Algorithm to Control Postprandial, Post Exercise and Night Glucose Excursions in a Portable Closed Loop Format,

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Artificial pancreas (Inreda Diabetic); Device: Insulin pump therapy (with or without glucose sensor)

• Registration Number: NCT03858062
• Lead Sponsor: J.H. DeVries

Brief Summary

In previous studies, the investigators tested the feasibility of a bi-hormonal reactive closed loop system without mealtime announcement. This system for automated control of blood glucose in patients with type 1 diabetes was tested in the clinical research center (APPEL 1 and 2) as well as at the home of the patients (APPEL 3 and 4). After the APPEL 4 study some improvements have been made to the miniaturized prototype to allow patients to operate the system independently and additional risk control measures were included. The main objective of this study is to assess the efficacy of this improved closed loop system.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-27
• Study First Posted: 2019-02-28
• Study Start: 2019-03-10
• Primary Completion: 2019-09-12
• Study Completion: 2019-09-12
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Diagnosed with diabetes mellitus type 1;
• Treated with SAP or CSII for a minimum of 6 months;
• Willing and able to sign informed consent.

Exclusion Criteria

• Impaired awareness of hypoglycemia (score ≥ 4) according to Gold and/or Clarke questionnaire;
• BMI > 35 kg/m2;
• HbA1c > 97 mmol/mol (=11.0 %);
• Use of heparin, coumarin derivatives or oral corticosteroids;
• Use of acetaminophen during the open loop or closed loop period, as this may influence the sensor glucose measurements;
• Limited ability to see, and to hear or feel alarm signals of the closed loop system;
• Skin condition prohibiting needle insertion;
• Pregnancy and/or breastfeeding;
• Living alone during the night during the closed loop period (the patient may ask someone to stay over temporarily);
• Expected poor connectivity with internet regarding 24/7 tele monitoring;
• Any condition that the local investigator feels would have interfere with trial participation or the evaluation of the results

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Closed loop	Artificial pancreas (Inreda Diabetic)	4-6 training + 14 days automated blood glucose control with the Artificial pancreas (Inreda Diabetic)
Open loop	Insulin pump therapy (with or without glucose sensor)	14 days patient-managed Insulin pump therapy (with or without glucose sensor) with blinded continuous glucose monitoring

Primary Outcome Measures

Name	Time	Method
Time in target	Week 1-2	Proportion of time spent in the target range (3.9-10 mmol/l)

Secondary Outcome Measures

Name	Time	Method
Time in hyperglycemia 2	Week 1-2 / Week 1 / Week 2	Proportion of time spent in hyperglycemia (\>13.9 mmol/l)
Mean or median glucose	Week 1-2 / Week 1 / Week 2	Mean or median sensor glucose concentration
Mean or median night glucose	Night time: Week 1-2 / Week 1 / Week 2	Mean or median sensor glucose concentration
Glycemic variability 2	Week 1-2 / Week 1 / Week 2	Coefficient of variation (CV)
DTSQ-status: Diabetes Treatment Satisfaction Questionnaire	Baseline / End week 2	Total score: Scale 0 (negative) to 36 (positive)
Algorithm active time	Week 1-2 (closed loop only)	Percentage of time that the closed loop algorithm is active
Time in hypoglycemia 1	Week 1-2 / Week 1 / Week 2	Proportion of time spent in hypoglycemia (\<3.9 mmol/l)
Time in target	Week 1 / Week 2	Proportion of time spent in the target range (3.9-10 mmol/l)
DTSQ-change: Diabetes Treatment Satisfaction Questionnaire	End week 2	Change in DTSQ; Total score: Scale -18 (negative) to 18 (positive)
Time in hypoglycemia 2	Week 1-2 / Week 1 / Week 2	Proportion of time spent in hypoglycemia (\<3.3 mmol/l)
Time in hyperglycemia 1	Week 1-2 / Week 1 / Week 2	Proportion of time spent in hyperglycemia (\>10 mmol/l)
Glycemic variability 4	Week 1-2 / Week 1 / Week 2	High blood glucose index (HBGI)
Usability score	End week 2 (closed loop only)	Questionnaire: Mobile Phone Usability Questionnaire (MPUQ); Total score: Scale 62 (low level of usability) to 310 (higher level of usability)
Hypoglycemic events	Week 1-2 / Week 1 / Week 2	Number of carbohydrate-treated hypoglycemic events
Mean or median day glucose	Day time: Week 1-2 / Week 1 / Week 2	Mean or median sensor glucose concentration
Glycemic variability 5	Week 1-2 / Week 1 / Week 2	Blood glucose risk index (BGRI)
Glucose measurement performance	Day 3, 4 or 5 of the training period prior to the closed loop	MARD
Glycemic variability 1	Week 1-2 / Week 1 / Week 2	Interquartile range (IQR)
Glycemic variability 3	Week 1-2 / Week 1 / Week 2	Low blood glucose index (LBGI)
Mean or median postprandial glucose	Postprandial: Week 1-2 / Week 1 / Week 2	Mean or median sensor glucose concentration
PAID: Problem Areas In Diabetes questionnaire	Baseline / End week 2	Total score; Scale 0 (no problems) to 80 (big problems)
EQ5D: EuroQol 5 Dimensions questionnaire	Baseline / End week 2	Quality of life measure; Scale 1 ("no problem) to 5 ("extreme problems")

Trial Locations

Locations (2)

Academic Medical Center; 🇳🇱 Amsterdam, Noord-Holland, Netherlands

Rijnstate Hospital; 🇳🇱 Arnhem, Gelderland, Netherlands