insulin-pramlintide with meal announcement.

    Peptide
    Pramlintide (Symlin)
    Outcome
    DecreaseEmotional distress
    Study

    n = 4

    Comparator
    FiASP-and-placebo with SMA
    Outcome group
    Anxiety and mood · Mental health and mood
    Studied dose
    1 U:10 μg FiASP:pramlintideAs given in this study (human).

    Source sentences

    Summary
    Emotional distress was moderate at baseline, after the FiASP-and-placebo with FCC and SMA interventions, and fell after the FiASP-and-pramlintide with SMA intervention.
    2 context sentences
    Summary · context
    We conducted a 24-hour feasibility study comparing a FiASP system with full carbohydrate counting (FCC) with a FiASP-and-pramlintide system with SMA.
    Summary · context
    We conducted a subsequent 12-day outpatient pilot study comparing a FiASP-and-placebo system with FCC, a FiASP-and-pramlintide system with SMA, and a FiASP-and-placebo system with SMA.

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).

  1. 03HumanNot a test of Pramlintide (Symlin) aloneNon-randomized trialEfficacy outcome

    In the feasibility study, FiASP-pramlintide with simple meal announcement and FiASP with carbohydrate counting had similar time in range.

    In plain wordsIn the feasibility study, insulin-pramlintide with simple meal announcement and insulin with carbohydrate counting had similar time in range.

    Peptide
    Pramlintide (Symlin)
    Outcome
    No significant changeFeasibility time in range
    Study

    n = 7

    Comparator
    FiASP with full carbohydrate counting
    Outcome group
    Glycemic control · Metabolic and weight

    Measurements

    Time in 3.9-10 mmol/L
    81 to 84%
    Feasibility study, both interventions (range 81%-84%)

    Source sentences

    Summary
    Time spent in 3.9-10 mmol/L was similar between both interventions (81%-84%).
    3 context sentences
    Summary · context
    Seven participants were included in the feasibility analysis.
    Summary · context
    We conducted a 24-hour feasibility study comparing a FiASP system with full carbohydrate counting (FCC) with a FiASP-and-pramlintide system with SMA.
    Summary · context
    We conducted a subsequent 12-day outpatient pilot study comparing a FiASP-and-placebo system with FCC, a FiASP-and-pramlintide system with SMA, and a FiASP-and-placebo system with SMA.

    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).

  2. 04HumanNot a test of Pramlintide (Symlin) aloneNon-randomized trialEfficacy outcome

    In the pilot study, FiASP-pramlintide with simple meal announcement and FiASP-placebo with carbohydrate counting had similar time in range.

    In plain wordsIn the pilot study, insulin-pramlintide with meal announcement and insulin-placebo with carbohydrate counting had similar time in range.

    Peptide
    Pramlintide (Symlin)
    Outcome
    No significant changePilot time in range versus full carbohydrate counting
    Study

    n = 4

    Comparator
    FiASP-placebo with full carbohydrate counting
    Outcome group
    Glycemic control · Metabolic and weight

    Measurements

    Time in 3.9-10 mmol/L
    70%
    Pilot, FiASP-and-placebo with FCC and FiASP-and-pramlintide with SMA (both 70%)

    Source sentences

    Summary
    Time spent in 3.9-10 mmol/L was similar between the FiASP-and-placebo with FCC and FiASP-and-pramlintide with SMA interventions (70%), but was lower in the FiASP-and-placebo with SMA intervention (60%).
    3 context sentences
    Summary · context
    Four participants were included in the pilot analysis.
    Summary · context
    We conducted a 24-hour feasibility study comparing a FiASP system with full carbohydrate counting (FCC) with a FiASP-and-pramlintide system with SMA.
    Summary · context
    We conducted a subsequent 12-day outpatient pilot study comparing a FiASP-and-placebo system with FCC, a FiASP-and-pramlintide system with SMA, and a FiASP-and-placebo system with SMA.

    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).

  3. 05HumanNot a test of Pramlintide (Symlin) aloneNon-randomized trialSafety outcome

    In the FiASP-pramlintide studies, time below 3.9 mmol/L was similar across all interventions.

    In plain wordsIn the insulin-pramlintide studies, time with low glucose was similar across all interventions.

    Peptide
    Pramlintide (Symlin)
    Outcome
    No significant changeTime below glucose range
    Study

    n: not reported in source

    Comparator
    All interventions
    Outcome group
    Glycemic control · Metabolic and weight

    Source sentences

    Summary
    Time less than 3.9 mmol/L and gastrointestinal symptoms were similar across all interventions.
    2 context sentences
    Summary · context
    We conducted a 24-hour feasibility study comparing a FiASP system with full carbohydrate counting (FCC) with a FiASP-and-pramlintide system with SMA.
    Summary · context
    We conducted a subsequent 12-day outpatient pilot study comparing a FiASP-and-placebo system with FCC, a FiASP-and-pramlintide system with SMA, and a FiASP-and-placebo system with SMA.

    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).

  4. 06HumanNot a test of Pramlintide (Symlin) aloneNon-randomized trialSafety outcome

    In the FiASP-pramlintide studies, gastrointestinal symptoms were similar across all interventions.

    In plain wordsIn the insulin-pramlintide studies, digestive symptoms were similar across all interventions.

    Peptide
    Pramlintide (Symlin)
    Outcome
    No significant changeGastrointestinal symptoms
    Study

    n: not reported in source

    Comparator
    All interventions
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal

    Source sentences

    Summary
    Time less than 3.9 mmol/L and gastrointestinal symptoms were similar across all interventions.
    2 context sentences
    Summary · context
    We conducted a 24-hour feasibility study comparing a FiASP system with full carbohydrate counting (FCC) with a FiASP-and-pramlintide system with SMA.
    Summary · context
    We conducted a subsequent 12-day outpatient pilot study comparing a FiASP-and-placebo system with FCC, a FiASP-and-pramlintide system with SMA, and a FiASP-and-placebo system with SMA.

    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).

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 ongoing · source ClinicalTrials.gov (opens in a new tab)

RecruitingPhase 2/3NCT07284511

A Clinical Trial Using Tirzepatide to Help Adults With Type 1 Diabetes Automatically Control Their Blood Sugar

McGill University Health Centre/Research Institute of the McGill University Health Centren = 10519 May 2026 to est. Jan 2029

Type 1 Diabetes · Type 1 Diabetes Mellitus · T1D · T1DM · T1DM - Type 1 Diabetes Mellitus

Trial pageClinicalTrials.govUpdated 27 May 2026

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.

  1. Version 2Current

    22 Oct 2026, 02:26 UTC

    Study results updated

  2. Version 1

    21 Oct 2026, 18:59 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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