Using an Artificial Pancreas System in Older Adult Type 1 Diabetes Mellitus Patients (T1DM AP)
16. November 2022 aktualisiert von: 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.
Studienübersicht
Status
Beendet
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
7
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
-
-
Connecticut
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New Haven, Connecticut, Vereinigte Staaten, 06510
- Yale New Haven Hospital
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
50 Jahre bis 75 Jahre (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Aktiver 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.
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CL/AP system enabled insulin pump/CGM combination
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Placebo-Komparator: usual care
Subjects in this control group will continue their usual diabetic care (insulin pump therapy) along with CGM recording.
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usual diabetic care (insulin pump therapy) along with CGM recording
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Brain Alternate Fuel Uptake
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Change in Cognitive Function: MOCA
Zeitfenster: 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
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Baseline to 8-10 weeks
|
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Change in Cognitive Function: Trail Test A
Zeitfenster: 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
|
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Change in Cognitive Function: Trail Test B
Zeitfenster: 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
|
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Change in Cognitive Function: Grooved Pegboard Test
Zeitfenster: 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.
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Baseline to 8-10 weeks
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Hauptermittler: Raimund Herzog, MD, Yale School of Medicine Department of Endocrinology
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
1. November 2017
Primärer Abschluss (Tatsächlich)
28. August 2019
Studienabschluss (Tatsächlich)
28. August 2019
Studienanmeldedaten
Zuerst eingereicht
9. November 2017
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
22. November 2017
Zuerst gepostet (Tatsächlich)
27. November 2017
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. November 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
16. November 2022
Zuletzt verifiziert
1. November 2022
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2000020059
- 1R01DK101984-01A1 (US NIH Stipendium/Vertrag)
- 1DP3DK112227-01 (US NIH Stipendium/Vertrag)
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Ja
Produkt, das in den USA hergestellt und aus den USA exportiert wird
Ja
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