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Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients (T1DM AP)

16. november 2022 opdateret af: Yale University

Restoring Brain Metabolism and Function in Older Adult T1DM Patients Using an AP System

To demonstrate that a new insulin pump system can prevent low glucose episodes and improve brain function in aged Type 1 diabetes mellitus subjects.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The goals of this proposal are to implement a Close-Loop/Artificial Pancreas (CL/AP) system in older patients with type 1 diabetes mellitus (T1DM) in order to reverse brain metabolic adaptations and restore metabolic sensitivity, hypoglycemia awareness and appropriate hormonal counterregulatory responses (CRR). For purposes of this study we are looking to enroll aged T1DM subjects under insulin pump treatment.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

7

Fase

  • Ikke anvendelig

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Connecticut
      • New Haven, Connecticut, Forenede Stater, 06510
        • Yale New Haven Hospital

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

Aldre berettiget til at studere

50 år til 75 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Provide signed and dated informed consent form
  • Male or female
  • Age 50-75 years (at least 50% over the age of 65)
  • T1DM (>20 years duration)
  • C-peptide undetectable
  • HbA1c of < 8%
  • Insulin pump therapy
  • History of frequent hypoglycemia with unawareness (defined as 2 or more episodes of severe hypoglycemia within one year requiring assistance) and 2 or more glucose values < 54 mg/dL during the week of Continuous Glucose Monitoring (CGM) (iPRO monitor, Medtronic) prior to enrollment
  • BMI <27 kg/m2
  • Good general health as evidenced by medical history and blood screening
  • Willing to comply with all study procedures and be available for the duration of the study
  • Willing to fast for a limited time period on the morning of a clamp study

Exclusion Criteria:

  • Significant diabetic complications (untreated proliferative retinopathy, creatinine ≥1.5 mg/dl, urinary albumin levels 300 mg/day, autonomic neuropathy, painful peripheral neuropathy)
  • Significant alcohol intake and vegetarian diet since both are known to have an impact on counterregulation and brain metabolism
  • Any contraindications for MRI scanning, including presence of metallic implants or claustrophobia.
  • Heavy exercise on a regular basis (i.e. marathon runners)
  • Known allergic reactions to components of the study product(s)
  • Treatment with another investigational drug or other intervention
  • Active infection including hepatitis C, hepatitis B, HIV
  • Any past or current history of alcohol or substance abuse
  • Psychiatric or neurological disorders under active treatment
  • Baseline hemoglobin < 10.5 g/dL in females, or < 12.5 g/dL in males. Blood donation within 30 days of the study
  • History of coagulopathy or medical condition requiring long-term anticoagulant therapy (low-dose aspirin treatment is allowed)
  • Co-existing cardiac, liver, and kidney disease
  • Abnormal liver function tests
  • Women that are on oral contraceptives, post-menopausal, pregnant (as assessed by pregnancy test that will be performed on female participants at reproductive age), or lactating.
  • Any medical condition or medication that, in the opinion of the investigators, will interfere with the safe completion of the study or study outcomes

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: CL/AP system
To improved glycemic control and strict avoidance of hypoglycemia via 8-week use of a CL/AP system (closed-loop/artificial pancreas) reverses brain metabolic adaptations in older adult T1DM patients.
Enhed: CL/AP system
CL/AP system enabled insulin pump/CGM combination
Placebo komparator: usual care
Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.
Enhed: usual diabetic care
usual diabetic care (insulin pump therapy) along with CGM recording

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Brain Alternate Fuel Uptake
Tidsramme: Baseline to 8 - 10 weeks

Change in brain alternate fuel uptake under hypoglycemia was measured by assessing the percent enrichment of Glutamine 4 (Gln4). Change was measured by subtracting follow up from baseline.

Astrocytic glutamine C4 enrichment is a measure of brain acetate metabolism (an alternate fuel to glucose). Previous studies have shown that in people who have been exposed to frequent hypoglycemic episodes, glutamine C4 enrichment increases. Therefore, we expected a reduction in Glutamine C4 percent enrichment in the follow up NMR scans in the intervention group who avoided frequent hypoglycemic episodes through the CL/AP system. In addition, there is no specific cut off value used for Glutamine C4 enrichment, rather a change or reduction was expected and noted."
Baseline to 8 - 10 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Cognitive Function: MOCA
Tidsramme: Baseline to 8-10 weeks
The Montreal Cognitive Assessment (MoCA) was designed as a rapid screening instrument for mild cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points; a score of 26 or above is considered normal. Change was calculated by subtracting follow up from baseline. https://www.parkinsons.va.gov/resources/MoCA-Instructions-English.pdf
Baseline to 8-10 weeks
Change in Cognitive Function: Trail Test A
Tidsramme: Baseline to 8-10 weeks
Trail making test (TMT) A is a test of visual attention and task switching. It provides information about visual search speed, speed of processing and executive function. Time is measured in seconds. The typical average time to complete the test is 29 seconds, a "deficient" performance would be >78 seconds; most people are able to complete in 90 seconds. Change was calculated by subtracting follow up from baseline.
Baseline to 8-10 weeks
Change in Cognitive Function: Trail Test B
Tidsramme: Baseline to 8-10 weeks
Trail making test (TMT) B is a test of visual attention and task switching. It provides information about visual search speed, speed of processing and executive function. Time will be measured in seconds. The typical average time to complete the test is 75 seconds, a "deficient" performance would be >273 seconds; most people are able to complete in 180 seconds. Change was calculated by subtracting follow up from baseline.
Baseline to 8-10 weeks
Change in Cognitive Function: Grooved Pegboard Test
Tidsramme: Baseline to 8-10 weeks
The grooved pegboard test is a manipulative dexterity test that assessed psychomotor speed, fine motor control, and rapid-visual motor coordination. It consists of a small board of holes with randomly positioned slots. Pegs with a key along one side must be rotated to match the hole before they can be inserted. The task was completed using the dominant hand. Time was measured in seconds.
Baseline to 8-10 weeks

Samarbejdspartnere og efterforskere

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

Sponsor

Yale University

Samarbejdspartnere

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Efterforskere

  • Ledende efterforsker: Raimund Herzog, MD, Yale School of Medicine Department of Endocrinology

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)

1. november 2017

Primær færdiggørelse (Faktiske)

28. august 2019

Studieafslutning (Faktiske)

28. august 2019

Datoer for studieregistrering

Først indsendt

9. november 2017

Først indsendt, der opfyldte QC-kriterier

22. november 2017

Først opslået (Faktiske)

27. november 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. november 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. november 2022

Sidst verificeret

1. november 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2000020059
  • 1R01DK101984-01A1 (U.S. NIH-bevilling/kontrakt)
  • 1DP3DK112227-01 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

produkt fremstillet i og eksporteret fra U.S.A.

Ja

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