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Insulin Pump Therapy and Continuous Glucose Monitoring in Diabetic Continuous Ambulatory Peritoneal Dialysis (CAPD) Patients

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01324557
Enrollment
44
Registered
2011-03-29
Start date
2011-03-31
Completion date
2013-12-31
Last updated
2011-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Poor Glycemic Control

Keywords

Continuous glucose monitoring, CAPD patients, Insulin pump

Brief summary

The aims of this study are to assess the potential efficacy and safety of insulin pump to improve glycemic control in conjunction with continuous glucose monitoring (CGMS) for diabetic continuous ambulatory peritoneal dialysis (CAPD) patients.

Detailed description

Diabetic nephropathy now accounts for 20% to 40% of all patients entering end-stage renal failure (ESRF) programs. The quality of glycemic control is known to be an important determinant of the rate of progression of patients with diabetic continuous ambulatory peritoneal dialysis (CAPD) patients. Diabetic CAPD patients are usually treated with dialysis fluids utilizing glucose as the osmotic agent to provide ultrafiltration. Most of diabetic CAPD patients had HbA1c readings above 7% despite the recommendation to keep the reading below 7%. The continuous blood glucose monitor (CGMS) has recently offered an opportunity to monitor blood glucose at 5-minute intervals for 72 continuous hours in diabetic patients. The CGMS patterns reveal blood glucose tracings well above the recommended standards of control in most of the diabetic CAPD patients. Good glycemic control is often difficult to maintain in diabetic patients treated with CAPD because they are continuously exposed to high concentrations of glucose in peritoneal dialysate. However, recent studies have suggested that diabetic patients who use insulin pump has been shown to reduce glycated hemoglobin levels without an increased risk of hypoglycemia, as compared with a regimen of multiple daily insulin injections, but results in diabetic CAPD patients have not been reported.

Interventions

PROCEDURECSII and MDI

The aims of this study are to assess the potential efficacy and safety of insulin pump(MiniMed Paradigm® REAL-Time Revel™ Insulin Pump) to improve glycemic control in conjunction with continuous glucose monitoring (CGMS) for diabetic CAPD Patients.

Sponsors

Guangdong Provincial People's Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Age 18 - 70 years old at registration 2. Type 1 or Type 2 Diabetic CAPD patients for at least 3 month and less than 60 months 3. Hemoglobin A1c of at least 7.5% at registration Kt/V is greater than 1.7

Exclusion criteria

1. Have peritonitis in recent 3 months other active bacterial infections 2. Unstable clinical conditions or evidence of malignancy 3. Pregnancy 4. Non-diabetic ESRD patients 5. Individuals already receiving diabetes therapy via an insulin pump

Design outcomes

Primary

MeasureTime frame
Glycosylated hemoglobin (HbA1c) measurement24 week follow-up

Secondary

MeasureTime frameDescription
The frequency of hypoglycemic episodesat 24 week follow-upGlycemic control, Glycosylated hemoglobin (HbA1c) measurement; Frequency of adverse events; Frequency of clinically significant abnormal laboratory values

Countries

China

Contacts

Primary ContactShi Wei, PHD
weishi_gz@126.com8602083827812
Backup ContactLiu Shuangxin, PHD
mplsxi@yahoo.com.cn86020837812

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026