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Feasibility of Automated Insulin Delivery With an Interoperable Algorithm Using an Alternative Insulin Pump (BELIEVE)

4 augusti 2022 uppdaterad av: Imperial College London
This clinical study assesses the feasibility of implementing the inControl automated insulin delivery algorithm with Dexcom continuous glucose monitoring and a compatible insulin pump in adults with type 1 diabetes. It additionally provides pilot efficacy outcomes for interoperable automated insulin delivery.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

Self-management of type 1 diabetes is challenging, efforts to optimise time spent in the target range can result in hypo- and hyperglycaemia. Structured education, glucose monitoring and advances in insulin delivery can increase time in range and reduce exposure to extremes of glucose and recent data confirm that automated insulin delivery can enable further increases in time spent in the target range of 3.9 to 10mmol/L (70 - 180mg/dL).

The inControl algorithm, developed by TypeZero technologies is embedded in the Tandem X2 insulin pump and operates with the Dexcom G6 continuous glucose sensor and transmitter in a CE-marked and commercially available system (known as Control-IQ). This system optimises time in range compared with sensor-augmented pump therapy, and the improvement was maintained when participants were further randomised to predictive low glucose suspend or automated insulin delivery. The United States Food and Drug Administration has defined interoperable standards for automated insulin delivery systems, including the iCGM designation for continuous glucose sensors, the interoperable automated glycaemic controller designation, and alternate controller enabled insulin pumps. However, while standards have been defined, to date, interoperability of automated insulin delivery components has not been demonstrated.

Studietyp

Interventionell

Inskrivning (Förväntat)

50

Fas

  • Inte tillämpbar

Kontakter och platser

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

Studiekontakt

Studieorter

  • Storbritannien
      • London, Storbritannien, W2 1PG
        • Rekrytering
        • Imperial College London, Imperial College Healthcare NHS Trust
        • Kontakt:
        • Huvudutredare:
          • Monika Reddy, MRCP
        • Huvudutredare:
          • Nick Oliver, FRCP

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

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Aged 18 years of age or older
  • Type 1 diabetes confirmed on the basis of clinical features
  • Type 1 diabetes for greater than 1 year
  • On an intensified insulin regimen with multiple dose injection or insulin pump for > 3 months
  • HbA1c >7.5% (58mmol/mol) (or %TIR 3.9-10mmol/L <52% for participants already using a continuous glucose sensor)

Exclusion Criteria:

  • Total daily insulin dose greater than 100 units
  • Weight greater than 140kg
  • Pregnant or planning pregnancy
  • Have active malignancy or under investigation for malignancy
  • Severe visual impairment
  • Reduced manual dexterity
  • Use of any automated insulin delivery system
  • Unable to participate due to other factors, as assessed by the Chief Investigator

Studieplan

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

Hur är studien utformad?

Designdetaljer

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

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Automated Insulin Delivery
The components of the automated insulin delivery system are the Dexcom G6 continuous glucose monitor (CGM), the InControl algorithm and an insulin pump (Ypsomed Ypsopump). The Dexcom G6 continuous glucose monitoring device is an approved device and is licensed to be used to inform insulin dosing decisions without confirmation. The algorithm (inControl 1.0) is approved when used embedded in the Tandem X2 insulin pump. We are using the algorithm for its intended purpose but are implementing it in a smartphone app to be installed in a compatible smartphone (Android). We are additionally assessing incremental benefit with the next software version of the algorithm. This will be the first time this updated software has been assessed in people with type 1 diabetes. The compatible insulin pump is a continuous subcutaneous insulin infusion device and is being used in line with its intended purpose, according to the manufacturer's instructions (YpsoMed Ypsopump).
Enhet: InControl
Automated insulin delivery system comprising continuous glucose sensor (Dexcom G6), controller (InControl embedded in smartphone app) and insulin pump (YpsoMed Ypsopump)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
% time spent in target glucose range measured by continuous glucose monitoring (3.9-10mmol/L, 70-180mg/dL)
Tidsram: Extracted from the final 28 days of the intervention period
Consensus measure of time in range
Extracted from the final 28 days of the intervention period

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
% time spent in hypoglycaemia (<3.0mmol/L, 54mg/dL)
Tidsram: Extracted from the final 28 days of the intervention period
Consensus measure of time in range
Extracted from the final 28 days of the intervention period
% time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL)
Tidsram: Extracted from the final 28 days of the intervention period
Consensus measure of time in range
Extracted from the final 28 days of the intervention period
% time in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)
Tidsram: Extracted from the final 28 days of the intervention period
Consensus measure of time in range
Extracted from the final 28 days of the intervention period
% time spent in hyperglycaemia (>10mmol/L, 180mg/dL)
Tidsram: Extracted from the final 28 days of the intervention period
Consensus measure of time in range
Extracted from the final 28 days of the intervention period
Number hypoglycaemic excursions (sensor glucose <3.0mmol/l for >= 20min)
Tidsram: Over 12 week intervention period
Consensus measure of exposure to hypoglycaemia
Over 12 week intervention period
Nocturnal Severe hypoglycaemia (defined as requiring third party assistance)
Tidsram: Over 12 week intervention period
Consensus measure of exposure to hypoglycaemia
Over 12 week intervention period
Severe hypoglycaemia (defined as requiring third party assistance)
Tidsram: Over 12 week intervention period
Consensus measure of exposure to hypoglycaemia
Over 12 week intervention period
Glucose variability assessed by %Coefficient of Variation (%CV)
Tidsram: Extracted from the final 28 days of the intervention period
Consensus measure of glucose variability
Extracted from the final 28 days of the intervention period
Glucose variability assessed by Mean Absolute Glucose (MAG)
Tidsram: Extracted from the final 28 days of the intervention period
Consensus measure of glucose variability
Extracted from the final 28 days of the intervention period
Glucose variability assessed by Low Blood Glucose Index (LBGI)
Tidsram: Extracted from the final 28 days of the intervention period
Consensus measure of glucose variability
Extracted from the final 28 days of the intervention period
HbA1c
Tidsram: At end of 12 week intervention period
Laboratory HbA1c assessment
At end of 12 week intervention period
Time spent in automated insulin delivery mode
Tidsram: Over 12 week intervention period
% of total time that automated insulin delivery is active
Over 12 week intervention period
Treatment satisfaction (DTSQ, AP acceptability)
Tidsram: At end of 12 week intervention period
Validated patient reported outcome
At end of 12 week intervention period
Gold score
Tidsram: At end of 12 week intervention period
Validated patient reported outcome of hypoglycaemia awareness (1-7, with greater value indicating loss of awareness)
At end of 12 week intervention period
Diabetes distress (DDS-17)
Tidsram: At end of 12 week intervention period
Validated patient reported outcome, Diabetes Distress Score 17 item, higher scores mean greater distress
At end of 12 week intervention period
Diabetes distress (PAID)
Tidsram: At end of 12 week intervention period
Validated patient reported outcome, Problem Areas In Diabetes 20 item
At end of 12 week intervention period
Change in total daily insulin dose (units)
Tidsram: At end of 12 week intervention period
Total insulin delivered by system per day
At end of 12 week intervention period
Change in weight (kg)
Tidsram: At end of 12 week intervention period
Weight in kg
At end of 12 week intervention period

Andra resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Direct Resource Utilisation Costs
Tidsram: Over 12 week intervention period
Health economic modelling exploratory outcome
Over 12 week intervention period
Indirect Costs
Tidsram: Over 12 week intervention period
Health economic modelling exploratory outcome
Over 12 week intervention period
Productivity lost
Tidsram: Over 12 week intervention period
Health economic modelling exploratory outcome
Over 12 week intervention period

Samarbetspartners och utredare

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

Sponsor

Imperial College London

Samarbetspartners

DexCom, Inc.

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)

1 april 2022

Primärt slutförande (Förväntat)

28 februari 2023

Avslutad studie (Förväntat)

28 februari 2023

Studieregistreringsdatum

Först inskickad

17 februari 2022

Först inskickad som uppfyllde QC-kriterierna

17 mars 2022

Första postat (Faktisk)

28 mars 2022

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 augusti 2022

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 augusti 2022

Senast verifierad

1 augusti 2022

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 20HH5892

Plan för individuella deltagardata (IPD)

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NEJ

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