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NCT05939895
To Identify Anytime Hyperglycaemia in Subjects With Normoglycaemia and Prediabetes
trial testing Medtronic G3 sensor in Healthy in 100 participants. Status unknown.
30 May 2024
Quick facts
| Lead sponsor | Diabetes Foundation, India |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 100 |
| Start date | 1 January 2020 |
| Primary completion | 30 May 2024 |
| Estimated completion | 30 June 2024 |
| Sites | 1 location across India |
Drugs / interventions tested
- Medtronic G3 sensor
Conditions studied
- Healthy — all drugs for Healthy →
Sponsor
Diabetes Foundation, India
Who can join
Adults 30 to 60, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To test these hypotheses, The Investigators will recruit 100 overweight and obese adolescents with HbA1c ranging across the ADA classification spectrum from normal to prediabetes,(nearly 40:normoglycemi, 30: IFG, 30:1GT) measure free-living glucose by continuous glucose monitoring (CGM), and assess the relationships among CGM outcomes, HbA1c, and OGTT results (FPG and 2-h glucose). Individual with overt diabetes will be excluded. This will be a 2 visit study. Subjects will be coming to Fortis CDOC after a minimum 8-hour overnight fast. Informed written consent and validated questionnaire in a language known to them (English/Hindi) will be obtained from all participants. Clinical details will be obtained from the case records of the patients. Note of visible markers of insulin resistance (acanthosis nigricans, buffalo hump, double chin, subcutaneous fat pads, skin) Anthropometry, skinfolds \& blood pressure will be recorded. Overweight and, obesity will be defined according to predefined guidelines for Asian Indian. Abdominal obesity is defined as waist circumference of ≥ 90 centimetres (cms) in males and ≥ 80 cms in females. A blinded iPro Continuous Glucose Monitor (Medtronic MiniMed, Inc) will be inserted. After a calibration period of 1 hour, fasting laboratory result will be collected: FPG, HbA1c. HbA1c will be done by HPLC (NGSP approved, turbid inhibition immunoassay). Then subjects will consume 1.75 g/kg glucose, maximum 75 g (glucose beverage) and will have a second venepuncture 2 hours later for plasma glucose measurement. While awaiting the 2-hour venepuncture, participants will be provided instructions on CGM device care and calibration. Participants will be instructed to wear the CGM device for a minimum of 72 hours and to not change any of their current dietary or activity habits for the period of CGM wear. They will be trained to use a glucose monitor and collect capillary blood glucose values at least three times daily, prior to meals. Participants will also be asked to complete a simple log of their activity, as well as record dietary intake, and sleep and wake times. The iPro and log-sheet will be returned in person after a minimum of 72 hours of recording time. Investigators and patients will be kept blinded to CGM recordings throughout the study. Daily glycaemic variability will be assessed by the change in the mean amplitude of glucose excursions (MAGE) index, and through the standard deviation (SD) of the mean 24-hour blood glucose concentration. Day-to-day variability will be assessed through the mean of daily differences (MoDD in mg/dL). Daily glycaemic control will be assessed by the mean (M) daily CGM value, as well as by the times (in minutes/day) spent in optimal glycaemic range (70-140 mg/dL) and above predefined hyperglycaemic thresholds (140 ,180 and 200 mg/dL) together with the corresponding area under the curve (AUC) values. In addition, areas under 24-hour glycaemic traces (AUCs) will be analysed to estimate: overall hyperglycaemia (defined asAUC≥100 mg/dL over the full 24-hour period = AUCtotal);postprandial hyperglycaemia (AUC\[0-4 h\], i.e. for four-hour periods after each of the main meals and, if considered relevant by the core laboratory, after additional snacks = AUCpp); and basal hyperglycaemia, i.e. overall hyperglycaemia - postprandial hyperglycaemia (AUCb)
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05939895
- Europe PMC full search
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05939895 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Diabetes Foundation, India
- Last refreshed: 20 February 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05939895.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing