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

J.H. DeVries36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (2)

Rijnstate Hospital

Arnhem, Gelderland, Netherlands

Academic Medical Center

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

Time in target

Proportion of time spent in the target range (3.9-10 mmol/l)

Time frame: Week 1-2

Secondary Outcomes

Time in hypoglycemia 1

Proportion of time spent in hypoglycemia (\<3.9 mmol/l)

Time frame: Week 1-2 / Week 1 / Week 2

Time in hypoglycemia 2

Proportion of time spent in hypoglycemia (\<3.3 mmol/l)

Time frame: Week 1-2 / Week 1 / Week 2

Time in hyperglycemia 1

Proportion of time spent in hyperglycemia (\>10 mmol/l)

Time frame: Week 1-2 / Week 1 / Week 2

Time in hyperglycemia 2

Proportion of time spent in hyperglycemia (\>13.9 mmol/l)

Time frame: Week 1-2 / Week 1 / Week 2

Hypoglycemic events

Number of carbohydrate-treated hypoglycemic events

Time frame: Week 1-2 / Week 1 / Week 2

Mean or median glucose

Mean or median sensor glucose concentration

Time frame: Week 1-2 / Week 1 / Week 2

Mean or median day glucose

Mean or median sensor glucose concentration

Time frame: Day time: Week 1-2 / Week 1 / Week 2

Mean or median night glucose

Mean or median sensor glucose concentration

Time frame: Night time: Week 1-2 / Week 1 / Week 2

Mean or median postprandial glucose

Mean or median sensor glucose concentration

Time frame: Postprandial: Week 1-2 / Week 1 / Week 2

Glycemic variability 1

Interquartile range (IQR)

Time frame: Week 1-2 / Week 1 / Week 2

Glycemic variability 2

Coefficient of variation (CV)

Time frame: Week 1-2 / Week 1 / Week 2

Glycemic variability 3

Low blood glucose index (LBGI)

Time frame: Week 1-2 / Week 1 / Week 2

Glycemic variability 4

High blood glucose index (HBGI)

Time frame: Week 1-2 / Week 1 / Week 2

Glycemic variability 5

Blood glucose risk index (BGRI)

Time frame: Week 1-2 / Week 1 / Week 2

Time in target

Proportion of time spent in the target range (3.9-10 mmol/l)

Time frame: Week 1 / Week 2

PAID: Problem Areas In Diabetes questionnaire

Total score; Scale 0 (no problems) to 80 (big problems)

Time frame: Baseline / End week 2

EQ5D: EuroQol 5 Dimensions questionnaire

Quality of life measure; Scale 1 ("no problem) to 5 ("extreme problems")

Time frame: Baseline / End week 2

DTSQ-status: Diabetes Treatment Satisfaction Questionnaire

Total score: Scale 0 (negative) to 36 (positive)

Time frame: Baseline / End week 2

DTSQ-change: Diabetes Treatment Satisfaction Questionnaire

Change in DTSQ; Total score: Scale -18 (negative) to 18 (positive)

Time frame: End week 2

Algorithm active time

Percentage of time that the closed loop algorithm is active

Time frame: Week 1-2 (closed loop only)

Usability score

Questionnaire: Mobile Phone Usability Questionnaire (MPUQ); Total score: Scale 62 (low level of usability) to 310 (higher level of usability)

Time frame: End week 2 (closed loop only)

Glucose measurement performance

MARD

Time frame: Day 3, 4 or 5 of the training period prior to the closed loop