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Safety Evaluation of MODI, an Insulin Titration Algorithm, in Adults With Diabetes (MODIUS)

27 augusti 2026 uppdaterad av: DreaMed Diabetes
A 13-week multi-center single-arm trial, preceded by a 2-week standard therapy phase, will be conducted to assess the safety of MODI, an insulin titration algorithm, in adults with type 1 diabetes (T1D) who use multiple daily insulin injections (MDI), or with type 2 diabetes (T2D) who use MDI, basal insulin only, or who are candidates to initiate basal insulin, in conjunction with continuous glucose monitoring (CGM).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

102

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Maryland
      • Baltimore, Maryland, Förenta staterna, 21201
        • Har inte rekryterat ännu
        • Baltimore VA Medical Center Univ of Maryland
        • Kontakt:
    • Michigan
      • Detroit, Michigan, Förenta staterna, 48202
        • Rekrytering
        • Henry Ford Health System
        • Kontakt:
        • Huvudutredare:
          • Davida Kruger
    • New York
      • Albany, New York, Förenta staterna, 12246
        • Rekrytering
        • SUNY Upstate Medical Center
        • Kontakt:
        • Huvudutredare:
          • Malek El Muayed, MD
    • North Carolina
      • Morehead City, North Carolina, Förenta staterna, 28557
    • Texas
      • Austin, Texas, Förenta staterna, 78731
        • Rekrytering
        • Texas Diabetes & Endocrinology
        • Huvudutredare:
          • Thomas Blevins, MD
        • Kontakt:
    • Utah
      • Sandy City, Utah, Förenta staterna, 84093
        • Rekrytering
        • Diabetes & Endocrine Treatment Specialisits (DETS)
        • Huvudutredare:
          • Timothy Graham, MD
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  1. Clinical diagnosis, based on investigator assessment, of T1D or T2D of at least 6 months duration at time of informed consent

  2. Insulin therapy as follows:

    1. If T1D, using MDI insulin therapy for at least 3 months prior to screening; willing to follow a mealtime insulin dosing approach during the study, using either (a) time-of-day-based dosing (breakfast, lunch, dinner) or (b) meal-size-based dosing (small, normal, large); and taking

      1 basal insulin injection per day for at least 1 week prior to screening

    2. If T2D, either:

    i. not using insulin in the 3 months prior to screening, but require initiation of a basal-only insulin regimen based on investigator assessment ii. using only basal insulin for at least 3 months prior to screening and taking 1 basal insulin injection per day for at least 1 week prior to screening iii. using MDI for at least 3 months prior to screening; willing to follow a mealtime insulin dosing approach during the study, using either

    (a) time-of-day-based dosing (breakfast, lunch, dinner) or (b) mealsize-based dosing (small, normal, large); and taking 1 basal insulin injection per day for at least 1 week prior to screening

  3. Age at time of consent 18-80 years
  4. HbA1c >7.5% and <12% as measured by point-of-care device or local lab at the time of screening
  5. Using only injected insulin types that are specified in the MODI Instructions for Use materials
  6. Stable doses of non-insulin glucose lowering medications over the 4 weeks preceding screening as determined by Investigator and no changes anticipated for the duration of the study, unless a dose reduction or discontinuation, as determined by Investigator, is indicated for safety reasons
  7. Stable doses of weight loss medications that may have a meaningful effect on glycemic control over the 4 weeks preceding screening and no changes anticipated for the duration of the study, unless a dose reduction or discontinuation, as determined by Investigator, is indicated for safety reasons
  8. Weight between 80 - 440 lb at the time of screening
  9. Willing to use FSL 3 System according to manufacturer instructions and to avoid use of any other personal CGM system during the period of study participation
  10. Willing to document insulin delivery, meals, and daily activities in the Diary mobile app
  11. Has a smartphone compatible with study requirements: either iOS version 17.0 or higher, or Android version 10.0 or higher, and willing to install required apps and use them as instructed during the period of study participation, with internet connectivity for a data upload at least once per day.
  12. Is deemed an appropriate candidate for automatic insulin guidance therapy per Investigator assessment
  13. Investigator has confidence that the participant has the cognitive ability necessary for study participation, can successfully operate all study devices, and can adhere to the protocol
  14. Has a sufficient understanding of written/spoken English for legally effective informed consent and successful use of the study mobile apps
  15. If woman of childbearing potential, is willing and able to have pregnancy testing

Exclusion Criteria:

  1. Use of an insulin pump within 3 months prior to informed consent
  2. Use of mixed insulin or intermediate insulin (NPH) within the past 3 months prior to screening
  3. Taking more than 128 units of daily basal insulin or more than 79 units in a single bolus insulin injection in the 7 days prior to screening
  4. Any medical condition which in the opinion of the investigator, would put the participant at an unacceptable safety risk, such as untreated malignancy, unstable cardiac disease, unstable or end-stage renal disease, and/or eating disorders (i.e. anorexia/bulimia)
  5. Current or known history of coronary artery disease that is not stable with medical management, including unstable angina, or angina that prevents moderate exercise despite medical management, or a history of myocardial infarction, percutaneous coronary intervention, or coronary artery bypass grafting within the 12 months prior to screening
  6. Any planned surgery during the study which could be considered major in the judgment of the investigator
  7. History of more than 1 severe hypoglycemic event in the 6 months prior to screening
  8. History of diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic syndrome (HHS) in the 6 months prior to screening
  9. Blood disorder or dyscrasia within 3 months prior to screening which in the investigator's opinion could interfere with determination of HbA1c
  10. Any condition or intervention that may affect red blood cell turnover, in the 3 months prior to the study and during the study, such as blood transfusion or donation
  11. Has taken oral or injectable corticosteroids within 2 weeks prior to screening or plans to take oral or injectable corticosteroids during the study
  12. Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the Investigator's clinical judgment
  13. Is an employee of DreaMed Diabetes, is a study Investigator or a member of the Investigator's study team, or is immediate family member (spouse, biological or legal guardian, child, sibling, parent) of any of the aforementioned
  14. Participation in another clinical study using an investigational drug or device in the 90 days prior to screening or intends to participate during the study period
  15. Pregnant or lactating, planning to become pregnant during the study, or is a woman of childbearing potential and not on acceptable form of birth control (acceptable includes abstinence, condoms, oral/injectable contraceptives, IUD, or implant); childbearing potential means that menstruation has started, and the participant is not surgically sterile or greater than 12 months postmenopausal)
  16. Unable to tolerate adhesive tape or has any unresolved skin condition that could impact the CGM sensor

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: MODI dose guidance, insulin titration application
Enhet: MODI Algorithm
All participants use MODI insulin titration algorithm. Includes Diary app used to view treatment plans shared by MODI and manually log events (insulin intake, meal, physical activity and others) by participants; also includes a bolus calculator.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
CGM-measured percent time <54mg/dL
Tidsram: 13 weeks
Change in CGM-measured percent time <54 mg/dL from 2 weeks of baseline to 4 weeks prior to the dose guidance week 12 visit (non-inferiority with margin 0.5%)
13 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
HbA1c
Tidsram: 13 weeks
Change in HbA1c from baseline to dose guidance week 12 visit
13 weeks

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

DreaMed Diabetes

Samarbetspartners

Jaeb Center for Health Research
Abbott Diabetes Care

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

25 maj 2026

Primärt slutförande (Beräknad)

1 januari 2027

Avslutad studie (Beräknad)

1 januari 2027

Studieregistreringsdatum

Först inskickad

14 maj 2026

Först inskickad som uppfyllde QC-kriterierna

14 maj 2026

Första postat (Faktisk)

20 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

28 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

27 augusti 2026

Senast verifierad

1 maj 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CL-1644

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

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