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Study · Not a test of the peptide alone · 2024

5 results

Simple meal announcements and pramlintide delivery versus carbohydrate counting in type 1 diabetes with automated fast-acting insulin aspart delivery: a randomised crossover trial in Montreal, Canada.

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

The Lancet. Digital health1 Jul 2024Cited by 16 (Europe PMC)

PMID38906614 (opens in a new tab)DOI10.1016/s2589-7500(24)00092-x (opens in a new tab)PepBankPUB-38906614
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: CC BY-NC. Results still quote short attributed sentences.

Results from this study5

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

Studies that did not test the peptide alone5

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. 01HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome

    In participants with type 1 diabetes, insulin-pramlintide with simple meal announcements reached time-in-range non-inferiority versus insulin-placebo with carbohydrate counting.

    In plain wordsIn participants with diabetes, insulin-pramlintide with simple meal announcements reached glucose time-in-range non-inferiority versus insulin-placebo with carbohydrate counting.

    Peptide
    Pramlintide (Symlin)
    Outcome
    Not applicableTime in glucose range non-inferiority
    Study

    n = 30

    Comparator
    Insulin-placebo system with carbohydrate counting
    Analysis
    Primary
    Outcome group
    Glycemic control · Metabolic and weight

    Measurements

    Time in range difference
    −5%
    Insulin-placebo system with carbohydrate counting minus insulin-pramlintide system with simple meal announcements

    Source sentences

    Summary
    Non-inferiority of the insulin-and-pramlintide system with simple meal announcements relative to the insulin-and-placebo system with carbohydrate counting was reached (difference -5% [95% CI -9·0 to -0·7], non-inferiority p<0·0001).
    3 context sentences
    Summary · context
    Two primary comparisons were predefined: the percentage of time in range (glucose 3·9-10·0 mmol/L) with a non-inferiority margin of 6·25% (non-inferiority comparison);
    Summary · context
    We performed a randomised crossover trial assessing 14 days of (1) insulin-and-pramlintide closed-loop system with simple meal announcements, (2) insulin-and-placebo closed-loop system with carbohydrate counting, and (3) insulin-and-placebo closed-loop system with simple meal announcements.
    Summary · context
    30 participants were analysed, including 15 adults (nine female, mean age 39·4 years [SD 13·8]) and 15 adolescents (eight female, mean age 15·7 years [1·3]).

    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. 02HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialEfficacy outcome

    In participants with type 1 diabetes, Emotional Burden scores did not differ significantly between insulin-pramlintide with simple announcements and insulin-placebo with carbohydrate counting.

    In plain wordsIn participants with diabetes, emotional burden did not differ significantly between insulin-pramlintide with simple announcements and insulin-placebo with carbohydrate counting.

    Peptide
    Pramlintide (Symlin)
    Outcome
    No significant changeEmotional Burden score
    Study

    n = 30

    Comparator
    Insulin-placebo system with carbohydrate counting
    Analysis
    Primary
    Outcome group
    Quality of life · Mental health and mood

    Measurements

    Emotional Burden score difference
    0.01 score
    Insulin-pramlintide with simple meal announcements versus insulin-placebo with carbohydrate counting

    Source sentences

    Summary
    No statistically significant difference was found in the mean Emotional Burden score between the insulin-and-pramlintide system with simple meal announcements and the insulin-and-placebo system with carbohydrate counting (difference 0·01 [SD 0·82], p=0·93).
    2 context sentences
    Summary · context
    We performed a randomised crossover trial assessing 14 days of (1) insulin-and-pramlintide closed-loop system with simple meal announcements, (2) insulin-and-placebo closed-loop system with carbohydrate counting, and (3) insulin-and-placebo closed-loop system with simple meal announcements.
    Summary · context
    30 participants were analysed, including 15 adults (nine female, mean age 39·4 years [SD 13·8]) and 15 adolescents (eight female, mean age 15·7 years [1·3]).

    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. 03HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome

    In participants with type 1 diabetes, no serious adverse events occurred during the trial of insulin-pramlintide and insulin-placebo systems.

    In plain wordsIn participants with diabetes, no serious adverse events occurred during the trial of insulin-pramlintide and insulin-placebo systems.

    Peptide
    Pramlintide (Symlin)
    Outcome
    Not applicableSerious adverse events
    Study

    n = 32

    Outcome group
    Adverse events · Whole body

    Source sentences

    Summary
    No serious adverse events occurred.
    4 context sentences
    Summary · context
    Serious adverse events were assessed in all participants.
    Summary · context
    32 participants were enrolled between Feb 14, 2020, and Oct 5, 2021; two participants withdrew before study completion.
    Summary · context
    We performed a randomised crossover trial assessing 14 days of (1) insulin-and-pramlintide closed-loop system with simple meal announcements, (2) insulin-and-placebo closed-loop system with carbohydrate counting, and (3) insulin-and-placebo closed-loop system with simple meal announcements.
    Summary · context
    30 participants were analysed, including 15 adults (nine female, mean age 39·4 years [SD 13·8]) and 15 adolescents (eight female, mean age 15·7 years [1·3]).

    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. 04HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome

    In participants with type 1 diabetes, mild gastrointestinal symptoms occurred in 47% with insulin-pramlintide and simple announcements versus 7% with insulin-placebo and carbohydrate counting.

    In plain wordsIn participants with diabetes, mild digestive symptoms were more frequent with insulin-pramlintide and simple announcements than insulin-placebo and carbohydrate counting.

    Peptide
    Pramlintide (Symlin)
    Outcome
    IncreaseMild gastrointestinal symptoms
    Study

    n = 30

    Comparator
    Insulin-placebo system with carbohydrate counting
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal

    Measurements

    Mild gastrointestinal symptoms
    47%
    Insulin-pramlintide with simple meal announcements
    Mild gastrointestinal symptoms
    7%
    Insulin-placebo with carbohydrate counting

    Source sentences

    Summary
    With the insulin-and-pramlintide system with simple meal announcements, 14 (47%) participants reported mild gastrointestinal symptoms and two (7%) reported moderate symptoms, compared with two (7%) participants reporting mild gastrointestinal symptoms on the insulin-and-placebo system with carbohydrate counting.
    2 context sentences
    Summary · context
    We performed a randomised crossover trial assessing 14 days of (1) insulin-and-pramlintide closed-loop system with simple meal announcements, (2) insulin-and-placebo closed-loop system with carbohydrate counting, and (3) insulin-and-placebo closed-loop system with simple meal announcements.
    Summary · context
    30 participants were analysed, including 15 adults (nine female, mean age 39·4 years [SD 13·8]) and 15 adolescents (eight female, mean age 15·7 years [1·3]).

    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).

  5. 05HumanNot a test of Pramlintide (Symlin) aloneRandomized controlled trialSafety outcome

    In participants with type 1 diabetes, two participants reported moderate gastrointestinal symptoms during insulin-pramlintide treatment with simple meal announcements.

    In plain wordsIn participants with diabetes, two reported moderate digestive symptoms during insulin-pramlintide treatment with simple meal announcements.

    Peptide
    Pramlintide (Symlin)
    Outcome
    Not applicableModerate gastrointestinal symptoms
    Study

    n = 30

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal

    Measurements

    Moderate gastrointestinal symptoms
    7%
    Insulin-pramlintide with simple meal announcements

    Source sentences

    Summary
    With the insulin-and-pramlintide system with simple meal announcements, 14 (47%) participants reported mild gastrointestinal symptoms and two (7%) reported moderate symptoms, compared with two (7%) participants reporting mild gastrointestinal symptoms on the insulin-and-placebo system with carbohydrate counting.
    2 context sentences
    Summary · context
    We performed a randomised crossover trial assessing 14 days of (1) insulin-and-pramlintide closed-loop system with simple meal announcements, (2) insulin-and-placebo closed-loop system with carbohydrate counting, and (3) insulin-and-placebo closed-loop system with simple meal announcements.
    Summary · context
    30 participants were analysed, including 15 adults (nine female, mean age 39·4 years [SD 13·8]) and 15 adolescents (eight female, mean age 15·7 years [1·3]).

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

CompletedNot applicableNCT04163874

Alleviating Carbohydrate Counting for Patients With Type 1 Diabetes Using a Novel Insulin-plus-pramlintide Artificial Pancreas

McGill Universityn = 3614 Feb 2020 to 30 Jan 2022

Type 1 Diabetes · Type 1 Diabetes Mellitus · Hyperglycemia, Postprandial

Trial pageClinicalTrials.govUpdated 10 Oct 2022

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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