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App-baseret Certificeret Diabetes Uddannelsesterapi (AB-CDE) (AB-CDE)

18. september 2026 opdateret af: Linda Lester, Oregon Health and Science University

Udvikling og evaluering af app-baseret certificeret diabetesuddannelse (AB-CDE) terapi til personer med type 1-diabetes, der bruger MDI

The purpose of this study is to learn more about a smartphone application (app) called DailyDose, an investigational decision support tool that may help in managing your diabetes. DailyDose tracks your continuous glucose monitoring (CGM) data, insulin use, and exercise, and uses this information to provide personalized recommendations for insulin dosing and carbohydrate intake during exercise or low blood sugar events. We want to find out if DailyDose can help lower blood sugar levels as measured by the hemoglobin A1c (HbA1c) test.

Studieoversigt

Status

Status

Angiver den aktuelle rekrutteringsstatus eller den udvidede adgangsstatus.
Rekruttering

Betingelser

Betingelser

Den sygdom, lidelse, syndrom, sygdom eller skade, der undersøges. På ClinicalTrials.gov kan tilstande også omfatte andre sundhedsrelaterede problemer, såsom levetid, livskvalitet og sundhedsrisici.

Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.

Detaljeret beskrivelse

Participants will be on study for 38 weeks (2-week run-in period and 36 weeks of intervention). Participants will begin the study with a training visit on the Dexcom G6 CGM system, the insulin dose capture system, and the Data-logging Mode of DailyDose. Participants will be provided with Novalog InPens for use with the insulin dose capture system. Participants will also receive an iPhone and Apple smart watch for acquiring sleep metrics and exercise data. Participants will use these devices during the next 14 days at home (2-week run-in). At the end of the run-in, participants will start the intervention. They will be trained at Visit 3 on using the DailyDose system. Participants will then use the DailyDose system for 12 weeks. Sensor glucose, exercise, insulin and meal data will be collected during the DailyDose portion of the study in order to produce recommendations for insulin dosing. Participants will wear the Dexcom G6 for the entire study. Insulin data will be collected using the insulin dose capture system (InPens). Participants will be instructed to use the bolus calculator within the DailyDose app. Participants will be asked to complete a 30-minute aerobic exercise video at home once per week starting with the first 12-week period. After 12 weeks, time in range (70-180 mg/dL, TIR) and time in hypoglycemia (<70 mg/dL) will be assessed from the prior 4 weeks based on the Dexcom G6. Participants that have TIR ≥ 60% and time in hypoglycemia <4% will continue with use of DailyDose. Those that have TIR < 60% and/or time in hypoglycemia ≥ 4% will receive DSMES and, if recommended, behavioral health based on the T1-Diabetes Distress Assessment System (T1-DDAS) for the next 12 weeks. Additionally, if the DSMES provider feels the participant would benefit from behavioral health intervention, they can refer the participant for this even if T1-DDAS scores do not meet the cut off. All participants will then be followed for a final 12-week period using DailyDose alone to assess sustainability of any improvements in glycemic outcomes.

Undersøgelsestype

Undersøgelsestype

Beskriver karakteren af ​​en klinisk undersøgelse. Undersøgelsestyper omfatter interventionelle undersøgelser (også kaldet kliniske forsøg), observationsundersøgelser (herunder patientregistre) og udvidet adgang.
Interventionel

Tilmelding (Anslået)

Tilmelding

Antallet af deltagere i en klinisk undersøgelse. Den "forventede" tilmelding er det mål for antallet af deltagere, som forskerne skal bruge til undersøgelsen.
99

Fase

Fase

Stadiet af et klinisk forsøg, der studerer et lægemiddel eller et biologisk produkt, baseret på definitioner udviklet af U.S. Food and Drug Administration (FDA). Fasen tager udgangspunkt i undersøgelsens formål, antallet af deltagere og andre karakteristika. Der er fem faser: Tidlig fase 1 (tidligere opført som fase 0), fase 1, fase 2, fase 3 og fase 4. Ikke relevant bruges til at beskrive forsøg uden FDA-definerede faser, herunder forsøg med enheder eller adfærdsmæssige indgreb.
  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiekontakt

Navn og kontaktoplysninger for den person, der kan besvare spørgsmål om tilmelding til en klinisk undersøgelse. Hvert sted, hvor undersøgelsen udføres, kan også have en specifik kontaktperson, som kan være bedre i stand til at besvare disse spørgsmål.

Undersøgelse Kontakt Backup

Studiesteder

  • Forenede Stater
    • California
      • Los Angeles, California, Forenede Stater, 90022
        • Rekruttering
        • University of Southern California
        • Kontakt:
        • Kontakt:
    • Colorado
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Rekruttering
        • Indiana University
        • Kontakt:
          • Viral Shah, MD
          • Telefonnummer: 317-274-7605
          • E-mail: shahvi@iu.edu
        • Kontakt:
    • Massachusetts
    • New York
      • New York, New York, Forenede Stater, 10029
        • Rekruttering
        • Mount Sinai School of Medicine
        • Kontakt:
        • Kontakt:
        • Underforsker:
          • Camilla Levister
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Rekruttering
        • Oregon Health & Science University , Portland
        • Ledende efterforsker:
          • Peter Jacobs, PhD
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Berettigelseskriterier

De nøglekrav, som personer, der ønsker at deltage i et klinisk studie, skal opfylde eller de egenskaber, de skal have. Kvalifikationskriterier består af både inklusionskriterier (som er nødvendige for at en person kan deltage i undersøgelsen) og eksklusionskriterier (som forhindrer en person i at deltage). Typer af berettigelseskriterier omfatter, om en undersøgelse accepterer raske frivillige, har alders- eller aldersgruppekrav eller er begrænset af køn.

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  1. Diagnosis of type 1 diabetes mellitus for at least 1 year.
  2. Age 18 years and older.
  3. Able to read, write and understand spoken English
  4. HbA1c or GMI 7.5- 11.5% at screening. GMI (%) = 3.31 + 0.02392 × [mean glucose in mg/dL] based on prior 30 days of CGM data with at least 70% time CGM active[6]
  5. Use of multiple daily insulin injections (MDI) for at least 30 days at the time of screening visit.
  6. Willing to use the approved study insulin and devices while on study - Humalog and Basaglar Tempo pens, Dexcom G6 CGM, study iPhone, Apple watch
  7. Willingness and ability to independently follow all study procedures, including attending all clinic and DSMES and behavioral health visits.
  8. Total daily insulin requirements of less than 200 units

Exclusion Criteria:

  1. Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide, and the man uses a condom), or abstinence.
  2. History of stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty.
  3. Renal insufficiency (GFR < 60 ml/min, using either MDRD** or CKD-EPI# equation as reported by the laboratory).
  4. Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
  5. History of severe hypoglycemia during the 3 months prior to screening or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses.
  6. History of diabetes ketoacidosis during the 3 months prior to screening, as diagnosed on hospital admission or as judged by the investigator.
  7. History of psychiatric admission during the 6 months prior to screening.
  8. Adrenal insufficiency.
  9. Any active infection.
  10. Known or suspected abuse of alcohol, narcotics, or illicit drugs.
  11. Uncontrolled seizure disorder.
  12. Active foot ulceration.
  13. Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
  14. Major surgical operation within 30 days prior to screening.
  15. Use of an investigational drug within 30 days prior to screening.
  16. Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
  17. Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
  18. Allergy to Humalog or Basaglar insulin.
  19. Current chronic administration of oral or parenteral corticosteroids.
  20. Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the 5 years prior to screening (except basal and squamous cell skin cancer).
  21. Initiation or titration of any medication used to lower glucose other than insulin in the 6 weeks prior to screening (e.g. metformin or semaglutide). Participants will not be excluded if they are non-insulin glucose lowering medication at a stable dose with no plans for discontinuation or dose modification during the course of the study). A positive response to any of the questions from the Physical Activity Readiness Questionnaire (see Appendix A) with one exception: participant will not be excluded if taking a single blood pressure medication and blood pressure is controlled on the medication (blood pressure is less than 140/90 mmHg).
  22. Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort.
  23. Gastroparesis.
  24. On a very low carbohydrate diet (less than 50g per day)
  25. Taking part in another diabetes or obesity-related treatment study.
  26. Any clinically significant disease or disorder which, in the opinion of the Investigator, may jeopardize the participant's safety or compliance with the protocol.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm

Deltagergruppe / Arm

En gruppe eller undergruppe af deltagere i et klinisk forsøg, der modtager en specifik intervention/behandling eller ingen intervention i henhold til forsøgets protokol.
Intervention / Behandling

Intervention / Behandling

En proces eller handling, der er i fokus for en klinisk undersøgelse. Interventioner omfatter lægemidler, medicinsk udstyr, procedurer, vacciner og andre produkter, der enten er til undersøgelse eller allerede er tilgængelige. Interventioner kan også omfatte ikke-invasive tilgange, såsom uddannelse eller ændring af kost og motion.
Eksperimentel: Intervention Group

AB-CDE intervention using DailyDose, study CGM, and CDE and BH counselling if indicated
Enhed: DailyDose

Our team has developed a smartphone-based application, DailyDose Decision Support Tool (DailyDose), that combines continuous glucose monitoring data and insulin data to provide decision support for people living with T1D taking MDI. DailyDose is an iPhone application that is designed to support this population by 1) allowing for bolus calculation based on inputs including carbohydrate intake, CGM value and trend, and exercise information, 2) providing recommendations for carbohydrate intake based on exercise type, intensity, and duration, and 3) providing weekly recommendations for adjustments in insulin doses at specific times of day, including basal insulin dose, carbohydrate ratios or fixed mealtime doses, and correction factors .
Ingen indgriben: Control Group

Usual care including MDI insulin therapy with study CGM and DailyDose in Data-logging Mode.

Hvad måler undersøgelsen?

Primære resultatmål

Primære resultatmål

I et klinisk studies protokol er det planlagte resultatmål, der er det vigtigste for at evaluere effekten af ​​en intervention/behandling. De fleste kliniske undersøgelser har ét primært resultatmål, men nogle har mere end ét.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in hemoglobin A1c (HbA1c) from baseline to 24 weeks
Tidsramme: Enrollment and 24 weeks after randomization

Hemoglobin A1c will be processed by a central lab. Lower values generally indicate better glucose control.
Enrollment and 24 weeks after randomization

Sekundære resultatmål

Sekundære resultatmål

I en klinisk undersøgelses protokol er et planlagt resultatmål, der ikke er lige så vigtigt som det primære resultatmål for at evaluere effekten af ​​en intervention, men som stadig er af interesse. De fleste kliniske undersøgelser har mere end ét sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in hemoglobin A1c (HbA1c) from baseline to 36 weeks
Tidsramme: Enrollment and 36 weeks

Hemoglobin A1c will be processed by a central lab.
Enrollment and 36 weeks
Change in percent of time in range (70-180 mg/dL) from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 24 after randomization compared with baseline
Change in percent of time in range (70-180 mg/dL) from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 36 after randomization compared with baseline
Change in percent of time in tight range (70-140 mg/dL) from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 24 after randomization compared with baseline
Change in percent of time in tight range (70-140 mg/dL) from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 36 after randomization compared with baseline
Change in percent of time in low glucose range (<70 mg/dL) from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 24 after randomization compared with baseline
Change in percent of time in low glucose range (<70 mg/dL) from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 36 after randomization compared with baseline
Change in percent of time in very low glucose range (<54 mg/dL) from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 24 after randomization compared with baseline
Change in percent of time in very low glucose range (<54 mg/dL) from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 36 after randomization compared with baseline
Change in percent of time in high glucose range (>180 mg/dL) from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 24 after randomization compared with baseline
Change in percent of time in high glucose range (>180 mg/dL) from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 36 after randomization compared with baseline
Change in percent of time in extreme high glucose range (>250 mg/dL) from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 24 after randomization compared with baseline
Change in percent of time in extreme high glucose range (>250 mg/dL) from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. Percent of time in this range during the two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 36 after randomization compared with baseline
Change in mean blood glucose from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The average of values collected during the two weeks before a study time point will be treated as representing mean glucose at that study time point.
Week 24 after randomization compared with baseline
Change in mean blood glucose from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The average of values collected during the two weeks before a study time point will be treated as representing mean glucose at that study time point.
Week 36 after randomization compared with baseline
Change in coefficient of variation of blood glucose from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The coefficient of variation (CV) of CGM values is calculated as SD / mean * 100, where SD = standard deviation. The two weeks before a study time point will be used to represent that study time point.
Week 24 after randomization compared with baseline
Change in coefficient of variation of blood glucose from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

Continuous Blood Glucose Monitor (CGM) values are recorded every 5 minutes. The coefficient of variation (CV) of CGM values is calculated as SD / mean * 100, where SD = standard deviation. The two weeks before a study time point will be used to represent that study time point.
Week 36 after randomization compared with baseline
Change in Low Blood Glucose Index (LBGI) from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

The Low Blood Glucose Index (LBGI) is designed to reflect the risk of hypoglycemia and increases with the extent and frequency of hypoglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rl(BG) = 22.7 * f(BG)^2 if f(BG) ≤ 0 and rl(BG) = 0 otherwise, and finally, by taking the average of the calculated rl(BG) values over all of the glucose readings measured in mg/dL.
Week 24 after randomization compared with baseline
Change in Low Blood Glucose Index (LBGI) from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

The Low Blood Glucose Index (LBGI) is designed to reflect the risk of hypoglycemia and increases with the extent and frequency of hypoglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rl(BG) = 22.7 * f(BG)^2 if f(BG) ≤ 0 and rl(BG) = 0 otherwise, and finally, by taking the average of the calculated rl(BG) values over all of the glucose readings measured in mg/dL.
Week 36 after randomization compared with baseline
Change in High Blood Glucose Index (HBGI) from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

The High Blood Glucose Index (HBGI) is designed to reflect the risk of hyperglycemia and increases with the extent and frequency of hyperglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rh(BG) = 22.7 * f(BG)^2 if f(BG) > 0 and rh(BG) = 0 otherwise, and finally, by taking the average of the calculated rh(BG) values over all of the glucose readings measured in mg/dL.
Week 24 after randomization compared with baseline
Change in High Blood Glucose Index (HBGI) from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

The High Blood Glucose Index (HBGI) is designed to reflect the risk of hyperglycemia and increases with the extent and frequency of hyperglycemic excursions. It is calculated by first taking f(BG) = (ln(BG)^1.084 - 5.381) for each blood glucose (BG) reading, then calculating rh(BG) = 22.7 * f(BG)^2 if f(BG) > 0 and rh(BG) = 0 otherwise, and finally, by taking the average of the calculated rh(BG) values over all of the glucose readings measured in mg/dL.
Week 36 after randomization compared with baseline
Change in T1-DDAS Core Score from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

The Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score is the average of 8 items on a scale from 1 to 5, where 1 is low distress and 5 is high distress associated with having type 1 diabetes.
Week 24 after randomization compared with baseline
Change in T1-DDAS Core Score from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

The Type 1 Diabetes Distress Assessment System (T1-DDAS) Core Score is the average of 8 items on a scale from 1 to 5, where 1 is low distress and 5 is high distress associated with having type 1 diabetes.
Week 36 after randomization compared with baseline
Change in T1-DDAS Management Difficulties Source Score from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

The Type 1 Diabetes Distress Assessment System (T1-DDAS) Management Difficulties Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to management of type 1 diabetes.
Week 24 after randomization compared with baseline
Change in T1-DDAS Management Difficulties Source Score from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

The Type 1 Diabetes Distress Assessment System (T1-DDAS) Management Difficulties Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to management of type 1 diabetes.
Week 36 after randomization compared with baseline
Change in T1-DDAS Hypoglycemia Concerns Source Score from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

The Type 1 Diabetes Distress Assessment System (T1-DDAS) Hypoglycemia Concerns Source Score is the average of 2 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to hypoglycemia.
Week 24 after randomization compared with baseline
Change in T1-DDAS Hypoglycemia Concerns Source Score from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

The Type 1 Diabetes Distress Assessment System (T1-DDAS) Hypoglycemia Concerns Source Score is the average of 2 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to hypoglycemia.
Week 36 after randomization compared with baseline
Change in T1-DDAS Technology Challenges Source Score from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

The Type 1 Diabetes Distress Assessment System (T1-DDAS) Technology Challenges Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to using devices to manage type 1 diabetes.
Week 24 after randomization compared with baseline
Change in T1-DDAS Technology Challenges Source Score from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

The Type 1 Diabetes Distress Assessment System (T1-DDAS) Technology Challenges Source Score is the average of 3 items rated from 1 to 5, where 1 is low distress and 5 is high distress. A higher score reflects higher distress related to using devices to manage type 1 diabetes.
Week 36 after randomization compared with baseline

Andre resultatmål

Andre resultatmål

For kliniske forsøg en planlagt måling beskrevet i protokollen, der bruges til at bestemme effekten af ​​en intervention/behandling på deltagerne. Til observationsstudier, en måling eller observation, der bruges til at beskrive mønstre af sygdomme eller egenskaber eller sammenhænge med eksponeringer, risikofaktorer eller behandling. Typer af resultatmål omfatter primært resultatmål og sekundært resultatmål.
Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in mean number of low glucose events / week from baseline to 24 weeks after randomization
Tidsramme: Week 24 after randomization compared with baseline

A single low glucose event is defined to start when the CGM drops below 70 mg/dL for at least three measurements and ends when the CGM rises above 69 mg/dL for at least three measurements. The two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 24 after randomization compared with baseline
Change in mean number of low glucose events / week from baseline to 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

A single low glucose event is defined to start when the CGM drops below 70 mg/dL for at least three measurements and ends when the CGM rises above 69 mg/dL for at least three measurements. The two weeks before a study time point will be treated as representing blood glucose control at that study time point.
Week 36 after randomization compared with baseline
Change in total daily dose of insulin (units) from baseline to 24 weeks
Tidsramme: Week 24 after randomization compared with baseline

Insulin use will be tracked using bluetooth-enabled insulin pens. The two weeks before a study time point will be treated as representing that study time point.
Week 24 after randomization compared with baseline
Change in total daily dose of insulin (units) from baseline to 36 weeks
Tidsramme: Week 36 after randomization compared with baseline

Insulin use will be tracked using bluetooth-enabled insulin pens. The two weeks before a study time point will be treated as representing that study time point.
Week 36 after randomization compared with baseline
Change in total daily dose of insulin per kilogram (units/kg) from baseline to 36 weeks
Tidsramme: Week 36 after randomization compared with baseline

Insulin use will be tracked using bluetooth-enabled insulin pens. The two weeks before a study time point will be treated as representing that study time point.
Week 36 after randomization compared with baseline
Change in body weight measured at 36 weeks after randomization
Tidsramme: Week 36 after randomization compared with baseline

Maintaining or losing weight, rather than gaining, would be considered a positive outcome.
Week 36 after randomization compared with baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sponsor

Den organisation eller person, der igangsætter undersøgelsen, og som har myndighed og kontrol over undersøgelsen.
Oregon Health and Science University

Samarbejdspartnere

Samarbejdspartnere

En anden organisation end sponsoren, der yder støtte til en klinisk undersøgelse. Denne støtte kan omfatte aktiviteter relateret til finansiering, design, implementering, dataanalyse eller rapportering.
Leona M. & Harry B. Helmsley Charitable Trust

Efterforskere

Efterforskere

En forsker involveret i et klinisk studie. Beslægtede termer omfatter stedets principal investigator, site sub-investigator, studieformand, undersøgelsesleder og undersøgelseshovedinvestigator.
  • Studiestol: Peter Jacobs, PhD, Oregon Health and Science University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

Studiestart

Den faktiske dato, hvor den første deltager blev tilmeldt en klinisk undersøgelse. Den "forventede" undersøgelses startdato er den dato, som forskerne tror vil være undersøgelsens startdato.
8. juli 2026

Primær færdiggørelse (Anslået)

Primær færdiggørelse

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention for at indsamle endelige data for det primære resultatmål. Hvorvidt det kliniske studie sluttede i henhold til protokollen eller blev afsluttet, påvirker ikke denne dato. For kliniske undersøgelser med mere end ét primært resultatmål med forskellige afslutningsdatoer refererer dette udtryk til den dato, hvor dataindsamlingen er afsluttet for alle de primære resultatmål. Den "forventede" primære afslutningsdato er den dato, som forskerne tror vil være den primære afslutningsdato for undersøgelsen.
15. juli 2027

Studieafslutning (Anslået)

Studieafslutning

Den dato, hvor den sidste deltager i et klinisk studie blev undersøgt eller modtog en intervention/behandling for at indsamle endelige data for de primære resultatmål, sekundære udfaldsmål og uønskede hændelser (det vil sige den sidste deltagers sidste besøg). Den "forventede" undersøgelses afslutningsdato er den dato, som forskerne tror vil være undersøgelsens afslutningsdato.
15. december 2027

Datoer for studieregistrering

Først indsendt

Først indsendt

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsendte en undersøgelsespost til ClinicalTrials.gov. Der er typisk en forsinkelse på et par dage mellem den første indsendte dato og postens tilgængelighed på ClinicalTrials.gov (den første offentliggjorte dato).
5. december 2025

Først indsendt, der opfyldte QC-kriterier

Først indsendt, der opfyldte QC-kriterier

Den dato, hvor undersøgelsens sponsor eller investigator første gang indsender en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Sponsoren eller investigatoren skal muligvis revidere og indsende en undersøgelsespost en eller flere gange, før NLM's kvalitetskontrolkriterier er opfyldt. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
5. december 2025

Først opslået (Faktiske)

Først opslået

Datoen, hvor undersøgelsesposten først var tilgængelig på ClinicalTrials.gov efter National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgang er afsluttet. Der er typisk en forsinkelse på et par dage mellem den dato, hvor undersøgelsens sponsor eller investigator indsendte undersøgelsesposten, og den første offentliggjorte dato.
15. december 2025

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering sendt

Den seneste dato, hvor ændringer i en undersøgelsespost blev gjort tilgængelig på ClinicalTrials.gov. Der kan være en forsinkelse mellem det tidspunkt, hvornår ændringerne blev indsendt til ClinicalTrials.gov af undersøgelsens sponsor eller investigator (datoen for sidste opdatering afsendt) og den sidste opdatering, der blev sendt.
23. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Den seneste dato, hvor undersøgelsens sponsor eller investigator indsendte ændringer til en undersøgelsespost, der er i overensstemmelse med National Library of Medicine (NLM) kvalitetskontrol (QC) gennemgangskriterier. Det er sponsorens eller investigatorens ansvar at sikre, at undersøgelsesposten er i overensstemmelse med NLM QC-gennemgangskriterierne.
18. september 2026

Sidst verificeret

Sidst verificeret

Den seneste dato, hvor undersøgelsens sponsor eller investigator bekræftede oplysningerne om en klinisk undersøgelse på ClinicalTrials.gov som nøjagtige og aktuelle. Hvis en undersøgelse med rekrutteringsstatus som rekruttering; rekrutterer endnu ikke; eller aktiv, ikke rekruttering er ikke blevet bekræftet inden for de seneste 2 år, er undersøgelsens rekrutteringsstatus vist som ukendt.
1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Andre undersøgelses-id-numre

Andre identifikatorer eller ID-numre end NCT-nummeret, der er tildelt til en klinisk undersøgelse af undersøgelsens sponsor, finansieringsgivere eller andre. Disse numre kan omfatte unikke identifikatorer fra andre forsøgsregistre og National Institutes of Health-bevillingsnumre.
  • 25791
  • 2207 (Andet bevillings-/finansieringsnummer: Helmsley Charitable Trust)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

IPD cannot be shared due to concerns about participant privacy and confidentiality.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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